Redução de custos hospitalares após implementação de ferramentas informatizadas na logística de um serviço de farmácia hospitalar Hospital / Hospital costs reduction after implementation of informatized tools in the logistics of a hospital pharmacy service

A farmácia hospitalar é atualmente uma unidade hospitalar que tem, entre outros objetivos, garantir o uso seguro e racional dos medicamentos e atender às demandas dos pacientes hospitalizados; para tanto, deve possuir um sistema eficiente de informações e dispor de um sistema de controle e acompanhamento de custos. As diversas inovações tecnológicas na informação e controle de dados aplicados aos serviços de saúde trazem agilidade no processo, maior segurança para os pacientes e melhor gerenciamento no processo logístico, reduzindo custos como aqueles associados à expiração da validade de produtos. Nessa perspectiva de análise de custo, o presente trabalho avalia os impactos que um processo de informatização da rastreabilidade e o uso de ferramentas informatizadas proporcionaram a um serviço de farmácia hospitalar, com o objetivo de descrever os impactos financeiros após a implementação dessas ferramentas. Realizamos um estudo observacional, longitudinal e retrospectivo a partir de dados financeiros relacionados a perdas por expiração de validade de medicamentos e produtos para a saúde e de compras emergenciais desses insumos em um período de seis anos. Os dados foram coletados em dezembro de 2021 referentes aos anos de 2015 a 2020 a partir de relatórios extraídos do Smart (Pixeon). Observamos que os custos com perdas por expiração de validade dos produtos para a saúde caíram substancialmente em 2019, com o menor custo em 2020, correspondendo a uma redução média de 47,9% nesses dois últimos anos em relação à média dos quatro anos anteriores. Também houve redução média de 70% nos custos com compras emergenciais ao longo desse período. Assim, quando avaliamos esses resultados, percebe-se que a informatização da rastreabilidade e o uso de ferramentas informatizadas para suporte no processo de trabalho logístico permitem contribuir significativamente para reduzir custos hospitalares.

The hospital pharmacy is currently a hospital unit that has, among other objectives, to guarantee the safe and rational use of drugs and to provide for the demands of inpatients; for such, it must have an efficient information system and have a cost control and monitoring system. The various technological innovations in information and data control applied to health services bring agility to the process, greater security for patients, and better management in the logistics process, reducing costs such as those associated with the expiration of product shelf life. In this perspective of cost analysis, the present study evaluates the impacts that a traceability informatization process and the use of informatized tools provided to a hospital pharmacy service with the objective of describing the financial impacts after the implementation of the process. We conducted an observational, longitudinal and retrospective study from financial data related to expiration losses of medicines and health products and emergency supplies purchases over a six-year period. The data was collected in December 2021 for the years 2015 to 2020 from reports extracted from Smart (Pixeon). We note that health product expiration loss costs fell substantially in 2019, with the lowest cost in 2020, corresponding to an average reduction of 47.9% in these last two years from the previous four-year average. There has also been an almost 70% reduction in emergency purchasing costs over this period. Thus, when we evaluate these results, it can be seen that the informatization of traceability and the use of informatized tools to support the logistical work process can contribute significantly to reducing hospital costs.

Prescripción off-labelde medicamentos: definición y consideraciones ético-regulatorias en Argentina / Prescripció off-labelde medicaments: definició i consideracions ètic-reguladores a l'Argentina / Off-label prescription of drugs: Definition and ethical-regulatory considerations in Argentina

Els metges estan facultats per a prescriure medicaments en una manera diferent a l'aprovada per l'agència reguladora, és a dir, per fora de l'indicat en el seu prospecte, per a un pacient determinat. Això pot derivar en l'ús del medicament en una indicació diferent a l'aprovada; o, en la mateixa indicació aprovada, però en un diferent subgrup de pacients; o bé, baix condicions diferents. Les prescripcions fora de prospecte o indicacions “off-label” són d'exclusiva responsabilitat del mèdic tractant. Llavors,ens preguntem quines precaucions ha d'adoptar el professional en l'acte prescriptiu, quins drets té el pacient sobre aquest tema, si aquest tractament ha de ser igualment cobert per l'assegurança mèdica i quines accions ha de prendre l'Estat, en cas de correspondre, com a garant últim de la salut de les personesresidents a l'Argentina. La necessitat i les especials circumstàncies que envolten els temes de salut determinen que és ètica i regulatòriament permissible la prescripció de medicaments fora de prospecte u off label. Això ha de donar-se baix condicions determinades, disposades pel mateix mèdic tractant, però també des de les autoritats, a fi de coordinar la participació de diversos actors del sistema i l'aplicació d'eines de monitoratge i d'afavorir la informació científica adequada, i tot això recolzarà l'ús fora de prospecte u off labelde medicaments per a brindar accés racional en un cas en concret i acceptat pel pacient.(AU)

Physicians have the authorityto prescribe medications in amannerdifferent from thatapproved by the regulatory agency, this means, outside of what is indicated in the package leaflet, for a specific patient. This may result inthe use of the medicinein an indication other than theapprovedindication; or, in the same approved indication, but in a different patientsubgroup; or,under different conditions. Off-label prescriptionsare the sole responsibility of the treating physician. The question then arises as to what precautions the professional should take in the prescribingact, what rights the patient has in this regard, whether suchtreatment should also be covered by healthinsurance,and what actions the Stateshouldtake, if any, as the ultimate guarantor of the health of people residing in Argentina. The need and the special circumstances surrounding health issues determine that it is ethically and regulatory permissible toprescribemedicinesoff-label. This should be doneunder certain conditions, setby the treating physician himself, but also bythe authorities, in order to coordinate the participation of various actors in the system and the application of monitoring tools and to promoteadequate scientific information, all of which will support the off-label use of medicinesto provide rational access in a specific case and accepted by the patient.(AU)

Los médicos están facultados para prescribir medicamentos en una manera diferente a la aprobada por la agencia reguladora, es decir, por fuera de lo indicado en su prospecto, para un paciente determinado. Ello puede derivar en el uso del medicamento en una indicación distinta a la aprobada; o, en la misma indicación aprobada, pero en un distinto subgrupo de pacientes; o bien, bajo condiciones diferentes. Las prescripciones fuera de prospecto o indicaciones “off-label” son de exclusiva responsabilidad del médico tratante. Entonces nos preguntamos qué precauciones debe adoptar el profesional en el acto prescriptivo, qué derechos tiene el paciente al respecto, si dicho tratamiento debe ser igualmente cubierto por el seguro médico y qué acciones debe tomar el Estado, en caso de corresponder, como garante último de la salud de las personas residentes en Argentina. La necesidad y las especiales circunstancias que rodean los temas de salud determinan que es ética y regulatoriamente permisible la prescripción de medicamentos fuera de prospecto u off label. Ello debe darse bajo condiciones determinadas, dispuestas por el mismo médico tratante, pero también desde las autoridades, a fin de coordinar la participación de diversos actores del sistema y la aplicación de herramientas de monitoreo y de favorecer la información científica adecuada, todo lo cual respaldará el uso fuera de prospecto u off labelde medicamentos para brindar acceso racional en un caso en concreto y aceptado por el paciente.(AU)

Considerations on the Use of Antivirals, Monoclonal Antibodies, and Other Interventions for the Management of COVID-19 Patients in Latin America and the Caribbean

Since the onset of the COVID-19 pandemic, a large number of clinical trials have been planned and developed to assess the effectiveness and safety of various interventions that could prevent hospitalizations and progression to severe disease in people infected with SARS-CoV-2. Currently, the World Health Organization (WHO) and the Pan American Health Organization (PAHO) recommend the use of corticosteroids, tocilizumab, baricitinib, and casirivimab e imdevimab (the latter in seronegative COVID-19 patients) and propose the use of sotrovimab, casirivimab/imdevimab, and molnupiravir in patients with non-severe illness who are at high risk for complications. Other potential therapeutic interventions are currently undergoing study or evaluation by WHO and PAHO. The interventions recommended at present and those that will be recommended at a later date pose challenges in terms of route of administration (e.g., oral or intravenous); efficacy, which depends on the viral variant; establishment of high-risk status (e.g., relative to vaccination status); cost; resources required to administer them; and other implementation-related aspects (e.g., distribution, drug safety monitoring, contraindications, interactions, etc.). To support decision-making for patient management, in this document PAHO presents considerations on the rational use of antivirals, monoclonal antibodies, and other interventions in light of the most current evidence, vaccination status, access, and the costs to countries of the Region.

Diagnostic test accuracy of telehealth assessment for dementia and mild cognitive impairment.

BACKGROUND: Many millions of people living with dementia around the world are not diagnosed, which has a negative impact both on their access to care and treatment and on rational service planning. Telehealth - the use of information and communication technology (ICT) to provide health services at a distance - may be a way to increase access to specialist assessment for people with suspected dementia, especially those living in remote or rural areas. It has also been much used during the COVID-19 pandemic. It is important to know whether diagnoses made using telehealth assessment are as accurate as those made in conventional, face-to-face clinical settings. OBJECTIVES: Primary objective: to assess the diagnostic accuracy of telehealth assessment for dementia and mild cognitive impairment. Secondary objectives: to identify the quality and quantity of the relevant research evidence; to identify sources of heterogeneity in the test accuracy data; to identify and synthesise any data on patient or clinician satisfaction, resource use, costs or feasibility of the telehealth assessment models in the included studies. SEARCH METHODS: We searched multiple databases and clinical trial registers on 4 November 2020 for published and 'grey' literature and registered trials. We applied no search filters and no language restrictions. We screened the retrieved citations in duplicate and assessed in duplicate the full texts of papers considered potentially relevant. SELECTION CRITERIA: We included in the review cross-sectional studies with 10 or more participants who had been referred to a specialist service for assessment of a suspected cognitive disorder. Within a period of one month or less, each participant had to undergo two clinical assessments designed to diagnose dementia or mild cognitive impairment (MCI): a telehealth assessment (the index test) and a conventional face-to-face assessment (the reference standard). The telehealth assessment could be informed by some data collected face-to-face, e.g. by nurses working in primary care, but all contact between the patient and the specialist clinician responsible for synthesising the information and making the diagnosis had to take place remotely using ICT. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from included studies. Data extracted covered study design, setting, participants, details of index test and reference standard, and results in the form of numbers of participants given diagnoses of dementia or MCI. Data were also sought on dementia subtype diagnoses and on quantitative measures of patient or clinician satisfaction, resource use, costs and feasibility. We assessed risk of bias and applicability of each included study using QUADAS-2. We entered the results into 2x2 tables in order to calculate the sensitivity and specificity of telehealth assessment for the diagnosis of all-cause dementia, MCI, and any cognitive syndrome (combining dementia and MCI). We presented the results of included studies narratively because there were too few studies to derive summary estimates of sensitivity and specificity. MAIN RESULTS: Three studies with 136 participants were eligible for inclusion. Two studies (20 and 100 participants) took place in community settings in Australia and one study (16 participants) was conducted in veterans' homes in the USA. Participants were referred from primary care with undiagnosed cognitive symptoms or were identified as being at high risk of having dementia on a screening test in the care homes. Dementia and MCI were target conditions in the larger study; the other studies targeted dementia diagnosis only. Only one small study used a 'pure' telehealth model, i.e. not involving any elements of face-to-face assessment. The studies were generally well-conducted. We considered two studies to be at high risk of incorporation bias because a substantial amount of information collected face-to-face by nurses was used to inform both index test and reference standard assessments. One study was at unclear risk of selection bias. For the diagnosis of all-cause dementia, sensitivity of telehealth assessment ranged from 0.80 to 1.00 and specificity from 0.80 to 1.00. We considered this to be very low-certainty evidence due to imprecision, inconsistency between studies and risk of bias. For the diagnosis of MCI, data were available from only one study (100 participants) giving a sensitivity of 0.71 (95% CI 0.54 to 0.84) and a specificity of 0.73 (95% CI 0.60 to 0.84). We considered this to be low-certainty evidence due to imprecision and risk of bias. For diagnosis of any cognitive syndrome (dementia or MCI), data from the same study gave a sensitivity of 0.97 (95% CI 0.91 to 0.99) and a specificity of 0.22 (95% CI 0.03 to 0.60). The majority of diagnostic disagreements concerned the distinction between MCI and dementia, occurring approximately equally in either direction. There was also a tendency for patients identified as cognitively healthy at face-to-face assessment to be diagnosed with MCI at telehealth assessment (but numbers were small). There were insufficient data to make any assessment of the accuracy of dementia subtype diagnosis. One study provided a small amount of data indicating a good level of clinician and especially patient satisfaction with the telehealth model. There were no data on resource use, costs or feasibility. AUTHORS' CONCLUSIONS: We found only very few eligible studies with a small number of participants. An important difference between the studies providing data for the analyses was whether the target condition was dementia only (two studies) or dementia and MCI (one study). The data suggest that telehealth assessment may be highly sensitive and specific for the diagnosis of all-cause dementia when assessed against a reference standard of conventional face-to-face assessment, but the estimates are imprecise due to small sample sizes and between-study heterogeneity, and may apply mainly to telehealth models which incorporate a considerable amount of face-to-face contact with healthcare professionals other than the doctor responsible for making the diagnosis. For the diagnosis of MCI by telehealth assessment, best estimates of both sensitivity and specificity were somewhat lower, but were based on a single study. Errors occurred at the cognitively healthy/MCI and the MCI/dementia boundaries. However, there is no evidence that diagnostic disagreements were more frequent than would be expected due to the known variation between clinicians' opinions when assigning a dementia diagnosis.

Pharmaceutical procurement among public sector procurers in CARICOM.

OBJECTIVE: To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. METHODS: An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. RESULTS: The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. CONCLUSIONS: The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

Pharmaceutical procurement among public sector procurers in CARICOM

[ABSTRACT]. Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%–67%). The percentage of medicines procured from generic companies is 60%–87%; and 25%–50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

[RESUMEN]. Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

[RESUMO]. Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%–67%). Do total, 60%–87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%–50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Media briefing on COVID-19 - 15/02/2021

00:00:31 FC Hello, everyone. This is Fadela Chaib speaking to you from WHO headquarters in Geneva and welcoming you to our global COVID-19 press conference today, Monday 15th February. We have simultaneous interpretation in the six official UN languages plus Portuguese and Hindi. Let me introduce to you the participants. Present in the room are WHO Director-General, Dr Tedros, Dr Mike Ryan, Executive Director, Health Emergencies, Dr Maria Van Kerkhove, Technical Lead on COVID-19, Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products. We are also joined today by an expert, Deusdedit Mubangizi; he's the Head of the Pre-qualification Unit at WHO; Dr Michelle Yao, Director, Strategic Health Operations, and Dr Sylvie Briand, Global Infectious Hazard Preparedness. Joining remotely are Dr Soumya Swaminathan, Chief Scientist, Dr Bruce Aylward, Special Advisor to the Director-General and Lead on the ACT Accelerator, and Dr Kate O'Brien, Director, Immunisation, Vaccines and Biologicals. Welcome, all. Now without further delay I would like to hand over to Dr Tedros for his opening remarks. You have the floor, Dr Tedros. TAG Thank you. Thank you, Fadela. Good morning, good afternoon and good evening. The number of reported cases of COVID-19 globally has now declined for the fifth consecutive week. Last week saw the lowest number of reported weekly cases since October. 00:02:28 So far this year the number of weekly reported cases has fallen by almost half from more than five million cases in the week of January 4th to 2.6 cases in the week starting February 8th, just five weeks. This shows that simple public health measures work even in the presence of variants. What matters now is how we respond to this trend. The fire is not out but we have reduced its size. If we stop fighting it on any front it will come roaring back. Every day with fewer infections means lives saved, suffering prevented and the burden on health systems eased just a little bit. Today we have even more reason to be hopeful of bringing the pandemic under control. Today WHO gave emergency use listing to two versions of the Oxford AstraZeneca vaccine, giving the green light for these vaccines to be rolled out globally through COVAX. 00:03:48 One of the vaccines is produced by SKBio in the Republic of Korea and the other is produced by the Serum Institute of India. Although both companies are producing the same vaccine because they are made in different production plants they required separate reviews and approvals. WHO emergency use listing assesses and assures the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for vaccines to be distributed by COVAX. This listing was completed in just under four weeks from the time WHO received the full dossiers from the manufacturers. In addition to the Pfizer BioNTech vaccine these are now the second and third vaccines to receive emergency use listing. We now have all the pieces in place for the rapid distribution of vaccines but we still need to scale up production and we continue to call for vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries. On Friday I mentioned WHO's new declaration on vaccine equity. Ensuring the rapid and equitable roll-out of vaccines globally is essential for saving lives and stabilising health systems but it's also essential for saving livelihoods and stabilising economies. 00:05:37 Fully funding COVAX represents the greatest possible stimulus and is a rounding error compared with the trillions of dollars that has been mobilised in G7 countries to support their economies. I am pleased that the G7 under the United Kingdom's presidency is meeting this Friday to discuss vaccine equity and I encourage all groups to sign WHO's declaration. We must continue to build the demand for vaccines by ensuring people have the right information. A year ago I said that we were not only fighting a pandemic, we were fighting an infodemic. In the past year we have seen the real harm that can be caused when people are overwhelmed by information, misinformation and disinformation. The answer is not just to fight misinformation and delete false or misleading statements. It is to listen to the real concerns and questions people have and to answer those questions with good information. That's part of the reason WHO holds these regular media briefings, publishes guidance, communicates on its social media channels and website, holds seminars with different community and professional groups and more. 00:07:15 Having the right information is essential in every outbreak situation. As you know, last week an outbreak of Ebola was detected in the Democratic Republic of the Congo. Four cases have now been reported and two people have died. Yesterday authorities in Guinea declared a separate outbreak of Ebola in the town of Goueke [?] in the south-east of the country. So far three cases have been confirmed among six people who reported Ebola-like symptoms after attending a funeral in late January. Two have since died while the other four are being treated in hospital. As you remember, Guinea was one of the three countries affected by the West Africa Ebola outbreak of 2014 to 2016, the largest Ebola outbreak on record. The outbreaks in Guinea and DRC are completely unrelated but we face similar challenges in both. Both outbreaks are occurring in areas that have recent experience with Ebola and are benefiting from that experience in terms of capacity for surveillance, rapid response, contact tracing, community engagement, clinical care and more. 00:08:45 But both outbreaks are also in hard-to-reach, insecure areas with some mistrust of outsiders. I'm pleased to say that vaccination started today in DRC and so far 43 people have been vaccinated out of 149 eligible contacts including 20 people who were vaccinated during the previous outbreak in 2019. WHO is working closely with health authorities in both contribute to engage with the affected communities to enhance trust and acceptance. Ebola and COVID-19 are two very different diseases. Both thrive on misinformation and mistrust but both an be stopped with proven public health measures, engaged communities, accurate information and vaccines. Fadela, back to you. Shukran. FC Thank you, Dr Tedros. I'd like to inform the media that they may have received by now a press statement on what Dr Tedros just announced in his opening remarks; WHO listing two version of the AstraZeneca Oxford COVID-19 vaccine for emergency use. It's also posted on our website. I will now open the floor to questions from members of the media. I remind you that you need to raise your hand using the raise your hand function in order to get in the queue. I would like to start by inviting Imogen Foulkes from the BBC to ask the first question. Imogen, you have the floor. 00:10:34 IM Hi, Fadela. Thanks for taking my question. This is about travel because traditionally WHO has always somewhat counselled against travel restrictions. I know we're well down the road in this pandemic but it's getting very confusing for people with different countries introducing different things. Your own WHO COVID-19 envoy this morning said he could foresee vaccine passports. Is that something the WHO thinks would be a good idea? FC Dr Ryan, you have the floor. MR Thanks, Imogen. The emergency committee made temporary recommendations in relation to a number of issues to the Director-General and I think we're quite clear that at this time - at the present time, I think they used specifically - they did not advise for the use of immunity certification as a prerequisite of travel. That is because, number one, vaccine is not widely available and it would actually tend to restrict travel more than permit travel. 00:11:48 Secondly we don't have enough data right now to understand to what extent vaccination will interrupt transmission and especially the risk of an individual to continue transmitting disease. So on that basis no but I think the envoy may have been referring to a future situation in which we have widely available vaccination and where we understand more about the impact of vaccination on transmission dynamics or if we get the second and third-generation vaccines where we may have more impact on transmission, at that point certainly. We've seen this with yellow fever and other diseases; vaccine can form part of a long-term strategy for disease control and for the prevention of disease potentially moving from one place to another as we've seen with yellow fever vaccination requirements, we have been in place for a large number of decades now. 00:12:43 So I would believe that that is a discussion that will be had in future. It will be based on emerging guidance from SAGE, on continuing discussions of the emergency committee and the technical programmes here. So no, we don't foresee this as an immediate requirement or need but certainly one that will have to be discussed in the coming months. FC Thank you, Dr Ryan. I would like to invite Simon Ateba from Africa News Today, Washington DC, to ask the next question. Simon, you have the floor. SI Thank you for taking my question. Can you hear me? FC Very well. Go ahead, please. SI Thank you for taking my question. This is Simon Ateba from Today News Africa in Washington DC. I would like you to react to the statement at the weekend by the Biden administration expressing concern over the first report that the WHO issued on the origin of COVID-19 in China. Thank you. FC Thank you, Simon. I think... 00:14:08 MK Thank you. Sorry, we were deciding who would start; apologies. The mission team from China has not actually issued their report yet. They have recently returned from China, arriving in their own countries and they are working on two reports, the first of which is a summary report which is shorter, just highlighting the work that has been done and some initial findings and recommendations. That will be followed by a longer report. The initial, summary report has not actually been issued yet. They've only done a press conference in Wuhan and they've answered some media questions but the idea would be that they would issue the summary report and then have a full press briefing themselves. MR Maybe I can also add that obviously there may be some misunderstandings here around the origins and the purpose do this mission. I think this mission was envisaged as a collaborative effort under the World Health Assembly Resolution where obviously working with China, a sovereign state and a member state of the WHO to better understand the origins of the virus so as to learn lessons for the future. 00:15:26 It was not as such an investigation of supposed wrongdoing or referring to any non-existent investigatory powers that WHO might have. WHO does not possess the mandate to enter uninvited into any nation state and must show due diplomatic respect to the process of engaging with governments but also the scientific process of working together with our Chinese counterparts to understand and make progress in the understanding of the origins of this disease. So as such this was and remains a collaborative process of discovery between scientists. Clearly there's a political layer on this that has been difficult for all parties to manage and it would be useful at this point if we could step back from that and really focus on what progress has been made scientifically in the understanding and to clearly identify where further progress will need to be made in the future in terms of future studies. So I think it is time that we look to the science now and look at that and then do our best collectively to work with all interested parties to identify further studies that will be needed to fundamentally and finally understand the animal origins of this virus. 00:16:58 FC Thank you, Dr Ryan. I would like now to call on Gabriela Sotomayor, a Mexican journalist from Proceso. Gabriela, you have the floor. GA Thank you, Fadela, thank you very much. My question is on treatment. I know vaccines are very important but my questions is on treatment. I would like to know, what is your assessment on the use of Ivermectin in the early stages of the disease? For example there is a group of specialists in the USA saying that they recommend the use of this very cheap and old drug so I don't know if you observed something on the use of this anti-parasite. Then a quick clarification; I would like to know if the hypothesis on the origin of the virus, the hypothesis of the laboratory incident is still alive. Thank you. FC Thank you, Gabriela. Dr Van Kerkhove will take the first question. MK I can take the first part of that. We also have Peter Ben Embarek online, who can answer the second part of that. 00:18:11 Yes, we have been asked the question about Ivermectin before and the clinical team is looking at data right now on different studies that have been evaluating Ivermectin. What they're doing is they're synthesising the data from different studies. Some of those studies had small sample sizes and the idea is to pool those together into a meta-analysis and apply what they call a grade framework to assess the certainty and the benefit or the risk based on each of those studies. They're using the same methodology that they've used for all of the living guidance that has been produced throughout this pandemic and they are hoping that they will have guidance in the coming weeks, in four to six weeks or so. They have a steering committee that are following the different results of clinical trials around the world and that is being used to trigger the development of the guidance by the WHO team so that has been triggered and that is currently underway. FC Thank you. Peter, are you online? Dr Ben Embarek, you have the floor. PBE Yes, Fadela, I'm online. 00:19:17 FC Thank you. PBE The question was with regard to the hypotheses we were looking at. It was a process to organise our thoughts and our planning of future studies. As you know, this mission was supposed to and did review all the work done under the phase-one studies that were agreed last July and in that process we were also planning to develop a series of hypotheses that we could explore further in the coming weeks and months through a series of new studies that we would recommend and put into motion and that's what we did. With regard to the four hypotheses we worked on and the hypothesis on the lab accident in particular, that one, based on the data and the discussion we had with our counterparts and colleagues in the different laboratories we visited in Wuhan and the amount of evidence that was presented to us from elsewhere as well, was not seen as a high-priority hypothesis for us, our joint China/WHO international team group, to move forward with. We decided to prioritise initially new studies on the more likely scenarios that we could easily set in motion since these are studies to enhance our understanding of the potential animal intermediate host, the bat origin issues, the persistence of the virus on frozen products, the entry into the Huanan market of farmed/wild animal products, etc. 00:21:14 Therefore the one on a laboratory accident was more seen as a lesser priority for us and therefore was categorised as an extremely unlikely scenario in our opinion based on what we had at hand. We also decided and agreed that all the hypotheses would be reviewed on a regular basis based on advance knowledge from our new studies and from evidence that could come up in the coming weeks and months. So that's the context under which this hypothesis and the others were designed and used and of course they're still all under consideration. In particular none of them were considered as impossible hypotheses otherwise we wouldn't even have considered them so they are on the table, we considered them. It's the first time we were able to put all these different hypotheses next to each other on the table and consider them in a rational way. So that's how we worked over the past months on these hypotheses. Thank you. 00:22:27 FC Thank you, Dr Ben Embarek. I would like to invite Dr Sylvie Briand to complement the first question we got from Gabriela about treatment. You have the floor, Dr Briand. SB Thank you very much, Fadela. Yes, just to complement on the issue of treatment. What is clear is that we may need to have many different treatments for COVID-19. The first studies were done on hospitalised patients, meaning patients with quite severe disease and we found that for instance dexamethasone was very useful for severe patients. But now there are many studies ongoing to see if we can treat patients that at out patients, not yet hospitalised, to prevent them from going to severe disease. So this treatment needs to be administered very early on in the disease and this is why those studies were more complicated, especially at the early stage of the pandemic. 00:23:26 But now we start to have more information on those treatments so Ivermectin is this type of treatment that is not specific. It's an antiparasitic drug, as you rightly said and this drug has a broad-spectrum activity and this is why it can be used at the early stage of the disease, trying to prevent further severe disease. So the studies are ongoing and we'll see if this treatment can be useful to prevent severe disease in COVID-19 patients. Thank you. FC Thank you, Dr Briand. I would like now to invite Esmir Milavich from Bosnian TV to ask the next question. Esmir, can you hear me? ES Hi, Fadela. I can hear you. Can you hear me? FC Very well. Go ahead, please, Esmir. ES My question is for Dr Tedros. In this year or so you spoke so many times about vaccine nationalism and big countries purchasing vaccines on their own and you highlighted the importance of the COVAX system. But even here in the region of the western Balkans we are seeing that countries are not relying on COVAX but they're purchasing vaccines on their own. How can you convince them to purchase and go through the COVAX system but also what kind of message does this send, that even countries like Bosnia are purchasing vaccines on their own? Thank you. 00:24:59 FC Thank you, Esmir. Dr Simao will take this question. MS Let me start and maybe colleagues will want to complement. I think, Esmir, you're raising a very important concern of many countries regarding access to vaccines and let me say that we have the facility up and running to start distributing vaccines this month, February and March and June and July. We have already secured two billion doses through the facility and the good thing about the COVAX facility is that actually countries don't need to go bilaterally. When we say bilaterally, countries don't need to go one-by-one to different companies trying to get the best price. With the announcement today of the emergency use listing of the two vaccines that are AstraZeneca vaccines that will be provided through the facility it also triggers a lot of the purchase orders and countries will be able to access, either through UNICEF or through the PAHO revolving fund, the early doses for the AstraZeneca. 00:26:18 Also countries already have been informed about indicative allocation from February to June this year so they can do the preparedness as soon as possible. There are several things that need to be ready at country level and these are two vaccines that have been approved today for emergency use listing. They are vaccines that are very easy to manage from a logistic perspective because they're vaccines that use what we call the cold chain, can use the usual refrigeration, two to eight degrees, in any health centre. So these are easy-to-use vaccines so the vaccines through the COVAX facility start to be rolled out from the end of February and there is the agreed number of doses that will be shipped to the different countries until June this year. So I think there's no need to panic and no need for countries to go buying in the market because they're going to pay more and they will have all the difficulties of ensuring the different contracts and that these vaccines will reach them in whatever time. But the facility is up and running as we speak. Thank you. 00:27:36 FC Thank you, Dr Simao. I would like now to invite the next journalist, Ker Simons from NBC. Ker, can you hear me? KE Yes, I can hear you. Can you hear me? FC Very well, Ker. You can go ahead. KE A question for the panel but also for Peter Ben Embarek. A couple of questions; there appear to be some slight disagreements between the team. Can you help me understand how you will reach a conclusive report or a report that everybody agrees on? What will the process be and how much will the Chinese side of the team have a say in what the final report says? Then a detailed question if I may; some confusion about the reporting referring to 13 sequences that were found, I think, in the 174 cases. Peter, were those 13 different sequences with slight differences or is it the case that eight of those sequences were the same and the others show slight genetic variations? Can you help unpick that piece of reporting and explain exactly what you found? 00:28:59 FC Thank you. Dr Ben Embarek, you have the floor. PBE Thank you. First responding to the last part of your question on the sequences, we identified 13 sequences in December 2019. These were mostly from cases but also from the market environment, as you probably know. These were mostly from different individuals but a few sequences were repeats from the same cases; we have in some instances several sequences from the same cases so it was not in total 13 different individuals. Some of them were very similar; these were the ones coming from cases who had a link with the Huanan market, indicating that the virus was circulating closely in that market environment and that's in line with the conclusions from the epidemiological studies. Some were slightly different and these were from cases with no link to the market. That suggested that the virus was circulating in Wuhan both in the close environment of the Huanan market but also in other parts of the city with some individual chains of transmission. That's again in line with the findings of the epidemiological investigations. 00:30:49 All that gave us the picture of a substantial circulation already in December, particularly in the second half of December 19 in Wuhan. With regard to the report the process is that the international team and the Chinese counterparts have already agreed on the summary report when we were in Wuhan on the last day of the mission and in particular on the key elements of that report in terms of key conclusions, key findings and key recommendations. Of course we will over the coming days and weeks finalise the technical parts, the background parts, the methodological parts of these reports, which are just descriptive material. The process is that the international team in the coming days together with our Chinese counterparts will finalise the interim report first and then work on the full report afterwards. It's a joint report. It will be two groups. We have worked on this together and therefore it's not a question of one side having a say on what the other side is concluding but more having a consensus document on our joint key findings, conclusions and recommendations because this is reflecting the nature of the work, as we discussed earlier today. 00:32:27 The mission was there to review a series of studies that were done in China over the past weeks and months as part of the phase-one studies we had agreed in July and make recommendations for future studies, more long-term studies to explore some of the hypotheses and advance our understanding of the origin of the virus. So it's a consensus document reflecting the joint activities. Of course the fact that we have different scientists from different backgrounds and different fields of experience means that everybody has their specific views, specific recommendations, specific interest in moving some studies forward in one direction or repeating some studies, etc. That's why we brought together a broad group of scientists with diverse backgrounds, diverse experience, diverse expertise, precisely to make sure that we have the best possible consensus, scientific and robust conclusions around this work. Thank you. FC Thank you, Dr Peter Ben Embarek. We are sorry, we had a small technical problem and we lost the video link to Dr Ben Embarek. Dr Ryan would like to add something. 00:33:59 MR I really congratulate the team and Peter's leadership and the work the whole team have done. In my experience particularly in field investigation or any scientific endeavour achieving an absolute consensus around every point is almost an impossibility in science. What we can do is reach a conclusion based on the evidence before us. We may not agree on whether there's enough data to make a decision. There may be differences in our understanding of the methodologies used to collect that data and even if we have enough data and we agree on methodologies we may differ in our interpretation of what that data means in the real world. So it is a difficult pursuit to achieve consensus between two scientists, never mind between 20 or 25 scientists around the same issue and again remembering there were different components to this; components around the environment, around animals, around labs, around the clinical, around the epidemiologic so it's a complex interweaving so a finding or a set of data in one area can affect how you look at information, at data in the other areas. 00:35:07 So I think this is a complex puzzle to put together. The team need the time to finalise that. They obviously are just tidying up that preliminary report. There will be a longer and deeper report but I think it's important for us to reflect on that fact. Again when we look at evidence for anything in public health or in science we have to make findings and conclusions but then we have to determine how strong the evidence is supporting that conclusion and what further data or evidence would help in further bringing certainty to that conclusion or to that finding. That's what we do all the time in science; we say, yes, we think the data tells us this but we'd be certainly happier to gather more data in this area to make us firmer in that conclusion. So I think we have to get away from the land of absolutes here; that's not how science works. Everything is relative; if the possibility of one hypothesis goes up the possibility of another hypotheses explaining the same set of facts actually goes down. So everything is moving dynamically and I think we need to give the team the space to be able to determine what their findings and conclusions actually are and then to determine what further data and what further studies would be helpful in further bringing certainty to those findings or conclusions or where conclusions cannot be reached what studies are needed to be able to generate the evidence needed. 00:36:36 I think we've always said that such a journey of discovery, certainly on the animal-human side, is difficult and it's fraught with obstacles in terms of being able to understand the true origins of any disease and I do believe it will take further studies for us to be able to fully understand that. I did say the last day that we certainly are making great progress thanks to the team and again recognising the scientists on both sides in that team and, Peter, your leadership in that group we've certainly made tremendous progress but we have to be very careful on the absolutes of declaring successes or missions accomplished. Mission accomplished is not a term we tend to use in public health. 00:37:27 TAG Yes, thank you so much, Mike. I just want to add a bit. As Mike said, reaching a consensus on everything may be difficult and it will not be possible, especially when you're just starting. So we would expect that, as Mike said, that there may not be consensus on all issues and there should not be consensus on all issues actually. So when the team faces that the solution is they can represent or indicate their differences in the report and that can help in proposing also future studies so that's what should be done. A joint report doesn't mean that we will have consensus on everything. A joint report can have a consensus on some issues but at the same time can have differences on other issues and the report can accommodate what was suggested by one group or one individual or another group or another individual. So that could be the solution and that, as I said earlier, can help in even proposing future studies so that's what we expect the team will do. But I think once the report is ready we will make sure that the team has the opportunity to have its own press conference either full, all experts, or as many experts as possible that they want to delegate if they want to but it will be up to them. 00:39:38 The last thing I would like to say is whatever conclusions come these are independent experts. Except two in the group the rest, ten of the members or experts are from different institutions, not even from WHO so they come from different institutions representing different countries actually; ten countries, ten institutions and they're independent and we don't tell them what to do. They will present their own independent report and that's what I think will of course make this study dependent on independent experts' opinion. Many times I hear that this is a WHO study or investigation. It's not. It's an independent study, a study which is composed of independent individuals from ten institutions and WHO's role here is co-ordination and that's what we should take into consideration too so that will be really helpful to understand. Thank you, Fadela. FC Thank you, Dr Tedros. I would like to invite Kate Kellan from Reuters to ask the next question. Kate, you have the floor. KA Thank you. I wonder whether you could give a more specific estimation of when the first vaccines that are being delivered via COVAX will get to countries and into the arms of people that are getting them through COVAX. 00:41:45 Also have you had any one of the countries that are due to receive AstraZeneca vaccines saying that they're not so keen now after the South Africa situation last week where they paused the roll-out? FC Thank you, Kate. Dr Simao. MS Let me start and then I'll ask Kate O'Brien or Dr Soumya to complement. Thank you, Kate, because this is a very important question right now. We don't have the exact date because at the moment there are purchase orders that are being put to the two manufacturers. For the Serum Institute of India I believe that there are seven or eight purchase orders that were already issued through the Serum Institute of India for some countries to receive that have been assessed as ready by WHO. Then there are the orders that will be placed for the Korean manufacturers, SKBio so we will publish the number of doses that will go now on the first round to the allocation quite soon, probably mid next week but the exact date each country will receive depends a lot on how the shipments will be made and the contracts that are being arranged through UNICEF and PAHO. Maybe Kate can address the second question. 00:43:13 FC Yes, Kate or Dr Swaminathan. KOB Sure, I can address the second question and then I'm happy for others to come in as well on this. We've spent quite a bit of time and effort both in this convening and with member states and in other convenings with them to clarify the recommendations from SAGE about the use of the AstraZeneca vaccine notwithstanding the very preliminary evidence that has started to come out about this product and a variety of the variants. Countries remain enthusiastic about receiving the AstraZeneca product while at the same time asking very relevant questions about what the evidence shows and what the evidence doesn't show. I'll just reinforce that three is no evidence on whether or not the AstraZeneca product against the B1351 variant has any change or that the change in that vaccine efficacy is a substantial change. 00:44:26 There are plausible reasons why we think that they will retain activity against severe disease. This is evidence that SAGE looked through and made that recommendation so in fact the engagement with countries has been with a lot of questions that they have had and I think what has been shared with them about what the evidence shows has reassured countries about moving forward and enthusiasm from countries to go ahead with the vaccination programmes with AstraZeneca vaccine. We are also working closely with the South African Government as they consider how they will accrue additional evidence on the AstraZeneca product in the setting of very wide distribution of the variant in South Africa. Remember that countries that have the variant in the countries; that does not mean that the majority of the strains that are circulating are from that variant. I'll end there and see if there's anybody who would like to add to that; Soumya or others perhaps. Thank you. FC I think you covered it fully. I would like now to invite a Chinese journalist from China Daily, Chen Wihua, to ask the next question. Chen, can you hear me? 00:45:57 CH Yes, thank you very much. Dr Tedros, you again mentioned misinformation and disinformation today. I don't know; are you actually referring to the war of words in the media? You have the US Government, a State Department official spokesman saying they're not going to accept the independent expert team report even before it comes out. You also have the other Peter, Peter Dazak from the expert team saying on Twitter, don't rely on US intel. Also he said, experts' words are being selectively used and also very angrily commented on the New York Times article, saying, shame on the New York Times. So I'm wondering what's the WHO's stance on the US' not going to accept the report and Peter here, Peter Ben Embarek, are you feeling [overtalking]? FC Can you just...? It's a very long question and comments. TAG Yes, okay. I will start. What I said today about misinformation and disinformation has nothing to do with any specific things that we heard yesterday or the day before yesterday. The reason we included it in our presser today is that it's the first anniversary since we started to advocate for the public to fight misinformation and disinformation and that's why also Dr Sylvie Briand is with us. 00:47:44 So we're actually celebrating the first anniversary of the initiative that we started. Sylvie can give you more background. Sylvie, please. SB Yes, thanks a lot, Dr Tedros. In fact it's because we have seen that every epidemic is accompanied by an infodemic which is a tsunami of information, accurate or not and that can be of course harmful if it's not accurate information. So WHO has done a lot of activities to make sure that people can access accurate information at any time during the outbreak and as you have seen, the difficulty with such a pandemic is that there's a lot of uncertainty. Science is moving very fast. Every day we have new findings and it's very hard for the public to understand what is going on and sometimes they are confused. Some people also use this confusion to send out information that is not completely accurate so what we try to do is really to listen to people and this listening is very important. We have developed not only tools to listen to people offline but also online and see what are their concerns and try to really answer their concerns and questions in real time and fill the void because we know that when there is a vacuum, when there is no information people will try to find this information wherever it comes from and sometimes it's not the right information. 00:49:28 This is why we wanted to celebrate somehow this one year because during this year a lot of organisations, UN organisation partners have been contributing to ensure that everyone on Earth has access to accurate information at any time. Thank you. FC Thank you, Dr Briand. I would like now to invite Helen Branswell to ask the next question. Helen, you have the floor. HE Hi. Thank you very much, Fadela. I'm wondering if we could have some information about the Ebola cases in DRC and Guinea. In particular is it known yet whether the virus in Guinea is Ebola Zaire and is there any thought that this is - is it known if it's a new spillover or if there might be an incidence of viral persistence? Thank you. 00:50:32 FC Dr Yao, you have the floor. MY Thank you very much. The first cases were confirmed and, as you know, the outbreak was declared yesterday by the national authorities so it's Ebola Zaire but the genotype has to be analysed and a sample has been sent to reference labs mainly in Senegal to do the sequencing so that at least we can know if it is the same virus that affected a few years ago or if it's a totally new one. So it's a bit early to answer precisely about this point but it's in process. MR If I can just add - thanks, Michel - again we would like to thank the Government in Guinea, the Governments in Sierra Leone, Liberia, Cote d'Ivoire and others who are taking immediate action both in terms of response and readiness. We saw similar responses in Congo before and the 14 and mainly in the nine really at-risk countries. This disease represents a regional risk and we very much welcome the regional and subregional response to that. I know our regional director, Dr Tshidi Moeti is already in touch with senior officials in many ministries and with the West African Health Organisation and many others in the region. 00:52:08 We do need a very coherent, co-ordinated response led by governments in country with the UN, other partners, NGOs supporting that response and WHO will do its part to support the Government. We already have, Michel, I think, I believe we have a team en route to Ensakore [?] right now to provide support. We are moving vaccines in country from both Geneva and US stockpiles. Those vaccines are still the investigational use doses. They will have to be used under investigational use protocol. We have previously approved protocols in the three countries. We're working with the Governments to have those updated. Currently vaccinators will be trained. We already have experienced vaccinators in all three countries but we have vaccinators and supervisors who've been working with us in Congo from Guinea and they're in Guinea already and will be working on this. 00:53:12 We also will be shipping therapeutics, both MAB114 and the Regeneron product, to the field and are working with ALINA and other colleagues and other NGOs, IMC and others, MSF, to see how best we can provide the higher standards of care that were achieved in Congo and transfer them to the management of patients in Guinea. We're not in the same situation we were a number of years ago. The disease is very much in the same area as before. It does threaten at least the three countries and therefore we have to be exceptionally vigilant, highly alert and we have to get surveillance, laboratory diagnostics, clinical management and all of the other things in place, much as we've had to do with COVID. WHO is ready to do its part and our systems are fully geared now to providing the absolute highest level of support to both the government of Guinea and Akri and to the surrounding countries so we've launched a comprehensive response. Michel Yao is our lead on that here but he is surrounded by a very competent team and Dr Socé Fall, our Assistant Director-General for Response, will also provide oversight to the response on behalf of Dr Tedros. FC Thank you, Dr Yao and Dr Ryan. I would like to give the floor for last question to Kai Kupferschmidt from Nature. Kai, you have the floor. 00:54:43 KI Hi, thanks for taking my question. I was wondering, given that we've seen five weeks of falling case numbers, whether you can give an idea, maybe Mike, how you think of this. Clearly there's a lot we don't understand about the virus but we are seeing a drop in a lot of places where fundamentally the public health measures haven't changed all that much. Could you just give us an idea of how you think about this drop and how you see the future also given the faster-spreading variants we're all concerned about? FC Thank you, Kai. Dr Ryan. MR Yes, I think the real expert on this will be Maria but, Kai, yes, thank you. I think we have to be very, very careful. When things go bad with an epidemic it's never all our fault and when things go well it's never all our doing because viruses have a natural cycle. They're ruled by seasonality, our behaviour and other things. 00:55:45 I think there has been a significant and global drop in disease week-on-week for the last four or five weeks. We haven't seen levels as low as this since last October. I do think a good proportion of that has been down to the huge efforts made by communities. There've been very swingeing lock-downs and stay-at-home orders and other things but also as part of that seroprevalence is rising, people are taking better care. We need to understand what is driving those transmission dynamics. Is it the natural seasonality and wave-like pattern of the disease, are we building up a level of immunity in the population that's preventing the disease finding the next case and are control measures having an impact on that? I think all of the above to an extent are true. I think the thing we have to remember is that this virus still has a high force of infection, a very high kinetic energy. There still are a large number of susceptible individuals out there and transmission will continue. I think as we look collectively at lifting some of the measures that are currently in place we're going to need to be exceptionally careful that we don't do the same thing as last autumn where we allow the disease to re-establish itself, reignite and re-accelerate. 00:57:08 I think it's the accelerations in this disease that have been the most worrying. The disease can move along at fairly low levels and then you see this really fast acceleration and spread. We need to avoid that the next time. We do believe that vaccines offer us an opportunity to reduce the hospitalisations and death and that's going to offer a different set of decisions in a number of months' time. If we can distribute vaccines equitable and the most vulnerable and the highest-risk people are protected then the decisions we make around this disease will understandably change because the consequence of transmission is different when we don't have death or hospitalisation as an endpoint and that's going to be a very important consideration going forward. So I think it's difficult to understand the dynamics but I would hate to think as these numbers drop that we're in any way about to declare some kind of victory. We've done that twice before. I don't think anyone has put up a victory flag but we collectively have taken a sigh of relief, moved on from a wave and then been very surprised two or three months later when we're in the middle of the next wave. 00:58:16 What we need to do - we said this many times last year; we need to avoid lurching from lock-down to lock-down, from peak to peak and get into a more stable relationship with this virus unfortunately. We need to get control on the virus. The virus still very much has control over us. We need to get to low, sustainable levels of transmission. We need to get to no deaths and minimal hospital admissions. If we achieve that then we will have other choices to move forward, possibly with second and third-generation vaccines and other opportunities to potentially eliminate or eradicate this virus. That is not on the immediate horizon. We need to take the heat out of this pandemic. We need to take the death out of this pandemic. We need to take the suffering out of this pandemic and I believe we can do that if we're really smart about continuing our own personal measures, continuing to reduce our own chances of being infected, if governments support people in being able to do that and if we can roll out vaccines in an equitable fashion so our most vulnerable and our most at risk are vaccinated as the highest priority. Maria. 00:59:25 MK Thanks, Mike, and thanks, Kai, for the question. I think the downward trend in cases and deaths is definitely a hopeful sign and there's likely a combination of factors that are pushing and driving transmission down and it comes down to individual-level measures, measures taken at the family level, the community level and by governments. We have reasons to be hopeful and I hope everyone is taking some comfort in the fact that we can drive transmission down, we do have the possibility to control transmission with our individual-level actions if we are enabled to do so. We do see that the public health and social measures are working across a number of countries including countries where the virus variants are circulating, where they are predominant, where they're being identified and that is good because we know what works and it's that combination of factors. 01:00:16 Getting down to the level of detail of which combination works where is what we're trying to better understand in terms of all of these public health and social measures but I think we have some challenges ahead. These virus variants and the changes, the natural evolution of the virus pose some uncertainty in terms of what is this virus going to do, how much is it going to change, are we in a position globally to rapidly detect these mutations, these virus variants and assess what they mean in terms of transmission, severity, impacts on diagnostics, therapeutics and vaccines. You know we are working with partners all over the world to set up this global risk assessment framework to be able to monitor them and study them in real time and that poses a challenge. The other challenge I think we have is while vaccines and vaccination is incredibly hopeful and an incredible achievement they will take time to roll out and they will take time to reach those who are most vulnerable and those most at risk in all countries. The third thing that I think is a big challenge that we have now is fatigue. The world is tired. All of us up here are tired as well and we want this to be over and we cannot become complacent. Even with downward trends we need to really stay the course and we need to hold on to what works and have some feeling of control, empowerment over what we can do. 01:01:46 There's a lot of work that is happening in this area and Sylvie may want to comment on this but working with communities, talking to communities, with communities, listening to communities, making sure that they are part of the solution, that they are informed, engaged and empowered, most importantly empowered and enabled to carry out the actions that are necessary. It's no good for us to lay out ten different things to do if a community is not enabled to do so so I think there're a number of reasons why we should be hopeful but it is no time to let down our guard. We need to really hold on to everything that we can do, take all of the measures at our own level to keep ourselves and our loved ones safe. FC Thank you. I would like to invite Mr Deusdedit Mubangizi, who's the Head of the Pre-qualification Unit, to say a few words about the important announcement made today. You have the floor. 01:02:51 DM Thank you, Fadela. Indeed today is a great day especially for COVAX. We started assessing these two vaccines hardly four weeks ago but when you look at the map that has been shown in various fora where you have continents that have access to vaccines and then other continents that don't have, I think any movement that increases capacity on the manufacturing and supply of vaccine is a great milestone for this world. If we are going to be safe, as the Director-General says, nobody will be safe unless everybody is safe and today's announcement of two vaccines, versions of AstraZeneca allows everybody to access vaccines. I would like to first of all use this opportunity to thank the experts that have been behind the assessment of these vaccines. I was excited yesterday; it was Valentine's Day but all the experts were around the table and assessing to make sure that today a final decision was made and people could access these vaccines. I want to assure people out there that experts have looked at this vaccine and it is safe, it's of good quality and it is effective. 01:04:42 Secondly we put a system in place that has assessors from every WHO geographical region to make sure that there is input not only from one part of the universe but all parts of the globe, to make sure that the input, the decision that goes into this decision that we've made today has a global input, has considered all the specificities of the different parts and and markets and health systems. We are confident that one of the concerns and the interests of the different populations have been considered but also that the aspects or ability to deliver this vaccine in the different health systems of the world has been considered. Therefore we now call upon our colleagues first of all in the national regulatory authorities. We have put in place a report that has had input from all parts of the world. Let's now make the quick decisions so that people can access these vaccines as quickly as possible. We will work with all of you to make sure that any questions that you have to facilitate quick authorisation at the national level are done and hopefully by the time we enter March the map will be different and everybody will have an opportunity to access this vaccine. Thank you very much. 01:06:19 FC Thank you. I would like to hand over to Dr Tedros for any final comment. You have the floor, Dr Tedros. TAG Thank you so much. I think Deus has said it very, very well on the vaccines and Valentine's. My colleagues didn't have a break even on Valentine's Day and it was also Sunday. Thank you so much for your hard work and for making it happen in a very short period, the approval of the AstraZeneca. This will help us to roll out quickly so thank you, Mariangela, for your leadership, Deus, Parwar [?] and... [Inaudible] TAG Carmen; okay. Thank you so much and I would like also to thank the media colleagues who have joined today. See you in our next presser. Thank you. FC Thank you, Dr Tedros. I would just like to let journalists know that we will be sending them the DG's opening remarks and the audio file of this press conference just after we close here. The full transcript will be available to you tomorrow morning. Thank you all. See you next time. 01:07:39

Pharmaceutical procurement among public sector procurers in CARICOM / Compras farmacéuticas por parte de organismos del sector público de CARICOM / Aquisição de produtos farmacêuticos por compradores do setor público da CARICOM

ABSTRACT Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

RESUMEN Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

RESUMO Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%-67%). Do total, 60%-87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%-50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Media briefing on COVID-19 - 11/12/2020

00:03:06 FC Hello, everybody. I am Fadela Chaib, speaking to you from WHO headquarters in Geneva and welcoming you to our global COVID-19 press conference today, Friday 11th December. Present in the room are the WHO Director-General, Dr Tedros, Dr Mike Ryan, Executive Director, Health Emergencies, Dr Maria Van Kerkhove, Technical Lead for COVID-19, Dr Ed Kelley, Director, Integrated Health Services, Dr Bruce Aylward, Special Advisor to the DG and who leads on the ACT Accelerator. Joining us remotely are Dr Soumya Swaminathan, our Chief Scientist, Dr Kate O'Brien, Director, Immunisation, Vaccines and Biologicals and Mr Joe Kutzin, who leads the WHO Health Financing team at WHO. Welcome, all. Simultaneous interpretation is provided in the six official UN languages plus Portuguese and Hindi. Now without further delay I would like to hand over to Dr Tedros for his opening remarks. Dr Tedros, the floor is yours. TAG Thank you. Thank you so much, Fadela. Good morning, good afternoon and good evening. This week vaccines against COVID-19 have started to be rolled out in the United Kingdom and we expect more countries to follow. To have safe and effective vaccines against a virus that was completely unknown to us only a year ago is an astounding scientific achievement. 00:05:02 But an ever greater achievement would be to ensure all countries enjoy the benefits of science equitably. WHO and our partners are focusing on three priorities. First we face an immediate funding gap of US$4.3 billion to procure vaccines for the most needy countries. I urge donors to fill this gap quickly so that vaccines can be secured, lives can be saved and a truly global economic recovery is accelerated. Second we have worked hard to secure political commitment from world leaders for equitable access to vaccines but we would like to see that commitment being translated into action. Third we're preparing countries to deliver countries by assessing gaps in infrastructure. Already almost one billion doses of three vaccine candidates have been secured as part of the COVAX facility and 189 countries are now participating. Our COVAX partner, GAVI, is in discussions with several other manufacturers and further deals will be announced in the near future. 00:06:25 Simultaneously WHO is working with GAVI and UNICEF to evaluate the first set of requests received from countries who are eligible for assistance through the COVAX facility. Addressing the financing gap is an urgent priority. On Monday WHO and the European Commission are reconvening the facilitation council for the ACT Accelerator with our co-chairs, Norway and South Africa. The council will scrutinise our strategic priorities and a draft financing framework to close the ACT Accelerator financing gap for 2021. This is crucial to ensuring all people everywhere are protected. We have all seen images of people being vaccinated against COVID-19. We want to see the same images all over the world and that will be a true sign of solidarity. Yesterday was Human Rights Day and tomorrow is Universal Health Coverage Day. These two days coming so close together at the end of this very difficult year are a reminder that as we rebuild from this crisis we must do so on the foundation of human rights including the rights to health. 00:08:03 2020 has reminded us that health is the most precious commodity on Earth. In the face of the pandemic many countries have offered free testing and treatment for COVID-19 and promised free vaccination for their populations. They have recognised that the ability to pay should not be the difference between sickness and health, between life and death. This year Universal Health Coverage Day takes on even more importance than usual. Apart from the death and disease caused by the virus itself millions of people have suffered and died as a result of disruption to essential health services. This week WHO is launching two initiatives to support and rapidly accelerate countries' journey towards universal health coverage. The first is a global programme to strengthen primary healthcare, better equipping countries to prevent and respond to emergencies of all kinds from the personal crisis of a heart attack to an outbreak of a new and deadly virus. The second is a new UHC compendium designed to help countries develop the packages of services they need to meet their people's health needs. WHO is also launching a new report that provides the first analysis of how global health spending has changed during 2020 in response to the COVID-19 pandemic. 00:09:46 Many governments have responded to the pandemic with exceptional budget allocations for their health systems and even larger allocations for economic stabilisation and social protection. At the same time COVID-19 has triggered a deep global economic crisis that could have a long-lasting impact on health financing. Public revenues are declining, forcing many countries to take on additional debt which will impact lower-income countries whose economies were vulnerable before COVID-19 struck. The report warns that higher debt servicing could make it more difficult to maintain public spending on health. But this is precisely the moment for investing in health. The pandemic has demonstrated that health is not a luxury. It is the foundation of social, economic and political stability. Indeed today's report highlights that the COVID-19 crisis provides an opportunity for a reset in countries with weak health financing systems. It makes six key recommendations for a new health financing compact. To draw more attention to universal health coverage we have also made it one of the main categories in the second WHO health for all film festival. 00:11:22 We're inviting all film-makers, whether professional or amateur, to submit short films focusing on access to quality care for any health need by 30th January 2021. Several hundred films have already been submitted and the two other categories for the festival are health emergencies, in which we invite short films about COVID and other humanitarian crises, and better health and well-being, in which we invite films about climate change, pollution, sanitation, nutrition, gender issues and more. We know that although children are less at risk of severe disease and death from COVID-19 than older adults millions of children have suffered from the pandemic in other ways including disruption to their education. According to data collected by UNESCO classrooms for nearly one in five schoolchildren globally or 320 million were closed as of 1st December, an increase of nearly 90 million in just one month. 00:12:41 In some places children have been out of school for nine months or more. Prolonged school closures are presenting an unprecedented challenge to children's education, health and well-being. Today WHO has released a new checklist to support schools in reopening and in preparing for resurgences of COVID-19 and similar public health crises. It lists 38 essential actions; a new checklist to support schools in reopening and in preparing for resurgence of COVID-19 and similar public health crises. It lists 38 essential actions to be considered by different stakeholders as they work to agree school reopening plans. More than 66 million cases of COVID-19 and 1.5 million deaths have now been reported to WHO. In the past six weeks the number of weekly deaths has increased by around 60%. Most cases and deaths are in Europe and the Americas. The festive season is a time to relax and to celebrate but we must not relax our guard. Celebration can very quickly turn to sadness if we fail to take the right precautions. As you prepare to celebrate over the coming weeks please, please consider your plans carefully. If you live in an area with high transmission please take every precaution to keep yourselves and others safe. That could be the best gift you could give; the gift of health, life, love, joy and hope. I repeat; the gift this season, the best gift this season you could give is the gift of health, life, love, joy and hope. I thank you. Happy holidays. 00:15:15 FC Thank you, Dr Tedros. I will now open the floor to questions from members of the media. I remind you that you need to use the raise your hand icon in order to get in the queue to ask your question. I think we will start with Laurent Zero from ATS, Swiss news agency. Laurent, can you hear me? LA Yes, thank you, Fadela. Can you hear me? FC Very well. Go ahead, please, Laurent. LA Very good. We have observed in recent weeks a trend downwards in countries like Switzerland and some of its neighbouring countries but then more recently since one week ago there is a kind of plateau at a high number of cases despite strong measures that have been taken by the different governments. How do you explain that? Thank you. 00:16:20 FC Thank you, Laurent. I'd like to invite Dr Van Kerkhove to take this question. MK Thank you for the question. Indeed across many countries in Europe we have started to see a decline in cases and I think that's a result of the measures that have been put in place and individuals who are adhering to those measures. But as you've said, it's starting to plateau in some locations and what this means is that we need to stay the course, we need to follow through, we need to continue to practise the physical distancing, staying home if asked, teleworking, following all the measures that are put in place to keep ourselves safe whether these are individual-level measures such as physical distancing, the wearing of masks, cleaning your hands, practising good respiratory etiquette, whether you are asked to stay at home; continue to stay at home. But we have to follow through. I think one of the lessons we can learn, especially across Europe, is over the summer Europe showed us that they brought transmission under control. In many countries cases were down to single digits and that can and that will be done again but we really must be vigilant and we really must stay the course. 00:17:26 Given the holidays that are coming up, as the Director-General just said, it is a time when many people want to come together but we really need to make very careful decisions about how we celebrate this year. We will celebrate but maybe it means we celebrate with just our households and maybe we do another type of Zoom celebration, as we will do with my family this year. But we do need to stay strong and we do need to make sure that we keep ourselves separated from others for the time being while we have the good news of vaccines coming online. But again just to repeat, we need to stay the course. It's very easy for us to go up quickly in case incidence. It takes quite some time to actually come down the other side of the mountain, as you've heard Mike say, in the spring so we have to follow through but we will do it, Europe will do this again and they will show us how to bring it under control. 00:18:24 MR I think, Maria, you're absolutely spot-on. I'll just repeat two of your words; follow through, make sure this time that we follow through on the measures. If we continue to build public health surveillance, we continue to work with communities to maintain those measures around physical distance, personal hygiene, avoiding crowds and then we add vaccines gradually in the coming year we can avoid the lock-downs. So this is about us all following through on our commitments as individuals, as communities and as governments in the coming months. FC Thank you. I would like now to call on Jason Bobia from NPR to ask the next question. Jason, are you with us? JA Yes, thank you very much. You mentioned, Dr Tedros, that the UK has now started vaccinating and the US appears to be on the verge of authorising the Pfizer vaccine and you talked about the need for equitable distribution but obviously that distribution can't start in many places until the WHO authorises a vaccine. Can you give us an update on when we can expect the WHO to authorise a vaccine that can start being distributed through COVAX? FC Thank you, Jason. We have with us remotely Dr O'Brien and Dr Soumya Swaminathan. Kate, do you want to start? Or Dr Swaminathan. 00:19:57 SS I don't think Kate is connected. FC Okay. Dr Swaminathan, you have the floor. SS Thank you, Fadela. Yes, I can start. The WHO has put out our criteria for emergency use licensing and we are open to receiving submissions from all manufacturers who are interested. In fact we've received several and it's a rolling submission so as more data is accumulated from the different phases of trials it's provided to WHO so that we're up to date and we can stay as updated as possible. We are now going to be looking at the Pfizer dossier followed by a couple of others as they come in and we expect that... We work quite closely with the European Medicine Agency along with some of the other national regulatory agencies and so we expect that in the next couple of weeks our committees will be reviewing the Pfizer BioNTech dossier and coming out with an opinion. Thank you. 00:21:11 FC Thank you. I think Dr Aylward would like to add something. BA Yes, thanks so much and, Jason, thanks for the question; super-important. When we established the COVAX facility to make sure that there would be absolutely no barriers to the most rapid access to vaccines possible for all countries in the world we're actually using a slightly different process and we are indeed looking at these products though the WHO emergency use listing procedure. At the same time we have an exceptional procedure in place where some products that are approved by what we call a stringent regulatory authority can also be considered by the COVAX facility so there will be no barrier to the speed with which these products could potentially be used globally. FC Thank you. I would like now to call on Isabel Sacco from EFE, the Spanish news agency. Isabel, you have the floor. IS Yes, good afternoon. I have more or less the same question as the previous one. I would like maybe to ask again if Dr Soumya can identify the vaccine candidates that WHO is reviewing and for the general public if she can explain the importance of this review by WHO, taking into account that we all know that there are many other national regulatory agencies that are doing the same procedure. Thank you. 00:22:59 FC Thank you, Isabel. Dr Swaminathan. SS Yes, thank you for that question. Indeed it's a bit confusing because, as you rightly pointed out, national regulatory authorities do have the mandate and the jurisdiction to make these assessments and decisions for use within their own countries so every national regulatory authority has the authority and the mandate to do that but that's limited to their own countries. Several countries rely on WHO's pre-qualification service for vaccines and for drugs and that's a service that WHO provides also for global procurement agencies like UNICEF and GAVI because it's a stamp of quality, safety, efficacy and manufacturing quality. 00:23:54 In the case of the emergency use licence of course we base this assessment on limited amounts of data and that's clearly laid out in the criteria so what should be the minimum efficacy, what's the minimum safety data that's needed as well as of course all the manufacturing details around the quality of the product. So, as I mentioned, we have opened the expressions of interest several weeks ago, I think it was about four to six weeks ago and we have been receiving both enquiries as well as submissions of dossiers from several companies, at least ten companies have either expressed an interest or submitted initial dossiers. The data will only be considered for an emergency use licence when there are some phase-three clinical trial results available and so there are only a couple of companies now that have those phase-three results and those are interim results. So we've started with the Pfizer dossier; we expect also to have the Moderna followed by the AstraZeneca dossiers examined in the next few weeks and we will be coming out with the decision, whether it is receiving an emergency use licence or not. The other thing that we're doing is of course working with the regulatory agencies, the International Coalition for Medical Regulatory Agencies, the ICMRA, with whom we have a letter of agreement now on how we would work together so that we can speed up things further. 00:25:36 We have regulators from several countries actually who have stepped up and volunteered to help the assessments that WHO will be performing so these will be joint assessments done with national regulatory agencies. We have asked countries also to prepare for licensing of vaccines by either accepting the WHO EUL or PQ procedures or by accepting one of the stringent regulatory authorities, as Bruce was just mentioning, so that they are in a position to receive vaccine doses from the COVAX facility. They have to accept either of these. What we don't want is for every country to start an assessment process for every vaccine because that's just going to take far too long and so therefore it is important to rely on a few regulatory agencies globally plus the WHO process. Thank you. FC Thank you, Dr Swaminathan. Dr Ed Kelley would like to add something. 00:26:35 EK Yes, thanks, Fadela. Just to complement the points made by Soumya on this, one of the pieces of work certainly is getting the vaccine through the regulatory process and getting it reviewed here at WHO but as we've always said, it's not the vaccines but vaccinations and vaccination programmes that will end up protecting people and there's tons of work going on right now; in fact the entire ACT Accelerator in many ways, as the person doing a lot of the work on the Health Systems Connector, has pivoted to support the assessment in countries. We were targeting 100 countries; we've now got 105 assessments already in and the picture of what is going on and how countries are preparing not just on the regulatory work, which does need some more work, but also on safety monitoring systems. We've got over 65% of countries that have already got safety monitoring systems in place so all of that work will be as important as the work that Soumya just mentioned. FC Thank you. I would like now to invite Jeremy Lunge from Radio France International, RFI, to ask the next question. Jeremy, do you hear me? JE Yes, I can hear you, Fadela. Thank you so much. A question about testing; a lot of people are thinking about getting tested ahead of Christmas. In France the Health Minister advised against it, saying that it might provide a false feeling of safety. I would like to know, do you have any comment on that, do you advise against or for testing before Christmas? Thank you. MR We certainly advise that all patients who are suspected of having COVID-19 are tested and that we expand testing through the use of rapid diagnostic tests in specific circumstances. Maria can go into details of how we see the strategic expansion of testing but we need more testing, not less. I think the Minister may have been relating to the specific issue of individual risk. Finding as many infected people in the community is very important but when you get a test and you test positive or negative on a certain day it doesn't mean you will test negative the next day or the next day. So doing more testing to find infected people; yes, good. Relying on a single test to guide your behaviour in the coming days or who you can meet or what you can do is problematic because knowing your status today does not guarantee your status tomorrow. 00:29:17 So we must sustain the behaviours of physical distancing, wearing masks, avoiding crowded spaces, ensuring we're using appropriate ventilation and doing all those things to minimise risk in those environments. That does not mean that targeted, strategic testing is not a good idea. We want to see an expansion of testing but we want to see it done for public health purposes. Individuals who have the resources to have themselves tested; there is nothing wrong with getting a test. It's really how you interpret that result and how that affects your behaviour and how it should or shouldn't affect your behaviour. Maria. MK Yes, thanks. Just to supplement what Mike has said, we encourage, we advise, we recommend strategic testing. We have since the beginning and anyone who meets the suspected case definition should be tested. We work very hard through our regional offices and our country offices to build testing capacity. This has been a PCR-based testing capacity and now all countries are able to test for COVID-19, test for SARS-Co-V-2 infection, the virus that causes COVID-19 and that is really quite an incredible feat. We now have antigen-based rapid diagnostic tests that are coming online. These are cheaper, quicker, easier to use and we recommend these be used in areas where there's a lot of virus, where there's a lot of virus circulating, where there are outbreaks that are happening, in areas potentially screening individuals like health workers who are at a higher risk of exposure because they had direct contact with known patients. 00:30:48 Those are really helpful to alleviate some of the pressure on the PCR-based system but testing for testing's sake must be linked to public health action, it must be linked to isolation of cases, clinical care of cases, contact tracing, supported quarantine of those contacts. As Mike has said, a test result gives you the result of that sample that was collected at the time of testing. You could become infected between the time that you took that test and the time you get that result back, which is why it's really important that we not only get tested with a high-quality either PCR or antigen-based test but that you get that result back quickly and you follow through with the public health actions that are there. 00:31:32 So in some countries testing will be expanded and this is good and we have seen a global expansion of testing but again it needs to to be fit for purpose, it needs to be linked to cluster investigations and case finding and making sure that you're working towards your goal of reducing transmission and you're breaking chains of transmission. So there are good products that are coming online. These rapid antigen-based tests are a game-changer in many ways because they can be used in lots of different settings and take the pressure off the PCR systems. But again we still, all of us, need to adhere to all of the measures that keep ourselves safe, keep our loved ones safe so keep up that physical distancing, keep following all of the measures that are put in place in the local area where you live, which is based on the transmission that's happening around you. FC Thank you. Moving now to Cancun in Mexico I would like to invite Paulina Alcazar from Ancadena News to ask the next question. Paulina, do you hear me? TR Yes, Fadela. Can you hear me? Thank you. Good day to everyone from Cancun. What considerations should be taken into account with the high number of reinfections or is it considered as a long COVID, a persistent COVID when someone is positive again at a test several months later? What do we consider it as? 00:33:07 MK Thanks for the question. There're two aspects to the question that you've asked. One is about reinfection and I think the other one is about long COVID so these are two separate things and let me just break them down very briefly. We do know that there are some individuals who may be reinfected with this virus and this has been detected in a number of countries that have good lab systems, that have been able to do a sequence of the first infection and a sequence of the subsequent, second infection and they can tell that there's a difference in that virus, a slight difference because the virus changes and that is indeed a subsequent infection. This is now starting to be picked up in a number of countries and we have more than 69 million cases that have been reported globally but the number of reinfections is a lot smaller than that. We're working with countries to help them better define what a reinfection is and to help them look to see how often this is happening. 00:34:04 So it doesn't seem to be happening very often but we can't quantify that at the current moment. The question around long COVID is that there are individuals who've been infected with the SARS-CoV-2 virus, they have an acute disease where they're very unwell or they're mildly unwell and then they seem to recover but they're having longer-term effects. We are learning more and more about what long COVID is in terms of the effect on the body. It seems to affect many different organ systems. It's not just a respiratory illness of two weeks; it seems to persist for months. We're working with many different patient groups, we're working with many different researchers to better understand what is happening. We have met and the Director-General has met with patient groups and the patient groups have said to us what they need is recognition that this is real and this is real and there's now an ICD code for what's called post-COVID syndrome. We're working with them because we need better research to understand the extent of this in different populations, to understand what disease looks like in terms of the long-term effects and the different effects on the organ systems and also rehab. 00:35:20 So we're working with clinicians to better design and work on rehabilitation for individuals who are suffering from this, to ensure that we give them the best care possible so we have a lot to learn in this area. There was a forum that was organised this week by ISARK [?] and partners which WHO participated in and we have seminars and working groups that have been established specifically to look at this so that we can provide adequate care. MR Let me just emphasise what Maria's been saying; it is best that we all try to avoid this infection and not to have to be concerned about your health going forward; also to reassure people, yes, the vast majority of people do have an infection that doesn't result in ongoing specific effects. But there's a significant minority of people who are suffering very, very long into a post-COVID period and our hearts go out to them as they approach this Christmas period because sometimes in life mortality and death is recognised and we all sympathise. It's very hard when you're carrying the after-effects of an illness; it can be a very lonely experience and people don't want to attract attention to themselves because people may think, I'm infected and I'm still coughing. 00:36:40 So people are going through a lot of psychological trauma as well as having those lingering effects so I think we should all be very kind to each other and particularly kind to those who've had to fight through very difficult infections and have the continued concern of the long-term impacts on their family. To our journalist I would say, given the weather here in Geneva we would love to be with you in Cancun. FC True. Let's go to Georgia; I think it's cold in Georgia. I would like to invite a journalist from Georgian television, Imeda, Kitivan Kardava, to ask the next question. Kitivan, are you with us? KI Yes. Good evening. Can you hear me? FC Very well. Go ahead, please. KI Thank you very much for this opportunity, Mr Director-General. When you were talking about vaccine and about the news about vaccine you said recently that a beam appeared at the end of the tunnel. How bright is that ray today, can you tell us? 00:37:48 As I represent Georgia I want to ask you about Georgia. Thousands of people are infected in my country every day. What would you say to the population of Georgia? They are watching your statements carefully every week. Also I have a question about information campaigns; how should information campaigns about vaccination be conducted so that the people have a confidence in the vaccine? We all know that vaccine will be effective in the case when people have confidence and trust in it. Thank you very much. FC Thank you. These are three questions. Maybe Dr Aylward would like to start. BA Sure, and Soumya may wish to come in on the issue around the confidence and everything that's being done to build that but in terms of the comment the Director-General made last week about the light at the end of the tunnel, I think was the phrase, and how bright that is, that light is getting brighter in fact. 00:39:00 If you look week by week at the number of companies that are announcing positive results in terms of the efficacy of vaccines that number is increasing and what's important is it's increasing not just in terms of the number of products but also the different technology platforms that they are being built on. As we're seeing now, there're three different technology platforms, as we'd call them, that have reported very positive efficacy and safety data. We haven't seen and scrutinised all of the data behind that, as we've emphasised multiple times. Some of this is still in press reports but it's positive which means that beam is looking brighter, to the point that you asked. But at the same time there're other considerations and Mike emphasises this repeatedly and Maria. I think it's so important an that is that there are real challenges with volumes; these are still very, very scarce products and just as some companies are announcing successes there are others - and we've had two over the last few days - that have said they have challenges with their product either in terms of the volumes they can produce or in terms of some of the trial results. 00:40:09 So this reminds us that while the beam, as you said, or light at the end of the tunnel is getting brighter over time it's still a long tunnel to get out of the battle against COVID and we still have a long winter in front of us. I think, to the points that Mike emphasises again and again, we have to do everything and we need to continue doing everything for the foreseeable future because with that light at the end of the tunnel we should have a new energy now to do the case finding right, do the contact tracing right, do the isolation right. So what this really should give us is the hope and the stamina to be managing this disease and implementing those measures that much more strongly in the near term. Perhaps Soumya'd like to comment to the broader agenda of work on confidence building. FC Thank you. Dr Ryan. 00:41:01 MR No, with specific reference to Georgia itself, Georgia's had a tough time over the last number of weeks. It's had a very steep rise in cases and has reached pretty high cases per million population overall although that's stabilised in the last week; there's been a 9% increase in cases in the last week and, I think, an 8% increase in deaths. So Georgia's had - certainly in the first wave earlier in the year Georgia managed to avoid a good deal of the impact of the first elements of this pandemic but has been hit quite hard this time around. I think the positive answers or news are that the case fatality rate has been relatively low and again credit to front-line doctors and nurses who continue to maintain front-line services. But I think the story here too for Georgia - and I think it's something that every country needs to look at; past success or past avoidance of a given scenario does not mean that that scenario can be avoided the next time around. You may have dodged a bullet the last time; you may get hit hard this time and therefore it's really important that you understand in a given setting... You see situations like for example at the moment in Korea and in Japan; they've been dealing with a bounce in cases in the last couple of weeks. Korea's been an extremely high performer in the area of disease control but it's going to have to turn and fight that disease again and each and every time there may be different risk groups, it may be a different part of the country, it may be a different age group. 00:42:35 Each time you fight this battle there are slightly different tactics required and that's why you need to be agile, you need to look at what's happening in your country, you need to not make assumptions about what's going to happen or things are going to go away or going to disappear or whatever all the other euphemisms are for this. You've got to fight what you see; knowledge and data drives that, understanding what's happening and then giving people the right information, intervening aggressively in the right places, adapting your control measures to the situation you see on the ground, expanding your testing and improving your capacity to understand clusters and amplification events and then supporting people in avoiding crowded settings and doing all of the other things we need to do. 00:43:16 The DG keeps saying it again and again; do it all. But I would also say, do it smart, when you have limited resources do it smart as well and use those resources and drive your public health interventions with the intelligence that comes from using science and using data, a data-driven, science, driven approach. Again Georgia is turning that corner. It is not an easy time and we've seen in Europe that as the disease has come under control in many of the Western European countries, many Central European countries, in the Caucasus and even in central Asia have continued to have a difficult time and then that shows how this disease is in a different... We're not in an epidemiologically stable situation. The virus is still working its way through the human population. The vast majority of people remain susceptible so it has not settled down into a pattern that you can predict and say, oh, this is what's going to happen next week and the week after. That is not the case and there are potentially unique aspects of every country's culture and behaviour and set-up that can drive transmission one way or the other. Maria. MK I just want to say, it's moving around from your question a little bit but I just want to highlight some of the things Mike has just said there. 00:44:31 It is about being in a state of readiness. We know so much more now, we're using data to drive our actions and if a country is having an increase in cases as we're seeing in Georgia you still have experience. There's a lot of experience and knowledge that is being used to help tailor the approach to what needs to be done, where it needs to be done and for the amount of time that it needs to be done. That's done at a political level, it's done at a community level, it's done at an individual level and with the example of Korea - and we could choose a number of countries that have seen a resurgence - it's about that state of readiness. If you use the system that you have in place - the world is not in the same place we were in a year ago. Many countries have built up this public health infrastructure, some at a faster rate than others but we still need to continue to invest in people in a workforce that can do active case finding, that can carry out those tests and that strategic testing so that lab results get back quicker, so that we carry out the contact tracing and the cluster investigations. 00:45:32 This virus likes people, it needs people to transmit between. It's primarily transmitting between people in close contact with one another. If you put a lot of people together, you're in an enclosed space, you add poor ventilation you are providing an ample opportunity for this virus to spread. We can take actions that can prevent all of that from happening and I think that's what's really critical right now. As Bruce said, as the vaccines are coming online there's a lot of hope that we have but I think many people will also feel a little bit frustrated because we won't be able to get to that light at the end of the tunnel as fast as we want to. We have to remain vigilant and your question was what should we tell the people of Georgia. Hang in there, do everything that you can to protect yourself and to protect your loved ones. You have individual-level measures that you can have. You have knowledge about where this virus is, how it spreads and you have the power to take decisions. 00:46:27 Each of these decisions that you take can minimise your risk. We are telling everyone, know your risk and take steps to lower that risk. We want people to feel empowered, that there's a lot you can do and again, especially as we're seeing in this holiday season, please make the right decisions to keep yourselves safe. While we are seeing in many countries across Europe a decline in cases, as the Director-General has said, the percent increase in deaths globally, as the Director-General said, has been a 60% increase in the last six weeks; a 60% increase in deaths in the last six weeks. That is not evenly distributed around the world where we've seen in EMRO a 10% increase, in AFRO a 50% increase, in EURO almost a 100% increase in deaths over the last six weeks, SIERO 7.5%, PAHO 54%, WPRO 15% so it isn't evenly distributed. This virus is still circulating. Most of the world remains at risk. We can take steps to protect ourselves. Please do everything you can to protect yourself and your loved ones. FC Thank you. Dr Tedros. 00:47:40 TAG Thank you. This is a rare treat from Georgia so thank you and greetings to Georgia first of all. That question is very important. As Bruce said, the light at the end of the tunnel is getting brighter - I fully agree - with more vaccines now in the pipeline. At the same time we have to also focus on some of the challenges we're facing to make the light really completely bright. There are three major areas where we're focused and the challenges we're facing are associated with those. Number one, funding. There is a need for immediate funding of up to US$4 billion; that's one. Second, we have all followed what has been happening in the last few months. Many world leaders, our political leaders have pledged to make vaccines a global public good. That pledge has to be translated into action so that's second. We expect our leaders to really honour their pledge. We see some concerns but I hope we will have the vaccines on the ground based on the pledges that have been made. Third is infrastructure; the whole supply chain, especially of developing countries, has to be strengthened, has to be prepared; the supply chain, training of health workers and so on. We're doing that and that's the other area where we're focusing because when we do these three things - the funding, the political commitment translated into action and preparing the infrastructure - then the vaccines that are coming into the pipeline will lead into vaccination. 00:49:49 At the end of the day the most important part of the whole process is when you see people vaccinated, when they have the inoculation and when that is done fairly and when that's done globally. When that's done then the world can recover faster and, as we said many times, sharing the vaccine and having the inoculation everywhere in all countries means faster recovery and it's in the interests of each and every country in the world. Lives and livelihoods will get back to the new normal and we believe that's what the world wants. Thank you. FC Thank you, Dr Tedros. Dr Swaminathan, you have the floor. SS Thank you, Fadela. Very quickly on building confidence in vaccines, which was the third question. It's really important that governments and public health officials start communicating with citizens in their countries to explain to them the process of the deployment of the vaccines because things are happening extremely fast and people are anxious for information, they have a lot of questions and very often it's genuine questions that people have that need to be answered. 00:51:23 They may have some fears that need to be allayed but a lot of times it's questions and doubts which really need to be addressed and it's only a minority of people, I think, who are anti-vaccine. The surveys that have been done showed that the majority of the world's people actually want a vaccine, they're waiting for a vaccine, they can't get it soon enough. At the same time they may have questions so this is the time to explain to people who are the population groups who have been prioritised, why have they been prioritised, when are the doses likely to come. The fact is that we are going to have limited doses in the first half of 2021 all over the world. Dose supplies are going to be limited. We need to prioritise those who are at the highest risk of getting the infection or dying from the infection. These are our front-line workers, our healthcare workers and the very elderly who are the most susceptible. 00:52:19 The rest of us have to be a little more patient. We have to continue with all the measures that we've talked about and these are the things that governments need to communicate so it's important to have a national vaccine deployment plan and a strategy. One of the key elements of that is the communication to the public and the more open and transparent we can be the more likely it is that people will have the trust and the confidence and will not only want to take the vaccine but will also be patient and wait for their turn. Thank you. MR Just very practically on that, we've been working very, very closely; the Immunisation Programme with Kate and the Emergencies Programme on our side have joined together with UNICEF and the International Federation of the Red Cross and Red Crescent Societies on a common service around risk communication and community engagement and specifically in the area of vaccination. 00:53:15 So if countries require more integrated systems and services and support there is the planning part but then there's the implementation so we take this deadly seriously. This is a science and this is a moment of translating our knowledge and communications into behaviour and action and demand and it doesn't happen by itself. It requires a dedicated and committed investment in social engagement so we stand ready as three organisations and others to support member states and people and nongovernmental organisations in the field in doing that and we are specifically investing in a strand of activity to support the implementation of the ACT Accelerator and the preparation of countries for successful vaccination campaigns. Kate O'Brien, Sylvie Briand and others are leading on that internally here at WHO. We have many excellent colleagues in UNICEF and Red Cross working with us on this portfolio. FC Thank you so much to all of you. I would like now to invite Sophie from SABC South Africa to ask the next question. Sophie, are you with us? 00:54:22 SO Yes, I'm here; Sophia Mkwena from the South African Broadcasting Corporation. The topic of vaccines on the African continent at times can be very controversial because there's a perception that the continent is being used for all the trials. There's a heated debate in South Africa currently. The Chief Justice of the Constitutional Court yesterday - a very religious person - when he was praying he prayed that there shouldn't be a vaccine that is being manufactured based on gammon [?]. Therefore that has generated a heated debate and it has instilled fear in some people, questioning, particularly after he also pointed out, why do you give people vaccine when they are not necessarily infected. I just want to check from Dr Ryan and Dr Tedros; this will demand a serious discussion and perhaps senior leaders to deal with the issue of perception. What is your advice to the African continent, particularly South Africa, at a time when the numbers are currently going up? We are in the second wave of the infection. FC Thank you, Sophie. Dr Ryan. 00:55:59 TAG Dr Tedros and Dr Aylward or Soumya may wish to comment but if we take a step back and look at it from the perspective of Africa, Africa has used vaccines as one of the single most effective public health interventions over the last 30 years on the continent. Africa has just recently eradicated the wild polio virus; it has put the wild polio virus to death on the continent using vaccination. The way in which African nations, even with weaker health systems, have prioritised immunisation of children; this has been the single biggest life-saving intervention on the continent. Therefore I think Africa is to be commended for the way in which immunisation has been used, has been trusted by populations and has been instrumental in reducing mortality rates. When a new vaccine is introduced there are always concerns and there are always questions and increasingly there are people who will distribute disinformation and misinformation and anti-vaccination information. The dialogue is needed at community level in order to address those concerns and we were just speaking about that, how we can deal with that. But certainly we need leaders and others to be very consistent in their messaging to people. We need people not to be raising fears but we need people at the same time not to be, in a sense, ignoring fears. You have to address people's fears with knowledge and with information and allow people to make up their own minds. 00:57:30 I have great faith in people in Africa in general. South Africa and other countries - and again in this African countries have actually shown the way in this response, in community engagement; they've led the way on community-led responses. African countries have - for example the laboratories in South Africa, in Senegal have been reference centres for diagnostics and even the development of diagnostic tests within Africa. Africa CDC and our African regional office have worked and the African Union have taken a big leadership role - the DG may wish to speak to that - on the continent. So Africa's doing well and Africans should be proud of what's being achieved. The next move of bringing in vaccines - and again South Africa, I believe, has participated in vaccine trials and has been at the leading edge of science and other types of trials for other diseases over many years. 00:58:23 It is really important though that countries that do support vaccine trials and countries that do participate in advancing science and innovation have fair and equitable access to the products that come from that process. That's another issue; the DG speaks to that process of equity but in this I think African nations and particularly South Africa are partners in science, they're partners in the innovation but communities have genuine questions that need to be addressed. Bruce may wish to speak or Soumya or others but again I think we need to be very rational in how we approach this discussion. Vaccination, immunisation are life-saving interventions, they have saved hundreds of millions of lives on this planet. We need to maintain our standards, we need to be sure that everything is safe and efficacious but we also need to trust in vaccination as a potentially game-breaking and game-changing intervention in this pandemic. Bruce. BA Thanks, Mike, and thanks, Sophie. These are such important questions and hardly unique to South Africa; you highlighted a couple of times specifically in the context of South Africa but in fact it's not just a South Africa issue - Mike alluded to this a little bit - but in every country there are people who raise questions. 00:59:42 But at the same time there's no question that vaccines are one of the most powerful public health tools that we have and certainly no population, no people would want to be disadvantaged in terms of being able to access them. That's what the entire COVAX facility, the ACT Accelerator is all about. At the same time we're got to make sure that when there are questions raised they get listened to and they get addressed and it's so important to create the fora for discussing these things, to listen to the concerns and then to use the science and the data available to be able to answer those. One of the striking things - Dr Tedros talked about in his opening remarks - was the speed with which science has created tools now and vaccines, it appears, to be able to tackle this disease. But at the same time as striking has been the amount of transparency and the amount of scrutiny that's been given to these products. It's extraordinary and I think one of the great advantages here - I'll come back to South Africa - is that in South Africa you have such experts in the area of vaccines and vaccination, really world leaders in fact, whose counsel we take. 01:00:56 So I think the country's in a very, very strong position, like all countries, to create those fora for the discussion, to listen to the issues and to address them but this has got to be anchored in what is now decades and decades of experience with vaccines, the power of vaccine and the countless millions of lives that have been saved as a result of them and that will be saved from COVID-19 as a result of these vaccines as they're proven and as they come eventually to market and to use. But again, as Dr Tedros said in his last intervention, a vaccine only saves lives when it's actually in someone, not in a vial so the big key now is making sure these products get out, get scaled to people as rapidly as possible. FC Dr Tedros, you have the floor. TAG Thank you. Thank you, Sophie, for those questions and I fully agree with what my colleagues said, especially with regard to some wrong perceptions of the vaccine, that's not just in Africa but it's all over the world. 01:02:01 Then when we come to the testing, especially the vaccines for COVID have been tested outside Africa more than in Africa. Having the testing, as long as the right protocols are followed, is very important and that's what has been done and the testing, I don't think, has been focused in Africa actually; it's more outside but the most important thing is whether it has followed the right protocols or not, whether it's done in Africa or other places but it's done in many places. Then when vaccines are introduced, whether they get emergency use least or finally pre-qualifications, the safety is central in addition to efficacy. So we follow that and other organisations, regulatory bodies also follow that and we will make sure that whatever vaccine is available the two important criteria are met; the safety first and then of course the efficacy. Then the issue you raised with religion; I remember when HIV reached its climax and some medicines started to appear and some people were saying, either you follow your religion or you follow the medicine, the two can't go together. 01:03:48 But religion and science can go together and I remember during that time religious leaders themselves came out and told the public that taking the medicine and doing their religious practices actually don't contradict one another. Many accepted that and many took medicines and they saved their lives. So for our religious leaders it's very important to see from the right authorities whether the right safety and efficacy measures; based on those the medicine or the vaccine is being provided or not; that's what they should focus on. Actually I would like to use this opportunity; it's the role of leaders - religious leaders, community leaders, political leaders - to be models and examples, to convince their followers to do the right thing. I hope our religious leaders will do their best to fight the pandemic, to fight the virus using the tools we have at hand and when vaccines are provided to also help their followers to benefit from the vaccines. I thank you. Thank you, Sophie. MR The DG mentioned something there and I think it was important. I think there are vaccine trials ongoing of different types in more than 50 countries around the world and only three are in Africa right now. The vast majority of trials are occurring in South America, in Central America, in North America, in Europe, in East Asia, in the Western Pacific, in Southern Africa and also, I think, in Kenya as well. 01:05:52 So the vaccine testing is distributed... In fact it's a wonderful example of the absolutely global collaboration. It's the most amazing thing to look at a world map and see the number of therapeutic trials, the number of vaccine trials that are going on and the way in which that data is being shared between the public and the private sector, the way that data is being shared between academics and WHO. So I think it's an actual sign of tremendous faith in the global system that such collaboration exists and Africa is part of that. FC Thank you so much. We will take a last question from China Daily. Chen from China Daily, you have the floor; last question. CH Hi, thank you very much for the opportunity. This year, 2020, looks quite bleak obviously. You mentioned about the light at the end of the tunnel. Could you give us a picture of what the coming year, 2021, will look like, how many miracles this vaccine will do? Are we still going to get our lives back or see new wave after wave of cases, lock-down after lock-down and travel restrictions still there? What's the picture in your mind? Thank you. 01:07:17 FC Thank you, Mr Chen. Dr Ryan. MR I suppose it's one of these moments where you say to everyone, let me give this to you straight. The situation globally is still very epidemiologically unstable. The vast majority of the world's population remains susceptible to this infection. Some countries are on a very negative trajectory in terms of the incidence and death rates for this disease and most countries even at low levels are still at risk of a disease resurgence. It's clear though and what we have learned and the hope is that many countries have demonstrated that this disease can be suppressed and controlled and that control can be maintained at low levels. But some countries face the current challenge of intense community transmission in the context of a seasonal period when it's very difficult to separate people adequately. For those countries who are not in that situation and are achieving lower levels of transmission avoiding intense community transmission must be an absolute objective in the coming weeks and months; avoiding going back into situations that require a lock-down because if that can be avoided and when we have now a vaccine coming online it can give great hope. 01:08:42 So our strategy is we must continue with a comprehensive approach to controlling this disease; control, containment, suppression and mitigation together while introducing vaccine in a stepwise way. Testing needs to continue to be expanded, we need more testing but strategic testing that tells us where the virus is. We still need more and better therapeutics. We tend to forget a little bit, we're all jumping on the vaccine story but actually dexamethasone and other drugs are saving lives so we need better and new therapeutics and that's another big piece of ACT at the moment. But vaccines will make a huge difference. I'll let Bruce speak to how that will and can happen. They're a massively valuable tool but vaccines by themselves will not equal zero COVID. They will have a major impact on morbidity and mortality, who gets sick and how sick people get and whether they die as we vaccinate those high-risk groups. 01:09:42 But the impact on transmission will not come until a much higher proportion of the population of a country is vaccinated and, as I said, as the DG says, we have to continue to do it all, we have to continue to do it smart but vaccine represent a major light at the end of the tunnel but we have much work to do to make that a reality. I'll hand over to Bruce or others who wish to comment and then the DG may wish to wrap up on that. BA Yes, thanks, Mike. I like the way Mike started when he said, I'll give it to you straight, because we'll go into the coming year with more hope definitely. We're in a completely different position in terms of the knowledge of this disease, the knowledge of the enemy and also the tools with which we'll fight the enemy; there's no question as well. But we also know that there're going to be challenges to scale up those tools, to get them out, to get them applied and to see them make the difference we want so you use that metaphor as well; the light at the end of the tunnel. 01:10:43 It's a long tunnel, to give it to you straight, it is a long tunnel and when we look at the epidemic curve - remember now, the world is used to looking at these curves and you'll remember, they don't go up like that and come straight down, do they? They go up and then they peak and then they come down slowly and they come down over time. Some of the tools will help us drive those curves down faster but it's not going to change, boom, like that overnight, which means again, to the point Mike, Maria and Dr Tedros make repeatedly, this should give us hope and with that hope we should have a new energy, a new stamina to apply the measures that can make a difference. There's no reason for us to see the same epidemic next year because we know how to beat this disease but we've got to apply the knowledge that we know in a way that we haven't to the degree possible in 2020. When you look at the places that have they had a very different epidemic. That's what we should be looking at. 01:11:43 FC Thank you. I think Dr Kelley would like to add something. Dr Kelley, you have the floor. EK Yes, just a quick thing to add to those two good comments. Next year IMF and World Bank are predicting that 3% of the world economy will contract and that we will have millions, 30 million people who will be put into poverty so on the eve of universal health coverage day next year for WHO certainly and for a lot of countries will be the year of trying harder. We'll have to continue on this push for the response, just as Mike was saying, just as Bruce was saying but we will also have to be continuing to work and expand this idea of what is essential; expanding access to healthcare to ensure that people have access for COVID but also to ensure that when this is all over we're able to say that we were able to treat those people that needed essential services as well. That, I think, will be something that will be coming through in the next year. FC Thank you, Dr Kelley. Dr Van Kerkhove would like to add something. MK I'm sorry. I know we shouldn't all answer the same questions but it's a really great question and I just want to talk at the individual level. We see countries right now that have brought COVID under control, that are opening up, that have stadiums full of people who are at sporting events and I've been getting a lot of questions lately at the end of the year thinking at the year round-up of, what is this going to look like. 01:13:09 You've heard us say before that it is completely in our hands. We have the tools now to bring this virus under control. Vaccine and vaccination is an additional tool that we will have but I think everyone needs to start to think about the patience that we will need in 2021 to get us through this, to see us through the end of this and what is our motivation to get there. I've seen a lot of really excellent interviews lately about people saying, I didn't think about this for me, I wasn't worried about me getting infected but I was worried about my most favourite person in the world, I was worried about the person that I love most in the world and I would do anything I could to keep them from getting infected. I think whatever it is that motivates you to protect yourself but even moreso to protect that person that you love most in the world, do that and do it now because that's what 2021 is going to look like. That is what is going to help us bring this under control and the vaccinations coming online is incredibly hopeful but we need the patience to get us to that endpoint and it will take some time. 01:14:17 So we don't have that exact end date but if you think of some of the countries that have actually brought it under control they're almost there. They have to keep it up, they have to remain vigilant and keep it down so that it doesn't resurge because no-one - you've heard Dr Tedros say this so often - no-one is safe until everyone is safe. But find your motivation that will help keep you and your loved ones safe because that is what 2021 means to me. FC Dr Tedros, you have the floor for your final comments. TAG Thank you. Thank you, everyone for joining and see you next week in our next presser. Bon week-end; have a nice weekend. FC Thank you, DG. Just to remind journalists, we will be sending the opening remarks of Dr... 01:15:07

Design and development of a mobile app of drug information for people with visual impairment.

BACKGROUND: People with visual impairment presents difficulties to access the labels information of medicines. In this sense, technological tools can contribute to improve access to this information and the appropriate use of medicines in this population. However, currently, in Colombia, there are no tools to facilitate this process. OBJECTIVE: To design and development of a mobile app of drug information for people with visual impairment, which allows them to access information for the appropriate use of medicines. METHODS: A user-centered design process is carried out in four phases was used: a) Identification the needs and barriers for appropriate use of medicines; b) Lifting of requirements, c) Interface design and prototyping, and development of the mobile app, and d) Usability test. RESULTS: The study involved 48 people with visual disability, of which 69% required assistance for the use of medicines. The main barriers identified were access to information and dosing. A total of ten user requirements were identified, based on these and international accessibility standards FarmaceuticApp was designed and developed, incorporating the problems that were identified in the usability test. CONCLUSION: A mobile app of drug information for people with visual impairment using a user-centered design process was designed and developed, highlighting the importance of involving the users and other stakeholders in the design and development m-health technologies. FarmaceuticApp could contribute to the appropriate use of medicines and improve therapeutic adherence, as well as autonomy and independence in people with visual impairment.

NPS MedicineWise: 20 years of change.

The cost and potential harms of medicines and other health technologies are issues of concern for governments and third party payers of health care. Various means have been demonstrated to promote appropriate evidence-based use of these technologies as a way to reduce waste and unintended variation. Since 1998, Australia has had a national organisation responsible for large scale programs to address safe, effective and cost effective use of health technologies. This article reviews 20 years of experience for NPS MedicineWise (NPS). NPS provides evidence-based information to health professionals and consumers using interventions that have been shown to be effective. A mix of academic detailing, audit and feedback and interactive learning is built into national programs designed to improve the use of medicines and medical tests. The target audiences have typically been general practitioners, pharmacists and nurses in primary care. Consumer programs, including mass media campaigns have supported the work with health professionals. NPS receives most of its income from the Australian Government and in return it is required to show saving for the Pharmaceutical Benefits Scheme and the Medical Benefits Schedule. Since 1998, total savings of AUD 1096.62 million have been demonstrated. In addition, changes in knowledge and attitudes, changes in prescribing and test ordering behaviours and improvements in health outcomes have been shown through annual evaluations.

Decisiones informadas en medicamentos de alto impacto financiero (DIME). Un ejemplo de transferencia de conocimiento a nivel regional / Informed decisions in high-financial impact medicines (DIME). An example of knowledge transfer at the regional level

Introducción: Las decisiones de inclusión de medicamentos en planes de beneficios deben estar basadas en Evaluaciones de Tecnología ­ET­ en metodologías transparentes, robustas y válidas, deben considerar los precios comparados a los que se compran los medicamentos, su estatus de competencia y deben considerar la información de decisiones de cobertura en otros países y las estrategias de uso racional que permitan modular los impactos de las de-cisiones sobre el consumo. Objetivo: Describir cómo se diseñó y puso en marcha un bien público regional consistente en una plataforma web basada en la gestión del conocimiento de países de Latinoamérica y el Caribe como respuesta a la presión impuesta por los fabri-cantes globales de medicamentos y tecnologías médicas sobre los presupuestos públicos del sector salud. Metodología: Se describen los antecedentes que motivaron la creación de una plataforma web de información sobre medicamentos de alto impacto financiero, la metodo-logía para su desarrollo y los resultados y productos diseñados gracias a una comunidad de expertos de organismos gubernamentales y universidades de distintos países de América Lati-na, para facilitar la trasferencia del conocimiento a los tomadores de decisiones en la región. Resultados: Los tomadores de decisiones farmacéuticas de la región cuentan con información comparada de precios, competencia, decisiones de cobertura, uso racional de medicamentos para 35 medicamentos. Se realizaron acciones de capacitación local en ET en los países parti-cipantes. En la actualidad se dispone de 25 informes de evaluación de tecnología regionales y modelos metodológicos para su desarrollo. La región latinoamericana y del Caribe cuenta con un importante grupo de investigadores con capacidad de trabajar en equipo para realizar acti-vidades de transferencia del conocimiento. Conclusiones: Es posible desarrollar estrategias de transferencia y gestión del conocimiento a nivel regional, con el fin de lograr una mejor gestión en medicamentos y tecnologías en beneficio de la salud de la población de la región

Introduction: Drug inclusion decisions in benefit plans should be based on technology as-sessments (ET) based as well on robust and valid transparent methodologies; they should consider prices as compared to market value, their competitive status and the information of coverage decisions in other countries, rational use strategies that modulate the impacts of decisions on consumption. Objective: To describe how a regional public good was designed and implemented; it consists in a web platform based on knowledge management in Latin American and Caribbean countries, done in response to the pressure imposed by global phar-ma and medical technologies manufacturers on public health sector budgets. Methodology:We describe the background that motivated the creation of a web platform for information on high financial impact medicines, the methodology for its development and results, and prod-ucts designed thanks to a community of experts from government agencies and universities in different Latin American countries. This was done to facilitate the transfer of knowledge to decision makers in the region. Results: Pharmaceutical decision makers in the region have comparative information on prices, competence, coverage decisions, and rational use of med-icines for 35 products. Local training actions were carried out in ET in participating countries. Currently, there are 25 regional technology assessment reports and methodological models for their development. The Latin American and Caribbean region has an important group of re-searchers with the ability to work as a team to carry out knowledge transfer activities. Conclu-sions: It is possible to develop knowledge transfer and management strategies at a regional level in order to achieve better management of medicines and technologies for the health of the population of the region

Garantías de la legislación para evitar adiccionesen los medicamentos / Legislation's guarantees to prevent addictionsin medicinal products

En la actualidad, las nuevas tecnologías de la información y comunicación (TICs) se aplican a distintos ámbitos, entre ellos, el farmacéutico. El acceso por internet a medicamentos y productos sanitarios es una realidad. El paciente que necesita el medicamento para su curación o mejora de su salud, es considerado para la legislación como consumidor, consume un producto y de ahí la aplicación de una normativa múltiple que está relacionada con su protección. Sin embargo, otra perspectiva es el medicamento como droga para determinadas patologías y la generación de una adicción, en los casos de consumo incorrecto o en combinación con otras sustancias no permitidas. El propósito del presente trabajo es analizar cuáles son los instrumentos de garantía que establece la normativa para el paciente-consumidor tras la reciente aprobación del Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios, así como las medidas para evitar la adicción y la protección que otorga la legislación para evitar dicho consumo inadecuado

The new information and communication technologies (Tics) are applied today in differ-ent areas, including the pharmaceutical field. Access over the Internet to medicines and sanitary products is a reality. The patient who needs the medicine for his/her treatment or improving his/her health, is considered as far as legislation is concerned as a consumer, consumes a product and therefore entails the application of a multiple regulation that is related to his/her protection. Nevertheless, from another perspective the medicinal prod-uct can be seen as a drug for certain pathologies and the generation of an addiction, in the cases of incorrect consumption or in combination with other, forbidden substances. The intention of the present paper is to analyze what guarantee instruments are established by the regulation for the patient-consumer after the recent approval of Royal Legislative Decree 1/2015, of 24 July enacting the consolidated restated text of the Spanish Act on guarantees and rational use of medicines and healthcare products, as well as the mea-sures to avoid addiction and the protection that is granted by legislation to prevent the aforementioned improper consumption

Avaliação econômica das abordagens terapêuticas para o tratamento das hepatites B e C: comparação das diretrizes nacionais e internacionais / Economic evaluation of therapeutic approaches for the treatment of hepatitis B and C: comparison of national and international guidelines

As hepatites virais B e C, nas últimas décadas, emergiram e se mantiveram em evidência como um grande problema de saúde pública. O desenvolvimento e a disseminação do uso de medicamentos antivirais vêm contribuindo para a diminuição da carga dessas infecções em nível individual e coletivo. Especialmente na última década, disponibilizaram-se tecnologias mais seguras e eficazes para o diagnóstico precoce e para o tratamento. No intuito de assegurar o uso racional desses insumos, muitos países elaboraram recomendações que incluem, os critérios de inclusão e exclusão para o tratamento e o estabelecimento do curso terapêutico. As recomendações nacionais e internacionais para o tratamento das hepatites B e C divergem em diversos aspectos, principalmente no que se refere aos fármacos eleitos como primeira linha de tratamento e ao público prioritário. No caso da hepatite C, o Ministério da Saúde brasileiro indica a terapia tripla somente para portadores de doença hepática avançada. O consenso internacional, representado pela OMS, pela AALSD e pelo NICE, assume direção oposta, ao propor como público prioritário, indivíduos com hepatite leve e moderada. As recomendações nacionais e internacionais para o tratamento da hepatite B se assemelham em grande medida, mas são conflitantes no que diz respeito aos medicamentos eleitos como primeira escolha. Com base nas divergências das diretrizes terapêuticas nacionais e internacionais, esse estudo objetivou confrontar as óticas nacionais e internacionais e avaliar as estratégias mais custo-efetivas para o tratamento contra o vírus da hepatite B (VHB) e o vírus da hepatite C (VHC) sob a perspectiva do SUS. Os resultados do modelo econômico construído indicam que o uso precoce e universal dos inibidores de protease (IPs) emerge como a conduta mais racional para o tratamento da hepatite C crônica na atualidade. Essa abordagem resulta em melhores desfechos clínicos e econômicos se comparada à terapia dual (peguinterferon + ribavirina) e ao uso de IPs no caso de refratariedade ao tratamento prévio e especialmente quando empregada restritamente aos casos de fibrose avançada, tal como recomendado pelas diretrizes nacionais. Na avaliação do custo-efetividade das recomendações terapêuticas para o tratamento contra o VHB em indivíduos HBeAg não reagentes, o uso do tenofovir se mostrou a estratégia mais eficiente. A terapia com tenofovir constitui a primeira linha de tratamento nas diretrizes nacionais atuais e foi a que apresentou maior efetividade associada ao menor custo global, contrariando as proposições de protocolos internacionais e de algumas publicações anteriores. Em síntese, a análise farmacoeconômica comparativa entre as diretrizes nacionais e internacionais para o tratamento das hepatites crônicas revela que a conduta de tratamento contra o VHB adotada no Brasil é adequada pelos pontos de vista clínico e econômico. Em contrapartida, as mesmas conclusões não se aplicam ao caso do tratamento da infecção do genótipo 1 da hepatite C, que, da forma como está sendo conduzido, penaliza uma parcela significativa dos indivíduos portadores, por oferecer o que há de mais avançado em tratamento antiviral exclusivamente aos pacientes com menores chances de resposta, maior risco de desenvolvimento de intolerância medicamentosa e já em estágio terminal da doença hepática

In the last decades, viral hepatitis B and C have emerged and have remained in evidence as a major public health problem. The development and dissemination of the use of antiviral drugs has contributed to reduce the burden of these infections at the individual and collective levels. Especially in the last decade, safer and more effective technologies have been made available for early diagnosis and treatment. In order to ensure the rational use of antivirals, many countries have developed recommendations that adds the inclusion and exclusion criterias for the treatment and establishment of the therapeutic course. National and international recommendations for the treatment of hepatitis B and C differ in several respects, especially for the drugs chosen as the first treatment line and for the priority public. In the case of hepatitis C, the Brazilian Ministry of Health indicates triple therapy only for patients with advanced liver disease. The international consensus, represented by WHO, AALSD and NICE, assumes the opposite direction proposing as a priority public, individuals with mild and moderate hepatitis. National and international recommendations for the treatment of Hepatitis B closely resemble each other but are in conflict with regard to medicines chosen as the first choice. Based on divergences among national and international therapeutic guidelines, this study aimed to compare national and international perspectives and to evaluate the most cost-effective strategies for the treatment of hepatitis B virus (HBV) and hepatitis C virus (HCV) from the SUS perspective. The results of the constructed economic model indicate that the early and universal use of protease inhibitors (PIs) emerges as the most rational conduct for the treatment of chronic hepatitis C today. This approach results in better clinical and economic outcomes compared to dual therapy (peginterferon + ribavirin) and the use of PIs in the case of refractoriness to previous treatment and especially when used strictly to cases of advanced fibrosis, as recommended by the national guidelines. In cost-effectiveness evaluation of the therapeutic recommendations for the treatment against HBV in non-reactive HBeAg individuals, the use of tenofovir was the most efficient strategy. In current national guidelines, tenofovir is recommended as the first-line treatment and was the one with the highest effectiveness associated with the lowest overall cost, contrary to the proposals of international protocols and some previous publications. In summary, the comparative pharmacoeconomic analysis between the national and international guidelines for the treatment of chronic hepatitis reveals that the treatment approach against HBV adopted in Brazil is adequate from the clinical and economic points of view. In contrast, the same conclusions do not apply to the treatment of hepatitis C genotype 1 infection, which, as it is being conducted, penalizes a significant portion of carriers because it offers the most advanced antiviral treatment exclusively to patients with lower chances of response, higher risk of developing drug intolerance and already in the terminal stage of liver disease

Políticas Públicas y Acceso a Medicamentos en el Ecuador / Public Policies and Access to Medicines in Ecuador

El documento recoge el debate del acceso a medicamentos, muestra como por un lado hay millones de personas que necesitan medicamentos esenciales y no tienen acceso a ellos, por otro la industria mantiene un incremento constante de sus beneficios, muestra como tal contradicción se presenta por que las industrias han priorizado la investigación, desarrollo y producción de los productos más rentables y no siempre los más necesarios.Se plantea que una política pública que pretenda favorecer el acceso a los medicamentos, debe basarse en generar listados de medicamentos esenciales, y pro-mover un uso racional de los mismos, además de establecer mecanismos de fijación de precios y regulaciones que permiten enfrentar el carácter imperfecto del mercado de medicamentos.

The document includes the discussion of the access to medicines, it shows how there are millions of people who need essential medicines and have no access to them, and by the other hand, the industry maintains a continuous increase in its profits, and it shows how a contradiction is presented because the industries have prioritized research, development and production of the most profitable products, and not always the most needed products.It is argued that a public policy that seeks to promote access to medicines should be based on establishing lists of essential drugs and promotes rational use of them, also they should establish mechanisms of pricing and regulations that allow facing the imperfect nature drug market.

Improving safety, quality and efficacy of medicines in the Americas / Mejora de la seguridad, calidad y eficacia de los medicamentos en la Región de las Américas

In the Region of the Americas, access to medicines and other health technologies constitutes a priority for countries as they continue to move towards universal access to health and universal health coverage. Ensuring the availability of affordable medicines and health technologies within health services is required as part of the comprehensive approach to disease prevention and control. Through the adoption of pharmaceutical policies and strategies at the national level, governments establish the framework that will ensure equitable access and affordability of medicines and health technologies, while promoting their rational use. Core to such policies and strategies is the principle of quality, safety and efficacy. The pharmaceutical and health technology sector plays a critical role in the health promotion and protection by ensuring that those products and technologies made available through the health systems respond to international norms of quality and safety. The role of the government, and in particular the ministry of health, jointly with interested stakeholders, is to create a regulatory environment that guarantees the quality of the product throughout its life cycle, to ensure patient safety and optimize health outcomes. As globalization continues, with an ever increasing flow of people and products across borders, product quality and safety becomes a co-responsibility between countries and interconnected regulatory systems—nationally, regionally and globally. The regulatory landscape for medicines and health technologies is complex, given the multiple different types of product (medicines, biologicals, medical devices, etc.), the co-existing of single, limited and multiple source products within the market, the increasing technological complexity of new products entering the market (genomic, biotechnical products, etc.), and the critical array of regulatory functions (clinical studies, manufacturing, distribution, post marketing surveillance, etc.)...

The use of 'Omics technology to rationally improve industrial mammalian cell line performance.

Biologics represent an increasingly important class of therapeutics, with 7 of the 10 top selling drugs from 2013 being in this class. Furthermore, health authority approval of biologics in the immuno-oncology space is expected to transform treatment of patients with debilitating and deadly diseases. The growing importance of biologics in the healthcare field has also resulted in the recent approvals of several biosimilars. These recent developments, combined with pressure to provide treatments at lower costs to payers, are resulting in increasing need for the industry to quickly and efficiently develop high yielding, robust processes for the manufacture of biologics with the ability to control quality attributes within narrow distributions. Achieving this level of manufacturing efficiency and the ability to design processes capable of regulating growth, death and other cellular pathways through manipulation of media, feeding strategies, and other process parameters will undoubtedly be facilitated through systems biology tools generated in academic and public research communities. Here we discuss the intersection of systems biology, 'Omics technologies, and mammalian bioprocess sciences. Specifically, we address how these methods in conjunction with traditional monitoring techniques represent a unique opportunity to better characterize and understand host cell culture state, shift from an empirical to rational approach to process development and optimization of bioreactor cultivation processes. We summarize the following six key areas: (i) research applied to parental, non-recombinant cell lines; (ii) systems level datasets generated with recombinant cell lines; (iii) datasets linking phenotypic traits to relevant biomarkers; (iv) data depositories and bioinformatics tools; (v) in silico model development, and (vi) examples where these approaches have been used to rationally improve cellular processes. We critically assess relevant and state of the art research being conducted in academic, government and industrial laboratories. Furthermore, we apply our expertise in bioprocess to define a potential model for integration of these systems biology approaches into biologics development.