RESUMEN
Introducción: El reconocimiento de la enfermedad COVID-19 como pandemia, planteó un reto a las Autoridades Reguladoras Nacionales del Medicamento (ARNs). Éstas tuvieron que desarrollar pautas, procedimientos, crear grupos de trabajo y alianzas para maximizar la eficiencia de la evaluación, revisión y autorización de las vacunas. El objetivo del presente trabajo es la exposición de los procedimientos empleados en Estados Unidos, Unión Europea y América Latina para autorizar el uso de las vacunas frente a la COVID-19; y ello con el fin de determinar si la multiplicidad de procedimientos ha dado origen al registro de un elevado número de vacunas. Método: Se realizó una revisión de la legislación farmacéutica usada para la emisión de autorizaciones de las vacunas para la COVID-19, durante la emergencia sanitaria. La información fue recopilada hasta el 15/10/2022. Las fuentes consultadas fueron sitios web gubernamentales de las ARNs: Estados Unidos, Unión Europea y América Latina. Resultados: Los Estados Unidos y la Unión Europea usaron actividades consignadas en sus flujos estándares, tales como el pre-Investigational New Drug, y el asesoramiento científico y rolling review, respectivamente. Por su parte, América Latina, hizo uso extensivo del reliance y la autorización de uso de emergencia, con el fin de acceder al mayor número posible de vacunas. Conclusiones: Los procedimientos usados son diversos, pero todos ellos están orientados a proporcionar de manera rápida un producto de contención a la pandemia. Está diversidad da como resultado la presencia de distintas vacunas en Estados Unidos, Unión Europea y América Latina. (AU)
Introduction: The recognition of the COVID-19 disease as a pandemic posed a challenge to the National Drug Reg-ulatory Authorities (NRAs). They had to develop guidelines, procedures, create working groups and partnerships to maximize the efficiency of vaccine evaluation, review and licensure.The aim of this article is to present the procedures used in the United States, European Union and Latin America to license the use of vaccines against COVID-19; in order to determine whether the multiplicity of procedures has led to the registration of a large number of vaccines. Method: A review of the pharmaceutical legislation used for the issuance of COVID-19 vaccines licenses during the health emergency was carried out. The information was collected up to October 15, 2022. The sources consulted were government websites of the NRAs: United States, European Union, and Latin America. Results: The United States and the European Union used activities included in their standard flows, such as pre-In-vestigational New Drug, scientific advice and rolling review, respectively. Latin America, on the other hand, made extensive use of reliance and emergency use authorization in order to access as many vaccines as possible. Conclusions: The procedures used are diverse, but all of them are oriented to provide a rapid pandemic contain-ment product. This diversity results in the presence of different vaccines in the United States, European Union and Latin America. (AU)
Asunto(s)
Humanos , Pandemias , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/tratamiento farmacológico , Vacunación Masiva/legislación & jurisprudencia , Estados Unidos , América Latina , Unión EuropeaAsunto(s)
Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , Programas de Inmunización/legislación & jurisprudencia , Programas Obligatorios/legislación & jurisprudencia , Vacunación Masiva/legislación & jurisprudencia , COVID-19/epidemiología , Humanos , Estados Unidos/epidemiologíaRESUMEN
Mass vaccination offers a promising exit strategy for the COVID-19 pandemic. However, as vaccination progresses, demands to lift restrictions increase, despite most of the population remaining susceptible. Using our age-stratified SEIRD-ICU compartmental model and curated epidemiological and vaccination data, we quantified the rate (relative to vaccination progress) at which countries can lift non-pharmaceutical interventions without overwhelming their healthcare systems. We analyzed scenarios ranging from immediately lifting restrictions (accepting high mortality and morbidity) to reducing case numbers to a level where test-trace-and-isolate (TTI) programs efficiently compensate for local spreading events. In general, the age-dependent vaccination roll-out implies a transient decrease of more than ten years in the average age of ICU patients and deceased. The pace of vaccination determines the speed of lifting restrictions; Taking the European Union (EU) as an example case, all considered scenarios allow for steadily increasing contacts starting in May 2021 and relaxing most restrictions by autumn 2021. Throughout summer 2021, only mild contact restrictions will remain necessary. However, only high vaccine uptake can prevent further severe waves. Across EU countries, seroprevalence impacts the long-term success of vaccination campaigns more strongly than age demographics. In addition, we highlight the need for preventive measures to reduce contagion in school settings throughout the year 2021, where children might be drivers of contagion because of them remaining susceptible. Strategies that maintain low case numbers, instead of high ones, reduce infections and deaths by factors of eleven and five, respectively. In general, policies with low case numbers significantly benefit from vaccination, as the overall reduction in susceptibility will further diminish viral spread. Keeping case numbers low is the safest long-term strategy because it considerably reduces mortality and morbidity and offers better preparedness against emerging escape or more contagious virus variants while still allowing for higher contact numbers (freedom) with progressing vaccinations.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Vacunación Masiva , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , COVID-19/epidemiología , COVID-19/prevención & control , Niño , Preescolar , Unión Europea/estadística & datos numéricos , Humanos , Lactante , Recién Nacido , Vacunación Masiva/legislación & jurisprudencia , Vacunación Masiva/estadística & datos numéricos , Persona de Mediana Edad , Adulto JovenAsunto(s)
Vacunas contra la COVID-19/uso terapéutico , COVID-19/prevención & control , Vacunación Masiva/legislación & jurisprudencia , Salud Pública/legislación & jurisprudencia , Estudiantes/legislación & jurisprudencia , COVID-19/epidemiología , Humanos , Programas Obligatorios , Estudiantes/estadística & datos numéricos , Universidades/legislación & jurisprudenciaRESUMEN
BACKGROUND: In Italy, in recent years, vaccination coverage for key immunizations as MMR has been declining to worryingly low levels, with large measles outbreaks. As a response in 2017, the Italian government expanded the number of mandatory immunizations introducing penalties to unvaccinated children's families. During the 2018 general elections campaign, immunization policy entered the political debate with the government in-charge blaming oppositions for fuelling vaccine scepticism. A new government (formerly in the opposition) established in 2018 temporarily relaxed penalties and announced the introduction of forms of flexibility. OBJECTIVES AND METHODS: First, we supplied a definition of disorientation, as the "lack of well-established and resilient opinions among individuals, therefore causing them to change their positions as a consequence of sufficient external perturbations". Second, procedures for testing for the presence of both short and longer-term collective disorientation in Twitter signals were proposed. Third, a sentiment analysis on tweets posted in Italian during 2018 on immunization topics, and related polarity evaluations, were used to investigate whether the contrasting announcements at the highest political level might have originated disorientation amongst the Italian public. RESULTS: Vaccine-relevant tweeters' interactions peaked in response to main political events. Out of retained tweets, 70.0% resulted favourable to vaccination, 16.4% unfavourable, and 13.6% undecided, respectively. The smoothed time series of polarity proportions exhibit frequent large changes in the favourable proportion, superimposed to a clear up-and-down trend synchronized with the switch between governments in Spring 2018, suggesting evidence of disorientation among the public. CONCLUSIONS: The reported evidence of disorientation for opinions expressed in online social media shows that critical health topics, such as vaccination, should never be used to achieve political consensus. This is worsened by the lack of a strong Italian institutional presence on Twitter, calling for efforts to contrast misinformation and the ensuing spread of hesitancy. It remains to be seen how this disorientation will impact future parents' vaccination decisions.
Asunto(s)
Confusión , Vacunación Masiva/psicología , Opinión Pública , Medios de Comunicación Sociales/estadística & datos numéricos , Cobertura de Vacunación/estadística & datos numéricos , Política de Salud/legislación & jurisprudencia , Política de Salud/tendencias , Italia , Vacunación Masiva/legislación & jurisprudencia , Vacunación Masiva/estadística & datos numéricos , Política , Cobertura de Vacunación/legislación & jurisprudenciaAsunto(s)
COVID-19/prevención & control , Erradicación de la Enfermedad/métodos , Pandemias/prevención & control , Enfermedad Relacionada con los Viajes , Viaje/legislación & jurisprudencia , COVID-19/epidemiología , COVID-19/transmisión , COVID-19/virología , Vacunas contra la COVID-19/administración & dosificación , Vacunas contra la COVID-19/inmunología , Erradicación de la Enfermedad/organización & administración , Salud Global , Humanos , Vacunación Masiva/legislación & jurisprudencia , Mutación , Políticas , SARS-CoV-2/genética , SARS-CoV-2/inmunología , SARS-CoV-2/patogenicidadRESUMEN
About a year into the pandemic, COVID-19 accumulates more than two million deaths worldwide. Despite non-pharmaceutical interventions such as social distance, mask-wearing, and restrictive lockdown, the daily confirmed cases remain growing. Vaccine developments from Pfizer, Moderna, and Gamaleya Institute reach more than 90% efficacy and sustain the vaccination campaigns in multiple countries. However, natural and vaccine-induced immunity responses remain poorly understood. There are great expectations, but the new SARS-CoV-2 variants demand to inquire if the vaccines will be highly protective or induce permanent immunity. Further, in the first quarter of 2021, vaccine supply is scarce. Consequently, some countries that are applying the Pfizer vaccine will delay its second required dose. Likewise, logistic supply, economic and political implications impose a set of grand challenges to develop vaccination policies. Therefore, health decision-makers require tools to evaluate hypothetical scenarios and evaluate admissible responses. Following some of the WHO-SAGE recommendations, we formulate an optimal control problem with mixed constraints to describe vaccination schedules. Our solution identifies vaccination policies that minimize the burden of COVID-19 quantified by the number of disability-adjusted years of life lost. These optimal policies ensure the vaccination coverage of a prescribed population fraction in a given time horizon and preserve hospitalization occupancy below a risk level. We explore "via simulation" plausible scenarios regarding efficacy, coverage, vaccine-induced, and natural immunity. Our simulations suggest that response regarding vaccine-induced immunity and reinfection periods would play a dominant role in mitigating COVID-19.
Asunto(s)
Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/farmacología , COVID-19/inmunología , COVID-19/prevención & control , Vacunación Masiva , Modelos Teóricos , Evaluación de Procesos y Resultados en Atención de Salud/estadística & datos numéricos , Humanos , Vacunación Masiva/legislación & jurisprudencia , Vacunación Masiva/normas , Vacunación Masiva/estadística & datos numéricosAsunto(s)
Vacunas contra la COVID-19 , COVID-19/prevención & control , Aprobación de Drogas/legislación & jurisprudencia , Empleo/legislación & jurisprudencia , Vacunación Masiva/legislación & jurisprudencia , Salud Laboral/legislación & jurisprudencia , COVID-19/epidemiología , Humanos , Estados UnidosAsunto(s)
COVID-19 , Programas de Inmunización , Pandemias , Negativa a la Vacunación/psicología , Vacunas , Actitud Frente a la Salud , COVID-19/prevención & control , COVID-19/psicología , Vacunas contra la COVID-19 , Francia , Personal de Salud/psicología , Humanos , Programas de Inmunización/métodos , Vacunación Masiva/legislación & jurisprudencia , Padres/psicología , Opinión Pública , SARS-CoV-2/inmunología , Confianza , Incertidumbre , Vacunas/efectos adversosAsunto(s)
Control de Enfermedades Transmisibles/legislación & jurisprudencia , Control de Enfermedades Transmisibles/métodos , Brotes de Enfermedades/prevención & control , Programas de Inmunización/legislación & jurisprudencia , Vacunación Masiva/legislación & jurisprudencia , Cobertura de Vacunación/estadística & datos numéricos , Femenino , Humanos , Inmunidad Colectiva , Irlanda , MasculinoRESUMEN
The national vaccination rate in young children in the Netherlands has decreased in recent years. This has led to social and political discussions, for instance about compulsory vaccination for children in child-care. The national commission on child-care and vaccination has advised that vaccination should be made compulsory when the rate of vaccination has declined to a pre-determined lower threshold, to be determined by the government. A frequently quoted lower threshold is 95%. The idea behind this is the concept of a critical vaccination rate, a threshold needed for elimination of an infection in a large, well-mixed population. In this article we argue why the critical vaccination rate does not offer a scientific basis for a lower threshold to the national vaccination rate.
Asunto(s)
Control de Enfermedades Transmisibles/organización & administración , Vacunación Masiva , Niño , Preescolar , Enfermedades Transmisibles/epidemiología , Disentimientos y Disputas , Regulación Gubernamental , Humanos , Tratamiento Involuntario/legislación & jurisprudencia , Vacunación Masiva/legislación & jurisprudencia , Vacunación Masiva/métodos , Países Bajos/epidemiologíaAsunto(s)
Brotes de Enfermedades , Vacunación Masiva/legislación & jurisprudencia , Vacuna Antisarampión , Sarampión/prevención & control , Medios de Comunicación Sociales , Niño , Preescolar , Humanos , Sarampión/epidemiología , Vacuna contra el Sarampión-Parotiditis-Rubéola , Metáfora , Gobierno Estatal , Estados Unidos/epidemiologíaRESUMEN
Typhoid fever is estimated to affect over 20 million people per year worldwide, with infants, children, and adolescents in south-central and southeast Asia experiencing the greatest burden of disease. The Typhoid Vaccine Acceleration Consortium (TyVAC) aims to support the introduction of typhoid conjugate vaccines into Gavi-eligible countries in an effort to reduce morbidity and mortality from typhoid. TyVAC-Nepal is a large-scale, participant- and observer-blind, individually randomized, controlled trial evaluating the efficacy of a newly developed typhoid conjugate vaccine in an urban setting in Nepal. In order to effectively deliver the trial, a number of key elements required meticulous planning. Public engagement strategies were considered early, and involved the implementation of a tiered approach. Approximately 300 staff were employed and trained in order to achieve the mass vaccination of 20 000 children aged 9 months to ≤16 years old over a 4-month period. There were 19 vaccination clinics established across the Lalitpur metropolitan city in the Kathmandu valley. Participants will be followed for 2 years post-vaccination to measure the rate reduction of blood culture-confirmed typhoid fever in the vaccination arm as compared to the control arm. The experience of conducting this large-scale vaccine trial suggests that comprehensive planning, continuous monitoring, and an ability to adapt plans in response to feedback are key.
Asunto(s)
Implementación de Plan de Salud/métodos , Vacunación Masiva/métodos , Fiebre Tifoidea/prevención & control , Vacunas Tifoides-Paratifoides/administración & dosificación , Adolescente , Niño , Preescolar , Implementación de Plan de Salud/legislación & jurisprudencia , Implementación de Plan de Salud/organización & administración , Humanos , Lactante , Vacunación Masiva/legislación & jurisprudencia , Vacunación Masiva/organización & administración , Nepal , Organización y Administración , Ensayos Clínicos Controlados Aleatorios como Asunto , Vacunas Conjugadas/administración & dosificaciónRESUMEN
Neisseria meningitidis serogroup B (MenB) has caused several recent outbreaks of meningococcal disease on US college campuses. In January 2015, a case of MenB was reported at a university in Oregon, culminating in an outbreak with a total of 7 cases (including 1 fatality) identified over a 5-month period. In response to the outbreak, the university organized a mass immunization campaign with 4 "opt-in" immunization clinics. The preparation, challenges, and resources required for organization and implementation of a mass immunization program in response to an outbreak at a large public university are discussed herein. Based on the logistical challenges as well as resource expenditures associated with planning and executing a mass immunization effort, this experience illustrates that proactive, routine immunization of incoming students is the best strategy for MenB outbreak prevention.
Asunto(s)
Programas de Inmunización , Vacunación Masiva/estadística & datos numéricos , Infecciones Meningocócicas/prevención & control , Vacunas Meningococicas/administración & dosificación , Estudiantes , Universidades/estadística & datos numéricos , Brotes de Enfermedades/prevención & control , Implementación de Plan de Salud , Humanos , Vacunación Masiva/legislación & jurisprudencia , Infecciones Meningocócicas/inmunología , Neisseria meningitidis Serogrupo B/inmunología , Oregon , Estados UnidosRESUMEN
Evidence on influenza vaccine effectiveness from low and middle countries (LMICs) is limited due to limited institutional capacities; lack of adequate resources; and lack of interest by ministries of health for influenza vaccine introduction. There are concerns that the highest ethical standards will be compromised during trials in LMICs leading to mistrust of clinical trials. These factors pose regulatory and operational challenges to researchers in these countries. We conducted a community-based vaccine trial to assess the efficacy of live attenuated influenza vaccine and inactivated influenza vaccine in rural north India. Key regulatory challenges included obtaining regulatory approvals, reporting of adverse events, and compensating subjects for trial-related injuries; all of which were required to be completed in a timely fashion. Key operational challenges included obtaining audio-visual consent; maintaining a low attrition rate; and administering vaccines during a narrow time period before the influenza season, and under extreme heat. We overcame these challenges through advanced planning, and sustaining community engagement. We adapted the trial procedures to cope with field conditions by conducting mock vaccine camps; and planned for early morning vaccination to mitigate threats to the cold chain. These lessons may help investigators to confront similar challenges in other LMICs.
Asunto(s)
Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Vacunación Masiva/organización & administración , Servicios de Salud Rural/organización & administración , Participación de la Comunidad , Humanos , India , Vacunas contra la Influenza/efectos adversos , Vacunación Masiva/efectos adversos , Vacunación Masiva/ética , Vacunación Masiva/legislación & jurisprudencia , Servicios de Salud Rural/ética , Servicios de Salud Rural/legislación & jurisprudencia , Población Rural , Vacunas Atenuadas/administración & dosificación , Vacunas Atenuadas/efectos adversos , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/efectos adversosRESUMEN
France is one of the countries with the highest prevalence of vaccine hesitancy in the world. In an attempt to raise vaccination coverages, the French government made on January 1, 2018 eight more vaccines mandatory in addition to the three required until then. The process that led to this policy choice is of particular interest. We describe how vaccines became contentious in France and how French authorities came to view mandatory vaccination as the solution to the rise in vaccine hesitancy. In a bold move, French public health authorities turned to a new type of institutional device grounded in the ideal of democracy and public participation to political decision-making: "a citizen consultation". This consultation anchored the idea that legal coercion could be the solution to France's crisis with vaccines. Time will tell whether the French extension of mandatory vaccination will reduce tensions around vaccines.