Vacuna Johnson & Johnson contra COVID-19: distribución mundial de la vacuna, mecanismo de acción, indicaciones, contraindicaciones y efectos secundarios. Una revisión bibliográfica / Johnson & Johnson vaccine against COVID-19: worldwide vaccine distribution, mechanism of action, indications, contraindications and side effects. A literature review

El SARS-CoV-2, causante de que estemos viviendo una pandemia mundial, tuvo sus orígenes en China, desde donde ha traspasado fronteras rápidamente, llegando a todos los rincones del mundo. Muchos han sido los equipos de investigación que se enfrentan el reto de conseguir una vacuna que logre combatir este mortal virus. Es por este motivo que en esta investigación se pretendió analizar la bibliografía referida a la vacuna Johnson & Johnson (J&J) contra COVID-19: distribución mundial de la vacuna, mecanismo de acción, indicaciones, contraindicaciones y efectos secundarios. Varios estudios demuestran que su eficacia varía de acuerdo con la edad y género de cada individuo; sin embargo, esta vacuna alcanzó un grado de certeza moderada. Los efectos adversos en su mayoría son leves y se resolvieron al cabo de dos días, siendo excepción algunos casos, ya que se registró un efecto adverso poco común denominado trombocitopenia prevalente en mujeres de 18 a 40 años, por este motivo, la FDA (Administración de Alimentos y Medicamentos de EE.UU.) recomienda la precaución en el uso de la vacuna con respecto a este efecto adverso que en algunos casos podría ser mortal (AU)

The SARS-CoV-2, which caused us to be experiencing a global pandemic, had its origins in China, from where it has crossed borders rapidly, reaching all corners of the world. Many research teams have faced the challenge of getting a vaccine to fight this deadly virus. For this reason, this research aimed to analyze the literature on the Johnson & Johnson COVID-19 vaccine: global distribution of the vaccine, mechanism of action, indications, contraindications and side effects. Several studies show that its effectiveness varies according to the age and gender of each individual, but this vaccine reached a moderate degree of certainty. The adverse effects are mostly mild and resolved within two days, with some exceptions being a rare adverse effect called prevalent thrombocytopenia in women aged 18 to 40 years. For this reason, the FDA recommends caution in the use of the vaccine with respect to this potentially fatal adverse effect in some cases (AU)

Inactivación potencial del coronavirus SARS-CoV2: ¿qué agentes germicidas se proponen? / Inativação potencial do coronavírus SARS-CoV2: quais agentes germicidas são propostos? / Potential inactivation of SARS-CoV2 coronavirus: which germicidal agents are proposed?

La enfermedad por coronavirus 2019 (COVID-19), una afección respiratoria aguda causada por el SARS-CoV2, ha sido clasificada como pandemia por la Organización Mundial de la Salud (OMS) una vez que se ha expandido a 215 países del mundo, ha infectado a más de 7.800.000 personas y cerca de 440.000 personas han muerto por su causa1. El SARS-CoV2 es un coronavirus tipo ß de características genómicas similares al MERS-CoV y al SARS-CoV1 los cuales afectaron a más de 10.000 personas en las últimas dos décadas2,3. Debido a la alta tasa de contagio y propagación del SARS-CoV2, diversas medidas de mitigación han sido empleadas. Entre las medidas adoptadas se encuentran la cuarentena, el distanciamiento físico, la limpieza de superficies y aerosoles, así como el uso de equipos de protección personal (EPP)2­6 Dado que no se dispone de vacuna y tratamientos suficientemente efectivos, evitar el contagio por contacto directo con superficies, aerosoles o suspensiones contaminadas con el SARS-CoV2 es la primera y más importante medida de contención contra la pandemia7. Esto obedece a que el SARS-CoV2 puede sobrevivir por 3 h en aerosoles, 4 h en superficies de cobre, un día en cartón, dos días en acero inoxidable y hasta 3 días en plástico8. Dada la alta demanda de los EPP, que provoca escasez y obliga a la reutilización de estos7,9, métodos eficaces de limpieza son cruciales.

Preparation of Coronavirus nosodes sourced from a clinical sample of SARS-Cov-2 positive patient, inactivated strain, and spike glycoprotein

IntroductionNosodes, the homeopathicpreparationssourcedfrom biological materials including clinical samples, cultures of organisms, and diseased tissues have been in use against the source-specific infections as well as other diseases. The nosodes have demonstrated some efficacy in managing epidemics, such as influenza, dengue, and leptospirosis.This article presents the need and process of development ofnosodes from the SARS-CoV-2 to explore its prophylactic and therapeutic potentials against certain related viral diseases.Materials and methodsA clinical sample of SARS-Cov-2 positive patient,based on the cycle threshold (CT) value of the qRT-PCR, heat-inactivated SARS-CoV-2, and spike glycoprotein all were processed for making nosodesas per the method described in Homoeopathy Pharmacopoeia of India.Molecular tests, such as qRT-PCR and sterility tests were performed to establish the live organisms, RNA material, and the absence of contamination.ResultsThree variants of CoronavirusNosodewere developed using a clinical sample,heat-inactivatedSARS-CoV-2, and spike glycoprotein.In potencies 3c and above, no detectableSARS-CoV-2 RNA material was found by PCR.The analytical results for nosodes were reported as compliant for sterility testing as per the IP.ConclusionThree variants of Coronavirus nosodes were preparedwhich need to be evaluated further through pre-clinical and clinical studies.(AU)

Inactivación del carbapenémico, un método alternativo para detectar carbapenemasa tipo KPC en Enterobacteriaceae / Carbapenem inactivation, an alternative method to detect carbapenemase type KPC in Enterobacteriacea

Objetivo: Evaluar al método de inactivación del carbapenémico (MIC*) frente a técnicas como el Test de Hodge modificado (THM), ácido 3-aminofenilborónico (APB) y la reacción en cadena de la polimerasa en enterobacterias productoras de carbapenemasas (EPC) tipo KPC. Materiales y métodos: Se seleccionaron 88 aislados clínicos de K. pneumoniae, K. oxytoca, E.coli, S. marcescens, C. freundii sensibles y 91 resistentes a los carbapenémicos. El APB y el método MIC* se realizaron siguiendo las publicaciones originales. El THM se realizó de acuerdo al CLSI 100S Edición 26-2016. El gen blaKPC se identificó por multiplex PCR. Resultados: El MIC* en EPC tipo KPC presentó una sensibilidad/especificidad cercana al 100% y kappa de 1 comparado con la PCR; se observó la ausencia de halo en todas los aislados EPC tipo KPC a diferencia de los aislados sensibles a los cabapenémicos que presentaron halo > 19mm. Se observó el 3 % de resultados falsos positivos y el 5 % de falsos negativos en THM y ABP respectivamente. Discusión y conclusiones: El MIC* y la PCR demuestran superioridad al THM y ABP para identificar carbapenemasas tipo KPC en EPC. Se recomienda su uso de forma rutinaria dentro del algoritmo para la contención de infecciones por este tipo de patógenos.

Objective: To compare the carbapenem inactivation method (CIM *) with the Modified Hodge Test (MHT), the acid 3-aminophenylboronic test(APB) and the polymerase chain reaction (PCR) detection of the blaKPC gene for the identification of KPC carbapenemase producing Enterobacteriaceae (ECP). Materials and Methods: We selected 88 susceptible and 91 carbapenems resistant clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca, Escherichia coli, Serratia marcescens and Citrobacter freundii. We performed APB and CIM* according to previously published methods and the MHT according to CLSI 100S Edition 26-2016. The blaKPC gene was identified by PCR multiplex. Results: The CIM* had a sensitivity and specificity close to 100% and a kappa score of 1 compared with gold standard PCR. The absence of zone diameter was observed in all isolated KPC producers, unlike in isolates susceptible to carbapenems, where a zone diameter >19mm was observed. Three percent of false positive and five percent of false negative was observed in THM and ABP respectively. Discussion and conclusions: The CIM* and the PCR were better than MHT and ABP at identifying carbapenemases in ECP. We recommend the routine use of the CIM* within the algorithm for ECP infection control.

Degradation and inactivation of adenovirus in water by photo-electro-oxidation / Degradação e inativação de adenovírus na água por fotoeletrooxidação

The present study analyzed the efficiency of the photo-electro-oxidation process as a method for degradation and inactivation of adenovirus in water. The experimental design employed a solution prepared from sterile water containing 5.107 genomic copies/L (gc/L) of a standard strain of human adenovirus type 5 (HAdV-5) divided into two equal parts, one to serve as control and one treated by photo-electro-oxidation (PEO) for 3 hours and with a 5A current. Samples collected throughout the exposure process were analyzed by real-time polymerase chain reaction (qPCR) for viral genome identification and quantitation. Prior to gene extraction, a parallel DNAse treatment step was carried out to assess the integrity of viral particles. Integrated cell culture (ICC) analyses assessed the viability of infection in a cell culture. The tested process proved effective for viral degradation, with a 7 log10 reduction in viral load after 60 minutes of treatment. The DNAse-treated samples exhibited complete reduction of viral load after a 75 minute exposure to the process, and ICC analyses showed completely non-viable viral particles at 30 minutes of treatment.

Resumo O presente estudo analisou a eficiência do processo de fotoeletrooxidação como metodologia para a degradação e inativação de adenovírus em água. A concepção experimental emprega uma solução preparada a partir de água estéril contendo 5,107 cópias genômicas/L (gc/L) de uma amostra padrão de adenovírus humano tipo 5 (HAdV-5), dividida em duas partes iguais, uma para servir como controle e outra tratada por fotoeletrooxidação (PEO) durante 3 horas e com uma corrente de 5A. As amostras recolhidas durante o processo de exposição foram analisadas por PCR quantitativo em tempo real (qPCR) para identificação e quantificação do genoma viral. Antes da extração de ácidos nucleicos, um passo de tratamento com DNAse paralelo foi realizado para avaliar a integridade das partículas virais. Um ensaio de qPCR integrado à cultura de células (ICC-qPCR) permitiu analisar a viabilidade de infecção em uma cultura de células. O processo mostrou-se eficaz testada para a degradação viral, com uma redução de 7 log10 da carga viral após 60 minutos de tratamento. As amostras tratadas com DNAse exibiram redução completa da carga viral após uma exposição de 75 minutos ao processo, e a análise de ICC-qPCR mostrou partículas virais completamente não-viáveis ​​em 30 minutos de tratamento.

In vitro inhibition of the bovine viral diarrhoea virus by the essential oil of Ocimum basilicum (basil) and monoterpenes

The bovine viral diarrhoea virus (BVDV) is suggested as a model for antiviral studies of the hepatitis C virus (HCV). The antiviral activity of the essential oil of Ocimum basilicum and the monoterpenes camphor, thymol and 1,8-cineole against BVDV was investigated. The cytotoxicities of the compounds were measured by the MTT (3-(4.5-dimethylthiazol-2-yl)-2.5-diphenyltetrazolium bromide) test, and the antiviral activities were tested by the plaque reduction assay. The oil or compounds were added to the assay in three different time points: a) pre-treatment of the virus (virucidal assay); b) pre-treatment of the cells; or c) post-treatment of the cells (after virus inoculation). The percentage of plaques inhibition for each compound was determined based on the number of plaques in the viral control. The results were expressed by CC50 (50% cytotoxic concentration), IC50 (inhibitory concentration for 50% of plaques) and SI (selectivity index = CC50/IC50). Camphor (CC50 = 4420.12 µgmL-1) and 1,8-cineole (CC50 = 2996.10 µgmL-1) showed the lowest cytotoxicities and the best antiviral activities (camphor SI = 13.88 and 1,8-cineol SI = 9.05) in the virucidal assay. The higher activities achieved by the monoterpenes in the virucidal assay suggest that these compounds act directly on the viral particle.

Viral inactivation in hemotherapy: systematic review on inactivators with action on nucleic acids

The aim of this study was to conduct a systematic review on the photoinactivators used in hemotherapy, with action on viral genomes. The SciELO, Science Direct, PubMed and Lilacs databases were searched for articles. The inclusion criterion was that these should be articles on inactivators with action on genetic material that had been published between 2000 and 2010. The key words used in identifying such articles were "hemovigilance", "viral inactivation", "photodynamics", "chemoprevention" and "transfusion safety". Twenty-four articles on viral photoinactivation were found with the main photoinactivators covered being: methylene blue, amotosalen HCl, S-303 frangible anchor linker effector (FRALE), riboflavin and inactin. The results showed that methylene blue has currently been studied least, because it diminishes coagulation factors and fibrinogen. Riboflavin has been studied most because it is a photoinactivator of endogenous origin and has few collateral effects. Amotosalen HCl is effective for platelets and is also used on plasma, but may cause changes both to plasma and to platelets, although these are not significant for hemostasis. S-303 FRALE may lead to neoantigens in erythrocytes and is less indicated for red-cell treatment; in such cases, PEN 110 is recommended. Thus, none of the methods for pathogen reduction is effective for all classes of agents and for all blood components, but despite the high cost, these photoinactivators may diminish the risk of blood-transmitted diseases.

Validación de la capacidad del proceso de pasteurización de la albúmina humana para inactivar virus / Validation of the capacity of the human albumin pasteurization process for virus inactivation

La validación de la capacidad de aclaramiento viral de los procesos de fabricación de productos biológicos constituye un requisito regulatorio en Cuba. Se recomienda introducir la pasteurización en los procesos de producción de la albúmina como un método capaz de inactivar virus; por ello, el objetivo del estudio fue validar la capacidad de inactivación viral de la etapa de pasteurización del proceso de producción de la albúmina humana al 20 y 25 por ciento. Los modelos virales que abarcan los posibles contaminantes de la materia prima, se diluyeron 1:10 en la albúmina en sus 2 concentraciones y se sometieron a tratamiento térmico a 60 °C durante 10 h. Se tomaron muestras a diferentes intervalos de tiempo para la confección de las curvas de cinética de inactivación. Se determinó el factor de reducción aportado por la pasteurización para cada virus. El tratamiento a 60 °C de la albúmina al 20 y 25 por ciento disminuyó significativamente la carga viral inicial con que se retó la etapa, con valores de p< 0,002 y p< 0,021, respectivamente, y se obtuvieron factores de reducción superiores a 4 log del título de todos los virus. La etapa de pasteurización le aportó a la albúmina humana al 20 y 25 por ciento un adecuado nivel de seguridad

The validation of the capacity of viral clearance in the manufacturing processes of biopharmaceuticals is a regulatory requirement in Cuba. It is recommended to introduce the pasteurization in the manufacturing processes of serum albumin as a method of inactivating viruses. The objective of this study was to validate the capacity of viral inactivation in the phase of pasteurization of the 20 percent and 25 percent human albumin production process The viral models covering the possible pollutants of the raw materials were diluted at 1:10 in albumin in 2 concentrations and they were heat-treated at 60 °C for 10 h. Several samples at different time intervals were taken to design the inactivation kinetic curves. The reduction factor of pasteurization for each virus was estimated. The treatment of 20 percent and 25 percent albumin at 60 °C decreased significantly the initial viral load in the stage, with p< 0.002 and p< 0.021 respectively. The reduction factors exceeded 4 log of the titers of all viruses. The stage of pasteurization gave adequate level of safety to the 20 percent and 25 percent human albumin

A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation

Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia.

Obteve-se concentrado de imunoglobulina G intravenosa IgGIV, altamente purificado, utilizando-se polietilenoglicol associado a uma única etapa de precipitação por etanol, em substituição ao tradicional método descrito por Cohn-Oncley, que emprega, em três etapas, o mesmo álcool resfriado, como agente precipitante. A purificação da fração bruta contendo mais de 95% de imunoglobulina G foi realizada utilizando-se cromatografia líquida com um trocador de cátion, a CM-Sepharose, como fase estacionária. Durante o processamento o produto foi submetido a dupla inativação viral sendo a primeira pela ação do caprilato de sódio, 30 mM a pH 5,1+/- 0,1 e a segunda por ação de mistura de solvente/detergente. O produto acabado foi formulado a 5% utilizando-se sucralose 10% como estabilizante. O rendimento da metodologia foi de 3,3g de IgG/litro de plasma. A análise do produto acabado demonstrou atividade anti-complementar inferior a 1CH50. O valor percentual de polímeros e agregados em cinco lotes realizados foi inferior a 3%. O estudo da capacidade de neutralização demonstrou a presença de anticorpos anti-bacterianos e anti-virais em concentração pelo menos três vezes maior que o plasma de origem. O produto acabado apresentou conformidade com todos os requisitos de pureza dispostos na farmacopéia européia IV edição.

Supervivencia y transporte de los virus entéricos humanos a través de los alimentos / Survival and transport of human enteric viruses in foods

Los virus se transmiten a los seres humanos vía los alimentos como resultado de la contaminación directa o indirecta de los mismos con heces; ésta es la esencia del análisis de peligro...