Información científica de vacunas contra el COVID-19 autorizadas para su uso en la emergencia por distintas agencias.
Introducción
Seguidamente, con una finalidad científica, se pone a disposición de los interesados información relevante de la autorización de emergencia de la FDA, la EMA y otras agencias de medicamentos, tomada de fuentes originales y oficiales.
Esta información corresponde alguna de las casi 10 vacunas que han sido o están próximas a ser aprobadas por distintas agencias de medicamentos en el mundo. La selección de los productos no juzga sobre las bondades y calidad de los mismos.
[El editor no se compromete a actualizar esta información].
En particular, todos estos documentos desmienten la información falsa y anticientífica publicada por columnistas de los diarios Clarín y La Nación que -a pesar del riesgo a la salud de la población que crean- han recibido escasas réplicas que, de todos modos, requieren más fundamentos médicos.
Vacuna mARN BioNTech / Pfizer
La tecnología y las patentes de la mRNA vaccine (anti SARS-CoV-2) corresponden a la titularidad de la firma Biontech de Alemania. Como antecedente esa firma desarrolló la tecnología de mRNA-based personalized cancer vaccine, de aplicación en oncología, una de sus divisiones de negocios.
Documentos relevantes
Como se podrá observar de la lectura de los informes, es de destacar que el informe de de evaluación y aprobación fue -en razón de las circunstancias apremiantes y la complejidad del problema- confeccionado y refrendado por un conjunto de profesionales que forman un equipo multidisciplinario.
Oxford University/AstraZeneca COVID-19 vaccine
Medicines and Healthcare products Regulatory Agency (RU)
Condiciones esenciales de la autorización extraordinaria de emergencia
- This temporary Authorisation under Regulation 174 permits the supply to and by the Crown of COVID-19 Vaccine AstraZeneca, based on the safety, quality and efficacy data submitted by AstraZeneca (AZ) to MHRA in the period from 24/09/2020 to 29/12/2020 December 2020.
- This authorisation is not a marketing authorisation for the purposes of Part 5 of the HMRs or Chapter 4 of Title III to the 2001 Directive.
- As provided in Regulation 174A(2) of the Human Medicine Regulations, the sale or supply of this vaccine will not be deemed to be licensed or approved under this Authorisation if the supply is for the purpose of any use other than the recommended or required use, or if a condition in this authorisation is breached (including the conditions of use incorporated into this Authorisation).
- The entities responsible for physically supplying the product in the United Kingdom are AstraZeneca AB, SE-151 85 Sodertalje, Sweden and AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA. These two entities (hereinafter AZ) will be jointly and separately responsible for placing the product on the market in the United Kingdom for the purposes of The Human Medicines Regulations including Regulation 345(3).
- AZ are jointly and separately responsible, with the manufacturers of the product, for the conditions relating to the manufacture of the product, product release to the market under the terms of this authorisation.
Agencia europea (EMA)
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
News 12/01/2021
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted.
Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data from laboratory studies (non-clinical data), data on the vaccine’s quality (on its ingredients and the way it is manufactured) and some evidence on safety and efficacy from a pooled analysis of interim clinical data from four ongoing clinical trials in the United Kingdom, Brazil and South Africa. Additional scientific information on issues related to quality, safety and efficacy of the vaccine was also provided by the company at the request of CHMP and is currently being assessed.
During the review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
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