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EMA - COVID-19 Vaccines

2nd December 2020

The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19:

·         EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine known as Moderna Covid-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Such a short timeframe 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 and also started assessing data on immunogenicity (how well the vaccine triggers a response against the virus) and safety from an early study.

·         EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2

EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available.

·         EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S

EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus. The company is currently conducting trials in people to assess safety and immunogenicity (how well the vaccine triggers a response against the virus), and effectiveness. EMA will evaluate data from these and other clinical trials as they become available.
 

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