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EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

The European Medicines Agency (EMA) has said it will not set a minimum level of efficacy for potential COVID-19 vaccines, instead opting to assess vaccines on a ‘case by case’ basis, according to Reuters.

This differs from guidance from the US Food and Drug Administration (FDA) which has advised that vaccine developers seeking approval need to have a minimum efficacy of at least 50%.

The FDA also added that data from phase 3 studies of any potential COVID-19 vaccines needs to include a median follow-up duration of at least two months after participants receive their final dose.

A number of COVID-19 vaccines have entered late-stage trials, and the EMA has already launched rolling reviews for a number of candidates – including those from Pfizer, AstraZeneca and Moderna.

A number of experts have called for increased transparency around the efficacy and safety data for potential COVID-19 vaccines as they move through advanced stage testing and toward regulatory approval.

“We really need safety information on the full planned sample size in order to give us the sort of good grounds to believe not only that a vaccine works but, crucially, that it’s safe,” bioethicist Charles Weijer told The BMJ.

“We’re going to be giving this vaccine to hundreds of millions of healthy people. To be able to reliably detect a very rare adverse event which is associated with the vaccine – something that occurs in one in 10,000 people – you need safety data on 60,000 people,” he added.

In September, leading researchers and bioethicists signed a letter urging Pfizer to delay submitting a marketing authorisation application for its COVID-19 vaccine, BNT162b2.

At the time, reports had emerged that Pfizer and its partner BioNTech were expecting conclusive results from a study of the vaccine in October.

Since then, Pfizer’s chief executive officer Albert Bourla said in an earnings call on 27 October that a data monitoring committee has not yet conducted any interim efficacy analysis of its COVID-19 vaccine.

He added that “in [the] case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know”.

Article by
Lucy Parsons

5th November 2020

From: Regulatory



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