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Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

Pfizer and BioNTech’s COVID-19 vaccine is the second candidate set to be evaluated by the European Medicines Agency’s (EMA) on a ‘rolling review’ basis.

Earlier this week, the EMA announced that its Committee for Medicinal Products for Human Use (CHMP) had begun a ‘rolling review’ of AstraZeneca/Oxford University’s COVID-19 vaccine candidate.

As part of this review process, the CHMP has already started to evaluating the first data on the Pfizer/BioNTech’s vaccine, including data from laboratories studies of the potential shot.

The ‘rolling review’ process will allow the EMA to analyse data from the potential vaccines as and when it becomes available, rather than traditional methods of submission that require all the data to be available for review.

The decision to begin the review of the vaccine candidate, BNT162b2, is based on preliminary results from non-clinical and early clinical studies in adults. In a phase 1 study of the Pfizer/BioNTech’s candidate, the vaccine demonstrated the ability to produce antibodies and T cells to fight against the SARS-CoV-2 virus, which causes COVID-19.

BNT162b encodes an optimised SARS-CoV-2 full length spike glycoprotein, meaning that it is mRNA-based.

An mRNA vaccine tricks the body into producing some of the targeted viral proteins that, in turn, can be detected by the immune system, which begins to produce antibodies against them.

This technology is so new that, currently, no mRNA-based vaccine has been approved for any infectious disease anywhere in the world.

Pfizer/BioNTech have launched large-scale clinical trials involving thousands of participants, with the first results expected to become available as early as this month.

Last month, a group of leading researchers and bioethicists co-signed a letter urging Pfizer to delay submitting a marketing authorisation with the US Food and Drug Administration for BNT162b2.

The letter was delivered following reports that Pfizer/BioNTech are expecting conclusive results from a study of the mRNA-based COVID-19 vaccine in October, raising concerns that the companies may seek regulatory approval before enough safety data is collected.

The EMA maintained that it will complete its assessment of BNT162b2 according to its ‘usual standards for quality, safety and effectiveness’. However, the ‘rolling review’ is likely to accelerate the timeframe of the evaluation, allowing for an expedited assessment of the COVID-19 vaccine.

Article by
Lucy Parsons

6th October 2020

From: Regulatory



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