Pfizer and BioNTech to request FDA Emergency Use Authorisation for their COVID-19 vaccine today

pharmafile | November 20, 2020 | News story | Medical Communications, Sales and Marketing BioNTech, COVID-19, Pfizer, Vaccine 

Pfizer and BioNTech are reportedly gearing up to submit a formal application for Emergency Use Authorisation to the FDA later today for their jointly-developed COVID-19 vaccine candidate, on the back of final Phase 3 analysis data in which it showed an efficacy rate of 95%.

The move comes only two days after the release of the final analysis data. Applications to other worldwide regulators will swiftly follow, according to the two companies.

Pfizer CEO Dr Albert Bourla said of the move: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

Once the FDA has received the application, the review process to properly evaluate the data will likely take a few weeks before any authorisation can be given. The process will see the vaccine candidate examined by a range of FDA-affiliated and independent experts; a meeting of an advisory committee to review the data is scheduled for early December.

Off the back of the promising vaccine data, Professor Uğur Şahin, Professor of Oncology at the University of Mainz and Chief Executive and Co-Founder of BioNTech, has said that an effective rollout of the candidate around the world in the coming months could mean a “normal winter” next year.

Matt Fellows

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