Pfizer Could Seek FDA Emergency Use Authorization for COVID-19 Vaccine in October

(New York, NY, USA) should know by October if its COVID-19 vaccine candidate currently under trial works, based on which it plans to immediately seek Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

Speaking at an online press briefing organized by the International Federation of Pharmaceutical Manufacturers and Associations, Pfizer’s Chief Executive Albert Bourla said that the company would submit the candidate for approval immediately if the vaccine, developed in partnership with Biopharmaceutical New Technologies (BioNTech Mainz, Germany), proved to be safe and effective in the studies.

Pfizer’s recruitment for the trial is currently progressing ahead of its original plans and 23,000 patients have been enrolled until now. According to Bourla, the availability of the vaccine’s study data would be determined by the speed at which its scientists work and the severity of COVID-19 infection at its study locations in the US, Argentina and Brazil.

"Based on our calculations, we are expecting that to be in October," said Bourla.

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Biopharmaceutical New Technologies