USFDA Commissioner Stephen Hahn said that USFDA has been preparing for review of EUAs for COVID-19 vaccines for the past several months and requests will be processed "as expeditiously as possible"
US health regulator has said that it will assess on December 10 the emergency use authorisation (EUA) submission by Pfizer and BioNTech for their experimental coronavirus vaccine. The authority said that its vaccine panel will convene to consider the request of this date.
The US Food and Drug Administration (USFDA) said that it "has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to discuss the request for emergency use authorisation (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH."
Emergency use authorisations are approvals granted by USFDA to medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.
A federal register notice with additional details of the meeting will be shared next week, USFDA said in a recent statement. The regulator said that it intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.
The notice will include information about a public docket for submitting comments. These comments will then be reviewed by USFDA.
"The FDA recognises that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA's process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible," said FDA Commissioner Stephen M Hahn.
Hahn said that USFDA has been preparing for review of EUAs for COVID-19 vaccines for the past several months and requests will be processed "as expeditiously as possible".
Earlier this week, Pfizer and BioNTech closed clinical trials for its mRNA coronavirus vaccine candidate BNT162b2, claiming 95 per cent vaccine efficacy. Shortly after, the companies had approached USFDA for EUA. Pfizer has said that it also in the process of securing approvals from regulators around the world.
The US-based pharma major has claimed that its EUA submission is based on vaccine efficacy rate of 95 per cent demonstrated in Phase 3 clinical study. The submission is also supported by solicited safety data from a randomised subset of approximately 8,000 participants aged 18 years or above and unsolicited safety data from approximately 38,000 trial participants, Pfizer said.