November 20, 2020 -- Pfizer and BioNTech will submit a request on November 20 to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their messenger RNA (mRNA) vaccine candidate, BNT162b2, against infection with the SARS-CoV-2 virus.
On this timeline, the companies expect the vaccine to be available for use in high-risk populations in the U.S. by mid to late December 2020.
The submission is based on phase III results demonstrating a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection. Of the 170 confirmed cases of COVID-19 in the trial, only eight cases were from the vaccine treatment group.
The submission also includes safety data on approximately 100 children ages 12-15 years old. To date, the independent data monitoring committee for the study has not reported any serious safety concerns.
"We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible," said Albert Bourla, DVM, PhD, chairman and CEO of Pfizer. Meetings with the FDA are tentatively scheduled for December 8-10.
The companies already have initiated rolling submission with several international regulatory agencies, including the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K.
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