Pfizer, along with BioNTech, will submit an emergency use authorization request on Friday to the U.S. Food and Drug Administration for their COVID-19 vaccine.
With the EUA, the vaccine could be used in "high-risk" groups in the United States “by the middle to end of December 2020," the companies said.
Final analysis of the COVID-19 clinical trial data released on Wednesday showed the vaccine is 95 percent effective.
The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants =18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine. (Pfizer)
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. 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,” said Pfizer Chairman and CEO Dr. Albert Bourla.
The companies expect to be able to "produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021."
Health and Human Services Secretary Alex Azar said once the companies receive authorization, shipments will begin within 24 hours.
“We will ship millions of doses of vaccine within 24 hours of FDA approval. So my message is hope and help are on the way,” he said Thursday.