CHICAGO (NewsNation Now) — Pfizer submitted its COVID-19 vaccine for emergency use authorization approval to the Food and Drug Administration Friday. The FDA has scheduled a meeting on Dec. 10 with its Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s request for emergency use authorization.
The emergency use approval could bring limited first shots as early as December to Americans.
Alejandro Cané, the North America chief of scientific and medical affairs for Pfizer’s vaccines division, said earlier this week he can’t confirm the “exact date” of the vaccine release, but said he was “expecting to receive an appointment to have the VRBPAC meeting, which is a requirement from the FDA in this particular cases, and with that, after maybe one or two weeks, we will have the final emergency health authorization that would allow us to distribute the vaccine and to be used based in the recommendations that the ACIP (Advisory Committee on Immunization Practices) will make.”
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
“It is with great pride and joy, and even a little relief, that I can say our request for emergency use authorization is now in the FDA’s hands. This is a historic day, a historic day for science and all of us,” CEO and Pfizer Chairman Albert Bourla said in a video released by the company Friday.
“We are so pleased to announce that this week we are submitting the information coming from our phase 3 clinical trial showing efficacy and safety of our MRNA vaccine’s base against COVID-19 disease. The idea is just to collect all the information from that trial and we are waiting now for the feedback from the FDA (The U.S. Food and Drug Administration) to have a VRBPAC (Vaccines and Related Biological Products Advisory Committee) meeting and after that a potential authorization for our emergency use authorization, and in that way the vaccine could be used and distributed in the U.S.”
Alejandro Cané
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to the FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
The Associated Press and Reuters contributed to this report.
