Pfizer and its German partner BioNTech will seek emergency use authorization from the Food and Drug Administration for its COVID-19 candidate vaccine. The companies intend to submit the request Friday.
The announcement comes two days after the companies revealed the vaccine, BNT162b2, is 95% effective and the ongoing study’s independent Data Monitoring Board did not report any serious safety concerns.
These two pieces of information mean the vaccine should qualify for emergency authorization from the FDA, the companies said. In addition to Friday’s submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
What happens if Pfizer’s vaccine is authorized?
Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
A few days before the meeting, the FDA will release its own internal analysis, which will set the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict. They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom.
So far, what’s known is based only on statements from Pfizer and BioNTech. Newly released data found the candidate vaccine prevented 95% of infections from the virus that causes COVID-19 after evaluating 170 people who were infected, 162 of whom took the placebo, the company said in a news release. Read Full Article >