Pharmaceutical giant Pfizer has put the kibosh on any dreams of rushing out its experimental covid-19 vaccine before the U.S. election day. The good news is that the company is optimistic that its vaccine will be ready to apply for the Food and Drug Administration’s emergency use authorization (EUA) by the end of November, raising hopes that it could see use in the U.S. before the end of 2020.
Pfizer is developing its vaccine in collaboration with the German firm BioNTech, and the companies had previously set a EUA submission target of mid-October. In an open letter published on Friday, Pfizer Chairman and CEO Albert Bourla outlined what steps need to be taken and shifted the estimate for a review in an effort to “clear up a great deal of confusion.”
Bourla explained that the vaccine has to go through three steps in development before FDA approval can begin. The first step is making sure it’s effective in preventing covid-19 infection in most patients. Pfizer believes that data should be in by the end of October. That process involves a review of the blinded data by an independent committee of scientists. The committee’s conclusions will be shared with the public shortly after they’re submitted to Pfizer.
Next, Pfizer has to prove the vaccine is safe and that the manufacturing process can guarantee the consistency and quality of the vaccine. The company said it expects to have the proper data for the manufacturing process in the coming weeks and that the safety trials should be complete by the third week of November.
Bourla’s repeated emphasis on providing “greater clarity” and reducing confusion appears to be related to political noise that has come from the White House in recent months. President Trump has repeatedly given false assurances that a vaccine would be ready before the November 3 election—causing anxiety that the White House could try to rush an unsafe vaccine to market to win points with voters. Facing the risk of losing public confidence in the efficacy of covid-19 vaccines, the FDA issued stricter guidelines for emergency approval reviews, requiring more safety data. The White House blocked those guidelines then quickly unblocked them. So, yeah, you could say there’s been some confusion.
“We are operating at the speed of science,” Bourla said.
At the moment, Pfizer has its eyes on approval in the U.S., but BioNTech plans to seek emergency approvals in Europe shortly after the FDA review, according to the Wall Street Journal. The companies expect to produce 100 million doses by the end of the year—enough to provide the two necessary shots for 50 million people.