Pfizer and BioNTech apply for clearance of their coronavirus vaccine
The application from Pfizer and its German partner BioNTech came after data released on Nov. 9 showed that their vaccine was remarkably effective. A week later, biotechnology company Moderna announced similarly spectacular results. And federal regulators have cleared the first fully at-home test for the coronavirus and the first antibody treatment for covid-19.
Pfizer’s filing with the Food and Drug Administration on Friday signals that a powerful tool to help control the pandemic could start to be available by mid- to late December. That news follows other upbeat developments: On Nov. 9, the FDA authorized the first antibody drug for covid-19. On Monday, Moderna’s vaccine candidate clocked in with nearly 95 percent efficacy in an early analysis. And on Tuesday, Lucira Health’s All-In-One test kit became the first rapid, at-home test authorized by the FDA.
Now, the vaccine effort will move to its next, deliberative phase — a weeks-long process in which career scientists at the FDA scrutinize the data and determine whether the vaccine is safe and effective for a broad population. A committee of external advisers will meet Dec. 10 to make nonbinding recommendations to the agency on whether to authorize a vaccine for broader use.
“It is with great pride and joy, and even a little relief, that I can say our request for emergency-use authorization for a covid-19 vaccine is now in the FDA’s hands,” Pfizer chief executive Albert Bourla said in a video message shared by the company. “This is a historic day — a historic day for science and for all of us.”
An emergency authorization for a vaccine is typically a lower standard than full approval, but FDA guidelines are requiring that a vaccine be at least 50 percent effective, with a minimum of two months of safety data on half the trial participants.
Only after the FDA has given the green light will a first, limited group of high-risk people be able to access the shots. Government officials expect to have enough vaccine to inoculate about 20 million people with the two-dose regimen in the United States in December, between Pfizer and BioNTech’s vaccine and the shot developed by Moderna. The United States will receive about half of the 50 million doses Pfizer is aiming to produce by the end of the year.
There will probably be enough vaccine for 25 million to 30 million people a month in early 2021, according to Moncef Slaoui, chief scientific adviser of Operation Warp Speed, the federal initiative to speed up vaccine development.
source: https://wapo.st/394aF7R
