Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter.
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.
The two companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration (FDA) can grant before the final testing is fully complete.
In addition to Friday's FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.
Friday’s filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready.
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.
About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March.
Recipients will need two doses, three weeks apart.
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