Pfizer, BioNTech formally seek emergency use of COVID-19 shots in US

Pfizer, BioNTech seek emergency use of COVID-19 shots in US Pfizer formally asked U.S. regulators Friday 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... AP NEWS

Pfizer formally asked U.S. regulators Friday 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 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....

Friday’s filing sets 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.

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. Globally, Pfizer has estimated it could have 50 million doses available by year’s end.

About 25 million may become available for U.S. use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart. The U.S. government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates than pan out, and has promised shots will be free.

Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks. ...