Pfizer, BioNTech apply for emergency approval in U.S. for COVID vaccine Friday

Pfizer is asking U.S. regulators to allow emergency use of its COVID-19 vaccine on Friday.

This starts 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.

Pfizer says it and its German partner, BioNTech, have “already initiated rolling submissions” across the globe, including in Canada. The pharmaceutical giant says the pair plans to submit applications for their COVID-19 vaccine candidate to global regulatory agencies “immediately.”

#Breaking Pfizer and BioNTech submit emergency use application for Covid-19 vaccine to the FDA. Potential for up to 50 million doses as soon as next month.

— Mike Eppel (@eppman) November 20, 2020

The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95 per cent 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 Friday’s FDA 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. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

Related articles: 

• Pfizer to seek COVID-19 vaccine approval after reporting 95% effectiveness

• Moderna says its COVID-19 vaccine candidate shows high efficacy rate

• Pfizer says early data signals COVID-19 vaccine is effective

“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally,” Ugur Sahin, M.D., CEO and co-founder of BioNTech, added. “As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

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.

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.

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.