Pfizer seeks emergency COVID-19 vaccine OK from U.S. regulators

Pfizer Inc. filed with U.S. regulators for an emergency-use authorization for its COVID-19 vaccine, seeking clearance for an experimental shot that’s expected to play an important role in an immunization effort to halt the virus.

The vaccine, developed by the U.S. drugmaker with its German partner BioNTech SE, is the first to seek authorization from the Food and Drug Administration. An emergency clearance would allow Americans to access the vaccine before it’s granted full approval. It is likely to be the first to be made available on a limited basis to health workers and older Americans.

Earlier this week, Pfizer said its experimental vaccine — which relies on messenger RNA technology never before used in an approved medicine — was 95% effective, protecting people of all ages and ethnicities from developing symptomatic COVID-19. So far, there have been no significant safety problems in the trial that includes nearly 44,000 participants.

The FDA is expected to spend the next few weeks reviewing the data, and the vaccine could be available by the middle to the end of December. A key step along the way is a meeting of outside FDA advisers, all experts in infectious diseases and vaccines. They’re set to confer Dec. 8 to 10, according to a person with knowledge of the situation, allowing the clinical trial data to be vetted in public to bolster confidence.

“Today we were able to submit a very robust data set that we believe meets and, in many cases, exceeds the FDA’s high standards,” Pfizer Chief Executive Officer Albert Bourla said in a video statement announcing the filing.

It took just 248 days from when Pfizer announced the collaboration with BioNTech to approach U.S. regulators for an emergency-use authorization, he said. It is likely to be the first be made available on a limited basis to those at highrisk of contracting COVID-19 or suffering from the disease.

Among the vaccine front-runners, the PfizerBioNTech project is the only one that didn’t take funding from the White House-led Operation Warp Speed program to accelerate development, manufacturing and distribution of COVID-19 shots. However, the two companies have secured a $2 billion deal to supply 100 million doses to the U.S., with an option for 500 million more.