Pfizer and partner BioNTech announced they are starting the process to seek full Food and Drug Administration approval in the U.S. for their COVID-19 vaccine.
Since December, their vaccine has been distributed in the U.S. under an "emergency use authorization," which is a distinct regulatory status reserved for emergency situations, such as a pandemic.
Pfizer is the first COVID vaccine maker to request full approval in the U.S., and it will likely take several months for the FDA to review additional data and make an approval decision.
As Pfizer submits the required data for full Biologics License Application (BLA) approval, the FDA will take several months to review the full set of data before granting it.
This submission shows Pfizer believes it has enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, Phase 3 trial. The regulatory requirements for the current emergency authorization required only two months of safety data. Vaccine specialists say that any safety problems from a vaccine are likely to arise shortly after injection.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, Pfizer Chairman and Chief Executive Officer, said in a statement Friday. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
Pfizer said it has delivered more than 170 million doses in the U.S.
"... the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said in a statement. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
Along with Pfizer, Moderna and Johnson & Johnson's COVID-19 vaccines were previously given emergency use authorization.
Moderna announced Thursday that it plans to start the BLA process later in May.
Companies were always expected to formally submit for approval, rather than emergency authorization, once they hit the six-month safety requirement.
As more Americans get vaccinated and cases decline in the U.S., the Centers for Disease Control and Prevention has updated its guidelines for mask-wearing outdoors, small group gatherings and more. Many states and cities have also quickly reversed strict lockdown policies. In New York, Gov. Andrew Cuomo announced the easement of most restrictions, while New York City Mayor Bill de Blasio said he expects the city to be fully open by July 1.
"After a long and incredibly difficult fight, New York state is winning the war against COVID-19, and that means it's time to loosen some restrictions put in place to protect the public health and help our local businesses," Cuomo said last week.
Since the pandemic began, more than 32 million Americans have been diagnosed with COVID-19, according to a count kept by Johns Hopkins University. Of those, at least 580,061 deaths have been reported.