2:58
- ABC News
- May 7, 2021
Pfizer seeks full FDA approval for COVID vaccine
The company 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.
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