Pfizer and European partner company BioNTech are seeking full approval from the federal government to market their two-dose COVID-19 vaccine directly to people age 16 and over, as well as businesses and schools.
The vaccine has been available in the United States since mid-December under an Emergency Use Authorization waiver by the Food and Drug Administration.
Since then, the companies have delivered more than 170 million doses of the vaccine across the United States.
“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,” Pfizer Chairman and Chief Executive Officer Albert Bourla, said in a statement. “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.”
The company is now asking the FDA for what's called a Biologics License Application, which, if approved, could make it easier for companies, schools, and government agencies, including the military, to require vaccinations.
The approval process is expected to last at least a month.
“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “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.”
Pfizer and BioNTech are hoping to get federal emergency approval as early as next week for children as young as 12 years old to be eligible to get vaccines.
Pzifer has headquarters in New York City (in midtown Manhattan) and the Hudson Valley (in the Rockland County hamlet of Pearl River). BioNTech's headquarters is in Germany.
The vaccine was 95 percent effective at preventing severe disease in clinical trials.
Moderna said on Thursday, May 6 that it plans to apply for full approval for its two-dose COVID-19 vaccine this month.
Earlier this week, Pfizer announced the vaccine lead to $3.5 billion in revenue in the first quarter of 2021, about a quarter of its total revenue.
“We have achieved important clinical, regulatory, and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 (the vaccine) to the world," Bourla said. "Each of these accomplishments further demonstrates our commitment to Pfizer’s purpose: Breakthroughs that change patients’ lives.”
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