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Photo: Christof Stache/AFP via Getty Images

Pfizer and BioNTech announced Friday that they have initiated the process of applying for full FDA approval of their COVID-19 vaccine for people 16 and older.

Why it matters: It's the first coronavirus vaccine to seek a Biologics License Application (BLA), which requires at least six months of data, according to CNBC.

The big picture: The Pfizer/BioNTech, Moderna and Johnson & Johnson vaccines are being administered in the U.S. after receiving emergency use authorization from the FDA.

  • This specific conditional authorization can only be given to vaccines during a public health emergency, and only requires two months of data, NBC News reports.
  • A full approval would allow the Pfizer vaccine to stay on the market after the emergency is declared to be over. The initial FDA review found Pfizer's vaccine to be 95% effective with no serious side effects.

Details: To be considered for full FDA approval, vaccine manufacturers must submit longer-term data on manufacturing, facilities, clinical studies and other information that guarantees that their vaccine is safe and reliable.

  • Pfizer/BioNTech are submitting data to the FDA "on a rolling basis," and a goal date will be set once the BLA is complete and formally accepted for review, according to a press release.

What they're saying: "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," Ugur Sahin, 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."

Go deeper

Dave Lawler, author of World
May 6, 2021 - World

Mixed response in Europe to Biden's vaccine patents bombshell

Illustration: Aïda Amer/Axios

The Biden administration surprised the world last night by coming out in favor of waiving patents for coronavirus vaccines — but Europe is divided on the issue.

What they're saying: European Commission President Ursula Von Der Leyen said Brussels would be willing to discuss it; French President Emmanuel Macron said he backed the U.S. position, but a German government spokesman said the proposal would cause "severe complications" for vaccine production.

May 6, 2021 - Health

Countries testing J&J vaccine doses after contamination at Baltimore plant

The Emergent BioSolutions plant in Baltimore, Maryland. Photo: Tasos Katopodis/Getty Images

The European Union, Canada and South Africa are withholding Johnson & Johnson coronavirus vaccines produced at an Emergent BioSolutions plant in Baltimore, Maryland, for safety testing after quality-control problems, according to the New York Times.

Driving the news: Johnson & Johnson said in March that workers at the Emergent facility, which had been producing Johnson & Johnson and AstraZeneca vaccines, had ruined about 15 million doses of its vaccine by contaminating a batch with ingredients used in the AstraZeneca vaccine.

Apr 21, 2021 - Health

FDA: Plant that ruined millions of J&J doses had multiple failures

The Emergent BioSolutions plant in Baltimore in April 2021. Photo: Saul Loeb/AFP via Getty Images

The Baltimore Emergent BioSolutions manufacturing plant that ruined 15 million doses of Johnson & Johnson's coronavirus vaccine had multiple procedural failures, including unsanitary conditions near sensitive manufacturing areas, the Food and Drug Administration stated in a report Wednesday

Why it matters: The FDA faulted Emergent for failing to thoroughly review the incident, which halted the potential production and shipment tens of millions of Johnson & Johnson doses this month.

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