Pfizer begins application for full FDA approval of COVID-19 vaccine
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."