Pfizer-BioNTech seek FDA authorization for COVID boosters for all adults
Pfizer and BioNTech said Tuesday that they have asked the Food and Drug Administration to expand authorization of their COVID-19 vaccine booster to include anyone 18 and older.
Why it matters: If the FDA agrees, it could significantly increase the number of people eligible for a booster.
- Currently, Pfizer-BioNTech and Moderna recipients are eligible to receive a booster six months after their second dose if they are 65 and older or an adult at high risk of severe infection.
- All Johnson & Johnson recipients over the age of 18 are eligible to receive a booster two months after receiving their first shot.
- The Centers for Disease Control and Prevention has also said people can choose what vaccine they want as their booster.
The big picture: Pfizer and BioNTech said their submission was based on efficacy and safety data from a Phase 3 randomized, controlled trial with more than 10,000 participants.
- "Data show a favorable safety profile and relative vaccine efficacy of 95% against COVID-19 compared to the two-dose schedule during a period when Delta was the prevalent strain," the companies said.