Sumary of FDA releases documents outlining Pfizer’s case for COVID-19 booster shots:
- In the documents, the vaccine’s maker, Pfizer, argues that the data support giving a booster dose to all people 16 and older who are six months removed from their second dose.
- To show that a third dose is necessary, Pfizer cites studies showing that protection from the two-dose vaccine wanes over time.
- Pfizer also included two small clinical studies that showed that giving a booster shot was safe and generated an immune response.
- The FDA’s own review, published online a few hours after Pfizer’s documents, avoided taking a firm stance on some of the largest questions surrounding boosters.
- The FDA notes that Pfizer didn’t formally evaluate the efficacy of boosters, for example.
- Pfizer makes the cases for boosters ahead of a crucial meeting The documents from Pfizer and FDA set the stage for a critical meeting that the regulator has scheduled for Friday, where a panel of independent experts will debate, and ultimately vote, on whether to recommend that people get an extra dose of the Pfizer-BioNTech coronavirus vaccine.
- Plastic surgeon Dr. Daniel Suver receives the Pfizer-BioNTech COVID-19 vaccine from Andrea Castelblanco during a vaccine clinic.
- Loren Holmes/Anchorage Daily News via AP, Pool That plan has stirred controversy because it was announced in advance of the FDA review.