FDA releases documents outlining Pfizer’s case for COVID-19 booster shots

fda releases documents outlining pfizers case for covid 19 booster shots

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.

Want to know more click here go to source.

From -

Close

Site Language


By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close