Sumary of FDA strikes neutral tone ahead of vaccine booster meeting:
- WASHINGTON (AP) — Influential government advisers will debate Friday if there’s enough proof that a booster dose of Pfizer’s COVID-19 vaccine is safe and effective — the first step toward deciding which Americans need one and when.
- Pfizer’s argument: While protection against severe disease is holding strong in the U.S., immunity against milder infection wanes somewhere around six to eight months after the second dose.
- The company gave an extra dose to 306 people at that point and recorded levels of virus-fighting antibodies threefold higher than after the earlier shots.
- More important, Pfizer said, those antibodies appear strong enough to handle the extra-contagious delta variant that is surging around the country.
- Pfizer said that translates to “roughly 95% effectiveness” when delta was spreading, comparable to the protection seen shortly after the vaccine’s rollout earlier in the year.
- The Israeli data, also published Wednesday in the New England Journal of Medicine, cannot say how long the boosted protection lasts.
- The FDA’s reviewers, however, suggested they would mainly look to research on how the vaccines are working among Americans, saying that “may most accurately represent vaccine effectiveness in the U.S. population.
- ”Overall, the data show that the Pfizer and other U.S.-authorized COVID-19 vaccines “still afford protection against severe COVID-19 disease and death in the United States,” the agency said, summarizing the evidence.