Pfizer Asks FDA To Authorize Its Booster For All Adults
Pfizer and BioNTech applied to the Food and Drug Administration to allow an additional covid vaccine dose to any American 18 and older.
NBC News:
Pfizer Asks For FDA Authorization For Booster For Everyone 18 And Up
Pfizer-BioNTech asked the Food and Drug Administration on Tuesday for emergency use authorization for its Covid-19 booster shot for all adults ages 18 and up, a move the company has been angling for over the past several months. Pfizer’s request will now be considered by the FDA, which will make a final decision in the coming weeks. It’s unclear whether the agency will ask its independent advisory group, called the Vaccines and Related Biological Products Advisory Committee, to offer guidance on authorizing the booster. (Miller, 11/9)
CNN:
Pfizer And BioNTech Seek FDA Authorization For Covid-19 Vaccine Booster For All Adults
The companies said the submission is based on results of a Phase 3 trial involving more than 10,000 participants; it found boosters were safe and had an efficacy of 95% against symptomatic Covid-19 compared with the two-dose vaccine schedule in the period when the highly transmissible Delta was the dominant strain. Pfizer released the booster efficacy data last month; it has not yet been peer-reviewed or published. (Sealy and Gumbrecht, 11/9)
In related news —
FiveThirtyEight:
The U.S. Is Relying On Other Countries’ Data To Make Its Booster Shot Decisions
One Thursday in October, the Food and Drug Administration’s vaccine advisory committee gathered to discuss booster shots for Moderna and Johnson & Johnson’s COVID-19 vaccines. Yet one of the first presentations wasn’t given by Americans — it featured scientists from Israel’s Ministry of Health and Weizmann Institute. And the presentation wasn’t about Moderna or Johnson & Johnson’s vaccines — the Israelis shared their findings from the country’s Pfizer booster shot campaign. This was less than ideal. Not only did the presentation focus on a different vaccine from the two up for discussion, it also centered around a population that’s much smaller and more homogenous than America’s. Plus, Israel’s vaccine rollout happened earlier and faster than the U.S.’s — meaning that the population had more vaccine-induced immunity but was potentially more vulnerable to the impacts of waning protection. (Ladyzhets, 11/9)
