Pfizer To Seek OK For Boosters For 16- And 17-Year-Olds
Pfizer and partner BioNTech are expected to seek emergency approval for a booster shot of their covid vaccine for younger people, which would be the first approved for those under 18. The FDA is expected to respond next week to the request.
The New York Times:
Pfizer Plans To Apply For Booster Shots For 16- And 17-Year-Olds
Pfizer and BioNTech are expected this week to apply for regulatory approval for a booster shot of their coronavirus vaccine for 16- and 17-year-olds, according to people familiar with the company’s plans. If approved, the shot would be the first booster available to people under 18. The Food and Drug Administration could authorize extra shots within roughly a week, the people said. (LaFraniere, 11/29)
The Wall Street Journal:
FDA Moving To Authorize Pfizer-BioNTech Booster For 16-, 17-Year-Olds
The Food and Drug Administration could authorize Covid-19 boosters from Pfizer Inc. and BioNTech SE for use in 16- and 17-year olds as soon as next week as concerns rise over a new, possibly more transmissible variant, according to a person familiar with the planning. The agency is planning to move rapidly to take action on a request by the companies to authorize boosters for 16- and-17 year olds, according to a person familiar with the matter. So far, only people 18 years and older are eligible for boosters. (Armour and Hopkins, 11/29)
The Washington Post:
Pfizer Poised To Request Authorization For Coronavirus Booster For 16 And 17 Year Olds
“Given the current overall situation of the pandemic, FDA will evaluate any such [emergency use authorization] request in a very timely manner,” the agency said. Kit Longley, a Pfizer spokesman, said: “We expect to share updates on this soon.” The Pfizer-BioNTech and Moderna vaccines have been linked to a rare side effect called myocarditis, a swelling of the heart muscle, in older male adolescents and young men. That has prompted regulators and some government advisers to take a cautious approach to boosters for younger people, though experts have repeatedly said the risks of heart problems from the coronavirus itself is far higher than from vaccination. (McGinley and Pager, 11/29)
