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December 2, 2021

Pfizer asks FDA to authorize booster shots for 16- and 17-year-olds

Daily Briefing

    On Tuesday, Pfizer and BioNTech asked FDA to extend the emergency use authorization (EUA) for booster shots of the their Covid-19 vaccine to teens ages 16 and 17—a request that could be authorized as early as next week.

    5 key considerations for the expanded booster shot rollout

    Officials urge booster doses for all eligible individuals amid rising concerns

    On Nov. 19, FDA authorized booster shots of the Pfizer-BioNTech and Moderna Covid-19 vaccines for everyone ages 18 and older six months following a second dose of either two-dose vaccine, and for the Johnson & Johnson Covid-19 vaccine two months after an initial dose. And now, officials are urging uptake of the booster shots amid a potential delta-driven surge of Covid-19 cases in the United States, as well as concerns about the new omicron variant.

    For instance, deviating from CDC's previous recommendation that young, healthy adults "may" get a booster shot, CDC Director Rochelle Walensky on Monday urged all eligible American adults to get booster shots of Covid-19 vaccines.

    Separately, the World Health Organization (WHO) on Monday warned that while there are "considerable uncertainties" surrounding the omicron variant, early evidence indicates it has mutations that could help it evade immune system response and increase its transmissibility. "Depending on these characteristics, there could be future surges of Covid-19, which could have severe consequences, depending on a number of factors, including where surges may take place," WHO said. "The overall global risk … is assessed as very high."

    As a result, President Joe Biden urged Americans to protect themselves from the delta and omicron variants by getting coronavirus vaccines and booster shots, the Washington Post reports. Biden on Monday said that booster shots would be part of the administration's strategy to combat omicron. Biden said that the administration will be "sparing no effort, removing all roadblocks to keep the American people safe."  But urged Americans not to "panic."

    Pfizer requests authorization for booster shots in individuals aged 16 and 17

    Amid the push for widespread booster shots, Pfizer CEO and Chair Albert Bourla on Tuesday announced that the company, along with its partner BioNTech, had submitted a request to FDA asking to extend the EUA of booster doses of the Pfizer-BioNTech Covid-19 vaccine to 16- and 17-year-olds, NPR reports.

    "It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant," Bourla said. According to NPR, research released by Pfizer and BioNTech in October found that in a randomized study of 10,000 participants ages 16 and older, a booster dose "restored vaccine protection against Covid-19 to the high levels achieved after the second dose."

    According to CDC data, 2.3 million 16- and 17-year-olds already received their second dose of the Pfizer-BioNTech vaccine at least six months ago. By the end of 2021, the New York Times reports that number is projected to increase to around three million, or 36% of the population in that age group. As a result, according to the Times, Pfizer and BioNTech's EUA request, if authorized, could quickly make several million teenagers eligible for an additional shot.

    For its part, an individual familiar with the matter said FDA plans to quickly act on the companies' request, the Wall Street Journal reports.

    "We expect to share updates on this soon," said Pfizer spokesperson Kit Longley. (LaFraniere, New York Times, 11/30; Weixel, The Hill, 11/30; Armour/Hopkins, Wall Street Journal, 11/29; Stone, "Shots," NPR, 11/30; LaFraniere, New York Times, 11/29; McGinley/Pager, Washington Post, 11/29)

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