Pfizer Covid-19 Booster Shot Set to Be Cleared for Younger Teens, NYT Reports
(Bloomberg) -- U.S. regulators are planning to clear Pfizer Inc.’s Covid-19 booster shot for younger adolescents on Monday, expanding access at a time when researchers have found that an additional vaccine dose provides better protection against the widely circulating omicron variant.
The Food and Drug Administration is preparing to grant emergency-use authorization for people ages 12 to 15 years old to receive a third dose of the messenger RNA vaccine, which Pfizer developed with partner BioNTech SE, the New York Times reported, citing people familiar with the matter. A booster is also expected to be authorized for children ages 5 to 11 who have immune deficiencies, the newspaper said.
The agency declined to comment. A Pfizer spokesperson referred questions to the FDA. A BioNTech representative declined to comment on the regulatory process. Pfizer rose 1.1% at 2:21 p.m. in New York, while BioNTech’s American depositary receipts gained 5.8%.
Granting a broader group of teens access to boosters could help tamp down cases as U.S. government officials aim to keep schools open. Many state and local leaders have expressed a desire to avoid moving to hybrid or remote schooling options out of concern over other health and educational consequences.
The risk of catching omicron is higher than other variants, even for fully immunized schoolchildren and adolescents. Studies by the drugmakers and other researchers have found that breakthrough infections with omicron, which now accounts for a majority of virus cases in the U.S., are more likely in people who haven’t yet been given a booster shot.
Pfizer said in December that in initial lab studies, company researchers observed a 25-fold reduction in neutralizing antibodies that fight the variant, compared with the original strain of the virus, in people who got just two shots. However, boosting with an additional shot of the vaccine restored protection to a level similar to the initial two-dose regimen.
Some researchers have questioned the need for booster shots in younger people, as most adolescents who contract the virus don’t develop severe disease and omicron doesn’t appear to be as virulent as other variants. Additionally, incidents of a heart condition called myocarditis have been seen in some people, especially younger males, who have received messenger RNA vaccines.
Recently, the U.S. has seen an increase in hospitalized children with Covid-19, according to Rochelle Walensky, the director of the Centers for Disease Control and Prevention. Most of those children haven’t been vaccinated, she said. Children under 5 aren’t yet eligible to receive one of the three vaccines authorized for use in the U.S., and adoption of the shots among younger school-age children has lagged behind the pace of adult immunizations.
The CDC’s advisory committee on vaccination is expected to meet by the middle of next week to discuss the changes, according to the Times. Walensky would have to sign off on the committee’s recommendation before any new policies are implemented. The CDC did not immediately respond to a request for comment.
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