U.S. regulators plan to authorize Pfizer Inc.’s COVID-19 booster vaccine for younger teens on Monday, expanding access at a time when researchers have found that an additional dose of vaccine provides better protection against the widely circulated omicron variant.
The Food and Drug Administration (FDAis preparing to grant an emergency use authorization for 12-15 year olds to receive a third dose of the vaccine from Messenger RNA, that Pfizer developed with his partner BioNTech SEThe 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 spokesperson for Pfizer referred the questions to the FDA. A representative of BioNTech did not immediately respond to a request for comment.
Giving access to boosters to a broader group of teens could help control cases, as US government officials aim to keep schools open. Many state and local leaders have expressed a desire to avoid moving to hybrid or remote education options because of concerns about other consequences for health and education.
Omicron risk
The risk of contracting omicron it is higher than other variants, even for fully immunized schoolchildren and adolescents. Studies by drug manufacturers and other researchers have found that advanced omicron infections, which now account for the majority of virus cases in the United States, are more likely in people who have not yet received a booster shot.
Pfizer It said in December that in initial laboratory studies, company researchers observed a 25-fold reduction in neutralizing antibodies that fight the variant, compared to the original strain of the virus, in people who received just two vaccines. However, booster with an additional vaccine 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, while most teens who contract the virus do not develop serious illness and omicron it does not appear to be as virulent as other variants.
In addition, incidents of a heart condition called myocarditis have been seen in some people, especially younger men who have received vaccines from Messenger RNA.
It is expected that the Vaccination Advisory Committee of the CDC meet in the middle of next week to discuss the changes, according to the Times.
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