Covid Live Updates: US Regulators Remove Pfizer-BioNTech Boosters For 16- And 17-Year-Olds

Picture Karolina Moran, 16, receiving the Pfizer-BioNTech coronavirus vaccine in Miami in May. Credit… Saul Martinez for The New York...

PictureKarolina Moran, 16, receiving the Pfizer-BioNTech coronavirus vaccine in Miami in May.
Credit…Saul Martinez for The New York Times

Federal regulators cleared the booster injections on Thursday of Pfizer-BioNTech coronavirus vaccine for 16 and 17 year olds, at least six months after receiving their second injection of this vaccine. This decision paves the way for several million teenagers to receive an additional injection.

All adults have been eligible since November 19 to receive a booster six months after their second injection of Pfizer or Moderna vaccines, or two months after a Johnson & Johnson injection. Nearly 50 million Americans – or a quarter of those fully vaccinated – have received additional vaccines.

The Food and Drug Administration has expanded Pfizer’s clearance to cover the younger age group in an emergency. The other two coronavirus vaccines, Moderna and Johnson & Johnson, are only permitted for adults.

The agency’s move, which was expected, comes as a first wave of lab tests suggested the fast-spreading new variant, Omicron, appeared to blunt the potency of two doses of the Pfizer vaccine.

“Since we first authorized the vaccine, new evidence indicates that the efficacy of the Covid-19 vaccine decreases after the second dose of the vaccine for all adults and for those in the 16 and 17 age group. years, ”said Dr. Peter Marks, who oversees the vaccines division of the FDA. A booster “will help provide continued protection against Covid-19 in this age group and older people,” he added.

Dr Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, quickly approved the move, saying the agency was encouraging teens to be given a booster dose.

“While we don’t have all the answers about the Omicron variant, early data suggests that Covid-19 boosters help broaden and strengthen protection against Omicron and other variants,” she said in a statement.

The CDC, which sets vaccine policy for the federal government, and the FDA acted without input from their expert vaccine advisory committees, which typically met publicly before vaccine eligibility was authorized and expanded. .

Those meetings would have given regulators and experts a chance to publicly discuss the merits of the decision, including a review of safety data collected from adolescents who had received the Pfizer-BioNTech vaccine.

Pfizer and BioNTech said on Wednesday that tests with blood samples from people who had only received two doses showed much lower levels of anti-virus antibodies against Omicron than against an earlier version of the virus. Antibodies are the immune system’s first line of defense against the virus, and results suggest that two doses may not be enough to protect against infection, the companies said.

With a boost, the level of antibodies working to neutralize the Omicron variant was comparable to those fighting the original variant after two doses, the companies said.

Senior health officials in the administration have said that Omicron, which contains dozens of never-before-seen mutations, is one more reason everyone eligible for a booster gets one. Over 200 million Americans – over 60 percent of the population – have been fully immunized.

Although the overall vaccination rate in the United States is still well behind some other countries, the discovery of Omicron has prompted many people to have their pictures taken, although many remain unknown about the variant.

Support for boosters has grown among public health experts facing the Omicron variant; some who were opposed to it are now supporting a broad campaign. The FDA expert committee rejected Pfizer-BioNTech’s request in September to recall 16- and 17-year-olds, in part because of concerns about what they considered insufficient data on a rare heart disease linked to Pfizer-BioNTech and Moderna injections, especially in younger men.

This condition, myocarditis or inflammation of the heart muscle, can also be caused by the virus. Federal scientists said cases tend to be mild and resolve quickly.

According to federal data, about 5.5 million adolescents between the ages of 16 and 17 – two-thirds of this age group – have received at least one dose of Pfizer’s vaccine. More than 4.7 million people have received two doses. About three million got their second shot at least six months ago and would be eligible for a third shot this month.

Dr Ugur Sahin, CEO of BioNTech, Pfizer’s German partner, said: “In the current situation it is important to offer everyone a booster, especially in the context of new and emerging variants such as the Omicron. Dr Albert Bourla, CEO of Pfizer, called the expansion of booster injections “a critical step”.

Pfizer is providing booster doses to the United States government under a deal negotiated months ago.

“Businesses don’t expect today’s news to impact existing supply agreements with governments and international health organizations,” a statement released Thursday by Pfizer said.

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Newsrust - US Top News: Covid Live Updates: US Regulators Remove Pfizer-BioNTech Boosters For 16- And 17-Year-Olds
Covid Live Updates: US Regulators Remove Pfizer-BioNTech Boosters For 16- And 17-Year-Olds
Newsrust - US Top News
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