FDA Panel for Weighing Pfizer Shots for Kids and Moderna Boosters

Food and Drug Administration Friday course Three days of public meetings with its team of independent vaccine experts later this month as the agency prepares to make high-level decisions on whether to allow emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and shots. Booster for adults with Moderna and Johnson & Johnson vaccines.

The FDA typically issues its decisions within a few days of advisory committee meetings, during which members discuss safety and efficacy data. The timing of the upcoming meetings indicates that the agency intends to move quickly to decide whether to allow the use of the booster vaccines and the pediatric shots.

The agency said that the committee will meet on October 14 and 15 to discuss the booster doses, and the Pfizer vaccine for children is tentatively scheduled for October 26.

“It is important that as many eligible individuals as possible are vaccinated as quickly as possible,” Dr. Peter Marks, the agency’s top vaccine regulator, said in a statement.

He added that “the available data show that protection against Covid-19 symptoms in certain populations begins to decline over time, so it is important to evaluate information regarding the use of booster doses in different populations.”

The committee’s decision to discuss the evidence for the boosters of Modeno and Johnson & Johnson two weeks before Pfizer’s pediatric vaccine was administered appears to reflect the FDA’s priorities and data availability. But the agency’s decisions on emergency use permits may come in quick succession.

Pfizer and BioNTech have not formally asked the US Food and Drug Administration (FDA) to authorize their vaccine’s emergency use for pediatric doses; They are expected to do so next week, according to people familiar with the companies’ plans. If regulators agree to the request, it could help protect up to 28 million children and ease the anxiety of parents across the country. Dr. Scott Gottlieb, a member of Pfizer’s board of directors, said the Food and Drug Administration could decide as early as Halloween.

Children rarely get seriously ill from the Corona virus, but The delta variant drove nearly 30,000 of them to hospitals in August. Over the course of the pandemic, at least 125 children between the ages of 5 and 11 have died from Covid, and nearly 1.7 million more have been infected by the virus in that age group.

They account for 5 percent of COVID cases and 9 percent of the country’s population, according to the Centers for Disease Control and Prevention.

The Pfizer vaccine is already licensed for emergency children 12 to 15 years of age, and is fully approved for those 16 and older. Moderna has also sought emergency permission to offer its vaccine to teens, but regulators have not yet decided on that request.

Pfizer-BioNTech’s pediatric dose clearance depends not only on the strength of clinical trial data, but on whether companies can demonstrate to the Food and Drug Administration that they can properly manufacture a new pediatric formula. Dr. Janet Woodcock, the US Food and Drug Administration’s acting commissioner, said again Friday that regulators will carefully review safety and efficacy data before making a ruling.

“We know from our extensive experience with other childhood vaccines that children are not young adults,” she said in a statement.

The decision on approving a pediatric vaccine for Pfizer may turn out to be more straightforward, however, than the issue of booster injections for Moderna and Johnson & Johnson recipients.

Last month, the Food and Drug Administration authorized a booster shot for many recipients of the Pfizer-BioNTech vaccine six months after their second shot, and the Centers for Disease Control and Prevention recommended their use. But those measures came after fraught meetings of the advisory committees of both agencies. Ultimately, the government decided to offer a third dose only to those 65 years of age or older who live in long-term care facilities. It also offers booster injections to adults with underlying medical conditions who are at greater risk of exposure to the virus because of their jobs or institutional settings — a broad category that includes health care workers and prisoners.

Besides deciding whether to allow the use of boosters for Moderna and Johnson & Johnson recipients, the FDA is also considering whether people should be allowed to get a booster dose of a different vaccine than the one they originally received. Researchers at the National Institutes of Health conducted what’s called a mix-and-match study to try to answer this question.

Separately, the Biden administration on Friday provided new details about a rule it announced last month requiring federal workers to be vaccinated against the coronavirus. management said in a note The memo said agencies could start enforcing this requirement on November 9.

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