FDA Panel Weighs Pfizer Shots for Kids, Boosters for Moderna

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Food and Drug Administration on Friday planned Three-day public meetings with its panel of independent vaccine experts later this month as the agency prepares to make high-profile decisions on whether to allow emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and booster vaccines for adults, as well as recipients of Moderna and Johnson & Johnson vaccines. .

The FDA usually makes its decisions within a few days of advisory committee meetings, where members discuss safety and efficacy data. The timing of upcoming meetings shows that the agency intends to act quickly to decide whether to allow both supporting and juvenile shots.

The commission will meet on October 14 and 15 to discuss booster doses, and the agency said it tentatively plans to discuss Pfizer’s pediatric vaccine on October 26. .

The agency’s top vaccine regulator, Dr. “It is critically important that as many eligible individuals as possible be vaccinated as soon as possible,” Peter Marks said in a statement.

“Available data clearly demonstrate that protection against symptomatic Covid-19 in certain populations begins to decline over time, so it is important to evaluate information regarding the use of booster doses in various populations.”

The committee’s decision to have the committee discuss the evidence for its Moderna and Johnson & Johnson booster vaccines two weeks before Pfizer does so for a pediatric vaccine appears to reflect FDA priorities and data availability. However, the agency’s decisions regarding these emergency use authorizations can come in rapid succession.

Pfizer and BioNTech have not yet formally requested the FDA to authorize emergency use of pediatric doses of their vaccines; The companies are expected to do so next week, according to people familiar with their plans. If regulators agree to this request, it could help protect as many as 28 million children and alleviate parental anxiety across the country. Pfizer board member Dr. Scott Gottlieb said the FDA could decide as early as Halloween.

Children rarely get seriously ill from coronavirus, but Delta variant took nearly 30,000 of them to hospitals in August. During the pandemic, at least 125 children aged 5 to 11 years have died from Covid, and about 1.7 million people in this age group have been infected.

They account for five percent of Covid cases and nine percent of the country’s population, according to the Centers for Disease Control and Prevention.

Pfizer’s vaccine is already authorized on an emergency basis for children ages 12 to 15 and is fully approved for ages 16 and older. Moderna has also requested emergency clearance to offer its vaccine to adolescents, but regulators have yet to decide on that request.

Pfizer-BioNTech’s pediatric dosing disclosure depends not only on the strength of clinical trial data, but also on whether companies can prove to the FDA that they can produce a new pediatric formulation. Acting commissioner of the FDA, Dr. Janet Woodcock said Friday once again that regulators will thoroughly review safety and efficacy data before making a decision.

“We know from our vast experience with other pediatric vaccines that children are not little adults,” he said.

However, the decision of whether to approve Pfizer’s vaccine for children may turn out to be simpler than the question of booster vaccines for Moderna and Johnson & Johnson recipients.

Last month, the FDA authorized a booster vaccine for many recipients of the Pfizer-BioNTech vaccine six months after the second vaccine, and the Centers for Disease Control and Prevention recommended its use. These actions, however, followed full-blown meetings of advisory committees for both institutions. Eventually, the government decided to offer a third vaccine only to those aged 65 and over and living in long-term care facilities. It also offers additional injections to adults with underlying medical problems and people who are at higher risk of exposure to the virus because of their work or institutional setting – a broad category that includes healthcare workers and inmates.

In addition to deciding whether boosters should be allowed for Moderna and Johnson & Johnson recipients, the FDA is also weighing whether people should be allowed to receive a different vaccine than the one they first received. Researchers at the National Institutes of Health are conducting a so-called mix-and-match study to answer this question.

Separately on Friday, the Biden administration provided new details on a rule it announced last month that requires federal employees to be vaccinated against the coronavirus. management said in a note “Employees who refuse to be vaccinated or provide evidence of vaccination are subject to disciplinary action, up to and including suspension from federal service or dismissal,” the memo said.



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