The Food and Drug Administration on Friday scheduled three days of public meetings with its panel of independent vaccine experts for later this mon
The Food and Drug Administration on Friday scheduled three days of public meetings with its panel of independent vaccine experts for later this month as the agency prepares to make key decisions on whether to authorize emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11 and booster shots for adult recipients of the Moderna and Johnson & Johnson vaccines.
The timing of the meetings indicates that the agency plans to move quickly to decide whether to authorize both the booster and pediatric doses, but only after it hears recommendations from the advisory committee.
The advisory committee will meet on Oct. 14 and 15 to to discuss booster doses, and is tentatively scheduled to discuss Pfizer’s pediatric dose on Oct. 26, the agency said. The F.D.A. typically issues its decisions within a few days of advisory committee meetings.
In a statement, Dr. Peter Marks, the agency’s top vaccine regulator, said, “It’s critical that as many eligible individuals as possible get vaccinated as soon as possible.”
He added that “the available data make clear that protection against symptomatic Covid-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations.”
The decision to have the committee first discuss the evidence for Moderna and Johnson & Johnson booster shots appears to reflect the agency’s priorities and the availability of data. But a ruling on the pediatric dose could come soon after.
Pfizer and BioNTech are expected to formally ask the F.D.A. to authorize emergency use of pediatric doses of their vaccine next week, according to people familiar with the company’s plans. If regulators agree, that could help protect as many as 28 million children and ease the anxiety of parents across the nation. Dr. Scott Gottlieb, a Pfizer board member, has said the F.D.A. could decide as early as Halloween.
Children rarely become severely ill from the coronavirus, but the Delta variant drove nearly 30,000 of them into hospitals in August. Over the course of the pandemic, at least 125 children between the ages of five to 11 have died from Covid, and nearly 1.7 million others in that age group have been infected with the virus.
They account for five percent of Covid cases and nine percent of the nation’s population, according to the Centers for Disease Control and Prevention.
Pfizer’s vaccine has already been authorized for children 12 to 15 on an emergency basis, and is fully approved for those 16 and older. Moderna has also sought emergency authorization to offer its vaccine to adolescents but regulators have yet to rule on that request.
The State of Vaccine Mandates in the U.S.
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- Vaccine rules. On Aug. 23, the F.D.A. granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for mandates in both the public and private sectors. Such mandates are legally allowed and have been upheld in court challenges.
- College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
- Schools. California became the first state to issue a vaccine mandate for all educators and has announced plans to add the Covid-19 vaccine as a requirement to attend school as early as next fall. Los Angeles already has a vaccine mandate for students 12 and older who are attending class in person starting Nov. 21. New York City has introduced a vaccine mandate for teachers and staff, but it has yet to take effect because of legal challenges. On Sept. 27, a federal appeals panel reversed a decision that temporarily paused that mandate.
- Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get vaccinated. Mandates for health care workers in California and New York State appear to have compelled thousands of holdouts to receive shots.
- New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations. City education staff and hospital workers must also get a vaccine.
- At the federal level. On Sept. 9, President Biden announced a vaccine mandate for the vast majority of federal workers. This mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services.
- In the private sector. Mr. Biden has mandated that all companies with more than 100 workers require vaccination or weekly testing, helping propel new corporate vaccination policies. Some companies, like United Airlines and Tyson Foods, had mandates in place before Mr. Biden’s announcement.
Clearance of Pfizer-BioNTech’s pediatric dose depends not just on the strength of the clinical trial data, but on whether the companies can prove to the F.D.A. that they can properly manufacture a new pediatric formulation. Dr. Janet Woodcock, the F.D.A.’s acting commissioner, said again on Friday that regulators would thoroughly review safety and efficacy data before ruling.
“We know from our vast experience with other pediatric vaccines that children are not small adults,” she said in a statement.
It may turn out that decision on whether to authorize Pfizer’s vaccine for children is more straightforward than the question of booster shots for Moderna and Johnson & Johnson recipients.
Last month, the F.D.A. authorized a booster shot for many recipients of the Pfizer-BioNTech vaccine six months after their second shot, and the C.D.C. recommended its use. But those actions followed fraught meetings of the advisory committees for both agencies.
In the end, the government decided to offer a third shot for those 65 and older and those who live in long-term care facilities. It is also offering booster injections to adults with underlying medical conditions and those who are at higher risk of exposure to the virus because of their jobs or institutional settings — a broad category that covers health care workers to prisoners.
The F.D.A. is now considering not only whether to authorize boosters for Moderna and Johnson & Johnson recipients, but whether people should be allowed to get a booster shot of a different vaccine than the one they originally received. Researchers with the National Institutes of Health have been conducting a so-called “mix and match” study in an effort to answer that question; the F.D.A.’s advisory committee will “hear presentations and discuss the available data” at the Oct. 15 meeting, the announcement said.
Amy Schoenfeld Walker contributed reporting.
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