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.
The status of vaccine mandates in the United States
- Vaccine rules. On August 23, the US Food and Drug Administration (FDA) Full approval for coronavirus vaccine granted to Pfizer-BioNTech For people aged 16 and over, paving the way for states in both general And Spread sectors. These states are legally allowed It was upheld in judicial appeals.
- colleges and universities. More than 400 colleges and universities have required students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. California becomes the first state to issue a vaccine mandate for all teachers And it announced plans to add a Covid-19 vaccine in the name of Prerequisite for admission to the school Early next fall. Angels It already has a vaccine mandate for public school students 12 and older who attend class in person beginning November 21. New York City has introduced a vaccine mandate for teachers and staff, but it has yet to go into effect due to legal challenges. On September 27, a federal appeals committee reverse resolution that has paused this authorization.
- Hospitals and medical centers. many Major hospitals and health systems They ask employees to be vaccinated. Mandates for healthcare workers in California And New York State He appears to have forced thousands of naysayers to take the shots.
- New York City. Proof of vaccination is required from workers and clients Indoor dining, gyms and shows And other internal situations. city education staff And hospital workers You should also get a vaccine.
- at the federal level. On September 9 President Biden announced the authorization of a vaccine for The vast majority of federal workers. This authorization will be applied to employees Executive Authority, including the White House, all federal agencies, and members of the armed forces.
- in TIt is the private sector. Mr. Biden has authorized it All companies employing more than 100 workers They require weekly vaccinations or testing, which helps drive new vaccination policies for companies. Some companies like United Airlines And Tyson Foods, had mandates in place before Mr. Biden’s announcement.
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.