The F.D.A. again warns parents not to get children under 12 vaccinated yet.
The U.S. Food and Drug Administration is “working around the clock” to make coronavirus vaccines available to young children, it said in a statement on Friday. In the meantime, however, the agency urged parents not to seek out the shots for children who are under 12, and therefore not yet eligible for vaccination.
The agency said that it hoped vaccines would be available for young children “in the coming months,” but that it could not offer a more specific timeline. However, once it has applications from the vaccine manufacturers in hand, it will “be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” Dr. Janet Woodcock, the acting F.D.A. commissioner, and Dr. Peter Marks, of the agency’s Center for Biologics Research and Evaluation, said in the statement.
The currently available vaccines, none of which have been cleared for children under 12, may not be a safe or effective dose for young children, the agency noted. Pediatric clinical trials, which will help determine the right vaccine dose for children under 12, are still underway.
“Children are not small adults — and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,” Dr. Woodcock and Dr. Marks.
Health officials have previously expressed concern that full approval of the Pfizer-BioNTech vaccine for people 16 and up might prompt parents to seek, or doctors to give, the shots off-label to young children, specifically warning against the move. Children younger than 12 make up a sizable unvaccinated population in the United States.
Some vaccine manufacturers are still enrolling children in their trials and others are still giving the shots and monitoring children for potential side effects, the F.D.A. noted in its statement. The trials will follow participants for at least two months to ensure that the researchers are able to detect any adverse events. Vaccine manufacturers then have to analyze the data and then formally apply for authorization or approval from the F.D.A.
Then, the agency “will carefully, thoroughly and independently examine the data to evaluate benefits and risks,” Dr. Woodcock and Dr. Marks said.
They added, “Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of Covid-19 vaccines in children will not cut any corners.”
In an interview published on Friday, Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told Der Spiegel, a German news site, that “we will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks.”
Initially reluctant to enact mandates, President Biden is now moving more aggressively than any other president in modern history to require vaccination, including in schools.
Understand Vaccine and Mask Mandates in the U.S.
- Vaccine rules. On Aug. 23, the Food and Drug Administration granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and up, paving the way for an increase in mandates in both the public and private sectors. Private companies have been increasingly mandating vaccines for employees. Such mandates are legally allowed and have been upheld in court challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
- 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. Both California and New York City have introduced vaccine mandates for education staff. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.
- Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
- New York City. Proof of vaccination is required of workers and customers for indoor dining, gyms, performances and other indoor situations, although enforcement does not begin until Sept. 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by Sept. 27, without the option of weekly testing. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.
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