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FDA authorizes Covid vax for teens; plans June meeting for all pediatric vaccines



The Pfizer and BioNTech Covid-19 vaccine that has emergency use authorization in adults and older teens can now be given to those 12 to 15 years of age. The FDA late Monday expanded the authorization to include the younger age group.

The initial authorization for that vaccine in adults also included those 16 and 17 years old. The other two authorized Covid vaccines, from Moderna and Johnson & Johnson, are cleared for those 18 and older. Clinical trials enrolling younger children are underway for all three vaccines. The expanded authorization for the Pfizer and BioNTech Covid vaccine was welcomed by Miguela Caniza, director of the infectious diseases program at St. Jude Children’s Research Hospital in Memphis, Tennessee.

“Vaccinating children for COVID-19 is a key component to reaching the two-thirds threshold necessary to obtain herd immunity and stop the pandemic from continuing to spread and mutate,” Caniza said in an emailed statement. “Today’s emergency authorization of the Pfizer vaccine for ages 12 to 15 is an important step in helping to control this virus in a safe and effective way for a larger percentage of the population.”

As Covid vaccines options expand to younger teens, the FDA is preparing for a broader discussion about vaccinating children. The FDA is convening a virtual meeting of its vaccines advisory committee next month to discuss pediatric use of Covid vaccines. The Vaccines and Related Biological Products Advisory Committee (VRBAC) is the same body that reviewed the three vaccines that have been granted emergency authorization. At the June 10 meeting, the FDA will provide an update on its approach to authorizing these vaccines in children 12 to 17 years of age. Meanwhile, the committee will discuss the data needed to support emergency authorization as well as full approval (a biologics license application) in children younger than 12. The FDA said that the committee will not discuss any specific products.

“As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a prepared statement.

The FDA will issue a notice with details about the meeting. When that notice appears in the Federal Register, the public may submit comments for consideration by both the advisory committee and the FDA. Additional meeting material, such as the meeting agenda with discussion topics and briefing documents from FDA staff, will be posted online at least two days before the meeting.

The advance material for these meetings usually includes questions that will be put to a committee vote. For the three Covid vaccines that were reviewed for emergency authorization, committee members were asked to vote on whether the benefits of the vaccine outweigh the risks. Since this meeting on pediatric use will not discuss specific products, it’s not clear whether there will be voting questions for the committee. It’s also not clear what role, if any, the vaccine developers will have in the hearing. The FDA did not respond to an email inquiry.

Pfizer and BioNTech have safety and efficacy data for their vaccine in adults and older teens six months after the second shot of the two-shot regimen. With those data, the companies last week submitted a rolling application to the FDA seeking full approval of that vaccine. Moderna said last week that it plans to start a rolling application seeking full approval of its vaccine later this month

Photo by FDA

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