FDA would authorize Pfizer vaccine in 12-15 year olds 0:47
(CNN) – The U.S. Food and Drug Administration (FDA) is set to authorize the Pfizer / BioNTech coronavirus vaccine in children and adolescents 12-15 years of age early next week. a federal government official told CNN.
Pfizer applied for an emergency use authorization for its coronavirus vaccine for adolescents and children ages 12-15. The FDA will have to modify the emergency use authorization for the vaccine, but the process should be straightforward, said the official, who was not authorized to speak about the process publicly and requested anonymity.
The FDA is reviewing the data submitted by Pfizer to support widespread use. Pfizer said in late March that a clinical trial involving 2,260 children between the ages of 12 and 15 showed that it is 100% effective and well tolerated. The vaccine is currently licensed in the US for emergency use in people 16 years of age and older.
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Before issuing the emergency use authorization for the three licensed coronavirus vaccines, the FDA held meetings of its Vaccine and Related Biologics Advisory Committee to review the data and vote on the recommendation. That will not happen by extending authorization to children ages 12 to 15, the FDA told CNN.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the application as quickly as possible using its comprehensive and science-based approach,” the FDA said in an email to CNN. last week.
“Based on an initial assessment of the information submitted, at this time, the agency does not plan to hold a Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting on this application to amend the emergency use authorization of the Pfizer-BioNTech’s covid-19 vaccine, the authorization of which was discussed and recommended at a VRBPAC meeting in December 2020. As with all FDA-cleared covid-19 vaccines, we are committed to transparency with this emergency use authorization review process. ‘
An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC), known as the Advisory Committee on Immunization Practices (ACIP), will schedule a meeting after any FDA decision to extend the authorization to new age groups. The ACIP will advise the CDC on whether to recommend use of the vaccine in children ages 12-15, and then CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group.
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Pfizer and Moderna are testing their vaccines in children as young as 6 months and hope to apply to the FDA for an emergency use authorization covering infants and children later this year.
Extending the authorization to younger children will be a different matter, the official said.
“In the group of older children, if there is nothing exceptional, if everything looks a lot like adults, the feeling is that it is not necessary to bring this to an advisory committee meeting,” said the official. “For younger children, we will almost certainly consider going to an advisory committee meeting more seriously.”
Meanwhile, Maryland-based Novavax announced Monday that it expanded its phase 3 trial for its COVID-19 vaccine to include up to 3,000 children ages 12 to 17 in the United States. They will receive either the vaccine candidate or the placebo in two doses 21 days apart.
Novavax’s covid-19 vaccine is not yet licensed for emergency use in the United States.