Pfizer is applying for an emergency authorization for its coronavirus vaccine for teenagers and children aged 12 to 15. The FDA will have to change the permit for emergency use of the vaccine, but the process must be clear, said the official, who was not authorized to speak publicly about the process and requested anonymity.
The FDA is currently reviewing data provided by Pfizer in support of expanded use. In late March, Pfizer said a clinical trial involving 2,260 children aged 12 to 15 showed that it was 100% effective and well tolerated. The vaccine is currently approved in the United States for emergency use in people 16 years of age and older.
Prior to issuing the EUA for the three authorized coronavirus vaccines, the FDA met with its independent Advisory Committee on Vaccines and Related Organic Products to review the data and vote on whether to recommend the EUA. This will not happen with the enlargement of the EUA to children aged 12 to 15, said the FDA from CNN.
“Although the FDA cannot predict how long it will take to evaluate the data and information, the agency will review the request as quickly as possible using its in-depth and scientifically sound approach,” the FDA said in an email to CNN last week.
“Based on an initial assessment of the information submitted, the Agency does not currently plan to hold a meeting of the Advisory Committee on Vaccines and Related Organic Products (VRBPAC) on this request to amend the EUA for Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended. to authorize a VRBPAC meeting in December 2020. As with all FDA-approved COVID-19 vaccines, we are committed to transparency with this EUA review process. “
The Advisory Committee of the US Centers for Disease Control and Prevention, known as the Advisory Committee on Immunization Practices, will schedule a meeting for any FDA decision to extend the EUA to new age groups. ACIP will advise the CDC whether to recommend the use of the vaccine in children aged 12 to 15, and then CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group.
Both Pfizer and Moderna are testing their vaccines on children as young as 6 months old and expect to ask the FDA for EUAs covering babies and children later this year.
Extending the EUA to younger children will be a different issue, the official said.
“In the larger group of children, if there is nothing exceptional, if everything looks very similar to adults, the feeling is that it is not necessary to bring this to a meeting of an advisory committee,” the official said. “For younger children, we will almost certainly consider going to a meeting of the advisory committee.”
Meanwhile, the Maryland-based Novavax announced Monday that it has expanded its phase 3 study for its Covid-19 vaccine to include up to 3,000 children between the ages of 12 and 17 in the United States. They will receive the candidate for vaccine or placebo in two doses with an interval of 21 days.
Novavax’s Covid-19 vaccine is not yet approved for emergency use in the United States.