PHILADELPHIA (KYW Newsradio) — The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for use on children between the ages of 12 and 15 by early next week, according to a federal health official who spoke to CBS News.
If that were to happen, Pfizer’s vaccine would be the first in the country to be approved for adolescents. The New York Times was first to report that the potential authorization could come soon. Currently, Americans as young as 16 years old can get the Pfizer doses. Moderna's and Johnson & Johnson’s vaccine is approved for those who are 18 and older.
CBS News Medical Contributor Dr. David Agus says changing the eligibility age is a key step towards ramping up vaccinations in the country.
"There are probably anywhere from 15 to 17 million children that will become eligible for this vaccine," Agus said. "And the hope is, over the next several weeks, we can vaccinate up to 10 million of them and provide extra protection for them as well as continue to stop the spread of the virus."
Expanding the pool to younger people would mean middle school and high school students could get vaccinated before the beginning of the next school year.
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In early April, Pfizer and its partner BioNTech, filed a request with the FDA to amend the emergency use authorization (EUA) to lower the eligibility age to 12. The drugmaker says vaccine efficacy was 100% in its Phase 3 clinical trials. There were 2,260 participants who were between 12 and 15 years of age. Pfizer says there were 18 positive COVID-19 cases in the placebo group and none in the vaccine group. The company says the vaccine side effects were typical of what those ages 16 and 25 experienced.
After the FDA expands on the EUA, the CDC’s Advisory Committee on Immunization Practices (ACIP) will go over the clinical trial information and come up with guidelines that would be sent to providers.
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"So, there will be a public ACIP meeting that will discuss the 12- to 15-year-old data, and our team is working to get that data ready to show ACIP," said Dr. Sara Oliver, who is part of the ACIP’s work group, during a panel discussion over the weekend with the Infectious Diseases Society of America.
Moderna and J&J are also completing clinical trials involving adolescents. Moderna’s results are expected to be released in the next few months.
Pfizer and Moderna are also conducting trials in children between six months and 11 years of age.
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