The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children.
Before the vaccine becomes widely available, it will also need to be recommended by the Centers for Disease Control and Prevention. The decision on that recommendation is made after a meeting of an expert committee, the Advisory Committee on Immunization Practices, or ACIP. The CDC director must then approve ACIP’s recommendations. That committee is scheduled to meet on Nov. 2.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock, in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
The Pfizer-BioNTech Covid vaccine for children 5 to 11 should be given as two doses three weeks apart, just like the version for older children and adults, but uses a lower 10-microgram dose, one-third the adult dose.
The FDA’s decision, which was widely expected, follows the meeting of the FDA’s advisory panel earlier this week. That panel voted 17-to-0, with one abstention, that the vaccine should be authorized. The FDA and CDC are not bound by the votes of their advisory committees, but generally follow their advice.
However, when recommending the authorization, FDA panel members expressed concerns about whether all children needed the vaccine, because the risk of complications from Covid infection in children is generally lower. They also discussed how to balance the risk of a rare side effect, an inflammation of the heart called myocarditis, with the number of Covid cases prevented. FDA modeling predicted that the number of hospitalizations from myocarditis would generally be fewer than the number of Covid hospitalizations prevented.
Still, those concerns could still prove a topic of debate for the ACIP when it meets next week.
The vaccine was not granted FDA approval, but instead an emergency use authorization. Emergency authorizations are used when the secretary of Health and Human Services has declared a public health emergency to more quickly clear the use of vaccines, treatments, and diagnostic tests. These authorizations lapse when the state of emergency ends. Pfizer’s vaccine was fully approved for those age 16 and older in August, and was previously granted an emergency use authorization for use in adolescents ages 12 to 15.
“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We are confident in the safety, effectiveness and manufacturing data behind this authorization.”
The Pfizer product is currently the only Covid vaccine authorized for use in people under the age of 18 in the U.S., though that could change soon. Moderna has filed an application to have its emergency authorization expanded to include youths 12 to 17 years of age; the FDA is expected to rule on the application soon.
“This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Pfizer’s chair and CEO, said in a statement. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”