(CN) — Children as young as 12 can now get vaccinated against the virus that causes Covid-19, after the U.S. Food and Drug Administration announced Monday that Pfizer’s vaccine is safe to be administered to adolescents between ages 12 and 15.
“Today’s action allows for a younger population to be protected from Covi-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Dr. Janet Woodcock, acting FDA commissioner, said in a statement.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations.”
In a clinical trial of more than 2,200 people in that age group, participants showed vaccine side effects similar to those reported in people ages 16 and older. Participants received the same doses, at the same three-week interval, as those in the adult trials.
Adolescents’ immune response was at least as good as that of older participants, according to the FDA’s analysis. No Covid-19 cases occurred among individuals who got a vaccine during the study — in other words, in the trial, it was 100% effective.
Pfizer said during a company earnings call last week that it will seek the FDA’s emergency authorization in September for children ages 2 to 11. The company plans to follow with a request in the fourth quarter of the year to vaccinate babies ages 6 months to 2 years.
Dr. Lee Savio Beers, president of the American Academy of Pediatrics, called Monday’s authorization a “critically important step in bringing life-saving vaccines to children and adolescents.”
“Our youngest generations have shouldered heavy burdens over the past year,” Beers said, “and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”
Before vaccination in the newly authorized age groups can begin, an advisory committee for the U.S. Centers for Disease Control and Prevention will make recommendations on immunization practices for adolescents.
Beers said the AAP looks forward to that decision, and in the meantime, “pediatricians stand ready to assist in efforts to administer this and other Covid-19 vaccines.”
Children have accounted for more than 3.8 million of coronavirus cases in the U.S., according to data compiled by AAP and Children’s Hospital Association.
The organizations’ analysis shows that overall, kids make up about 14% of Covid-19 cases in the U.S. That number has increased in recent weeks --- kids made up 24% of the new cases for the week ending May 6.
While children are less likely to get seriously ill from the virus, 306 children have died and more than 15,000 had been hospitalized.
Pfizer also recently filed for the FDA’s full approval of its vaccine, which is currently authorized for emergency use along with the Moderna and Johnson & Johnson vaccines.
The approval process could take several months, but would give way to vaccine mandates at public university systems on both coasts.
The State University of New York, University of California and California State University systems have each said they will make Covid-19 vaccination a requirement for students — and faculty and staff, in the case of the California schools — as long as the FDA has fully approved a vaccine by the fall semester.
FDA approval is also likely to make businesses more comfortable mandating coronavirus vaccination as a condition of employment, experts say, which could help the distribution effort as the country's adult population hits a vaccine plateau.Follow @NinaPullano
Subscribe to Closing Arguments
Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.