US regulators on Monday authorized Pfizer and its partner BioNTech’s Covid vaccine for use in children as young as 12, widening the country’s inoculation program even as vaccination rates have slowed significantly.
The vaccine has been available under an emergency use authorization (EUA) to people as young as 16 in the United States. Today’s decision means the FDA is amending the EUA to include children aged 12 to 15. The vaccine makers said they had started the process for full approval for those ages last week.
“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Janet Woodcock, the acting FDA commissioner.
“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,” Woodcock added.
According to the FDA, about 1.5m cases have been reported to the Centers for Disease Control and Prevention (CDC) in individuals 11 to 17 years of age between March 2020 and April this year.
Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up.
While children are far less likely than adults to get seriously ill, the age group represents nearly 14% of coronavirus cases in the US. At least 296 have died in the US after contracting the virus and more than 15,000 have been hospitalized, according to the American Academy of Pediatrics (AAP).
The agency also said “the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.”
“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.
The CDC says unvaccinated people – including children – should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.
The latest news is welcome for many families struggling to decide what activities are safe to resume when only the youngest family members remain unvaccinated.
For Carrie Vittitoe, a substitute teacher in Louisville, Kentucky, who is fully vaccinated, as are her husband and 17-year-old daughter, the FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son who would be unvaccinated.
“I can’t feel totally comfortable because my boys aren’t vaccinated,” Vittitoe told the Associated Press. “We can’t really go back to normal because two-fifths of our family don’t have protection.”
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects.
Another US company, Novavax, has a Covid-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds as well.
The next hurdle is to test whether the vaccine works for even younger children. Both Pfizer and Moderna have begun studies in children aged from 6 months to 11 years that explore whether babies, preschoolers and elementary-age kids will need different dosages to teens and adults.
Outside of the US, AstraZeneca is studying its vaccine among six- to 17-year-olds in Britain. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three.
The AAP welcomed FDA’s decision.
“Our youngest generations have shouldered heavy burdens over the past year, 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,” said Dr Lee Savio Beers, the AAP president, in a statement.