U.S. regulators on Monday cleared Pfizer and its partner BioNTech to use the Covid vaccine in children as young as 12, expanding the country’s vaccination program even as vaccination rates have slowed dramatically.
The vaccine is available under Emergency Use Authorization (EUA) for people as young as 16 years old in the United States. Today’s ruling means the FDA amends the EUA to include children between the ages of 12 and 15. Vaccine makers said they began the full approval process for these ages last week.
“Today’s action allows a younger population to be protected from Covid-19, which brings us one step closer to a return to a sense of normalcy and the end of the pandemic,” said Janet Woodcock, the Acting Commissioner of the FDA.
“Parents and guardians can rest assured that the agency has undertaken a rigorous and in-depth review of all available data, as we have done with all of our authorizations for emergency use of the Covid-19 vaccine,” said added Woodcock.
According to the FDA, approximately 1.5 million cases were reported to the Centers for Disease Control and Prevention (CDC) in people aged 11 to 17 between March 2020 and April of this year.
Pfizer’s vaccine is used in several countries for adolescents as young as 16, and Canada recently became the first to expand its use to 12 years and older.
While children are much less likely than adults to become seriously ill, the age group accounts for nearly 14% of coronavirus cases in the United States. At least 296 have died in the United States after contracting the virus and more than 15,000 have been hospitalized, according to the American Academy of Pediatrics (AAP).
The agency also said that “the known and potential benefits of this vaccine in people 12 years of age and older outweigh the known and potential risks, supporting the use of the vaccine in this population.
“With science guiding our assessment and decision-making process, the FDA can assure the public and the medical community that the available data meets our rigorous standards to support the emergency use of this vaccine in adolescents. Ages 12 and up, ”said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The CDC said unvaccinated people – including children – should continue to take precautions such as wearing masks indoors and keep away from other unvaccinated people outside their households.
The latest news is welcome for many families who are struggling to decide which activities can be safely resumed when only the youngest family members are not vaccinated.
For Carrie Vittitoe, a substitute teacher in Louisville, Kentucky, who is fully vaccinated, just like her husband and 17-year-old daughter, the FDA ruling means her 13-year-old son may soon be eligible, leaving just his 11-year-old. . one year old son who would not be vaccinated.
“I can’t feel totally comfortable because my boys aren’t vaccinated,” Vittitoe told The Associated Press. “We can’t really get back to normal because two-fifths of our family have no protection.”
Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said that preliminary results from his study in 12-17 year olds show strong protection and no serious side effects.
Another American company, Novavax, has a Covid-19 vaccine in advanced development and has just started a study in young people aged 12 to 17 as well.
The next hurdle is to test whether the vaccine works for even younger children. Pfizer and Moderna have both started studies in children aged 6 months to 11 years that explore whether babies, preschoolers, and elementary-aged children will need different doses for teens and adults.
Outside the United States, AstraZeneca is studying its vaccine in children aged 6 to 17 in Britain. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing that its vaccine is safe in children as young as three.
The AAP praised the FDA’s decision.
“Our younger generations have taken on a heavy load over the past year, and the vaccine is a sign of hope that they can begin to experience all the activities that are so important to their health and development,” he said. AAP President Dr Lee Savio Beers said in a statement.