The Food and Drug Administration authorized Pfizer booster shots for 16- and 17-year-olds on Thursday, clearing a hurdle for about 2.6 million more people to get a second dose of the COVID-19 vaccine.
OMICRON FEARS BOOSTING VACCINATIONS
“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”
The Centers for Disease Control and Prevention will have to weigh in before teenagers as young as 16 can start rolling up their sleeves for extra shots. The agency will likely back up the FDA’s decision, which resembles booster shot guidance for adults. People in that age group will become eligible for extra doses six months after the completion of a vaccination regimen — two shots of Pfizer or Moderna or the one of the Johnson & Johnson vaccine.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” said acting FDA Commissioner Janet Woodcock.
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The Pfizer vaccine is the only one to be authorized for use in people under 18. Children as young as 5 can get vaccinated with the Pfizer shots, but the FDA has yet to authorize the Moderna vaccine for children. The agency said in October that it would hold off approving the Moderna vaccine for people under 18 due to the risk of myocarditis, or inflammation of the heart muscle, posed by mRNA vaccines. The Pfizer vaccine also relies on mRNA technology, but FDA scientists concluded that the benefit of the booster outweighed the relatively low risk of causing myocarditis.
"Pfizer is conducting post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis," the FDA said.
Less than a month has passed since the FDA authorized booster doses of the Pfizer vaccine to all adults at the six-month mark following vaccination. With the threat of a new variant, omicron came a flurry of sign-ups for vaccinations. To date, more than 60% of all Americans have been fully vaccinated.