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FDA authorizes first Covid-19 booster shot for teens aged 12 to 15

( Stat News )


The Food and Drug Administration on Monday extended the emergency use authorization for the Pfizer and BioNTech Covid-19 booster shot to include teens aged 12 to 15, paving the way for them to be eligible for the jabs later this week.


It is the first booster shot to be authorized for this age group.


A panel of independent experts that advises the Centers for Disease Control and Prevention on vaccination policy will meet Wednesday to discuss the policy change. It’s possible the ACIP will issue what’s known as a permissive recommendation — saying youths aged 12 to 15 may get a booster if they wish, but stopping short of urging them to do so.


If the committee goes this route, it will likely be because of still outstanding questions about the risk of myocarditis and pericarditis — inflammation of the heart and tissue surrounding the heart, respectively — that may be associated with getting a booster shot for this age group. The ACIP’s recommendation must be approved by CDC Director Rochelle Walensky before it can come into effect.


Janet Woodcock, the acting FDA commissioner, said in a call with reporters that the FDA expects that myocarditis would be “extremely rare” in a third dose given to 12- to 15-year-olds, and that data collected from the use of the vaccine in Israel seems to back up that idea.


Peter Marks, the director of the FDA’s Center for Drug Evaluation and Research, told reporters that the myocarditis risk seems to peak in 16- to 17-year-old males. Ninety-eight percent of cases have been mild, and among males between 16 and 30, the rate of myocarditis is about one in 1,000 vaccine recipients. The risk appears to be lower, he said, with a third booster shot than with a second dose. Marks said the FDA would continue to monitor the condition.


The Biden administration is pushing to get booster shots into as many Americans as possible as the highly transmissible Omicron variant sweeps across the country. Though infections associated with this latest variant of concern appear to be mild to moderate for many people, the transmissibility of the virus is pushing case counts to new heights. Even if most cases are mild, having hordes of people sick at once is already wreaking havoc on many sectors, including air travel and health care.


As 12- to 15-year-olds became eligible to be vaccinated in May of last year, many will be ready for a booster when Walensky approves the expanded EUA.


The extension will only apply to the Pfizer vaccine, which is the sole Covid vaccine in this country authorized for use in anyone under the age of 18.


The FDA also announced that it is shortening the interval after which people are eligible for a booster shot, moving it to five months post-completion of a primary vaccination series from six months. This relates to adults, teens, and preteens eligible for a booster who have received the two-dose series of the messenger RNA vaccines made by Pfizer or Moderna. People who received the one-dose Johnson & Johnson vaccine are urged to get a second shot two months after the first jab.


The FDA also announced that children aged 5 to 11 who are moderately or severely immunocompromised will be able to get a third dose of the Pfizer vaccine 28 days after they receive their second dose. Third doses for moderately or severely immunocompromised people 12 and older were previously approved by the FDA and the CDC.

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