FDA authorizes first COVID booster for children ages 5 to 11

A child with a mask and a doll gets a shot
First grader Rihanna Chihuaque, 7, receives a COVID-19 vaccine at Arturo Velasquez Institute in Chicago final November.
(Scott Olson/Getty Images)

The Food and Drug Administration Tuesday licensed the primary COVID-19 vaccine booster for kids ages 5 to 11.

The authorization makes all youngsters in that age group who acquired their second shot at the least 5 months in the past eligible to obtain a 3rd shot of the Pfizer-BioNTech vaccine.

The corporations requested the authorization based mostly on a small research that the businesses and FDA mentioned demonstrated a 3rd shot is protected and may considerably enhance antibody ranges, countering waning immunity and offering added safety towards the virus, together with the extra contagious omicron variant.

Until now, solely youngsters ages 12 and older and adults had been eligible for a booster.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” mentioned FDA Commissioner Robert M. Califf in an announcement.

“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19,” Califf mentioned. “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.”

It stays unclear how a lot of a requirement there can be for the boosters. Less than a 3rd of youngsters ages 5 to 11 are absolutely vaccinated, and solely a few quarter of adolescents have acquired a booster.

Many docs and fogeys have been hoping for the authorization, saying it’s necessary to supply youngsters with as a lot safety as potential, particularly because the variety of individuals catching the virus is rising once more and so few individuals at the moment are carrying masks.

“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” mentioned Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an announcement.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks mentioned.

But others are skeptical, saying two photographs are nonetheless offering robust safety towards critical illness and dying, and the it stays unclear how a lot added safety a 3rd shot will present or how lengthy it is going to final.

The FDA didn’t ask its exterior advisers for enter on the choice as a result of the company mentioned the committee had beforehand mentioned the problems and no new questions had been raised.

The Centers for Disease Control and Prevention’s advisers on vaccine practices will meet Thursday and are anticipated to debate implementation of a booster dose for this age group.

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