FDA authorizes booster shot for 12 to 15 year olds despite lack of input from panel

Without consulting its own advisory panel, the Food and Drug Administration (FDA) authorized booster shots for 12 to 15-year-olds on Monday, despite the fact that severe disease and death rates for children are even lower than the seasonal flu.

The FDA said their decision came from Israeli data in which 6,300 children received boosters, and there were no ill effects from the third dose, such as myocarditis cases in the youngsters.

Still, critics questioned why boosters were needed in this age group, which is at extremely low risk of severe disease, hospitalization or death.

Dr. Marty Makary pointed out in an op-ed last month that the boosters could do more harm than good to children, and suggested that the vaccines could go to poor countries around the world to protect the elderly and high-risk populations there.

“Excessive and wasteful”

“Forcing immune, young, healthy, low-risk students to get a third vaccine shot is excessive and wasteful. These precious vaccine doses should be going to poor countries that still don’t have enough,” Makary concluded.

Sen. Rand Paul (R-KY), who is also a physician, agreed with Makary, tweeting Sunday that the government was “ignoring its own rules to push booster vaccines on kids for a disease that is less deadly in children than the seasonal flu.”

Encouraging children to get boosters was “focusing on the people who are already protected,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the F.D.A.’s vaccine advisory committee, told the New York Times ahead of the FDA decision.

Are boosters needed?

Indeed, the FDA has not been in agreement about whether booster shots are really needed for those under 65 and not at high risk from COVID-19.

After the advisory committee disagreed with President Joe Biden and said boosters really were not needed outside the elderly and high risk, the director of the FDA’s Office of Vaccines Research & Review, Marion Gruber, and its deputy director Phil Krause resigned from the agency.

Biden has continued to push the booster shots for everyone, even though their additional protection is likely not long-lasting.

All three of the approved vaccines in the U.S. continue to provide protection against most severe disease without the booster. It is thought that the booster may prevent more transmission of the omicron variant, but data is still limited.

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