GOP Lawmakers Demand Answers to FDA's 'Troubling' Covid Booster Approval Process for Kids

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Posted: Jan 19, 2022 7:00 AM
GOP Lawmakers Demand Answers to FDA's 'Troubling' Covid Booster Approval Process for Kids

Source: AP Photo/Ted S. Warren

More than two dozen Republicans sent the Food and Drug Administration a letter on Tuesday asking why the agency skipped its traditional committee approval process for Covid-19 booster shots for 12-15 year-olds.

"This is extremely puzzling and, frankly, quite troubling," the lawmakers wrote, according to Fox News. "Children are still growing and developing, and these are relevant factors for consideration to ensure that this additional vaccine dosage is appropriate, especially as early teens in the 12 to 15 age group are at extremely low-risk for death and hospitalization from COVID-19."

The VRBPAC voted in September 2021 to authorize a third Pfizer shot for adults 18 years and older who had already received the first two rounds of vaccine shots at least six months prior. The committee then voted to authorize the additional Moderna booster in October 2021. But the committee does not appear to have approved such authorization for Pfizer booster shot for children, despite granting FDA approval on Jan. 3.

The group of Republicans argued that uncertainties surrounding the vaccine remain when it comes to children getting the jab.

The lawmakers pointed to a non-peer-reviewed study that has suggested that boys ages 12-15 who received the second dose of the coronavirus vaccine may have been under a higher risk of cardiac adverse events (CAE). […]

Additionally, the lawmakers noted another study that found myopericarditis, a condition that relates to inflammation of the heart, occurred in 1 in 2,650 boys ages 12-17 after their second shot of the vaccine. The study also noted it has not yet been peer-reviewed. (Fox News)

"The FDA’s unusual decision to bypass their normal committee approval process puts children at risk," said Rep. Chip Roy, who signed the letter. "The accumulation of mistaken federal policies carried out by executive fiat in response to the pandemic — from lockdowns, to perpetual masking, and rushed vaccine policies — deeply concern me."

Earlier this month critics blasted the FDA for bypassing its traditional approval process.

"Dear President Biden, FDA is bypassing it's scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable – undermines the integrity of the FDA's standard process! Please require FDA to put this authoriz [sic] before the [Vaccines and Related Biological Products] advisory comm for a vote!" tweeted Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center.