GOP lawmakers ask FDA for answers in Pfizer COVID-19 booster approval process for children: ‘Quite troubling’

GOP lawmakers ask FDA for answers in Pfizer COVID-19 booster approval process for children: ‘Quite troubling’

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FIRST ON FOX: GOP lawmakers on Tuesday asked the Food and Drug Administration (FDA) for answers as to why the top agency did not rely on its typical committee approval process before authorizing a third Pfizer COVID shot for children ages 12-15.

In a letter to FDA Acting Commissioner Janet Woodcock, more than two dozen Republicans in the House and Senate questioned the decision by the administration to forego the approval of the booster shot by the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

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A 13-year-old boy holds a sign in support of COVID-19 vaccinations as he receives his first Pfizer vaccination at the Cook County Public Health Department.

A 13-year-old boy holds a sign in support of COVID-19 vaccinations as he receives his first Pfizer vaccination at the Cook County Public Health Department. (AP/Shafkat Anowar)

“This is extremely puzzling and, frankly, quite troubling,” the lawmakers, led by Texas Sen. Ted Cruz and Rep. Chip Roy wrote. “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.

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7 year-old receives his COVID-19 vaccination at the Salt Lake County Health Department Wednesday, Nov. 3, 2021, in Salt Lake City.

7 year-old receives his COVID-19 vaccination at the Salt Lake County Health Department Wednesday, Nov. 3, 2021, in Salt Lake City.

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).

“One study found that CAE in boys without comorbidities aged 12-15 who received their second vaccine was 3.7 to 6.1 times higher than their 120-day COVID-19 hospitalization risk,” the lawmakers wrote. Though it is important to note the study said its research has “yet to be evaluated and so should not be used to guide clinical practice.”

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. 

Lawmakers additionally questioned whether the White House or Dr. Anthony Fauci were involved in the authorization-making process. 

A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic in the Norristown Public Health Center in Norristown, Pa.

A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic in the Norristown Public Health Center in Norristown, Pa.

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“We owe it to Americans to stand up against bureaucrat-driven policies that take away power and information from parents to make good choices for their children,” Sen. Chip Roy, R-Texas, told Fox News Digital.

“The FDA’s unusual decision to bypass their normal committee approval process puts children at risk,” he added. “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.”

Fox News could not immediately reach the FDA for comment. 

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