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

FIRST ON FOX: GOP lawmakers on Tuesday asked the Food and Drug Administration (FDA) for answers as to why the top agency did not trust its typical committee approval process before approving 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 administration’s decision to waive the approval of the booster shot by the Vaccines and Related Biological Products Advisory Committee (VRBPAC).


“This is extremely enigmatic and frankly quite worrying,” wrote lawmakers, led by Texas Senator Ted Cruz and rep. Chip Roy. “Children are still growing and developing and there are relevant factors to consider to ensure that this additional dose of vaccine is appropriate, especially as early teens in the age group of 12 to 15 years have an extremely low risk of death and hospitalization due to COVID-19 . “

VRBPAC voted in September 2021 to approve 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 before. The committee then voted to approve the additional Moderna booster in October 2021. But the committee does not appear to have approved such an authorization for the Pfizer booster shot for children, despite giving FDA approval on January 3rd.

The group of Republicans claimed that there are still uncertainties surrounding the vaccine when it comes to children getting the icing on the cake.


Legislators pointed to a non-peer-reviewed study that suggested that boys ages 12-15 who received the second dose of the coronavirus vaccine may have been at a higher risk of cardiac side effects (CAE).

“A study showed that CAE in boys without concomitant diseases aged 12-15 who received their second vaccine was 3.7 to 6.1 times higher than their 120-day COVID-19 hospital risk,” the legislators wrote. Although it is important to note that the study said that its research “has not yet been evaluated and therefore should not be used to guide clinical practice.”

In addition, lawmakers noted another study that found myopericarditis, a condition related 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 The study also noted that it has not yet been peer-reviewed.

Lawmakers also questioned whether the White House or Dr. Anthony Fauci was involved in the approval process.

“We owe it to Americans to stand up to bureaucratic policies that remove power and information from parents to make good choices for their children,” Senator Chip Roy, R-Texas, told Fox News Digital.

“The FDA’s unusual decision to circumvent their normal committee approval process puts children at risk,” he added. “I am deeply concerned about the accumulation of erroneous federal policies pursued by executive fiat in response to the pandemic – from lockdowns, to perpetual masking and hasty vaccine policies.”

Fox News could not immediately reach the FDA for comment.

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