GOP lawmakers ask FDA for answers in Pfizer COVID-19 booster approval process for children: 'Quite troubling' - Fox News

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.

FDA APPROVES PFIZER CORONAVIRUS VACCINE BOOSTERS FOR CHILDREN AS YOUNG AS 12.

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.

"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.".

But the committee does not appear to have approved such authorization for Pfizer booster shot for children, despite granting FDA approval on Jan.

CDC RECOMMENDS PFIZER COVID-19 BOOSTER SHOT AT 5 MONTHS.

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.

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