Sen. Ted Cruz of Texas and other Republicans want the Food and Drug Administration to explain why it did not convene its outside panel of advisers before authorizing the Pfizer-BioNTech COVID-19 booster shot for children aged 12 to 15.
In a letter to acting Commissioner Janet Woodcock, dozens of House and Senate Republicans said the FDA’s Jan. 3 approval was not vetted in an open meeting by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), according to Fox News.
While the agency does not have to convene the advisers, it has relied on their input for some decisions during the pandemic while bypassing it on others.
“This is extremely puzzling and, frankly, quite troubling,” Mr. Cruz, Rep. Chip Roy of Texas and other GOP lawmakers 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 advisory panel weighed in on Pfizer and Moderna booster shots for adults in the fall but not the later approval, which was given amid a flurry of January actions that included shortening the interval for a booster from six months to five amid a push to thwart the highly contagious omicron variant of COVID-19.
The lawmakers want the FDA to explain whether it weighed the relative risks of COVID-19 versus the risk of myocarditis, or inflammation of the heart muscle, that’s been linked to the second dose of the vaccine, especially in young men.
“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,” Mr. Roy told Fox News Digital.
Scientists have acknowledged the link between myocarditis and the vaccine, but also point to evidence that people are more likely to get the condition from a COVID-19 infection than the vaccine.
For more information, visit The Washington Times COVID-19 resource page.