WASHINGTON – On Wednesday, U.S. Sen. Ron Johnson (R-Wis.) joined U.S Sen. Ted Cruz (R-Texas), U.S. Rep. Bill Posey (R-Fla.), U.S. Rep. Louie Gohmert (R-Texas) and 18 of their colleagues in a letter calling for answers from the Food and Drug Administration (FDA) and its Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel regarding the Emergency Use Authorization (EUA) application for the use of COVID-19 vaccines in children under the age of five. The VRBPAC panel will meet on June 15 to consider the authorization of the vaccine for emergency use.
“The broad approach of the CDC and FDA to date has been a one-size fits all policy – get the vaccine regardless of age, risk factors, the underlying health of the individual, or previous infection. Yet, to date there remain many unanswered questions about these EUA-approved COVID-19 vaccines and only a small percentage of the safety data about these vaccines that are in the possession of the FDA and the manufacturers has been released for review,” said the senators.
“We believe it is prudent and necessary that the FDA provide answers to a number of questions before approving EUA vaccines for children under age 5, including more than 70% of whom are already seropositive for COVID-19,” continued the senators.
A few of the questions asked by the bicameral group of legislators are:
· Why has the FDA recently lowered the efficacy bar for COVID vaccines for the youngest children?
· If approved and widely used among children ages five and under how many lives does the FDA estimate will be saved in this age group over the next year? Given the injuries reported in the FDA’s own VAERS system, how will the FDA evaluate potential tradeoffs of serious vaccine injuries versus serious COVID outcomes?
· CDC reports 10 seropositivity of 68% of children 1-4 years, 77% for those 5-11, and 74% children ages 12-17. With two additional COVID waves since this data was reported and corresponding increases in seropositivity, what percentage does FDA consider herd immunity?
Sens. Johnson and Ted Cruz, along with Reps. Posey and Gohmert are joined on the letter by Representatives Ralph Norman (R-S.C.), Mary Miller (R-Ill.), Andy Biggs (R-Ariz.), Chip Roy (R-Texas), Dan Bishop (R-N.C.), Lauren Boebert (R-Colo.), Andrew Clyde (R-Ga.), Thomas Massie (R-Ky.), Warren Davidson (R-Ohio), Jeff Duncan (R-S.C.), Diana Harshbarger (R-Tenn.), Matt Rosendale (R-Mont.), Vicky Hartzler (R-Mo.) and Bob Good (R-Va.).
The full text of the letter can be found here.