U.S. Reps. Louie Gohmert and Bill Posey, along with U.S Senators Ted Cruz and Ron Johnson led a letter signed by 18 Members of Congress calling for answers from the Administrator of the Food and Drug Administration (FDA) and its VRBPAC panel regarding Emergency Use Authorization (EUA) approval for use of the COVID-19 vaccines in children ages 6 months and up. The VRBPAC panel is scheduled to meet on June 15 to consider emergency use authorization of the vaccine. Among the question asked are:
- Why has the FDA recently lowered the efficacy bar for COVID vaccines for youngest children?
- If approved and widely used among children ages five and under how many lives does 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?
- How many healthy children ages five and under without pre-existing medical conditions have died or been hospitalized from COVID or its variants?
- CDC reports 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?
- Why has the FDA been so slow to release the hundreds of thousands of pages of data from pre-approval manufacturer studies, post-approval adverse events data, other post-approval manufacturer data submitted to the FDA as required by law?
“The rush to approve emergency use authorization for COVID vaccines for our nation’s youngest children is deeply disturbing, especially considering the 99.995% COVID survival rate for children. Coupled with the fact that we do not know the long-term side-effects of the shot as well as the sudden increase in post-vaccination myocarditis and pericarditis of other damages that may be done to our youth, the push for vaccine approval seems absolutely reckless.
“Just last month, the FDA essentially announced that people should no longer take the Johnson and Johnson vaccine due to dangerous blood clotting side effects. This, after telling us the J&J vaccine was safe and effective for over a year. As Americans, we have every right to demand that the utmost safety & efficacy standards be implemented and rigorous studies and testing be performed before these injections are approved for anyone, especially innocent children.
“The CDC and FDA work for the American people, not Big Pharma, and it’s time they are reminded of that. There are many questions I’d like to see answered before any final decision is made on administering this shot to young children,” said U.S. Rep. Louie Gohmert.
“I am concerned that in a rush to mandate a ‘one-size-fits-all’ policy, the FDA is failing to consider that this age group is least at risk for complications from COVID and that the CDC estimates 68% of those under five have already had COVID. Commonsense would suggest that VRBPAC members have already asked these questions, so we would expect a response by the time they meet. If we don’t receive answers, it is right to assume they haven’t asked basic benefit and risk questions about using this vaccine for millions of children who are at very little risk from COVID,” said U.S. Rep. Bill Posey.
“We are in our third year with COVID-19, and we know vastly more about the virus now than we did in 2020. One of the most important things we know is that this virus poses minimal risk for children. Before the FDA approves an Emergency Use Authorization for a children’s vaccine, parents should be able to see the data and paperwork they would use to justify this decision. This is the least the FDA can do for families in Texas and across the country so parents can make the best decisions for their children,” said U.S. Senator Ted Cruz.