A group of lawmakers led by Reps. Louie Gohmert and Bill Posey, along with Sens. Ted Cruz and Ron Johnson are still awaiting a response to questions and concerns they raised about the federal government's Emergency Use Authorization (EUA) for Covid-19 vaccines for the babies and toddlers.
The Congressional members sent a formal letter to FDA Commissioner Robert Califf and members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 7 asking the following questions:
- 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?
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.”Rep. Bill Posey (R-Florida)
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.”Sen. Ted Cruz (R-Texas)
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."Rep. Louie Gohmert (R-Texas)
Read the full letter here.
Rep. Louie Gohmert also publicly voiced concerns at an "Open Public Hearing" held by FDA and VRBPAC regarding Emergency Use Authorization (EUA) on June 15.
Listen to Sharyl Attkisson's interview with Gohmert on The Sharyl Attkisson Podcast below.
— Lindsay (@TexasLindsay) June 15, 2022
Since the public hearing, the FDA has formally given the green light to the EUA for both Pfizer and Moderna Covid vaccines for babies and children 6 months of age and up and CDC approved.