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Sen. Cruz, Colleagues Demand Answers From FDA Panel Regarding COVID Vaccines for Babies and Toddlers

WASHINGTON, D.C. – U.S Senators Ted Cruz (R-Texas) and Ron Johnson (R-Wis.) joined by U.S. Reps. Bill Posey (R-Fla.) and Louie Gohmert (R-Texas) led a letter with 18 Members of Congress calling for answers from the Administrator of the Food and Drug Administration (FDA) and its Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel regarding Emergency Use Authorization (EUA) approval 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.

Among 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?
  • How many healthy children ages five and under without pre-existing medical conditions have died or been hospitalized from COVID or its variants?

About the letter, Senator Cruz said:

“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.”

Read the letter here.


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