Unanswered Questions About Vaccine’s Effect On Young Children Among Concerns Cited In Letter to Abbott
Representatives Bryan Slaton (House District 2), Jeff Cason (HD 92) and Kyle Biedermann (HD 73), as well as House District 93 candidate Nate Schatzline, emailed a letter Friday, July 7, 2022, to Governor Greg Abbott requesting he direct the Texas Health and Human Services Commission to halt distribution of COVID-19 vaccines to children under 4 years of age.
The letter was written in response to the U.S. Food and Drug Administration’s June 17, 2022, emergency use authorization of Moderna and the Pfizer-BioNTech COVID-19 vaccines for use in children down to 6 months of age.
For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older. The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.
For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.
According to the FDA, the agency’s “evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.” Thus, the FDA “determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.” The federal agency noted in the June 14, 2022 announcement that “prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations.”
[For the FDA June 17 announcement of the Moderna and Pfizer COVID-19 vaccines for children from 6 months to 17 years, click here.]
The three House Representatives and HD 93 candidate contend in their letter to Abbott that “all objective standards this Covid ’emergency’ has long been over,” negating the need for the extended emergency use authorization of the vaccines, especially for children as young as 6 months.
“The FDA’s Authorization for the COVID-19 vaccines for infants has raised many concerns and unanswered questions across the country, as we highlighted in our letter,” Slaton commented in a news release Friday, July 8, 2022, about the letter. “Governor Abbott has often publicly committed himself to protecting children, and my colleagues and I are respectfully requesting that he do that in this situation. Until these concerning questions regarding the effects of this vaccine on infants have been answered, it is our firm belief that Texas should pause all distribution of the vaccine to young children.”
The letter states as follows:
