FederalHealthcareCruz, Gohmert, Roy Among Legislators Questioning FDA Over COVID Vaccines For Babies, Toddlers

“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,” Cruz said in a statement.

Addressed to FDA Commissioner Robert M. Califf, the letter cites a May 2022 study from the Centers For Disease Control and Prevention indicating that 68 percent of children between the ages of one and four have previously had COVID-19 and statistics from the American Academy of Pediatrics showing children have a 99.98 percent COVID-19 survival rate.

Questioning the “one-size-fits-all” approach regarding young children, the group of legislators submitted 19 questions for Califf they say must be answered before the FDA’s Vaccines and Related Biological Products Advisory Committee meets on June 15 to consider authorization of the vaccine for emergency use.

One question asks why the FDA recently lowered the bar for COVID vaccines for young children to an efficacy threshold of less than 50 percent, especially since the previous vaccine EUA for ages 16 and older relied on data claiming 90 percent effectiveness. While data from trials of Moderna’s two-dose vaccinations showed a 51 percent effectiveness in children aged six months to two years, the rate dropped to 37 percent for two- to five-year-olds.

Other questions posed by the group concern the safety of the vaccines for children, referencing cardiac risk factors, the possibility of increasing a child’s risk for future variants, and the possibility of recipients developing antibody dependent enhancement phenomenon, a condition that leaves a patient more vulnerable to a virus after an initial period of immunity.

A recent Journal of the American Medical Association study found that Pfizer vaccine effectiveness against symptomatic infection in patients 12 to 15 years old dropped significantly four months after full vaccination, with participants more likely to have symptomatic infection than unvaccinated persons after seven months.

Dr. Peter McCullough, a well-known Dallas internist, cardiologist, and trained epidemiologist has warned of adverse COVID vaccine effects in adult and teen recipients that include not only myocarditis, but also blood clots, bleeding, skin rashes, immune system problems, and death.

Additional data sought by the legislators include numbers of children under age five who have died from COVID both with and without pre-existing medical conditions, numbers of healthy children hospitalized for COVID, and a list of medical emergencies of children one to four years old that would justify the EUA.

“The data show that the risks of serious adverse outcomes for COVID for children five and under is very low and as such the standard for evaluating EUA interventions must be very high,” the legislators wrote.

The Biden administration announced this week a plan to distribute 10 million doses of Moderna, Pfizer, and BioNTech SE vaccines for children under five as early as June 21, if the FDA approves the EUA next week.

Cruz is urging FDA transparency prior to approval, saying, “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.”

Earlier this week, an FDA panel also recommended the agency give EUA to a new vaccine from Novavax, but noted some incidents of myocarditis within 20 days of receiving a shot.