A group of Republican lawmakers, including several from Florida, wants the Biden administration to better explain why American children under 5 need COVID-19 vaccines – when the data show an astronomically high survival rate for kids, estimated at 99.995 percent in one study, for that age bracket.
Seventeen GOP lawmakers wrote to Centers for Disease Control and Prevention Director Rochelle Walensky and Robert Califf, commissioner of the Food and Drug Administration, about requests by Pfizer and Moderna for emergency use authorization to provide the vaccines.
Pfizer seeks to make vaccines available to children between 6 months and 4 years old, while Moderna, whose shot is not yet authorized for people under 18, has petitioned for the 6-month to 6-year-old bracket.
In response, the lawmakers wrote that they wanted to share their concerns about these applications.
“Our greatest duty is to ensure the safety of America’s youngest generation, to ensure that their health is considered and protected accordingly. This generation is the population at least risk for serious adverse complications from COVID-19, therefore we should take caution when promoting a vaccine for their developing bodies,” they wrote.
“We believe in the need for a very high standard for safety and efficacy, especially in the younger populations. There are many extremely important questions regarding the safety of mRNA COVID-19 vaccines that must first be answered, many of which have not been answered by the FDA.”
The GOP lawmakers pointed out that mRNA vaccines are “unprecedented,” and “were created rapidly, lack long-term studies made available to the public, and have been causing myocarditis — especially in children and young adults.”
The FDA, they added, has directed Pfizer to investigate the risk of heart inflammation from a COVID-19 vaccination and agreed with Pfizer’s suggestion that such reporting can be delayed until Oct. 31, 2025.
“The lack of concern with experimenting on our children is extremely shocking, especially because there has been a rapid decline in the prevalence of COVID-19 cases,” the lawmakers noted.
New COVID-19 infections have gone from a record high of more than 1.3 million cases reported on Jan. 10, 2022, to a low of 23,358 as of April 24. Meanwhile, the CDC maintains that the omicron variant caused less severe illness than previous variants.
As of March 30, 2022, the CDC had reported 363 deaths in 0-to-4-year-olds since the pandemic started in March 2020. The agency, the letter added, has not said if the deaths were directly caused by COVID-19 infection, and if any were connected to omicron.
Pfizer, they point out, now says three shots are needed for young children, since two doses were insufficiently effective. They also noted Pfizer reported its vaccine was effective in only 12 percent of children 5-to-11 after 30 days.
“How will a third dose boost this large of a decline in efficacy, and what is the decline in efficacy for 0-to-4-year-olds?” the lawmakers asked.
Yet children have been found to develop a “strong and robust” antibody response after infection, more so than in adults, and maintained that level for six months.
But, they pointed to a November 2021 study, funded by Pfizer, that determined the vaccine is safe for children between 5 and 11, even though that age group has witnessed 10,157 adverse reactions from Dec. 14, 2021, to April 1, 2022.
“Does the FDA believe this to be a conflict of interest? Why are the companies who are producing unprecedented mRNA vaccines for children the same companies that are funding the study for safety and efficacy?” they asked.
They noted that Moderna also seeks FDA permission, even though its two-dose cycle reduced infection by 44 percent in children 6 months to 2 years and by 38 percent for kids 2 to 6.
Thus, Moderna still seeks authorization, even though it failed to meet the required 50 percent efficacy rate, and conducted a trial of 6,700 children, which did not meet the appropriate research threshold.
“Moderna is treating our children as statistical numbers that they can manipulate, not the developing and vulnerable children that they are,” the lawmakers argued.
“Given the low risk that COVID-19 poses to children, and the robust strength of their immune systems, it is concerning that the FDA is considering a vaccine that has an extremely low efficacy rate in children and comes with risks such as myocarditis — something that can be fatal or pose chronic health issues. Furthermore, no one knows the potential long-term adverse effects of COVID-19 mRNA vaccines, especially in young and rapidly developing children.”
“Given these facts,” they concluded, “we are very concerned that FDA approval of these vaccines for healthy children – who have a 99.995% survival rate against COVID-19 – may pose significantly more risk than benefit.”
“We believe this issue deserves the greatest attention, and we would like to hear directly from the FDA about the details of the risks and benefits should the FDA consider broad approval of these vaccines for the youngest of children.” The Florida Republicans who signed the letter include Reps. Bill Posey or Rockledge, Greg Steube of Sarasota, and Michael Waltz of St. Augustine.