FDA commissioner: ‘I don’t know’ whether healthy children should get COVID shots
FDA Commissioner Dr. Marty Makary surprised conservatives recently by saying he is unsure whether healthy children should receive multiple COVID-19 shots.
Makary made the remarks in an April 30th appearance on CBS, where he was asked by Major Garrett about research and development on Novavax, a protein-based COVID shot.
“It’s my general feeling—not with this particular product, which I can’t discuss in depth—but with drugs in general, that we need to know if they work today in order to be able to recommend them,” said Makary. “So we are asking some companies in general, to do clinical studies—a basic clinical study so we can educate the population and have information to work with. Should a 12-year-old, thin, healthy girl get a seventh COVID shot this year? I don’t know the answer to that because we don’t have good clinical data.”
‘The data was never there’
Prior to his appointment at the FDA, Makary repeatedly asserted that the COVID shot should not be administered to young, healthy people.
In 2023 congressional testimony to the House Select Subcommittee on the Coronavirus Pandemic, Makary said the notion "that young people benefit from a booster [is] misinformation. Our two top experts on vaccines quit the FDA, in protest over this particular issue, pushing boosters in young, healthy people. The data was never there.”
‘No healthy child 5-17 has died of COVID’
In other congressional testimony, Makary noted that healthy children are not at risk from COVID.
“Germany reported that no healthy child 5-17 has died of COVID during the first 15 months of the pandemic, when nearly all children were unvaccinated,” he said. “The CDC has never told us if any U.S. COVID deaths in children have been in healthy children.”
“Let me be clear, there is nothing that represents American waste, excess, and arrogance more than requiring a young, healthy, low-risk student who had the infection in the past and already has natural immunity to get a booster,” he added.
Dr. Makary also promoted the use of alternative treatments for COVID-19, like fluvoxamine and inhaled budesonide, instead of the shots.
What is a vaccine?
While Makary’s recent comments about boosters for young, healthy children may be seen as diplomatic, what remains unclear is how the FDA and other HHS agencies define “vaccine.” Under the Biden administration, the CDC in 2021 changed the definition of “vaccine” from a shot that “prevents” disease to one that vaguely “protects” against it. The change was made after it became clear that the COVID-19 shots did not prevent infection or transmission as promised.
Now, as the FDA monitors the development of non-mRNA vaccines, it remains to be seen whether these products will be held to the traditional standard of prevention, or if, like the mRNA shots, they will be considered vaccines despite being no more than therapeutics.
