Food and Drug Administrator Marty Makary said he has a “moral duty” to inform the public of the risks of the COVID-19 vaccine after the agency found the shot may have been responsible for 10 children’s deaths.
“We did an investigation where we looked into it to decide whether or not there was a probable or possible link,” Makary told The Daily Signal in an exclusive interview. “That work is ongoing, but this data accrued over the last four years. So the moral question is now that the FDA has data where links to a child’s death have been made to the COVID vaccine, do we have a moral duty to let the public know what we know more as we learn more about the details of it? I believe we do have a moral duty to do that.”
A internal memo, first obtained by the New York Times, showed an FDA agency official saying the COVID-19 vaccine may have played a role in the deaths of at least 10 children.
Makary said the FDA needs to listen to parents who believe the COVID shot harmed their children.
“Parents have said that they believed their children had died from the COVID shot because the kid was otherwise healthy and then suddenly had a cascade of events starting immediately after the COVID shot,” he said. “And remember, many of these shots in the era of the last four years were mandated on young, healthy students to get into college or stay in college.”
“When parents have said things about their children, we need to listen,” he said. “So we did an investigation where we looked into it to decide whether or not there was a probable or possible link.”
This information is not new, Makary said.
“We’ve known that there have been deaths from the COVID vaccine,” he said. “We don’t want to be alarmist or create hysteria out there because these complications are rare. But denying that they occur is also not true. So we have a radical transparency agenda to try to rebuild public trust.”
A July 2024 poll showed that 28% of Americans believe that the COVID-19 vaccines have been responsible for thousands of deaths, up from 22% in June 2021.
The theory that “a young 6-year-old boy needs another 70 or 75 COVID shots in his average lifespan” may be incorrect, Makary said.
“It’s a theory, and there are pros and cons of that theory, and now we have at least one piece of information that says it’s not 1000% safe and free of any myocarditis risk,” he said. “We now know there are some risks, albeit rare, and so that’s information that people can use.”
Cases have been documented in the New England Journal of Medicine of young males dying from myocarditis after getting the COVID vaccine, Makary said.
“It’s been out there,” he said. “So it’s been known that this is a complication. Myocarditis can affect as many as one in 2,600 young males after one of the COVID shots, and a rare sub complication of myocarditis is severe illness and ICU stay and even death.”
Mitigating the Risks
To mitigate the risk of myocarditis, Makary said kids with natural immunity to the circulating strain of COVID should not be vaccinated.
“The other opportunity is to space out the COVID shots,” he said. “We could have spaced out the first and second dose during the pandemic in young, healthy children, especially boys who are at higher risk of myocarditis. But that recognition came too late. And so, if we would have looked at these data earlier, we could have potentially avoided many of these cases.”
The Trump administration does not support COVID vaccine mandates which have cost people their jobs.
“Of course, the issue of vaccine mandates in children has been very controversial, and our feeling has been that we don’t support kicking kids out of school, insisting soldiers leave the military, insisting teachers be fired, that firefighters be fired and other people be fired if they don’t agree to the COVID shot mandate,” he said.
“And so this is a moment where people want some closure over what happened over those four years,” he continued. “And if you look back, insisting that upwards of a million people be fired from their jobs for not getting the vaccine, even if they already had circulating antibodies from natural immunity, even though they were ultra-low risk—people want some closure to that issue. And this is a time for all the data to come out.”
Part of rebuilding trust in the FDA will come from admitting what it doesn’t know, Makary said.
“Trust in doctors and hospitals went from 71% of the public trusting us in 2019 down to 40% last year. That’s a 31-point drop in the last administration,” he said. “So we need to rebuild that trust. And part of the way we’re going to do that is to show some humility and to be transparent with what we know and to say ‘I don’t know’ when we don’t know something.”
Makary Defends Controversial Pick to Lead Drug Center
The FDA tapped Tracy Beth Høeg, a COVID vaccine skeptic, to serve as acting director of the Center for Drug Evaluation and Research, leading to complaints from some FDA officials who told CBS her appointment “will harm the agency’s reputation as a reliable steward of the nation’s drug supply.” But Makary told The Daily Signal he maintains “full support” for her.
“She’s terrific,” he said. “So first of all, MD, PhD, high-level scientist with an epidemiology background. She has an incredible command of so many subjects. She’s highly respected in the field, trained at some of the best institutions, served on the faculty at MIT and others. We want this type of high-caliber scientist at the FDA.”
“Many people have perceived that the FDA has been corrupted over the years,” he said. “And some people believe that the industry feels they own the FDA, but the FDA is not owned by the industry—it’s owned by the American people. And so my job is to safeguard the public and at the same time make sure that the agency is entirely independent in its scientific evaluations. And so Tracy Beth Høeg is perfect in fitting in line with our mission to deliver an amazing FDA, to bring more cures and meaningful treatments to the American public, faster and safer.”
Universal Flu Shot
Makary’s effort to improve the safety and efficacy of vaccines is not limited to COVID-19. He is also overseeing the development of a universal flu shot through a project titled Generation Gold Standard.
“I believe it’s in phase 1 clinical trials or between phase 1 and phase 2,” he said. “The current flu shot doesn’t work very well. You get it, you come back the following year, we take another guess as to which strain is going to be circulating. The guesses are not very good.”
“Overall, the flu shot is a bit of a crapshoot each year when it comes to guessing which strain is going to be dominant,” he continued.
A universal flu shot, Makary said, would protect against all strains and mutations, even those which have not yet occurred in nature.
“Then you may be able to get decades-long protection from a single flu shot if it has different targets of that flu vaccination, and so that’s a very promising concept,” he said. “It has garnered a lot of interest. And I personally would love to see us have lifelong immune protection to the flu instead of every year doing this whole roundup of people to say ‘come in and get your flu shot.'”
Ted Ross, the director of Global Vaccine Development at the Cleveland Clinic, has praised Generation Gold Standard.
“I’m glad to see that this administration is still wanting to invest in developing next-generation influenza vaccines or respiratory vaccines in general,” he said.
But some scientists, like Dr. Gregory Poland, who leads the Atria Academy of Science and Medicine in New York, said the universal flu shot would revert back to 50-year-old technology.
“This is what influenza vaccines in the 40s, 50s and 60s looked like,” he said.
Hepatitis B Vaccine
The Advisory Committee on Immunization Practices voted Friday to remove the universal recommendation that babies receive the hepatitis B vaccine at birth. Makary praised the decision.
“The moms who test negative for hep B are asking, ‘Why do I need to do this on the day of birth?’ So, I was pleased to see the ACIP committee use some nuance and get away from absolutism and recognize that the risk in a hep B–negative mom is extremely infinitesimally low for that child, that it’s entirely reasonable to wait till the kid is 8 or 10 or 12 or something like that,” he said.
Makary said this is another area where the FDA needs to listen to parents.
“And if we’re really following the data on this, the data supports hep B immunization for babies when the mom is hep B–positive or the vaccine status is unknown,” he said.
Co-Administration of Vaccines
Makary is also working on new regulatory standards on the co-administration of vaccines. He said there have been “few standards” on the subject thus far.
“We’re just saying we want to see a little more science,” he said. “If you’re going to propose giving two vaccines at the same time—two different vaccines—one of the ways vaccines work is they promote an inflammatory and immune response. And so when you give multiple pro-inflammatory therapeutics at the same time, you’re going to increase the body’s inflammation.”
“And inflammation is now recognized to not only have some positive benefits but also some negative health effects,” he added. “So, we’re just saying we want to use basic principles that we use for other medications and apply those to vaccines as well.”
Makary clarified that the FDA will not take away “anyone’s flu shot or anyone’s vaccine on the childhood schedule.”
“We always have to be vigilant for safety signals we can’t predict or may not know about, but there’s no plan to take away anyone’s vaccines or anyone’s opportunity to get a vaccine,” he said. “But there’s a big fear machine out there trying to say otherwise. So we need to be honest and truthful and remind people that we are here to advance vaccine science and not take away anyone’s vaccines.”
