About 90 seconds into his presentation on Covid-19 vaccine safety at a closely watched meeting of advisers to the US Centers for Disease Control and Prevention last month, Dr. Bruce Carleton made a startling revelation: The government grant supporting his research had been abruptly terminated.
The statement was surprising for a few reasons. Carleton had been asked to share his findings with a group entirely put in place by US Health and Human Services Secretary Robert F. Kennedy Jr. after Kennedy summarily dismissed all 17 previous experts on the committee, known as the Advisory Committee on Immunization Practices or ACIP, in June. In its first two meetings, the newly composed committee has shown an outsized interest in vaccine safety, in line with Kennedy’s frequent protest that he’s “not anti-vaccine; I am pro-safety.”
Yet Kennedy’s HHS canceled a major CDC grant focused on the subject in March, curtailing Carleton’s work to understand genetic drivers of rare vaccine safety risks.
“They canceled [a grant to study] vaccine safety, and yet now we’re talking about vaccine safety,” Carleton later told CNN.
Carleton’s statement in the meeting was also surprising because, almost immediately, an HHS spokesperson denied that it was true.
“FYI – as you see below, we did not cancel the grant,” HHS Director of Communications Andrew Nixon said in an email to reporters during the ACIP meeting, providing a link to the grant information on the agency’s website.
Nixon noted that the grant’s “period of performance” ended March 25. The website, though, shows a negative subtotal of more than $2 million, suggesting money allocated to the grant that was unspent. Paperwork ending the grant shared with CNN states that “the purpose of this amendment is to terminate this award.” And it’s included on an HHS list of terminated grants.
“The grant was canceled,” said Dr. Steven Black, the primary investigator of the project and co-director of the Global Vaccine Data Network, which received the award and supported Carleton’s work. It “was supposed to run for more than a year after that.”
Nixon didn’t respond to CNN’s requests for comment.
Studying rare vaccine risks
The idea of harnessing data from multiple countries to assess rare vaccine safety risks came about long before the Covid-19 pandemic; the playbook was established more than a decade earlier, for vaccines targeting the 2009 H1N1 flu, said Dr. Frank DeStefano, who was head of the CDC’s Immunization Safety Office from 2009 to 2021.
Finland, and then several other European countries, detected an increased risk of narcolepsy, or excessive daytime sleepiness, after the rollout of 2009 flu vaccines, and the CDC funded a multinational study to look at the issue, DeStefano told CNN. The connection was never detected in the US, and an association remained only in Sweden in the CDC’s study; DeStefano noted it still remains somewhat of a mystery.
“We learned a lot from that project,” DeStefano said. “We developed some of the methodology to be able to align data systems for different countries, establish standardized case definitions and how to gather the data so it could be analyzed comparably from different countries.”
So as billions of people were being vaccinated against Covid-19 in 2021, DeStefano and others reached for that playbook again; the CDC awarded $5.6 million to the Global Vaccine Data Network in April 2021 and an additional $4.5 million in 2022, for a total of a planned $10.1 million through April 2026, according to Black.
“We wanted a big database, covering the different vaccines and different populations,” DeStefano said. “One that would be able to detect these rare adverse events sooner.”
Myocarditis, or heart inflammation, emerged as a rare risk of mRNA Covid-19 vaccines as they were rolled out broadly, with the risk most pronounced in teenage boys and young men. It also was found to be a risk of infection with the coronavirus itself. People who experienced it after vaccination typically fully recovered, CDC analyses have shown.
Other vaccine technologies carried different safety risks; adenoviral vector vaccines — such as those made by Johnson & Johnson and AstraZeneca, which are no longer on the market — were linked with a rare risk of blood clots.
The Global Vaccine Data Network project was designed to study both, as well as other outcomes, Black said.
“It was meant to guide public health policy not only in the US but also globally,” Black told CNN.
Carleton, a researcher in the Department of Medical Genetics at the University of British Columbia, told those at the September ACIP meeting that he’d planned to do a genetic analysis of 275 people who experienced adverse events after getting a Covid-19 vaccine, compared with people who were vaccinated and didn’t experience those events.
The work would serve two purposes.
“First of all, it helps us understand the biological mechanisms underlying the pathophysiology of adverse events,” Carleton said. “And second, in patients who have risk variants, we can allow for more personalized vaccine schedules; in the case of mRNA vaccines and myocarditis, switching patients to either protein or adenoviral vector vaccines, for example, would be one option.”
Because the grant was canceled in March, Carleton said, he was able to do genetic analysis of only 50 patients with myocarditis.
It spurred discussion at the meeting nonetheless.
“The data presented by Dr. Carleton on myocarditis was actually fascinating,” said Dr. Grant Paulsen, an outside liaison to ACIP representing the Pediatric Infectious Diseases Society. “I could quite closely geek out on that … and ask lots of questions on the genetics of vaccine-induced myocarditis versus that induced by Covid itself or other causes.”
Paulsen emphasized, though, that even as further monitoring for myocarditis is warranted, “the data are fairly clear” on the overall benefits and risks of Covid-19 vaccination, particularly for the youngest children. “Continued research is vital but should not be a barrier to families looking to access this tool to protect their children,” he said.
A newly appointed ACIP member, Dr. Kirk Milhoan, a pediatric cardiologist, praised Carleton’s presentation and the suggestion of improving “individualizing care, even within vaccines.” He also referenced the presentation to bring up what he called a dramatic increase of “dysregulation between the autonomic nervous system and the body” that he suggested he’d been seeing in children in his own practice.
That kind of interpretation worried other outside liaisons, who participate in ACIP meetings but don’t vote on vaccine policy recommendations to the CDC like members of the committee do.
Dr. Jason Goldman, the liaison representing the American College of Physicians, told CNN that he was concerned Carleton’s presentation was skewed toward emphasizing concerns about vaccine safety. “I felt that they were trying to make an increased implication of vaccine risks that we don’t necessarily have evidence of,” he said later.
Carleton, who told CNN he gets vaccinated against Covid-19 to protect the kids and families he sees as a health-care provider, said he felt that his results were “important data to share about myocarditis” and that he thinks “the work needs to continue, that the surveillance model needs to be reinforced and refunded.”
One ACIP member, Dr. Evelyn Griffin, who like Milhoan had been added to the committee by Kennedy three days before the meeting, asked Carleton why his study had been canceled so abruptly. Carleton responded that he didn’t know.
‘No longer necessary’
Six months earlier, Black and his team had received a questionnaire from HHS asking them to state the public health value of the research, he told CNN. They received the questionnaire on a Friday and were given 48 hours – and 70 to 80 characters – to respond, he recalled. Two weeks later, the grant was canceled.
The funding was terminated “for cause,” according to the notice they received – the cause being the end of the Covid-19 pandemic declaration.
“The end of the pandemic provides cause to terminate COVID-related grants and cooperative agreements,” the notice read. “These grants and cooperative agreements were issued for a limited purpose: to ameliorate the effects of the pandemic. Now that the pandemic is over, the grants and cooperative agreements are no longer necessary as their limited purpose has run out.”
It was around the same time the Trump administration ended multiple Covid-19-related grants, including to state and local public health departments. But even though the pandemic has been declared over, Covid-19 itself is still here, Black pointed out, and “the implications of this go way beyond Covid.”
“People would like to use the mRNA platform for other diseases, including cancer prevention,” Black said. “So the implications of the safety data and identifying the risk factors and why people are getting these side effects go well beyond just the Covid pandemic.”
Kennedy’s hand-picked panel of vaccine advisers continues to focus on Covid-19 vaccines and their safety as well, taking a vote at September’s meeting on whether to require prescriptions to access them. The vote narrowly failed, with the committee chair breaking a tie.
The committee had also invited Carleton to join its working group on Covid-19 vaccines; he said he presumes they didn’t know that HHS had canceled his research funding.
Kennedy has been asked directly to reinstate the funding for the project and said he would look into it, according to Black, who noted that he hasn’t heard anything back.
Following the science
As an infectious disease specialist, Black said, he’s concerned that the conversations at the highest levels of vaccine policy in the US now focus more on potential side effects of vaccines than the diseases they mitigate.
“I’m old enough I saw someone die of diphtheria,” Black said. “I’ve seen a child suffer with tetanus. Babies with whooping cough turn blue, and it’s extremely frightening.”
With the exception of smallpox, he said, “none of these diseases is gone; they’re all out there waiting to come back.”
Black himself got myocarditis after a Covid-19 infection and said he was quite sick. “It’s not a trivial disease.”
Considerations about vaccines need to account for the balance of benefits and risks, he said – with rigorous research to understand both.
“Kennedy says he wants to follow the science; you can’t follow the science if you’re not funding the science,” Black said. “If he’s not generating the data that’s necessary to identify people at risk or understand the side effects, what’s he following?”