On March 10, Dr. Nisha Acharya got a letter from the National Institutes of Health terminating her grant to study the safety and effectiveness of a vaccine recommended for all adults 50 and older in the US.
The grant was canceled after a change in NIH policy to not “prioritize research activities that focus on gaining scientific knowledge on why individuals are hesitant to be vaccinated and/or explore ways to improve vaccine interest and commitment,” according to the termination letter.
The policy shift was no surprise: Robert F. Kennedy Jr., a prominent vaccine skeptic, now leads the US Department of Health and Human Services.
What was surprising about her grant cancellation is that she’s not studying vaccine hesitancy.
Rather, in a written description of her research, Acharya said, “I had the words ‘hesitancy’ and ‘vaccine’ in the same sentence.”
She thinks her funding was caught in a dragnet of NIH grant cancellations driven by haphazard, error-prone word searches rather than careful review of the research in question. HHS has not clarified how it is selecting grants for termination.
Over the past few weeks, the NIH has canceled at least two dozen grants to researchers who were looking at ways to increase vaccination rates or fight vaccine hesitancy.
The changes come as scientists and universities are already reeling from cuts to funding for research about climate science, HIV and many other topics.
For Acharya, the cancellation wipes out just over three years of funding on her current grant that she says is worth almost $2 million in direct and indirect costs.
As a result, she plans to lay off three full-time employees who were working with her to analyze large amounts of data related to the vaccine. Acharya, a clinician scientist at the University of California at San Francisco, will keep her job seeing patients, although the grant paid about 35% of her salary, which she used for time to conduct research.
“I don’t have a way of continuing this work,” said Acharya, who is planning to appeal the decision.
During his Senate confirmation hearings, Kennedy, a lawyer, testified that he was “pro-safety” and “pro-good science.” He denied being anti-vaccine and has said he wants people to know the risks and benefits of the vaccinations before they get them, a principle called informed consent.
That’s what Acharya wants, too. She believes that studies on vaccine hesitancy are valid and worthwhile and should continue to be funded — but it’s not what she’s studying.
“I’m not anti-vax. I am pro-science, whether it’s positives or negatives,” she said. “I understand that with any medicine, any vaccine, there may be things that are very good and things that people may need to be cautious about. That is the goal, right?”
Research halted
Acharya is an ophthalmologist, or eye doctor, who studies inflammatory diseases of the eye. Until March 10, she was studying the benefits and risks of the shingles vaccine, particularly as it relates to an infection called herpes zoster ophthalmicus: shingles in the nerves around the eye. This complication is painful and can lead to blindness.
About 1 in 3 adults will have shingles at some point in their lives, and Acharya said that 10% to 20% of those cases will involve shingles of the eye.
The clinical trials that test vaccines can tell researchers whether a shot will generally be effective at preventing the more severe complications of an infection. Clinical trials can also catch common safety issues.
But rare side effects and adverse events from vaccines often aren’t picked up until they’re launched across the population and used by hundreds of thousands of people of different ages and sexes and with different underlying conditions.
Acharya was studying all those questions related to the Shingrix vaccine, which landed on the US market in 2018. It is recommended for all adults 50 and older to prevent painful bouts of shingles, a reactivation of the virus that causes chickenpox.
Acharya said she saw an opportunity to gather more data. “Those trials that led to FDA approval did not include people who had had shingles already. They don’t really include people who are sick or had a lot of medical problems.
“We need to really understand how well the vaccine is working for different age groups, for different people, maybe people who have different comorbidities or different conditions, like who are immunocompromised, people who already have had shingles, already have had shingles on the eye. There’s all these questions that we have no data for, no information,” she added.
She applied for and won a grant through the NIH to study these questions. It’s a highly competitive process that requires months of work to prepare and submit, and goes through rounds of review from peers before it’s awarded.
After her first five-year grant, Acharya was able to show that her work had produced important findings: for example, that the vaccine was safe and effective at preventing shingles – including around the eye – in people who had not had it before. So the NIH awarded her another round of five-year funding to continue.
She said she wanted her second round of research to dig into a question that made her fellow ophthalmologists hesitant to recommend the vaccine to their patients: Many of them had seen people who got the vaccine experience a dangerous reawakening of the virus in their eyes. Was it a coincidence or a real risk?
“I’m in a very specialized field, and we actually have a little bit of concern in this very specialized subgroup of people who already have shingles in the eye,” Acharya said.
Acharya wanted to see whether it was true that the vaccine could trigger another bout of shingles inflammation. In a recent study published in the journal JAMA Ophthalmology, she showed that it could — an important safety consideration. GSK did not immediately respond to a request for comment about the study.
In the study, Acharya urged more monitoring of patients. She imagined that this data might eventually be used to refine recommendations about who should get the vaccine. But it was just the first study; more research is needed for such a change.
Still, her grant was cancelled.
HHS didn’t answer specific questions about how it was deciding to terminate grants.
Acharya calls it “ironic” that her grant was flagged. “I never got to explain.”
She says the program officers overseeing her grant at the NIH knew her work well, and “they didn’t have any part in this decision.”
A chance to appeal
The letter gives her 30 days to appeal the termination if she believes that it was made in error, and the appeal goes directly to Dr. Matthew Memoli, who has been acting director of the agency while new NIH Director Dr. Jay Bhattacharya was awaiting confirmation.
What really makes Acharya sad is the effect of the funding cuts on her colleagues.
“I can’t save them,” she said. “I’m trying to call people and try to get jobs for them. I’m trying to set up interviews and stuff, but it’s really hard.”
Universities have lost so much federal research funding that many are coping with their own grant cancellations and doing their own belt-tightening. There’s a hiring freeze at UCSF.
“It’s not these people’s fault that they ended up being in a research group that was good, it was so promising, and their careers would have been made, and now it’s gone, and they’re gonna be out of a job,” she said.