Two University of Pennsylvania vaccine authorities strongly criticized the U.S. Department of Health and Human Services’ (HHS) recent announcement of a change in vaccine policy requiring all new vaccines to undergo placebo-controlled trials before receiving a license.

Speaking at a virtual seminar titled “New Rules for Vaccine Approval,” organized by Penn’s Leonard Davis Institute of Health Economics (LDI) and the nonprofit news organization Tradeoffs, Paul Offit, MD, and Alison Buttenheim, PhD, MBA, questioned the accuracy of the HHS statements, expressed confusion about the meaning of certain wording, and warned that switching to such a system poses serious ethical and logistical problems that could directly affect the availability of crucial vaccines and the health of large numbers of Americans.

Offit is Director of the Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP), Professor of Vaccinology at Penn’s Perelman School of Medicine, and an internationally recognized authority in vaccine development. Buttenheim, an LDI Senior Fellow, is a professor of both Family and Community Health at the Penn School of Nursing and Medical Ethics and Health Policy at the Perelman School. She is recognized as a leading expert for her pioneering work on vaccine acceptance and hesitancy and the application of behavioral economics to infectious disease prevention.

Analyzing Trump Policies

Both were panelists in the first of what will be a series of “Decoding the Moment” seminars moderated by Dan Gorenstein, Founder and Executive Editor of Tradeoffs. As she opened the session, LDI Executive Director Rachel M. Werner, MD, PhD, explained that Decoding the Moment will be an ongoing effort to analyze the latest health care-related policies of the Trump administration to better understand what they mean for the future.

On May 1, HHS Secretary Robert F. Kennedy Jr. announced the new placebo testing policy for all new vaccines. He called it “a radical departure from past practices” and described it as a move to a “gold standard” of safety testing that will enhance public trust.

Offit disagreed. “The administration has made it sound like we’re entering a new and golden age of vaccine testing, where now we’re going to do placebo-controlled trials for new products, which we’ve been doing pretty much for the last 80 years,” he said. “So I’m not sure what they’re talking about. If you look at a truly new vaccine, like the Human Papillomavirus vaccine (licensed in 2006), for which there was not an existing vaccine, that was a large, placebo-controlled trial. When the rotavirus vaccine was ultimately licensed in 2006, there was not an existing rotavirus vaccine at the time, so that was a placebo-controlled trial.”

Kennedy has a long history as an anti-vaccine activist—a reputation that deeply shaped public and political reactions to his appointment as Secretary of Health and Human Services and to his agency’s subsequent vaccine policy moves.

State Level Concerns

Buttenheim expressed concern about the effect of the new policy at the state level, where most vaccination law and regulation happens, as statehouses set rules for what vaccines schoolchildren must receive and who qualifies for exemptions from vaccine mandates.

“A policy like this new federal placebo testing requirement could open the door in state legislatures to propose all kinds of bills to loosen our vaccine mandate system,” Buttenheim said. “In the last five years, something like 2,500 bills related to immunization and exemptions have been introduced—just 400 in the last legislative cycle. You can imagine a state legislature that isn’t crazy about vaccinations taking this new federal law and saying, ‘Okay, you can only mandate a vaccine that’s been placebo-controlled, trial-tested.’ There are states already introducing bills that prohibit mandating a mRNA vaccine. We have to be concerned about a floodgate of such state actions when federal policy is rolling back the way vaccines are approved, as well as its support for vaccine mandates.”

Buttenheim and Offit both noted that HHS has not provided a clear, detailed definition of what constitutes a “new vaccine,” especially regarding updated booster vaccines for existing diseases like COVID-19. Recent statements from HHS spokespersons suggest that updates to COVID vaccines could make them “new vaccines” requiring placebo testing.

Strict Ethical Rules

But placebo testing is governed by strict ethical rules. Withholding an effective vaccine from placebo groups exposes participants to preventable disease risks. For example, in COVID-19 booster trials, placebo recipients would lack protection against severe outcomes such as hospitalization or death. The World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) deem placebo use unethical in such cases unless risks are minimal or mitigated.

In the United States, federal regulations require that Institutional Review Boards (IRBs) review and oversee research conducted by academic institutions, health care organizations, government agencies, and private companies to ensure ethical standards and participant safety.

“For instance,” said Offit, “you can’t give a placebo in a trial knowing that this virus, SARS-CoV-2, is circulating. You can’t do that. So, I don’t see any institutional review board ever signing off on the ethics of that kind of trial.”

“With Robert F. Kennedy Jr., it’s about what he says versus what he really means,” said Offit. “He doesn’t trust the system because the scientific data that have been generated don’t support his fixed, immutable beliefs such as ‘vaccines cause autism.’ There have been 24 studies at this point looking at whether the combination measles, mumps, rubella—or MMR—vaccines cause autism. They’ve all found the same thing. No association. He doesn’t believe that, so when he talks about gaining trust, it’s really just a smokescreen for what he really means.”

A Misleading Paper

“What he really means,” Offit continued, “is that he wants to do the studies that will support his belief. And I worry that over the next year or so, he’ll do a poorly done study to shoehorn his fixed beliefs into data that will be just as bad as that paper he held up at his second congressional confirmation hearing. He said that paper by Mawson and colleagues said vaccines cause autism. But that paper was never published in a scientific journal. It was never published in a medical journal, never peer reviewed, and was supported by an anti-vaccine group.”

Buttenheim characterized the new policies as “a solution to a problem that doesn’t exist. You can so clearly pin each of RFK Jr.’s strategies here to the misinformation playbook. It’s clickbaity stuff that is setting up impossible expectations about what vaccine safety testing and vaccine effectiveness look like. And its leading people away from the reality of what we already do. Overall, this is the quite deliberate, undermining of national confidence so that high-coverage vaccination for these vaccine-preventable diseases doesn’t happen. They seem to want less vaccination and less protection against these dangerous diseases, which just seems horrendous.”

Offit concurred. “I think the real goal is to scare people at some level by saying, ‘We’re now going to do something we’ve never done before. We’re going to really test these vaccines to see whether or not they’re safe or effective, because we don’t really know that now.’ It’s a way to just further decrease trust in vaccines and the vaccine infrastructure. And I think that’s what we’ll be seeing more of as he moves forward.”

Vaccine Mandate Erosion

“HHS is also saying they don’t want to recommend a COVID vaccine for children as a yearly dose and they don’t want to give the COVID vaccine to pregnant women,” Offit continued. “It’s the beginning of a gradual erosion in vaccines. Let’s say that they do follow through with their threat to not give a COVID vaccine yearly for children. Does that include all children, including children at high risk? And what will that mean, then, for people who want to get the vaccine? Will the CDC’s Vaccines for Children (VFC) program not cover it? Will insurance companies not cover it? Will this make it more expensive and less available? Because I think that’s the goal. I think Robert F. Kennedy Jr., our Secretary of Health and Human Services, has been an anti-vaccine activist and science denialist for 20 years, and he’s still that guy.”

---

---