RFK Jr.'s latest vaccine plan threatens future of shots, experts say
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A major change in the way HHS plans to evaluate vaccine safety is raising fears that approvals will become unnecessarily onerous and make shots for COVID-19 and other viruses scarcer.
Why it matters: The change under Secretary Robert F. Kennedy Jr. could result in a slow-walking of innovative technologies for future vaccines and runs counter to long-held ethical and scientific standards for ensuring vaccines are safe and effective.
- "It's going to do some damage to the speed at which we get new vaccines, and just the basic availability of new vaccines to prevent diseases," said Richard Hughes, a partner at law firm Epstein, Becker & Green and former vice president of public policy at Moderna.
The big question: HHS is proposing that all new vaccines undergo safety testing in placebo-controlled trials. But it's not clear what HHS will define as a new vaccine.
- New vaccines have always been required to be tested against placebos, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's vaccine advisory committee since 2018.
- But established vaccines, like the flu vaccine, aren't continually tested against placebo because the underlying platform has been shown to be safe. The "new" element each year is that vaccine is updated to work on the latest strain of the virus.
Critics say the policy change, first reported in the Washington Post, could sow mistrust in vaccines and make it more costly and slow for companies to develop updated innoculations.
- This all tracks with Kennedy's worldview, Offit told Axios.
- "That's who he is. That's who is our head of Health and Human Services. It is a dangerous time for America's children," he said.
State of play: World Health Organization guidelines say placebos in vaccine trials are acceptable when no safe and effective vaccine for the condition already exists.
- But WHO's expert panel says placebo use in vaccine trials is unacceptable when there's another accessible and safe vaccine for the same condition, and when the risks of delaying the vaccine can't be adequately mitigated.
Zoom in: Requiring placebo-controlled trials for measles and polio vaccines would be of particular ethical concern, said Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan.
- New polio vaccines are under development to overcome the challenges presented by oral polio vaccines still used in some parts of the world. They rely on weakened live poliovirus and can result in the spread of vaccine-derived polioviruses.
- Any new polio vaccine would be expected to be tested against the established vaccine technology that has 70 years of data, Rasmussen said.
- "But if something like that requires a placebo-controlled trial, that means that you would have a population of thousands of children that are not getting polio vaccines," Rasmussen said. "You'd be exposing children to a virus that can cause death, but also, in many cases, causes permanent, irreversible disability."
What they're saying: An HHS spokesperson called the new policy a "radical departure from past practices."
- "Except for the COVID vaccine, none of the vaccines on the CDC's childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products."
- Kennedy's core base is pleased with the news.
- Required placebo trials for new vaccines will help "healthcare providers to deliver care grounded in truth, not assumption," Kat Lindley, director of the Independent Medical Association's fellowship program, said in a statement. The group advocates for mass reform of government health agencies, typically in line with Kennedy's positions.
Between the lines: The change is bad news for vaccine makers' stocks.
- If the change is implemented, the world will turn to other countries for the gold standards of vaccine testing, per an analyst note from investment bank Leerink Partners indicates.
- "HHS's judgment appears questionable and risky, in our view," the note says.
Of note: HHS announced on Thursday that it plans to invest $500 million into new research around a universal vaccine for pandemic-prone vaccine production.
- The agency said it would use an inactivated, whole-virus platform, a move met with skepticism by Rasmussen and some other scientists.
What to watch: The policy shift to require placebo-controlled trials could delay new COVID-19 vaccines and updated boosters in particular, Hughes said.
- FDA last month already delayed approval for Novavax's COVID jab and asked for another clinical trial. That vaccine has been through four randomized placebo-controlled clinical trials, BioSpace reported.
