Some leading vaccine manufacturers could be exposed to litigation they've been protected from for decades if the U.S. decides to adopt a new childhood vaccine schedule resembling Denmark's, as it appears likely to do in the new year.
Why it matters: The threat of expensive lawsuits could ultimately drive vaccine makers from the U.S. market, upending access to shots like those protecting against the seasonal flu, hepatitis and meningitis.
Driving the news: The Department of Health and Human Services is planning to propose a new childhood vaccine schedule. Health Secretary Robert F. Kennedy Jr. came close to promoting Denmark's slimmed-down recommendations before pulling back on Friday, Politico reported.
- But the change is still likely to happen — a risky political gamble, but one seemingly in sync with President Trump's recent directive to top health officials to "align U.S. core childhood vaccine recommendations with best practices from peer, developed countries."
- "The final decisions and announcement have been postponed until the new year," said Robert Malone, vice chair of a key Centers for Disease Control and Prevention advisory committee and an ally of Kennedy.
- The decision "regarding the revised vax schedule will rely on other medical advisers," not the CDC advisory committee he is a part of, Malone added. "Final plans must pass internal legal review before announcement and deployment."
What they're saying: "Unless you hear it from HHS directly, this is pure speculation," said HHS spokesperson Andrew Nixon when asked about reports the U.S. has designs on embracing Denmark's schedule.
- But a recent CDC advisory committee hearing featured a presentation on the Danish vaccine schedule.
- Malone wrote a Substack post on the U.S. adoption of the Danish schedule on Thursday, concluding that "this could be ... the biggest Christmas present ever for Children's Health Defense, The Informed Consent Action Network, a wide array of smaller organizations representing vaccine injured, and the trial lawyers of America."
Between the lines: Adopting a slimmer childhood vaccine schedule could have a domino effect.
- The most direct outcome would be a potential falloff in the number of U.S. children who receive the non-recommended vaccines, followed by a rise in the prevalence of those diseases.
- But pulling back official recommendations could also effectively unwind the federal liability protections that have shielded vaccine manufacturers for decades.
How it works: A law passed in 1986 created a special legal pathway for vaccine-injured Americans to receive compensation while also protecting manufacturers from being held liable for those injuries.
- The law was passed as a response to the looming threat of vaccine shortages resulting from lawsuits against manufacturers.
- Kennedy has said he wants to "fix" the program. And anti-vaccine activists who've long made it a target contend it removes the incentive for drug companies to put out safe products. (These same activists also make claims about widespread vaccine harms without reliable evidence and contrary to the findings of the scientific establishment.)
Getting rid of it altogether would require an act of Congress, which is highly unlikely at this point.
- But in a video he posted on X, anti-vaccine lawyer and past Kennedy ally Aaron Siri claimed that "there is a way to get rid of the [manufacturers'] immunity without Congress," saying that to be covered a vaccine needs to be "routinely recommended."
- Siri worked with Kennedy for years on vaccine-related lawsuits. He recently gave a presentation on the childhood vaccine schedule at a meeting of the CDC advisory committee.
- Siri noted that COVID vaccine, which is no longer recommended for children, is as a result no longer protected by the federal liability shield and that "if you took the other vaccines ... and you made them non-routine, they would be out."
Yes, but: Legal experts disagree with Siri's assessment.
- "I can easily read the statute to mean they can add and remove injuries but they can't add or remove vaccines" from the compensation program, said Richard Hughes, a professor of vaccine law at George Washington University and a partner at Epstein, Becker & Green.
- But if Siri's argument is affirmed by courts, "then that is a problem," Hughes added. "It does create a pre-1986 challenge where you have this risk of courts being flooded with claims."
The bottom line: Copying Denmark's vaccine schedule isn't just a matter of whether that country's vaccine recommendations make sense for the U.S.
- It could also impact whether vaccines that are freely accessible in the U.S. today remain so.
