New US Vaccine Guidance for Kids Raises Risk for Injury Program

The Trump administration’s unprecedented decision to slash the number of recommended vaccines for children opens the door to changes in a program for individuals seeking compensation from drug manufacturers over immunization injuries.

The Centers for Disease Control and Prevention announced this week that it will no longer universally recommend childhood vaccines against Covid-19, rotavirus, flu, meningococcal disease, hepatitis A, and hepatitis B. While some of those vaccines are still recommended for certain high-risk populations, the US government now suggests that individuals speak with a doctor before getting those shots, a process known as shared clinical decision-making.

The downsize in recommendations is the latest move by US Health Secretary Robert F. Kennedy Jr. against the traditional vaccination schedule, and could be a tipping point for vaccine skeptics seeking to remove hurdles to directly challenge manufacturers over immunization injuries.

Individuals harmed by certain vaccines must first exhaust their claims under the US Department of Health and Human Services National Vaccine Injury Compensation Program (VICP) before they can pursue legal actions against a manufacturer. The program, which covers most vaccines routinely given in the US, grants significant protection to vaccine makers from various injury lawsuits.

But that immunity “only applies to vaccines that are recommended for routine administration to children and/or pregnant women,” said Aaron Siri, managing attorney of Siri & Glimstad LLP, who’s challenged vaccine mandates and formerly served as Kennedy’s lawyer.

Siri pointed to the National Childhood Vaccine Injury Act of 1986 in arguing in a social media post last month that vaccines that are “non-routine” and are recommended as shared clinical decision-making don’t receive liability protections under the VICP.

“If vaccines are safe, why do they need immunity for the harms they won’t cause?” Siri said in an interview Tuesday.

Other vaccine attorneys, however, are skeptical of Siri’s claims, highlighting the potential for legal battles over the injury program in the near future.

“He relies on this interpretation of the word routine to say that if it’s not a routine vaccine, it’s not included in the program,” said Richard Hughes IV, a member of Epstein Becker & Green PC and a former executive with Moderna Inc. who has worked on legal challenges to some of Kennedy’s actions around vaccines. “He’s trying to create an end run around the liability shield that keeps manufacturers and providers from being in court all the time.”

Any protections on vaccines also “do not disappear automatically or by tweet,” as the HHS would need to engage in formal notice-and-comment rulemaking to amend the Vaccine Injury Table that lists vaccines and injuries covered under the VICP, said David Carney, president of the Vaccine Injured Petitioners Bar Association.

“Until that regulatory process occurs, the vaccines remain covered, and manufacturers retain liability protections,” Carney, a partner at Green & Schafle LLC, said in an email.

Andrew Nixon, a spokesperson for the HHS, said in an email Wednesday that “vaccines recommended by the CDC for children based on shared clinical decision-making continue to be covered by the VICP.” The change to shared decision-making doesn’t result in table changes, he said.

Injecting Uncertainty

While the new CDC recommendations could fuel Siri’s argument to sue manufacturers directly instead of going through the VICP, a court would likely run into legal questions when trying to interpret the definitions of routinely recommended and shared clinical decision-making, vaccine experts say.

“On the merits, in spite of what Mr. Siri says, there is an open legal question about whether shared clinical decision-making is or isn’t under the VICP,” said Dorit Reiss, a professor of vaccines at University of California San Francisco College of the Law. “What does it mean to have the vaccine routinely recommended?”

Reiss said that while there’s a plausible argument that a routine vaccine doesn’t include shared clinical decision-making, others may argue that anything on the CDC’s immunization table is still considered a routine vaccine and must be covered under the VICP, including shots where patients should connect with a provider.

Other attorneys raised concerns that if certain vaccine recommendations are fully withdrawn, it would leave injured individuals—who currently rely on the program as their realistic avenue for compensation—without any viable legal recourse.

“Aaron’s public statements appear to champion the removal of these recommendations without grappling with the downstream consequences: injured individuals forced into protracted, expensive civil litigation; manufacturers and providers exposed to unpredictable tort liability; and a public-health system destabilized by the absence of a robust safety net,” Carney said.

Recognizing that the vaccines don’t have protection under the VICP also “introduces and injects a great deal of uncertainty and chaos and a system that is already overburdened,” said Renée Gentry, director of the Vaccine Injury Litigation Clinic at The George Washington University Law School.

“There are certainly attorneys out there that want to sue civilly, and organizations that want manufacturers to not have this immunity anymore,” Gentry said. “But if those vaccines are removed from the table, it could do a tremendous amount of damage to those individuals that are injured by vaccines.”

Another ‘Shoe to Drop’

Other vaccine experts expect Kennedy to take more specific actions to overhaul the VICP.

Kennedy, who’s described the law creating the program as a problematic protection for drug companies, said last year that he plans to “fix” the “broken” system.

The decades-old program has taken in over 28,000 petitions since 1988, around 25,000 of which have been adjudicated, according to the HHS’ Health Resources and Services Administration. Total compensation paid over the life of the program is approximately $5.4 billion.

“I expect that they are going to make a separate effort to undermine the VICP through a radical expansion of covered conditions,” said Brian Dean Abramson, a vaccine law professor at the Florida International University College of Law.

“With the current HHS administration I always feel like we’re waiting for the other shoe to drop, where a change that should not have any broader effect is suddenly transformed into one having a much broader effect,” Abramson said.