Childhood Vaccine Schedule Modifications May Remove Manufacturer Liability Protections

Multiple media outlets have reported that HHS is looking to overhaul the childhood vaccination schedule to align with Demark’s schedule, and Attorney Aaron Siri says this could remove manufacturer immunity for the shots that are removed from the schedule. Denmark only recommends 11 total doses to protect against 10 diseases. The US schedule included 72 doses from birth to the age of 18, including annual doses of COVID-19 and influenza. The COVID-19 vaccine has since been removed from recommendation by the administration to align with other peer nations that stopped recommending the vaccine for healthy children.

How to get rid of the 1986 Act immunity.@DanicaPatrick pic.twitter.com/W23TVtzJLZ

— Aaron Siri (@AaronSiriSG) December 19, 2025

There has been no official announcement, but President Donald Trump issued a memorandum to HHS Secretary Robert F. Kennedy Jr. asking him to fast-track a comprehensive review of the childhood vaccine schedule and to align the schedule with other nations that recommend fewer vaccines. This happened shortly after the ACIP advisory group voted to remove universal birth dose recommendations for the Hepatitis B vaccine.

Denmark only recommends the Hepatitis B vaccine for high-risk infants who are born to mothers who test positive. The ACIP panel in the US removed the birth dose recommendation for low-risk infants when the mother has tested HBsAg-negative, but still calls for individual-based decision-making with a healthcare provider. Those modifications have been officially adopted by the CDC. The schedule further recommends that these infants begin receiving the three-dose series no earlier than two months of age.

Denmark does not routinely give the Hepatitis B vaccine, Rotavirus, Varicella (Chickenpox), Hepatitis A, Meningococcal, RSV, Influenza, or COVID-19. Since the US already removed COVID-19 from the schedule for healthy children, there are seven more vaccines that could be removed if the administration aligns child vaccine recommendations with Denmark’s schedule.

When speaking with Danica Patrick, Siri said there is one way to remove manufacturer immunity without an act of Congress. “Under the 1986 Act, the vaccine does need to be routinely recommended amongst two other requirements. It has to be a routine recommended vaccine,” Siri said. “If you took the other vaccines and you made them non-routine, they would be out. And who could do that? The CDC director with a stroke of a pen.” Siri added that the issue would have to be litigated.

Siri also explained that the COVID-19 vaccine does not receive manufacturer immunity from the 1986 act, but it does receive PREP Act immunity. In March 2020, HHS Secretary Alex Azar signed a declaration under the PREP Act that provides manufacturers with immunity for countermeasures approved during an emergency. His successor, Secretary Xavier Becerra, signed the 11th amendment to extend the declaration just as the public health emergency declaration was set to expire without renewal by President Biden in May 2023. That was set to expire in December 2024, but Secretary Becerra signed a 5-year extension weeks before the Trump administration took office, with Kennedy announced as the successor as Secretary of HHS. The expiration of the countermeasures immunity declaration will occur during the next presidential administration.

Former FDA Commissioner Scott Gottlieb, who also serves on the boards for Pfizer and UnitedHealth, spoke on CNBC about the potential loss of liability protections if vaccines are removed from the list of routinely recommended vaccines. “If they move away from recommending these vaccines and move them to a different configuration on the CDC schedule called shared clinical decision making, there’s a question of whether or not they will still have liability protection under the vaccine injury compensation program,” Gottlieb said.

Gottlieb also said there are others who think the protections would remain in place or that federal rulemaking would also be required to remove manufacturer protections for vaccines that were once included in the vaccine injury compensation program.

Axios reported that “legal experts disagree with Siri’s assessment,” while providing a quote from Richard Hughes a vaccine attorney who represents pharmaceutical companies and previously served as the vice president of public policy at Moderna. “I can easily read the statute to mean they can add and remove injuries but they can’t add or remove vaccines,” Hughes told Axios. He said it’s a problem if the courts affirm Siri’s argument. “It does create a pre-1986 challenge where you have this risk of courts being flooded with claims.”

The HRSA website states, “The National Vaccine Injury Compensation Program (VICP) covers most vaccines routinely given in the U.S. For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women, and it must be subject to an excise tax by federal law.” Siri has argued that there should be no need for manufacturer liability protections if the products are safe.”

Stat News reported that William Thompson, a former CDC whistleblower, has been promoted to the highest level of civilian government workers and will be “overseeing research into adverse childhood experiences.” Thompson revealed in 2014 that his colleagues omitted data that showed a statistically significant association between African American males who received the MMR vaccine before three years of age and an increased risk of autism.

“I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics,” Thompson wrote in 2014. “The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.”

Paul Offit, a former ACIP member and Merck Rotavirus patent holder, recently said that he believes Secretary Kennedy will claim there is an association between aluminum adjuvants and autism. Offit said he believes Kennedy will add that to the VICP, which will “break that program.”