RFK Jr. Warns Docs of Liability if They Stray From CDC on Vaccines
By Joyce Frieden,
Washington Editor, MedPage Today
"AAP should ... be candid with doctors and hospitals
that recommendations that diverge from the CDC's official list are not shielded
from liability under the 1986 Vaccine Injury Act," Kennedy posted this week on X.
The AAP recommendations,
released on Tuesday, included a strong endorsement of COVID-19 shots for
children ages 6 months to under 2 years. The group also recommended COVID shots
for older children if the parents want to do that. Those recommendations differ
from guidance issued by the CDC,
which has said the vaccines are not specifically recommended for children
although they can still get them if parents and providers agree.
Was Kennedy correct about the liability issue? "As has
become common for Secretary Kennedy, this is misleading," Dorit Reiss,
PhD, a law professor at the University of California San Francisco, said in
a Facebook post on
Wednesday. "Whether a vaccine falls under VICP [the Vaccine Injury
Compensation Program, the part of the Vaccine Injury Act that deals with
liability issues] has nothing to do with whether AAP recommends it, and the
liability protections are not removed by this."
"If a vaccine is covered by VICP, liability protections apply to manufacturers and administrators: anyone claiming a vaccine harm from a childhood vaccine that is under VICP has to go through the program first," she said. "ACIP has not actually changed the current recommendations in ways that affect VICP." Furthermore, "COVID-19 vaccines for children are not under VICP, but that's not because of anything AAP did or the secretary, even, did -- it's because Congress has not yet legislated to create an excise tax for COVID-19 vaccines, and until Congress does that, they're not within VICP."
Anna Kirkland, PhD, JD, professor of health management and
policy at the University of Michigan, in Ann Arbor, agreed with Reiss that the
COVID vaccine doesn't fall within the VICP and so is not affected by the CDC's
new recommendation. However, "it could hint at future changes if Kennedy
plans to withdraw recommendations from other childhood vaccines that are
currently covered under the Vaccine Injury Act, which would mean that they no
longer meet the statutory definition for coverage in the compensation program,"
she said in an email.
"This development should not change doctors'
willingness to recommend pediatric vaccines, which still have all the safety
and compensation protections that they had prior to Kennedy taking
office," she added. "There do seem to be changes in the Vaccine
Injury Compensation Program on the way, though it's hard to know from
Kennedy's remarks exactly what he has planned. Removing childhood vaccines from
the compensation program could upend vaccine markets and leave the small number
of people who suffer an adverse reaction without a plausible path to
compensation."
In her Facebook post, Reiss reminded readers that "in
spite of [his] implied threat, Secretary Kennedy would not be bringing any
cases" to court related to vaccine injuries. Instead, "parents who
think their children were harmed by COVID-19 vaccines are the relevant ones
here."
If Kennedy did want to remove another vaccine from the VICP,
she noted, "ACIP would have to completely not recommend it for children
and pregnant women" instead of just saying it had to be administered after
shared decision making between parents and providers. "And then," she
added, "the secretary would have to open a rulemaking process -- publish
the change in the Federal Register, solicit comments, and publish a
final decision. And a company making that vaccine, or someone denied a vaccine
because of removal of liability protections, could sue."
In his tweet, Kennedy also called the AAP recommendations
"corporate-friendly" and said that "The Trump administration
believes in free speech and AAP has a right to make its case to the American
people. But AAP should follow the lead of HHS and disclose conflicts of
interest, including its corporate entanglements and those of its journal
-- Pediatrics -- so that Americans may ask whether the AAP's
recommendations reflect public health interest, or are, perhaps, just a
pay-to-play scheme to promote commercial ambitions of AAP's Big Pharma
benefactors."
The AAP fired back. "This attack on the integrity of
pediatricians is unfortunate, but it does not change the facts," AAP
President Susan Kressly, MD, said in a statement sent to MedPage Today. "Our immunization
recommendations are rooted in decades of peer-reviewed science by the nation's
leading health experts. We are transparent about our funders, follow rigorous
conflict-of-interest disclosures, and maintain safeguards to ensure the
integrity and independence of our guidance. We welcome an opportunity to sit
down with the secretary to review our recommendations and restore our seat at
the table."
The last sentence in AAP's statement referred to some
changes that Kennedy has made to vaccine policymaking at the CDC. In June,
he fired all 17 members of
the CDC's Advisory Committee on Immunization Practices (ACIP) -- which advises
the CDC on its immunization recommendations -- and replaced them with eight
people, including known vaccine skeptics; some of the new members
reportedly have their own conflicts of interest related to serving as expert
witnesses in legal proceedings targeted at vaccine manufacturers.
In addition, the AAP, the American Medical Association, and
other healthcare groups were told at the end of
July that they could no longer participate in ACIP work groups, which
convene in between ACIP meetings to develop recommendation options for ACIP.
Joyce Frieden oversees
MedPage Today’s Washington coverage, including stories about Congress, the
White House, the Supreme Court, healthcare trade associations, and federal
agencies. She has 35 years of experience covering health policy. Follow
