Rfk Jr.'s Vaccine Panel Says Not All Newborns Need Hep B Shots

ATLANTA — The CDC’s committee of vaccine advisers voted Friday to do away with the universal hepatitis B birth dose recommendation — fulfilling a longtime priority of the anti-vaccine movement.

By a margin of 8-3, the panel voted to end the blanket recommendation that all infants get vaccinated at birth, maintaining that guidance only for infants whose mothers test positive for the infection or have unknown status. A mother can pass the infection, which can cause severe liver disease and cancer, to her infant at birth.

Mothers who test negative, the panel said, should talk with their health care provider and decide themselves when to vaccinate their child, but “suggests” they get it no earlier than two months if not at birth. Most states currently require children be vaccinated against hepatitis B to attend daycare or school; all permit medical exemptions, and most allow families to claim religious or personal exemptions.

"This has a great potential to cause harm, and I simply hope that the committee will accept its responsibility when this harm is caused,” ACIP member Joseph Hibbeln said after voting against changing the guidance.

The change will only go into effect if endorsed by the CDC, and is not expected to affect insurance coverage.

“Thoughtful inquiry is always commendable, but that inquiry should not be confused with baseless skepticism, which is what I think we're encountering here,” Cody Meissner, a Dartmouth professor of pediatrics and the only member who served on the panel before HHS Secretary Robert F. Kennedy Jr. remade it, said ahead of the vote.

Meissner voted against the change.

Even before the vote, the meeting revealed how Kennedy has remade the influential panel. Kennedy fired all of the members of the Advisory Committee on Immunization Practices and appointed new ones, many of whom share his skepticism of vaccines. Since then, the panel has abandoned many of its traditional practices for evaluating changes to recommendations and has invited testimony from longtime activists in the anti-vaccine movement. The committee proceedings have frequently been plagued by heated disagreements and procedural confusion.

“A diverse set of viewpoints is good for a robust scientific discussion,” said HHS spokesperson Andrew Nixon.

Ahead of the hepatitis B vote, no career CDC subject matter experts presented on the shot. In his opening statement Friday, Vice Chair Robert Malone said that vaccine scientists Paul Offit and Peter Hotez were also invited to present at the meeting but declined.

Offit said he doesn’t recall the invitation, but that “it’s possible” he was asked to appear.

“This is a political committee, not a scientific committee,” he told POLITICO in a text message. “And that kind of statement proves that it’s political. This group will continue to provide dangerous and misleading advice to parents of children in this country. I don’t want to have any part of that.”

Hotez said he declined the invitation “because ACIP appears to have shifted its mission away from science and evidence-based medicine.”

Cynthia Nevison, a climate and autism researcher at the University of Colorado with anti-vaccine movement ties, and Mark Blaxill, an anti-vaccine activist, made the case for eliminating the universal birth dose. Neither is a medical doctor, and their presentations weren’t vetted by the agency’s career subject matter experts, according to a CDC official granted anonymity for fear of retribution. Aaron Siri, a leading anti-vaccine lawyer who worked on Kennedy’s campaign, is slated to present on the childhood vaccine schedule on Friday.

Nixon noted that Nevison and Blaxill’s presentations included CDC data.

Nevison said Thursday that the universal birth dose was not responsible for a large decline in hepatitis B infection, arguing that other measures — including increased blood screening, improvements in dialysis, and safe sex practices stemming from the AIDS epidemic — played a larger role.

The CDC official granted anonymity for fear of retribution told POLITICO that much of what Nevison presented was misleading. "There were no experts in public health surveillance or epidemiologic modeling on the workgroup," the official said.

Jason Goldman, liaison to the panel from the American College of Physicians, lambasted the panel during the Thursday meeting, calling it "political theater."

“This meeting is completely inappropriate for an administration that wants to avoid fraud, waste and abuse. You are wasting taxpayer dollars by not having scientific rigorous discussion on issues that truly matter,” Goldman said.

Longtime CDC subject matter experts, who had presented at two previous meetings of Kennedy’s hand-picked panel, were allowed to answer questions but did not present data or analysis.

“Where were they? Why weren’t they allowed to speak?” John Grabenstein, a former Defense Department vaccine scientist and Merck executive, told reporters after Thursday’s meeting.

Some ACIP members took issue with the presentations.

“I take strong positions against each of the three presentations that have been made,” Cody Meissner said of the presentations by Nevison, Blaxill and Vicky Pebsworth, an ACIP member who reported on the findings of the panel’s work group that examined hepatitis B data prior to the meeting.

Many outside experts echoed Meissner’s concerns.

Daniel Jernigan, who resigned from the CDC in August after Kennedy ousted former agency Director Susan Monarez, said the presentations put too much emphasis on potential risks while ignoring vaccine benefits demonstrated over decades.

“There's just a lack of preparation, a lack of discipline and, in some ways coming across now, a hubris for their views,” he told POLITICO.

Meissner and Hibbeln also raised concerns about the organization of the meeting after a last-minute change left members confused about what they were voting on.

The hepatitis B vaccine debate

Pebsworth said U.S. policy is out of step with recommendations in other developed countries. She and other presenters frequently pointed to Europe, where few countries recommend a universal birth dose of hepatitis B vaccine due to low transmission risk.

American public health experts caution against comparing U.S. vaccine policies to those in peer countries with socialized health care systems that can comprehensively track patient records. The U.S. shifted to universal infant immunization after taking a risk-based approach to hepatitis B vaccination in the 1980s that didn’t meaningfully dent disease transmission.

One outside expert who served on the childhood vaccine schedule workgroup ahead of the meeting abruptly resigned Wednesday, according to an email seen by POLITICO, citing concerns that she had not been able to review materials the workgroup had prepared for the meeting.

“Without an opportunity to review the workgroup’s recommendation language and materials that will be presented at tomorrow’s ACIP meeting and vote on hepatitis B vaccinations in children, I personally do not feel comfortable being listed as a workgroup member,” Amy Tang, director of viral hepatitis and tuberculosis programs at North East Medical Services wrote to the Pebsworth, who led the panel. “I respectfully submit my resignation from the workgroup and request that my name be removed from any slides or materials presented tomorrow since I have not reviewed them.”

Nevison presented on the burden of the hepatitis B infection. She and Blaxill previously published a study with another Kennedy ally, the Brownstone Institute’s Toby Rogers, examining the “societal cost” of rising autism rates.

The Journal of Autism and Developmental Disorders retracted the study, reporting “misrepresentation of the incidence of autism and insufficient attention given to various other factors that might account for apparent changes in rates. The journal said that the authors’ conflict-of-interest statement did “not accurately reflect the non-financial interests of the authors.”

ACIP has recommended that all infants get vaccinated against hepatitis B since 1991.

The recommendation coincided with a drastic reduction in hepatitis B cases, with incidence declining 98 percent from 1990 to 2006 in children under 15.

The CDC updated its guidance in 2005 to recommend the first shot be given to everyone at birth.

Skeptics often argue that because the infection is usually spread through illicit drug use or sexual transmission, newborns don’t need the shot, especially if their mothers test negative for the infection. But many who work in public health in the U.S. argue the shot is a necessary safety net and can prevent a devastating disease in the case of false negative tests or if mothers acquire hepatitis B late in pregnancy. Infants can also acquire the highly transmissible virus through casual contact with family members or caregivers who may not know they have it.

Blaxill, who introduced himself as a long-time CDC critic but is now working at the agency, said the hepatitis B safety evidence is “limited, and it's often concerning.”

He pointed to millions of dollars in hepatitis B-related claims paid out of the Vaccine Injury Compensation Fund, with Nevison suggesting they amount to documentation of known adverse events, even though compensation program settlements don’t prove causality.

“I can absolutely tell you that these are not confirmed associations,” said Meissner, a former chair of the compensation program. “They reached an agreement during the trial to settle a case, but there was no agreement [on causality]."

Multiple ACIP members pushed Blaxill for a documented example of risks associated with the birth dose, which he could not provide.

“Speculation and limited evidence … Okay! Got it,” said Hibbeln, a psychiatrist and former acting chief of the Section of Nutritional Neurosciences at the National Institute on Alcohol Abuse and Alcoholism, after Blaxill couldn’t point to concrete examples of harm.

“There is evidence of benefit … and there is no evidence of harm,” Meissner said.