CDC Panel Reverses Call to Give Newborns Hepatitis B Shot (2)

An influential panel of US vaccine advisers voted to revoke a longstanding recommendation that all babies receive hepatitis B shots within 24 hours of birth, a move expected to reverse the country’s progress toward eliminating the disease.

The decision is the most consequential action taken by the Advisory Committee on Immunization Practices since the group was recast under US Health and Human Services Secretary Robert F. Kennedy Jr. earlier this year.

The vote allows parents to delay the shot for at least two months if the mother tests negative for the virus. The panel also said parents and health-care providers can use blood tests to determine whether further shots in the full three-dose course hepatitis B shot are warranted, though there is no evidence showing such tests can prove a person’s immunity. The panel confirmed that these changes would also apply to the Vaccines for Children federal program, which offers free immunization for children who are on Medicaid or are uninsured.

The US Centers for Disease Control and Prevention has recommended the hepatitis B shot for newborns for 35 years, and in that time infections in children and teens have practically disappeared.

Friday’s 8-to-3 vote in favor of ending the shot for newborns prompted strong objections from some panel members.

“We have heard do no harm is a moral imperative,” said Cody Meissner, a professor of pediatrics at Dartmouth Geisel School of Medicine and the former chief of pediatric infectious diseases at Tufts Medical Center. “We are doing harm by changing this wording.”

“This has a great potential to cause harm and I simply hope that the committee will accept its responsibility when this harm is caused,” said Joseph Hibbeln, a psychiatrist and neuroscientist who worked at National Institutes of Health.

ACIP members were split over the implications of the vote. Some said it will have no impact, as doctors and parents can use the vaccinations however they want, and they will continue to be fully covered by health insurance programs at no additional cost. Others said the change signals that something was wrong with the original, universal recommendation, and should lead to a rethinking of how the shots are used.

“We’ve given doctors and patients the freedom, and we’ve made sure it was paid for,” said Kirk Milhoan, a pediatric cardiologist and the panel chair. “I have the freedom in this vote to either do it at birth or do it whenever I’d like with shared decision making,” he said.

But Retsef Levi, an operations professor at the Massachusetts Institute of Technology, said that the shift to giving the hepatitis B vaccine based on individual decision making suggests the old recommendation to give the shot to all newborns was not appropriate. “Parents should carefully think about whether they want to take the risk of giving another vaccine to their child,” he said.

The American Medical Association called the committee’s decision as “reckless” and said it “undermines decades of public confidence in a proven, lifesaving vaccine.”

“We urge the CDC to reject this recommendation and uphold its commitment to science and public health,” AMA trustee Sandra Adamson Fryhofer said in a statement. “The consequences of failing to do so are too severe and the potential harm too great.”

ACIP is highly influential because its recommendations help determine which shots insurers are required to cover.

Children need three doses of the hepatitis B vaccine, usually given throughout the first 18 months of life, to be considered fully vaccinated.

President Donald Trump and Kennedy, a vocal vaccine critic, have questioned medical consensus on whether babies should get hepatitis B shots, raising unrelated concerns that the disease can be contracted sexually. Newborns that contract hepatitis B typically get it from infected mothers. Kennedy has also promoted debunked links between vaccines and autism, and has encouraged the ACIP panel to examine the entire childhood shot schedule.

The panel’s Thursday session included presentations from speakers who hold views far out of sync with mainstream scientists.

Mark Blaxill, a prominent figure in the anti-vaccine movement with no medical background, spoke about the safety of the hepatitis B immunization. He floated the possibility that babies who are fussy after a shot may actually be suffering from encephalitis, a condition that involves dangerous brain swelling. There’s no evidence hepatitis B shots lead to encephalitis, but in rare cases the condition can be caused by the virus itself. He also referred to research conducted by David Geier, another prominent voice in the anti-vaccine movement and a discredited researcher.

Cynthia Nevison, a climate researcher, told the vaccine panel that the CDC’s 1991 decision to recommend all newborns get a hepatitis B vaccine had no impact on the number of cases. CDC data show that since it began calling for those shots, infections in children and teens have declined by 99%. Nevison also said the risk for hepatitis B positive mothers was primarily among immigrants rather than US citizens, and the risk of a child getting the disease from a family member is higher in immigrant communities.

Heated Exchanges

Some of the ACIP members appeared disturbed by the statements and exchanges at times grew testy.

“This disease has gone down in the United States thanks to the effectiveness of our current immunization program,” Meissner said. Robert Malone, vice chair of the panel, urged Meissner to say that was just his opinion. “OK,” Meissner responded, laughing. “These are facts, Robert.”

Public health experts have criticized the arguments Kennedy has deployed against hepatitis B vaccines. Hepatitis B is a dangerous viral infection of the liver. A preliminary paper showed that delaying the shot by two months would potentially result in more than 1,400 more new hepatitis B cases, 304 new instances of liver cancer and more than $222 million in additional health-care costs in the first year. The study, led by Oregon Health & Science University, hasn’t yet been formally published.

Several representatives from major medical groups also used a comment period to excoriate the panel. “This committee shows no understanding of the gravity of the moment of the recommendations that you make,” said Jason Goldman, president of the American College of Physicians.

Malone announced Thursday that ACIP would be adding a new so-called work group that would analyze vaccinations in pregnancy.

Revamped Panel

In June, Kennedy fired every member of ACIP and many of the replacements hold views similar to his. In a last-minute change this week, HHS appointed the former ACIP Chair Martin Kulldorff to a permanent position in the administration. Milhoan, a pediatric cardiologist and Covid vaccine critic, took over as the new chair.

The outside experts that were given presentation slots were also aligned with the anti-vaccine movement. Some were associated with the Children’s Health Defense, the anti-vaccine organization Kennedy once chaired.

Nevison, now a contract employee with the public health agency, is a contributor to the CHD blog. Aaron Siri, a vaccine injury lawyer and Kennedy’s lawyer during his presidential bid, is scheduled to present on the broader children’s immunization schedule Friday. Tracy Beth Høeg, a Covid vaccine critic, was named the acting director of the drug division at the Food and Drug Administration on Wednesday. She spoke Thursday on behalf of the agency and will lead the discussion Friday on the US and Danish vaccine schedules.

Fallout

The decision to delay the shots means many newborns could still contract an infection and have to live with chronic hepatitis B later in life. Additionally, blood tests aren’t currently used to determine if a child needs to complete their three-shot hepatitis B course because they don’t show that someone is fully protected against illness.

Adam Langer, the CDC’s acting principal deputy director at the center for HIV, viral hepatitis, STD and TB prevention, said “we have no data at all” to show whether blood tests determine if someone should complete a vaccine series. Suggesting someone needs an extra test also opens the door for people to skip out on later doses needed to become fully immunized.

Hepatitis B shots for infants are made by Merck & Co. Inc. and GSK Plc. Executives from the companies and from Sanofi SA, which makes a combination shot, have defended the safety of the vaccines and said delays could lead to lower overall vaccine uptake and supply issues.

“We await additional information and an official adoption of today’s recommendations by CDC to fully understand the potential impact,” a GSK spokesperson said in a statement.

ACIP was originally scheduled to vote on hepatitis B shots in September, but delayed the move after a two-day meeting marked by technical glitches and confusion. During that session, ACIP declined to back a combined shot for measles, mumps, rubella and chickenpox that some families prefer.

It also voted to require people consult a health-care provider before receiving a Covid shot, a decision that left many people unsure of how to access the vaccines. Earlier in the year, ACIP voted against the use of thimerosal in shots, a mercury-based preservative that health experts say is safe but has falsely been linked to autism.

(Updates with details on the reach of the panel’s decision and additional comments from panel members and the American Medical Association from the third paragraph. An earlier version was corrected for a mother’s hepatitis status required for the shot to be delayed.)

--With assistance from Madison Muller.

To contact the reporters on this story:
Gerry Smith in New York at gsmith233@bloomberg.net;
Jessica Nix in New York at jnix20@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

Anne Cronin, Michelle Fay Cortez

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