By Michael Erman NEW YORK, Dec 2 (Reuters) – Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory committee will vote later this week on whether to delay hepatitis B shots for most American children but has not settled on exactly how long to recommend pushing them back, the new chair of the committee said […]
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US vaccine committee to vote this week on delay of hepatitis B shots
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By Michael Erman
NEW YORK, Dec 2 (Reuters) – Health Secretary Robert F. Kennedy Jr.’s hand-picked vaccine advisory committee will vote later this week on whether to delay hepatitis B shots for most American children but has not settled on exactly how long to recommend pushing them back, the new chair of the committee said in an interview.
Delaying the decades-old practice of administering the hepatitis B vaccine to newborns is an idea that has been pushed by long-time anti-vaccine activist Kennedy as part of his campaign to remake U.S. vaccination policy.
“We try to avoid giving things to the most vulnerable,” Dr. Kirk Milhoan, a pediatric cardiologist named to run the CDC’s Advisory Committee on Immunization Practices, said on Monday. “We want to test these things incredibly thoroughly before we give it to them, especially in a neonatal period or in a pregnant mother. So these are things that we have a very high suspicion of.”
A review of more than 400 studies and reports by independent vaccine experts released on Tuesday found that the U.S. policy of giving the hepatitis B vaccine to newborns cut infections in children by more than 95%.
NO CONVERSATIONS WITH VACCINE MAKERS
The vaccine advisory committee to the U.S. Centers for Disease Control and Prevention has not spoken directly to vaccine makers about potential supply concerns they have raised that could result from delaying the shots, Milhoan said.
“We’re not really dealing with that issue right now,” he said. “We haven’t had those discussions, and that might not be really appropriate for the (committee) to have those discussions outside of the meeting.”
Even small changes to the vaccination schedule could disrupt the supply of hepatitis B vaccine or others given in combination with that inoculation, such as the polio vaccine, for a year or longer, several vaccine makers and experts told Reuters.
The committee is scheduled to meet on Thursday and Friday.
Sources at vaccine makers, who spoke on the condition of anonymity, told Reuters the committee has not asked for specific data or details on how any changes to the hepatitis B vaccination schedule could impact vaccine supply in the U.S.
That is a departure from how it proceeded previously when the CDC would communicate directly with industry ahead of ACIP meetings, said John Grabenstein, a consultant and former Merck vaccine executive. Merck is one of the manufacturers that makes a hepatitis B shot used in the U.S.
“Manufacturers could anticipate a vote coming up to increase demand and they might take a corporate decision to increase their supply a little bit,” he said.
He described the committee as being far less predictable, saying that “uncertainty is not good in industry.”
A spokesperson for the U.S. Department of Health and Human Services did not respond to a request for comment.
SIGNIFICANT SUPPLY DISRUPTION POTENTIAL
Hepatitis B is a viral infection that causes liver inflammation. It primarily spreads through blood, semen or certain other body fluids, but can also be spread through more casual contact.
In addition to Merck, GSK makes a hepatitis B vaccine and Sanofi makes a combination shot with Merck that includes six different vaccines.
The hepatitis B vaccine is currently recommended for all American children in a series of three shots. The first shot is given in hospitals soon after a child is born with the final two generally administered as part of combination shots. The multi-dose shot includes vaccines against other illnesses like diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b.
The combination shots could become useless if the recommendations on timing for the vaccines no longer align, Grabenstein said.
“This is what I call the tyranny of just-in-time inventory,” Grabenstein said. “To maximize efficiency, they will have minimized their stockpile, and if there’s an abrupt change, it could lead to shortages.”
Sanofi at the last ACIP meeting said any delay could “cause significant supply disruptions for a year or longer as production of vaccines is adjusted given the long lead time required.”
Merck has said that changes to the established schedule could lead to a resurgence of preventable disease.
(Reporting by Michael Erman; editing by Caroline Humer and Bill Berkrot)