(statnews.com)
Once upon a time, the group that advises the government on vaccine policy followed a set formula for making a new recommendation: it methodically studied cost analyses, reviewed data on the benefits and risks, and, critically, analyzed how the proposed policy would play out in doctors’ offices, birthing hospitals, and other locations where vaccines are administered.
No more, it seems. When it voted last week during a two-day meeting to jettison a 30-plus year recommendation that all babies get vaccinated at birth against hepatitis B, the Advisory Committee on Immunization Practices appeared to give little, if any, consideration to the knock-on effects their votes could have.
For some families, the ramifications could be considerable. Because subsequent doses of the hepatitis B vaccine are often bundled into combination shots that protect against other diseases, parents who opt not to vaccinate their infants against hepatitis B may find it difficult to immunize their children against four or five other significant threats, like polio or pertussis, which claimed the lives of at least two children in Louisiana this year.
“If people just decide ‘I don’t want to do the hep B vaccine,’ that is obviously their choice. But then what happens is that you wouldn’t be able to administer a combo vaccine and there’s not enough of the other shots as standalones to be able to cover the demand,” said Demetre Daskalakis, who led the CDC’s National Center for Immunization and Respiratory Diseases before he resigned in August to protest the firing of CDC Director Susan Monarez.
Sean O’Leary, a pediatric infectious diseases specialist at Children’s Hospital Colorado, said the ACIP’s new recommendations failed to consider a key feature of vaccine delivery.
“They’re not taking into account the issue of the combination vaccines,” said O’Leary, who is chair of the American Academy of Pediatrics’ infectious diseases committee and who for years was the AAP’s nonvoting representative on the ACIP. “That’s just yet another example of how completely incompetent this committee is.”
The AAP has been boycotting ACIP meetings since health secretary Robert F. Kennedy Jr. fired the former expert panel and largely replaced it with known vaccine critics.
The AAP has told its membership to ignore the two ACIP votes last week, and dozens of other medical organizations have loudly denounced the newly recommended approaches to hepatitis B vaccination. A number have called on Jim O’Neill, the acting director of the Centers for Disease Control and Prevention, to reject them, but that outcome appears unlikely when the agency takes action on the recommendations.
What seems most probable is that many or most pediatricians and OB-GYNs will follow the advice of their professional organizations and continue to urge parents to allow their babies to be vaccinated against hepatitis B at birth. But ACIP members’ doubts that most babies need the vaccine will almost certainly lead to an increase in the number of parents who decline to vaccinate their infants against the virus.
In fact, that’s already happening, O’Leary said.
“This is sowing a lot of confusion for parents. Even this being on the agenda the last time,” — the ACIP’s September meeting, when a decision was deferred — “has increased people refusing the birth dose,” he said.
Kennedy’s anti-vaccine base objects strongly to the birth dose of hepatitis B vaccine, arguing that the only babies at risk of contracting the virus at birth or early in life are those born to sex workers, intravenous drug users, or immigrants from countries where infection rates are high. The risk to the “average American child” has been overstated, Cynthia Nevison, a climate scientist and anti-vaccine advocate who has been hired as a CDC contractor, told the committee last week during a presentation on the burden of hepatitis B disease.
ACIP’s decision to revisit the hepatitis B policy appeared not to be based on new questions about the vaccine’s effectiveness or safety, but on the objections of some parents.
Infectious disease experts have repeatedly pointed out that previously about half of young children who became infected lived in households where no one else was infected, proof that it is impossible to easily identify all high-risk babies. And they note the birth dose brought rates of hepatitis B infection in infants to historically low numbers, averting deaths in the process. Roughly 90% of babies who contract hepatitis B in the first year of life develop chronic infections and about a quarter of them will die prematurely of liver disease.
The first ACIP recommendation suggested that babies born to mothers who tested negative for hepatitis B during pregnancy don’t need to get a dose of hepatitis B at birth. The committee said parents of those babies should talk with their medical providers and decide when and if they want to vaccinate their children against hepatitis B, recommending that the process only start after 2 months of age if it’s undertaken at all.
The second vote recommended that parents who proceed with hepatitis B vaccination ask about having their babies undergo a blood test after the first dose, to see if one dose might suffice. (The vaccine is licensed to be given in three- or four-dose series.)
The committee appeared to be guessing that antibody levels seen after three doses — that are thought to indicate lifelong immunity — might also equate to long-term protection if seen after one dose. There are no data suggesting a single dose in early childhood can offer durable protection against hepatitis B, a fact ACIP member and pediatrician Cody Meissner stressed during the meeting; the question simply hasn’t been studied. Meissner’s intervention didn’t dissuade the majority of his colleagues from voting for the recommendation.
Both of these proposed policies, if adopted, could create difficulty for parents who want to forgo hepatitis B vaccination for their babies — or minimize the number of doses they get — but still hope to protect them against other serious diseases. And the more parents who take up these options, the more problematic the knock-on effects will be, experts warned.
“I think it’s going to cause some chaos unless people completely ignore it,” said Jesse Goodman, a former head of the Food and Drug Administration’s biologics division who is now director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University.
The issue, as O’Leary said, is that many vaccines are marketed in multivalent formulations, protecting against several diseases. The goal of this long-standing approach is to minimize the number of injections children — and adults — have to receive. Think MMR (measles, mumps, and rubella) vaccines for kids or Tdap, formulated to give adults booster doses of tetanus, diphtheria, and pertussis (whooping cough).
The hepatitis B vaccine given to infants at birth is a monovalent; it only protects against that infection. But when a baby goes to a pediatrician for a second dose of hepatitis B vaccine at 1 or 2 months of age — and the third at 6 months of age — he or she will almost certainly be offered a vaccine that protects against five or six pathogens. The same will likely be true for babies whose parents decide against a birth dose and wait, as the ACIP recommended, until their baby is 2 months or older to start hepatitis B vaccination.
Sanofi and Merck’s Vaxelis, the market leader among these combination vaccines, protects against hepatitis B plus diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b, more commonly known as Hib. GSK’s Pediarix protects against five diseases — everything in Vaxelis except Haemophilus influenzae type b.
There are a number of other combination products that are licensed for the U.S. market, such as Sanofi’s Pentacel (it protects against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b), that do not include hepatitis B, but they make up a much smaller portion of the market and are therefore produced in small amounts.
If parents decide they don’t want to vaccinate their babies against hepatitis B, or would prefer to wait until the child is older — President Trump suggested 12 years of age — they would have to either skip vaccinating against the other diseases, find a doctor who had supplies of a combination shot without hepatitis B, or try to find doses of monovalent vaccines to protect against the other diseases. The market doesn’t produce enough of these products to meet significant increased demand, experts warned.
That would likely lead to an increase in children who miss other key vaccines, because their parents either can’t find doses of the vaccines they wanted, or because the demand outstrips the limited available supply.
Noel Brewer, a former ACIP member who Kennedy fired last June, suggested this is part of the goal.
“Making vaccines harder to get appears to be an explicit strategy of the current ACIP,” said Brewer, a professor of health behavior at the University of North Carolina. “Decades of research have shown us that small improvements to access increase vaccine uptake. It stands to reason that these small decreases in access will have the opposite effect and reduce uptake of vaccines.”
In the months-long lead up to the ACIP’s votes on hepatitis B, vaccine manufacturers and an industry organization tried to warn the committee that the vaccine supply market is carefully calibrated, and cannot easily adapt to unplanned changes in demand. Their concerns were not addressed in the committee’s discussions.
“Vaccines are complex biologics with exceptionally long production timelines, often at least 12 to 18 months from start to finish, and substantially longer when changes to licensing requirements are made. Even seemingly modest changes, such as modifications to dosing schedules or shifts that affect combination vaccine configurations, can have far-reaching impact,” the Biotechnology Innovation Organization, which is a nonvoting member of the ACIP, warned in a written comment it submitted in advance of the vote.
“Changes to recommendations for any component within a combination vaccine risk reducing options for families and could disrupt vaccine supply and limit access for years. These supply challenges would extend beyond combination vaccines to include stand-alone vaccines that prevent diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and polio,” Ayman Chit, head of medical affairs for Sanofi Vaccines, wrote in a letter the company filed urging against the changes to the birth dose policy.
Jason Goldman is president of the American College of Physicians, another organization which has nonvoting status on the ACIP. After attending dozens of meetings of the advisory committee, he said the way the group is now functioning bears little resemblance to the processes that ACIP used to follow.
“There were no modeling studies, no cost analyses, no surveys of patients and pediatricians and OB-GYNs regarding how this would affect their practices,” Goldman said.
“Nothing was done correctly. Nothing was done with a rigorous scientific or evidence-based review. The process was a complete shambles and that is why it cannot be trusted,” he said.