The vote from all but one of the 12 members of the Advisory Committee on Immunization Practices comes as a de-escalation in the mounting tensions over vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., a long-time skeptic of the status quo on childhood vaccines.
Hepatitis B vaccines have been one of the most critical issues for the broader anti-vaccine movement, in large part due to the fact that the first dose is given to infants on their first day of life if they are delivered in a hospital setting.
The committee was originally poised to change the recommendation and instead issue guidance that the first dose of the Hepatitis B vaccine should be delayed until a one-month infant wellness visit for mothers who test negative for the virus when they present at the hospital for childbirth.
Prior to tabling the recommendation vote, the committee unanimously adopted a measure “all pregnant women should be tested for hepatitis B infection,” which is already part of routine standards of care within the first and second trimesters.
ACIP’s review of the Hepatitis B vaccine comes amid significant political controversy at the CDC following the firing of the agency’s director, Susan Monarez.
Monarez told the Senate during an oversight hearing on Wednesday that Kennedy fired her in August because she refused to “preapprove” decisions on the childhood vaccine schedule to be made during the September ACIP meeting, regardless of the scientific evidence.
It is unclear whether the committee will be reviewing the Hepatitis B vaccine recommendations during its next meeting this year, scheduled for Oct. 22 and 23.
Several non-voting liaisons members from various medical professional organizations requested that the decision be delayed until a CDC work group could be convened to thoroughly examine evidence on both sides of the contentious debate.
Exposure to Hepatitis B virus
Critics of the current recommendations to vaccinate newborns on their first day of life highlight that Hepatitis B is considered a sexually transmitted infection, passed through primarily through sexual activity and intravenous drug use.
Proponents of the newborn dose say that the primary mechanism that children are infected with chronic Hepatitis B is from their mother, and the universal vaccination policy in the United States has dramatically reduced contraction of chronic Hepatitis B since the 1990s.
But those who advocate for delaying the first dose, including HHS advisor Calley Means, argue that other developed countries do not recommend Hepatitis B vaccine for newborns unless the mother tests negative.
Retsev Levi, Massachusetts Institute of Technology professor of operational systems, questioned during the meeting whether there is any evidence of transmission of the virus to young infants other than through maternal transmission.
The CDC expert who presented at Thursday’s panel highlighted one study of U.S.-born children to immigrant mothers who tested negative at the child’s time of birth that 7% to 11% later tested positive for Hepatitis B surface antigen.
“They did not get it from mom, because mom is negative. They got it after birth, and they were certainly far too young to have a sexual exposure or injection drug exposure,” said the CDC expert.
Unknown side effects of Hepatitis B vaccine
Vicky Pebsworth, affiliated with the anti-vaccine group the National Vaccine Information Center, on Friday morning before the vote referenced several studies that were not presented during the formal discussions following the CDC career scientists’ presentations on Thursday.
Pebsworth cited studies indicating “systemic reactions in Hepatitis B vaccinated children,” with 5% reporting fever, 32% reporting drowsiness, and 3% with “severe irritability.”
“These are not trivial reactions,” said Pebsworth, saying that they could be signs of developing neurological problems that will only be detected later in life.
Dr. Robert Malone, a vaccine specialist who became a prominent critic of the public health establishment in the wake of the pandemic, on Friday referenced an Institute of Medicine report that was highlighted by CDC career scientists the day prior, which was presented as evidence that the Hepatitis B vaccine is safe for newborns.
But Malone criticized the presentation of the IOM report, saying that it was an “error of omission.” Malone said that the IOM found several findings of harm from the Hepatitis B vaccine, but it could not determine the statistical significance of the findings.
“We have widespread claims, case reports, case series suggesting that there are harms, and we have an IOM report indicating that they could not conclude statistically whether or not those were had merit, that that does not mean that it’s safe,” said Malone.
Health equity concerns
Several members of the committee said during debates on Thursday brought up that patients most at risk for contracting
Dr. Cody Meissner, professor of pediatric medicine at Dartmouth, voiced concerns about getting the Hepatitis B vaccine to populations most often lost to follow-up or who do not have regular contact with the healthcare system.
“It’s very hard to identify, as we’ve seen, very hard to identify people who are most likely to be exposed and infected to Hepatitis B, such as IV drug abusers or sex workers. You can’t find them, homeless people. You can’t, they don’t, it’s hard to get them vaccinated,” Meissner said.
Meissner also said that the Hepatitis B vaccine, from the data available, appears to confer at least some lifelong immunity following the birthday dose.
Dr. Raymond Pollack, transplant surgeon and immunologist, also said during Thursday’s debate that he was primarily concerned that infants not vaccinated during the perinatal period immediately after birth often “will not come back to be vaccinated later on.”
“That particularly affects single mothers and women of low socioeconomic status, and those you know, persons of color and also high-risk groups such as Alaskans, First Nations and so on,” Pollack said.
