ACIP Votes on Hepatitis B Vaccine Mark More Confusion, No Supportive Safety Data, and Uncertainty of Public Health Policy

After yesterday’s decision by Advisory Committee on Immunization Practices (ACIP) members to delay the votes until today, the committee did cast votes on 3 recommendations.

The committee’s votes were the following:

1. They voted in favor of offering a recommendation of “the initial dose administered no earlier than 2 months of age.”

2. They voted to offer a novel anti–hepatitis B (HB) serology testing post vaccination.

3. They voted to confirm the Vaccines for Children (VFC) resolution.


In looking at the language of the votes, both ACIP panelist Joseph R. Hibbeln, MD, ABNP, CAPT USPHS; and ACIP panelist H. Cody Meissner, MD, expressed their confusion before and after the votes.

For example, in looking at vote 1, which covers the former birth dose, the language leaves it open for interpretation: “For those not receiving the HBV [HB virus] birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.”

The language for the votes is listed below:

Vote 1

"For infants born to HBsAg [HB surface antigen]-negative women: ACIP recommends individual-based decision making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age."

The committee approved the recommendation, and the members voted 8 to 3 in favor of the recommendation.

Vote 2

"When evaluating the need for subsequent HBV vaccine dose in children, parents should consult with health care providers to determine if a post-vaccination anti-HB serology testing should be offered. Serology results should determine whether the established protective anti-HBs titer threshold of ≥ 10mIU/mL has been achieved. The cost of this testing should be covered by insurance."

The committee approved the recommendation, and the members voted 6 to 4 in favor. One member abstained.

Vote 3

"Approve the updated Vaccines for Children (VFC) resolution for prevention of hepatitis B."

The committee approved the recommendation, and the members voted 8 to 0 in favor, with 3 members abstaining.

Debate Before the Vote

Before the votes, all the ACIP members spoke about the HBV vaccines, with many trying to seed doubt about informed consent and the safety of the vaccines and offering no safety data to move the vaccine schedule back. Throughout the meeting’s proceedings, there was a very distinct divide among the members and their beliefs in vaccines. Association liaison and meeting attendee Jason Goldman, MD, spoke of there being ideology presented over data.

Hibbeln said the last line of vote 1 is why they tabled the vote for 3 months. He made the point that no discussion about this has happened since and that no new data were presented.

Regarding vote 2, Hibbeln said the novel concept serology test could be required before the full series is completed. “No information has been presented. The full series of doses is required to achieve 90% efficacy…. There have been no data that this plan would work.”

Meissner said inquiry is always commendable but that inquiry should not be based in skepticism, which is what he felt they were encountering during the meeting. He noted the potential of losing a protective benefit of doing the first dose at 2 months of life and that no data were presented to suggest why the change was made.

“I would like someone to explain to me what is the advantage of giving the vaccine at 2 months.... I don’t think there is any reduction of risk,” he said.

“We are giving it to protect the infant, not society,” Meissner said of why birth doses are administered.

Regarding vote 2, Meissner took issue with the serology discussion that had taken place and was used in the language. He said that testing serology at less than 3 months is made up: “We are pulling stuff out of the air.”

He went on to say the HB vaccine schedule is well established, very safe, and very effective and that by making the change, we would see more children and adolescents infected with HB.

Calling in remotely, ACIP Chair Kirk Milhoan, MD, PhD, tried to justify the voting languages. Specifically, he talked about neonates’ vulnerability at birth and suggested that at 2 months, infants move out of the perinatal period.

Adam Langer, DVM, MPH, principal deputy director (acting) and associate director for science at the Centers for Disease Control and Prevention’s National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, weighed in on the comparisons of other countries that do not utilize universal immunization. He noted Denmark, which was cited as an example during the discussion, saying that the country only has 6 million people, more than 95% of women in the country are tested for HBV, prenatal care is free, and for pregnant women with HBV positivity in that country, their children are followed up after birth.

In contrast, in the US, the country is much bigger, does not have universal health care, and children are lost to follow-up after release from the hospital.

Langer pointed out that Denmark and all other nations are not like the US and that the country is unique. “Let’s talk apples to apples and not apples to oranges,” Langer said.

In noting that, he said Canada is the closest country to being like the US, and Canada's medical professional societies have made it known they are working toward universal HBV vaccination.

After the votes, the panel is taking up vaccines and aluminum adjuvants. One of the ongoing complaints of the reconfigured ACIP committee is that they are cherry-picking data and not looking at their totality.

Check out our continuing coverage next week as we receive feedback from clinicians, researchers, and members of professional medical societies.