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

After yesterday’s decision by 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 ant-HB serology testing post-vaccination.

3.And they vote 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 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 birth dose it is suggested that the initial dose administered no earlier than 2 months of age.”

The language for the votes is listed below:

Vote1

For infants born to HBsAg-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 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 ant-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, and 3 members abstain.

Debate Before the Vote

Before the votes, all the ACIP members spoke about the HBV vaccines, many trying to seed doubt about informed consent, the safety of the vaccines, and offering no safety data to move the vaccine schedule back. Throughout the meeting’s proceedings the last 2 days, there has been a very distinct divide in the members and their beliefs in vaccines. Association liaison and meeting attendee Jason Goldman, MD, spoke of their being ideology presented over data.

ACIP panelist Hibbeln said the last line of Vote 1 is why they tabled the vote for 3 months. He made the point that no discussion around this has happened since, and that no new data was 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 has been no data that this plan would work.”

ACIP panelist 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 doing the first dose at 2 months of life and no data presented to suggest why the change.

“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,” Messiner said, of why birth doses are administered.

In regard to Vote 2, Meissner took issue with the serology discussion that has 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 hepatitis B vaccine schedule is well-established, very safe, and very effective, and to make the change that we would see more children and adolescents infected with hepatitis B.

Calling in remotely, ACIP Chair Kirk Milhoan, MD, PhD, tried to justify the voting languages, specifically he talked about neonates’ vulnerability at birth and he 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 CDC’s National Center for HIV, Viral Hepatitis, STD, and TB 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, and that the country only has 6 million people, that more than 95% of women in the country are tested for HBV, prenatal care is free, and for HBV positive women in that country, children are followed up.

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 to being like the US, and its medical professional societies have made it known they are working towards 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 they are cherry picking data and not looking at its totality.

Check out our continuing coverage next week, as we get feedback from clinicians and members of professional societies and organizations.