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Pregnant women should be tested for hepatitis B, but the best time for vaccinating babies against it remains up in the air.
The Advisory Committee on Immunization Practices (ACIP) will not change recommendations for hepatitis B vaccines for infants at birth, at least for now.
ACIP took up the issue regarding that shot with lengthy deliberations, but no formal vote, on Sept. 18, the first day of its two-day session. A day later, the panel voted 12-0 on Vote No. 1 about that topic, recommending: All pregnant women should be tested for hepatitis B infection.
Vote No. 2 stated: The pediatric vaccine schedule should be updated to reflect the following change:
If a mother tests HFsAG-negative:
- The first dose of the hepatitis B vaccine is not given until the child is at least one month old.
- Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making, also referred to as shared clinical decision-making.
Members Vicky Pebsworth, OP, PhD, RN, and Robert Malone, MD, MS, pointed to safety concerns in studies presented the day before and in other sources. Member Joseph Hibbeln, MD, ABNP, CAPT USPHS (Ret.), suggested the language of Vote No. 2 was unclear, because it appeared to bar administration of the vaccine to a child less than a month old, then say the vaccine could be given to an infant that age based on clinical decision-making.
Member Raymond Pollak, MD, FACS, FRCS, said the committee needed a formal motion to open debate. Then Malone said that there was enough ambiguity in the findings that a vote would be premature. He suggested ACIP table the recommendation, and Pollak called the question. ACIP members voted 12-0 to table in the interest of having additional research and debate.
ACIP member Cody Meissner, MD, commented on Malone’s statements and noted it is difficult to prove the absence of harm, and it is not a practical objective. Member Catherine Stein, PhD, countered that the committee members should avoid making absolute statements that something is harmful or not. Meissner responded that everyone should understand no vaccine is 100% safe or 100% effective, but that physicians must think about particular patients and whether benefits of protection exceed possible side effects of vaccines.
Testing more mothers-to-be
Chair Martin Kulldorff, PhD, allowed public comments on the issue, and discussion expanded to the ACIP methods for analyzing studies and evidence.
Flor Munoz, MD, MSc, a board member of the National Foundation for Infectious Diseases, noted hepatitis B testing already is standard of care for pregnant women. While that may be the case, Kulldorff said current testing rates are at 86% to 87% and the ACIP members want to see it closer to 100%.
Munoz also spoke in support of the infant immunization program.
What are the methods?
Robert H. Hopkins, Jr., MD, medical director of the National Foundation for Infectious Diseases, asked for a full review, including an evidence to recommendation framework including the domains of equity. Jason Goldman, MD, MACP, asked Kulldorff to present and describe the process and methodology the committee will use to vet information. Kulldorff said he hoped the board would come back to that in a future meeting, and he was not skilled enough to do a quick response to that.
Amy Middleman, MD, MPH, MSED, FSAHM, representing the Society for Adolescent Health and Medicine, said she supported Meissner’s comments. Every intervention, from Tylenol to amoxicillin to chemotherapy, has some risk, but ACIP’s job is to determine if benefits outweigh the risks.
It is easy to get distracted by one study, but the committee should use a methodical scientific method to weigh risks and benefits appropriately using grades or evidence to recommendation, she said.
“This is important for all vaccine decisions and this is what I think some of us are really concerned about in terms of the absences of it,” Middleman said.