ACIP postpones vote on hepatitis B vaccines at birth

The Advisory Committee on Immunization Practices has delayed for a day its vote on recommendations about hepatitis B vaccines for babies at birth.

On Dec. 4, ACIP began the first day of its third, two-day meeting during the tenure of Health and Human Services Secretary Robert F. Kennedy, Jr.

The agenda was loaded with talking points about hepatitis B to expand on deliberations that began in the September meeting. The only vote was to postpone a formal vote on the recommendations, based on the amount of information and desire to have clear language for government regulators, physicians and other clinicians, and patients.

The ACIP members are: Chair Kirk Milhoan, MD, PhD; Vice Chair Robert W. Malone, MD, MS; Hillary Blackburn, PharmD, MBA; Evelyn Griffin, MD; Joseph R. Hibbeln, MD, ABNP, Capt. USPHS (Ret.); Retsef Levi, PhD; H. Cody Meissner, MD; James V. Pagano, MD, FACEP; Vicky Pebsworth, PhD, RN; Raymond Pollak, MD, FACS, FRCS; and Catherine M. Stein, PhD.

How we got here

The meeting started with presentations by Pebsworth and U.S. Centers for Disease Control and Prevention contractor Cynthia Nevison, PhD, and CDC staffer Mark Blaxill.

Pebsworth said the review was prompted by at least three reasons:

• Feedback from stakeholders
• Misalignment of existing recommendations in most developed countries
• Prolonged time since the last comprehensive review, per ACIP’s charter

For years dating from the 1960s, health professionals targeted transmission of hepatitis B among high-risk groups, as vaccine safety, technology and liability evolved. CDC figures showed a rapid rise of reported acute U.S. cases of hepatitis B from about 1965 to 1990, based on factors including an influx of immigration from Southeast Asia after Vietnam; expanding intravenous drug use; and expanding sexual networks involving men and women.

CDC physicians proposed vaccination at birth as a way to move toward eliminating hepatitis B transmission. The universal birth dose recommendation dates from 1991, Pebsworth said, and the recommendation to vaccinate with 12 to 24 hours of birth dates from 2005. The ACIP members also have become aware of stakeholder and parent dissatisfaction, including a survey in Oregon in 2014 and a KFF/Washington Post survey this year.

The members also needed to consider risk of the disease and the vaccine, and whether immunization policies could be better aligned with other countries, Pebsworth said. The United States is an outlier with its universal recommendations; other developed, low-prevalence nations have flexible policies or no universal childhood hepatitis B vaccination policy.

Disease burden and safety

CDC contractor Cynthia Nevison, PhD, presented data on the burden of disease, and CDC staffer Mark Blaxill presented on vaccine safety.

Based on hepatitis B tracking figures, it appeared disease rates began dropping due to targeted measures starting in the 1980s, such as promotion of safe sex practices, needle exchange programs, and screening and case management of mothers with antigens and targeted vaccination of their infants, Nevison said. Looking at the age range in the decline of hepatitis B cases, the universal birth dose contribution to acute case declines is likely very small, Nevison said.

Blaxill’s presentation stated: “Safety evidence is limited and often concerning.” There were no randomized placebo-controlled trials in infants. Cited trials used short follow-up periods of seven days or less and discounted safety concerns, the presentation said.

Discussion begins

The day continued with discussion about hepatitis B, the effects on human health in infants and adults, and the practical effects of shots and policies. Based on the comments, it appeared the board did not necessarily walk in lockstep on the issues.

“Let me begin by saying that I take strong positions against each of the three presentations that have been made,” Meissner said. He questioned Nevison’s analysis of immunity due to the vaccine, and noted globally more people have a chronic infection from hepatitis B than tuberculosis, HIV or malaria. The infection rate in the United States may be relatively low, but even 0.5% would be 1.5 million people, which is a lot, he said.

“The question is, is there any evidence of harm? There is clearly evidence of benefit,” Meissner said.

Levi later said that may not be the right question, because the data presented had very low numbers, very short follow-up times, and no comparisons to placebos.

Commenting on the presentations and the work group studying hepatitis B vaccination, Griffin noted screening of pregnant women has declined from 96.5% in the early 2000s to 84% to 87% now.

“How did this screening gap widen? And so this speaks to an opportunity for us to close the gap in prenatal care, and should we be pushing this off to the babies? That is my concern,” she said. A CDC staffer noted that agency has a strategic priority to close that gap and prioritize testing of pregnant women for hepatitis B.

The move toward elimination of hepatitis B is one of the most great accomplishments in biology and medical science in this country, Hibbeln said. “So we have a high burden of proof to change this system or change our recommendations,” he said. Hibbeln pressed for evidence on rates of risks and harm of giving babies the vaccine before or after 30 days old.

Nevison cited Blaxill’s figures taken from the Vaccine Injury Compensation Program with millions of dollars paid for debilitating effects, including Guillain Barre Syndrom, transverse myelitis, rheumatoid arthritis and multiple sclerosis, on children and adults. Meissner, a two-year chair of that program, countered that those are not confirmed associations, and settlements are not based on agreement that the vaccines caused those reactions.