During a contentious meeting dominated by racial innuendo and anti-vaccine talking points, advisors to the Centers for Disease Control and Prevention (CDC) today voted to delay a decision on whether to recommend scaling back infant vaccinations for hepatitis B, a virus that kills 1.1 million people around the world each year.
Several members of the Advisory Committee on Immunization Practices (ACIP) asked for the postponement after complaining that they hadn't been given sufficient time to consider the wording of the proposal. The committee, whose members were handpicked by Health and Human Services Secretary Robert F. Kennedy, is now scheduled to vote on hepatitis B vaccines tomorrow.
Although the hepatitis B vaccine is widely heralded as a public health success story, Kennedy has long targeted the vaccine as unnecessary and dangerous. He has suggested, without evidence, that hepatitis B vaccines cause autism.
Joseph Hibbeln, MD, a psychiatrist, said committee members weren’t consulted when developing the questions on which to vote.
"I protest the description that the ACIP members have been consulted in developing these questions,” said Hibbeln, who worked at the National Institutes of Health and served in the US Public Health Service. He complained that the wording of the proposal had changed three times in the past three days, which prevented committee members from considering it carefully.
"We are trying to evaluate a moving target, Hibbeln said. "We really need to know what we are voting on."
The hastily updated wording also caused a CDC scientist to revise her presentation about how a new recommendation would affect coverage by the federal Vaccines for Children (VFC) Program (VFC), which pays for immunizations for about half of children. The committee waited for her to update her slides, then moved on and eventually came back to her.
We are trying to evaluate a moving target. We really need to know what we are voting on.
Representatives of the VFC Program and the Centers for Medicare and Medicaid Services both said they would continue to cover hepatitis B vaccines.
Grant Paulsen, MD, a liaison member representing the Pediatric Infectious Diseases Society, asked the committee why it decided to revisit the hepatitis vaccine’s safety when there have been no new publications that raise concerns.
The reply came from committee member Vicky Pebsworth, PhD, RN, the research director of the National Vaccine Information Center, one of the country’s oldest anti-vaccine groups. Her answer was vague: “We were aware that there was pressure coming from stakeholder groups wanting the policy to be revisited,” she said.
Confusion reigns
This was the not the first time that ACIP has struggled to cast a vote. The committee also postponed a vote on hepatitis B vaccines at its September meeting.
Also at the September meeting, the committee reversed a decision made the day before about whether to recommend VFC coverage for a vaccine against measles, mumps, rubella and chickenpox, known as the MMRV. Members of the committee asked for a do-over because several said they were confused about what they were voting for.
Many of ACIP members have expressed anti-vaccine views.
Kirk Milhoan, MD, PhD, who replaced Martin Kulldorf, PhD, as chair of ACIP earlier this week, is a senior fellow at the Independent Medical Alliance, which has criticized mRNA vaccines and promoted ivermectin as a treatment for COVID-19, in spite of clinical trials finding it’s not effective.
Milhoan did not speak during the meeting. Vice chair Robert Malone, MD, who ran the meeting in his place, said Milhoan could not weigh in on the discussion because he was boarding a flight to Asia.
Two of the speakers invited to the meeting — Mark Blaxill, MBA, who spoke about vaccine safety, and climate researcher Cynthia Nevison, PhD, who spoke about the burden of disease — wrote a study on autism that was retracted by the Journal of Autism and Developmental Disorders for methodological flaws and undisclosed conflicts of interest.
Although hepatitis B commonly spreads from mother to child during delivery, the virus is extremely contagious and can spread through microscopic amounts of blood. Research shows that healthy children can become infected by household members, contracting the virus from items such as toothbrushes.
According to the World Health Organization, countries in Africa and the Western Pacific have some of the highest burden of chronic infections. Nevison introduced race into the ACIP discussion, pointing out that hepatitis B infections are more common in people from Asia.
“This is an exceptional circumstance, where horizontal transmission is occurring but is unlikely to apply to the average American child,” Nevison said.
She suggested that immigrants should be tested for hepatitis B before entering the country.
In fact, the CDC already recommends testing adult immigrants for hepatitis B if they haven’t previously been tested. The agency notes that most refugees are tested for hepatitis B before departing for the United States. The US Customs and Immigration Services already requires immigrants to be vaccinated against hepatitis and other contagious diseases.
Later in the day, ACIP member Evelyn Griffin, MD, again brought up the issue of immigration.
“That elephant in the room that I'll mention is immigration,” said Griffin, an obstetrician-gynecologist. “We have had years of illegal immigration, undocumented people coming in from higher endemicity countries.”
Demanding better data
Only two members of ACIP—physicians Hibbeln and H. Cody Meissner, MD—defended the safety and efficacy of hepatitis B vaccines.
During the meeting, Hibbeln pointed out that the virtual elimination of chronic hepatitis B infections in the generation of children born since 1991, when ACIP first recommended immunizing newborns within 24 hours of birth, is considered one of the 10 greatest accomplishments in science and medicine.
Cases of acute hepatitis B infections among children and young adults fell 99% from 1990 to 2019, even as infection rates rose among older people. The universal HBV birth dose has prevented more than 500,000 childhood infections and prevented an estimated 90,100 childhood deaths.
Given that success, “we have a high burden of proof to change this system or change our recommendations,” Hibbeln said.
He criticized a presentation that suggest the vaccine’s risks outweigh its benefits, describing it as “speculation based on limited evidence.”
We have a high burden of proof to change this system or change our recommendation.
At times, the meeting became confrontational. Meissner called out the morning's first three presentations as misleading.
“I take strong opposition to each of the three presentations,” Meissner said. “There were so many statements that I disagree with, it’s hard to be succinct.”
When one speaker suggested that vaccine protection against hepatitis B wanes over time, he said she appeared to misunderstand how immunity is measured. Nevison said that adolescents vaccinated against hepatitis B at birth had few antibodies to the virus in their blood. Meissner pointed out that even people with few antibodies can be well-protected by immune memory cells, which are more difficult to measure. What matters, he said, is not how many antibodies a person has before being exposed to the virus, but how the immune system responds after it encounters the virus.
“The evidence is very strong that there is life-long immunity to hepatitis B after completing the series” of vaccinations, Meissner said.
Medical professionals who are liaison members of the committee criticized what they called ACIP’s selective use of evidence.
“You are wasting taxpayer dollars by not having scientific, rigorous discussion on issues that truly matter,” said Jason Goldman, MD, president of the American College of Physicians. “The best thing you can do is adjourn the meeting and discuss vaccine issues that actually need to be taken up. You are basing this whole presentation on the concerns of individuals who want to refuse the vaccine.
“Please have respect for the American public and the science and do what is right by making sure you use a process that we can depend on, and stop cherry-picking the data by individuals who do not have the scientific evidence and data-driven background to make those presentations,” Goldman added.
Calls for more screening
Several ACIP members suggested recommending birth doses of hepatitis B vaccine only to the babies of mothers who test positive for the virus.
"We could implement universal screening in pregnancy, rather than asking babies to fill that gap,” Griffin said.
Although all pregnant women are supposed to be screened for hepatitis B at their first prenatal visit, the reality is that 18% of women are not tested before delivery, according to a review of 400 studies spanning 40 years released yesterday by the Vaccine Integrity Project at the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), publisher of CIDRAP News.
"The way I look at the neonatal birth dose, is that it is a safety net” to protect babies whose mothers’ infections aren’t caught before birth, Meissner said.
Su Wang, MD, an internal medicine doctor, told the committee that she learned she had hepatitis B only when she volunteered to give blood while in college.
Although her mother wasn’t infected with hepatitis B, Wang believes she was infected during her first months of life when her grandparents—who were medical professionals who may have been infected at work—came to take care of her.
“Hepatitis B is often discussed in numbers, but let's remember the people behind those numbers,” Wang said. “They are countless stories of families, mothers, children, and generations whose lives have been changed by a virus we now have the tools to prevent.”
Wang said she wouldn’t have developed a chronic infection if she had been vaccinated as a newborn.
“We cannot predict a child's future risk,” Wang told the committee. “Like seat belts, our overall risk of getting into an accident are low, but we universally wear them because we cannot control the world around us. So let's do the same and continue to universally give every infant a hepatitis B-free future.”
Some committee members suggested vaccinating children when they are older. But waiting more than 24 hours to vaccinate puts babies at risk, said Noah Louis Ferdinand, representing Voices for Vaccines, a nonprofit advocacy group.
“Once the baby is exposed to the virus, the immune response to the vaccine must begin immediately to get ahead of viral replication and prevent this lifelong infection,” Ferdinand said. “Delaying the vaccine even by a day increases the risk of transmission to the newborn. Administering the vaccine as soon as possible after delivery thus provides the strongest protection.”
Haphazard approach doesn’t instill confidence
ACIP, which was once revered for its scientific rigor, is now disparaged by many public health leaders. Today’s meeting didn’t change their opinion.
At an American Academy of Pediatrics (AAP) press briefing after the meeting, Jose Romero, MD, said committee members, “spoke without evidence, and in most cases, they were just downright wrong.”
He warned that omitting the hepatitis B birth dose would have devastating consequences for newborns and families and be confusing to parents. “Hepatitis B remains a real and serious threat to infants,” he said. “Delaying the birth dose would leave children unprotected in a critical period in their lives… The US has made progress against hepatitis B precisely because of the birth dose.”
The implications for omitting the birth dose would have ripple effects on the rest of the childhood vaccination schedule, including for diphtheria, tetanus, pertussis (whooping cough), haemophilus influenza type b (Hib), and polio, Romero said.
“The best approach to hepatitis B [prevention] is an evidence-based, race-neutral approach,” he said. “That is what we’re doing today: the universal screening of all pregnant women and the universal administration of vaccine to all children.”
This type of a situation engenders a lack of confidence, or distrust, in the recommendations that are going to come.
The haphazard way today’s ACIP discussion was conducted was “a radical departure from the way ACIP was conducted in the past,” Romero said. “This type of a situation engenders a lack of confidence, or distrust, in the recommendations that are going to come.”
Tomorrow’s ACIP meeting is scheduled to focus on additional topics that are popular with anti-vaccine activists, including the safety of aluminum as a vaccine ingredient, as well as a comparison of vaccine schedules in the United States and Denmark. Although an agenda posted on the CDC mentions that the committee will take up the “childhood/adolescent immunization schedule,” the agency did not provide any details about which aspect of the program will be discussed.
