Why review hepatitis B vaccine at birth? It’s a question of trust, ACIP says

© Alexey Novikov - stock.adobe.com

When the Advisory Committee on Immunization Practices (ACIP) had discussion about safety of the hepatitis B vaccine, physicians had a question for them: why now?

The deliberations were part of the first day of the ACIP two-day session scheduled for Sept. 18 and 19. Doctors asked why ACIP would review a vaccine that has been administered to millions, largely without dangerous side effects, and with a clear health benefit for the nation. The answer is that ACIP must deal with vaccine safety, but also must rebuild public trust that eroded in the United States due to the COVID-19 pandemic and other reasons, said ACIP member Robert Malone, MD.

Robert W. Malone, MD
_{© rwmalonemd.com}

“The question in my mind is a little disingenuous,” he said. “The signal that is prompting this is not one of safety. It's one of trust. And it's one of parents uncomfortable with this medical procedure being performed at birth in a rather unilateral fashion, without significant informed consent at a time in particular, when there has been a loss of trust in the public health enterprise and in vaccines in general.”

Good medical news

The presentations about the hepatitis B vaccine included a medical bright spot. Since 1980, vaccination, including shots for infants, “has been the cornerstone of hepatitis B control for decades and has brought the U.S. within reach of elimination.”

Vicky Pebsworth, OP, PhD, RN
_{© National Vaccine Information Center}

Cody Meissner, MD
_{© Dartmouth International Vaccine Initiative}

Presentations about the hepatitis B birth dose vaccination prompted more discussion, with members analyzing data and offering their thoughts about the best way to protect babies from that illness. The data, differences among patients, potential health concerns, and the concepts around vaccination all spurred discussion. ACIP member Vicky Pebsworth, OP, PhD, RN, noted at least one study concluded the evidence was inadequate to accept or reject a causal relationship between the hepatitis B vaccine and a number of neurological conditions. ACIP member Cody Meissner, MD, later countered that infant irritability may or may not be an early indicator of neurological disturbances or further neurological difficulties, but ACIP “can’t vote on speculation. We have to vote on, on where there’s data of concrete harm or benefit.”

A bias for children

Many infants get the hepatitis B vaccine at birth. How soon is too soon to start giving shots? Kirk Milhoan, MD, PhD, declared a bias developed in his medical career.

“It's good to declare biases, and I am an advocate for children,” Milhoan said. “And to answer some people's questions, the neonatal purity period is a very sacred period, and interventions at those periods are very cautionary, and you do everything you can to avoid things in the neonatal period, often, because if things happen, then the events that we need to do to evaluate and possibly treat the child often are very invasive.”

Medically, there is an interesting hand-off between physicians as a pregnant woman transitions from an obstetrician-gynecologist taking care of mom and baby, to a pediatrician taking care of baby, he said, noting the presence of ACIP member and OB/GYN specialist Evelyn Griffin, MD.

Any change in a baby’s behavior, or a fever, will take the doctors “down a completely different road of how we care for that baby,” Milhoan said. He also contrasted aims of public health and individual medical care.

“So my bias is, is that public health often favors the patient as well, but it doesn't always favor the individual patient, and I think that when we make decisions on the most vulnerable, we have to be, have an abundance of caution,” Milhoan said.

So what’s the problem?

The ACIP members had additional discussion about factors including the gestation and birth of the child, the time periods and results of studies, and changes to the technologies behind the hepatitis B vaccine. When the panel began taking comments from liaison organization representatives, physicians had questions and comments about the analysis.“The first question is really a question that some of your voting members have actually asked as well. I'm wondering what problem exists in the current schedule that has prompted this entire discussion?” said Amy Middleman, MD, MPH, MSED, FSAHM, representing the Society for Adolescent Health and Medicine. The discussion was fascinating and the staff presenters did a good job presenting the evidence, she said. It’s clear that the hepatitis B vaccine has been incredibly successful, with a benefit to risk ratio that is quite high. “It doesn’t mean there’s no risk,” she said.

Middleman said she also wanted to get the liaison members back into the ACIP working groups so that they share from their knowledge of working with patients.

Why aren’t there more long-term studies?

Retsef Levi, PhD
_{© MIT}

In his response, ACIP member Retsef Levi, PhD, noted he has taken the hepatitis B vaccine as an adult before traveling to areas where he might be at risk in a medical setting. His six children received it probably on the first days of their lives, but with no discussion between doctors, other clinicians, and parents. That is a sample size of six that could indicate the frequency of informed consent, he said.

Levi said he felt uneasy about the statement that there is no evidence of harm from a vaccine given to a healthy baby, at low or no risk of hepatitis B, on the first day of its life.

“So I want to ask the following question: What is the reason? What is the reason that we don't have large and long-term RCTs, randomized clinical trials, to actually … finish the debate? What is that reason? And I think that the reason why we don't have that, in my mind, captures a lot of the things that are currently wrong with our medical system in general, but with vaccines in particular.”

There is no reason not to have those studies, Levi said, calling the lack of evidence a staggering question and the elephant in the room.

The hepatitis B vaccine is “absolutely critical” to babies, children and adults at risk, Levi said.

“I took it myself,” he said. “But this notion that we sit here with very lousy evidence and argue that there is no problem whatsoever, is not building trust, and it's not scientific, and it's not what the public here should expect from us.”

Keep the shots against hep B, physicians say

Other physicians and advocates spoke in favor of the vaccine.

American Medical Association liaison Sandra Fryhofer, MD, recalled her time as a medical student on rotation in a hepatitis ward.

“Those were the sickest patients I had ever seen in my life, and I knew I never wanted to get that,” she said. “And so when that hepatitis B vaccine was available, I signed up as soon as I could to get it. And I'm so thankful we now have a hepatitis B vaccine to protect our little babies from day one, to keep them healthy.”

The data presented to ACIP speaks for itself about an infectious disease that is edging toward elimination. “This is not something that we can say lightly from any infectious disease, and it is through vaccination that this has been done,” said Flor Munoz, MD, MSc, a board member of the National Foundation for Infectious Diseases.

Munoz and Grant Paulson, MD, liaison with the Pediatric Infectious Diseases Society, acknowledged the system of vaccine recommendations and policies is not perfect, but the hepatitis B vaccine largely has been safe and effective.

Stacy B. Buchanan, DNP, RN, CPNP-PC, liaison for the National Association of Pediatric Nurse Practitioners, and Judy Shlay, MD, liason for the National Association of County & City Health Officials, also spoke in favor of the vaccine.

Carol Hayes, representing the American College of Nurse-Midwives, said in most facilities, a woman in labor signs a universal consent form that includes the hepatitis B birth dose for the baby. But it can be refused, she said.

A question of trust

Malone addressed the question about the timing of the ACIP review.

As a father of two, Malone said the time of a birth is challenging, stressful and exciting, all which make it difficult to think clearly about patient informed consent.

He also pointed to the example of Sweden, a country with no vaccine mandates, but with vaccine uptake and infectious disease outcomes among the best in Europe.

“And one might ask the question, why?” Malone said. “Why, in the absence of vaccine mandates, is there such high vaccine acceptance and infectious disease outcome measures? And the answer is because the Swedish people trust public health in Sweden. And. I think that that's what's really, in my opinion, underlying this.”