ACIP and the hepatitis B vaccine: recommendations, mandates and patient informed consent

A universal recommendation for a vaccine should not become a medical mandate for patients, said members of the Advisory Committee on Immunization Practices (ACIP).

The federal vaccine review panel had a workday’s worth of discussion about the science and health effects of infant vaccination against hepatitis B. That is universally recommended now, but there are problems with how it is handled across U.S. health care, some ACIP members said.

ACIP took comments from representatives of pharmaceutical companies that make the shots, and ACIP member Catherine Stein, PhD, followed up on remarks about patients having informed consent.

“I don't see how a universal policy is informed consent,” Stein said. “I'll speak on behalf of mothers who have spoken to me to say that was that it was violated for them.”

In September, ACIP members first discussed the hepatitis B shot. They agreed that violation should not happen, “but it does,” she said. The new recommendation language that ACIP is considering does point more to informed consent compared to a universal recommendation, Stein said.

‘They’re just unaware’

ACIP member Evelyn Griffin, MD, an obstetrician and gynecologist, went into detail about the medical rush that surrounds delivery. The birth dose of the hepatitis B vaccine is expected to be given between 12 to 24 hours after birth.

“Often, how logistically this ends up happening is, a woman comes to labor and delivery, is in the throes of contractions and pain, is given a stack of papers to sign,” Griffin said. “And this may ideally happen where informed consent occurs in the prenatal visits before, but often it is not discussed.”

Once the baby is born, the birth dose becomes part of a rapid succession of a lot of events right after delivery, Griffin said.

“A lot has to get accomplished within the first few hours after birth, and so I have spoken with many parents. They're just unaware,” she said. “Patients are unaware that their babies are getting a lot of different interventions in the first few hours of life. There's other interventions other than hepatitis B and often, and I will challenge the media, I'll challenge the public, you know, to ask themselves: Do you know what your baby got within the first few hours of delivery? And most people are shocked to hear what happened.”

There are times when parents want to opt out of the vaccine, but the newborn ends up getting injected in the rush of treatment, a violation of parental rights, Griffin said.

‘A truth bomb’

ACIP member Retsef Levi, PhD, said he has received the hepatitis B vaccine as a precaution when traveling to countries where there is a greater risk of transmission and questionable quality of health care facilities. But for four of his six children born in the United States, neither he nor his wife ever discussed with a clinician whether the vaccine should be given to their children.

“Informed consent doesn't happen, at least in some frequency. That is quite significant,” he said.

What’s more, not having a mandated hepatitis B vaccine can block children from going to kindergarten or getting care in pediatric practices, Levi said.

“So to say that we are giving options and we are having an informed consent is a far-reaching statement that I don't think stands the factual situation,” Levi said. “What we're trying to do here is to go back to basic, good public health policy that is based on risk and that is based on informed consent and informed individual decision making, when parents can think about the assessment of the risk and the benefits and make a decision.”

In later discussion, Levi praised the work of physicians, but said the information communicated to doctors and other medical professionals is not necessarily based on fact.

“So we used really outrageous clinical trials, we then decided to go and vaccinate basically every child,” Levi said. “And now we are in a position where we tell parents very confidently and also the doctors, but to medical professionals, very confidently that the vaccine is safe, then there are no problems whatsoever. And I don't think that that's a very, very reliable statement.”

Griffin called Levi’s comments “a truth bomb.”

“To your point in medical school, you are taught this is the pediatric vaccine schedule, and we just memorize it,” Griffin said. “So to your point, yes, there is a problem, systematic problem, going back into our education. I fully believed that this was vetted very well. The safety studies are not that ironclad.”

The other ACIP members are Chair Kirk Milhoand, MD, PhD; Vice Chair Robert W. Malone, MD, MS; Hillary Blackburn, PharmD, MBA; Joseph R. Hibbeln, MD, ABNP, Capt. USPHS (Ret.); H. Cody Meissner, MD; James V. Pagano, MD, FACEP; Vicky Pebsworth, PhD, RN; and Raymond Pollack, MD, FACS, FRCS.