The Arizona Department of Health Services (ADHS) is pushing back against the Trump administration’s top health officials on the hepatitis B vaccine.
ADHS was responding to the most recent CDC Advisory Committee on Immunization Practices (ACIP) meeting on Thursday. As their name implies, ACIP develops federal vaccine recommendations. ADHS defended the current recommendation of hepatitis B vaccines for all newborns, regardless of known exposure. Many on ACIP want to shift to a risk-based approach.
ADHS said the risks of infection outcomes, though likelihood of infection is low, outweighed any benefit to delaying vaccination.
“The universal hepatitis B birth dose is one of the simplest, safest, most powerful ways to protect Arizona babies from a liver infection that is completely preventable. The complications of infection can be devastating and last a lifetime,” said Dr. Joel Terriquez, ADHS Medical Director of the Bureau of Infectious Diseases Services and the Bureau of Immunization Services.
The CDC began recommending hepatitis B vaccines in 1991 under the administration of then-President George H.W. Bush. The United States was a moderate endemic region at the time.
Officials and experts at the time and modern proponents declared it a safety net approach: although the possibility of infection was minimal for children born to non-infected mothers, the near-certain guarantee of a permanent and potentially fatal infection should one occur justified vaccination: a 90 percent likelihood of infection becoming permanent, with 15 to 25 percent of the infected facing early death due to liver cancer or cirrhosis.
Prior to 1991, infection rates in infants and children under 10 years old were around 18,000 annually. About 9,000 of those infected were born to infected mothers and contracted the virus during delivery. Experts speculate that the other half of this demographic were infected through household contact with an infected person. Given the difficulty of tracing transmissions, the speculation is widely accepted as the cause for that remaining half.
After 1991, the safety net approach caused annual infection rates to drop significantly. In recent years, the average amounts to less than 1,000 for children and less than 20 for infants.
The United States has come nowhere near being an endemic region since 1991, and does not qualify as one.
Modern infant infections occur mainly in non-Western foreign countries across Asia, Africa, South America, and the Middle East. The World Health Organization reported the countries with the highest infection rates to be, in order from greatest to least: China, India, Indonesia, Nigeria, Ethiopia, Bangladesh, Vietnam, Philippines, and Pakistan.
Excluding babies infected at birth, infections arise predominately from certain poor and unsafe lifestyle choices: drug users who share drug equipment like needles, and sexually active gay men.
Infection in infancy or childhood results in lifelong infection, sometimes existing asymptomatically.
ACIP had planned to do more than talk about the hepatitis B vaccine on Thursday; they had scheduled a vote on whether to end the decades-old recommendation that all infants receive the hepatitis B vaccine. Disagreements between the advisers — all appointed by Health and Human Services Secretary RFK Jr. — prompted a postponement of a scheduled vote.
Dr. Tracy Beth Hoeg — appointed Wednesday as acting director of the FDA’s Center for Drug Evaluation and Research (CDER) — asked during Thursday’s meeting why a sweeping recommendation exists for low-risk babies when other low-endemic nations have historically accepted and continue to implement a risk-based approach.
“Why are we stating that it is absolutely necessary to give this dose at birth, when high income nations throughout the world are not?” asked Hoeg.
Hoeg also indicated concerns over the lack of trial data on adverse events. The medical community generally accepts the safety and efficacy of the hepatitis B vaccine to be proven through implementation science, or observation. ADHS affirmed this approach in their Thursday press release, asserting the hepatitis B vaccine had “a strong safety record” with limited side effects like soreness at the injection site.
However, the CDC presentation at Thursday’s ACIP meeting on hepatitis B vaccinations revealed there are more questions than answers on safety and efficacy.
There were no randomized placebo-controlled trials in infants prior to the 1991 recommendation. The three other trials that did occur had small sample sizes and some specifically targeted infants who had Asian-American, hepatitis B-positive mothers.
Also, these trials had short follow-up periods of a week or less and, according to the CDC, had a troubling pattern of “discount[ing] safety concerns.” The CDC noted in its presentation that the adverse effects reported in infants who received the vaccine were potentially consistent with encephalitis: fatigue, fever, weakness, and irritability.
The CDC further found there to be an “absence of evidence to assess potential adverse effects” of the vaccine, and the trials failed to provide findings proving or disproving “chronic, late-onset effects.”
The presentation also cited an Israel-based study which found unexplained fever rates spiking following the introduction of universal hepatitis B vaccination.
Further studies mentioned in the presentation indicated other, more recent findings of adverse effects, such as a significant disparity in birth weights (much higher weights among unvaccinated). The CDC noted concern over a study that dismissed the higher rate of SIDS among vaccinated versus unvaccinated infants.
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ACIP rescheduled the vote for Friday, along with consideration of other subjects like this country’s vaccine schedule compared to others.
Marty Makary told Fox News on Thursday that the Trump administration wants to encourage more doctor-patient prudence on a case-by-case basis when it comes to hepatitis B vaccines, and deemphasize government influence in personal health decisions.
“A lot of doctors have moved from an absolutist, all-or-nothing approach to a nuanced approach to say if the mom tests for hep B and is positive or if the mom is not tested and the status is unknown, then immunize the kid for hepatitis B and move on,” said Makary. “But if the mom is hep B negative — which is the vast majority of women in the United States today — and they want to delay it until the kid is 8 or 10 or 12, let’s be honest: hepatitis B is a sexually transmitted and blood-bourne pathogen. There’s essentially no risk of them getting it before then.”
The Vaccine Injury Compensation Program has paid out $18 million for hepatitis B vaccinations in combination with other vaccines for children’s compensation claims.
ACIP meetings are available to watch live and post-meeting on the CDC YouTube:
Most important, do your research!!!
Attn: Parents young and older,
Do Not be timid about refusing any vaccine they try to push on your child. When they first came out with the HPV vaccine I said no, and that nurse was shocked. You see months previously I had read an article by the head of research at CDC and was told it was not safe. So when approached I said NO.
The nurse tried to convince me, first by saying that I was not a health care professional and was doing my child a disservice by refusing, then the claws came out trying to guilt trip me. Ha! My daughter is a healthy 30yr old today.