Three decades after universal newborn hepatitis B vaccination nearly eliminated infant infections in the United States, those gains may be at risk.
In a Dec. 5 vote, a federal immunization advisory committee recommended making the birth dose optional, allowing most infants to delay vaccination until two months of age. Pediatricians warn that the shift could leave thousands of newborns susceptible to a virus that becomes chronic — and sometimes fatal — in the overwhelming majority of babies infected at birth.
What is hepatitis B?
Hepatitis B is the most common liver infection in the world: An estimated 2.4 million Americans — and 250 million people worldwide — live with a chronic form of the disease; there are 20,000 new cases annually. A highly contagious viral illness, hepatitis B is spread through contact with infected blood or body fluids. The most common modes of transmission are unprotected sex, injecting illicit drugs with contaminated needles, and childbirth.
While hepatitis B infections can be life-threatening and lead to acute liver failure, the vast majority of victims have mild, flu-like symptoms lasting weeks to months. Many have no symptoms at all, and the Centers for Disease Prevention and Control (CDC) estimates that two in three victims are unaware that they are even sick — and contagious.
In at least 6% of infected adults, hepatitis B becomes chronic. Victims can feel well for years, even decades, as the virus gradually damages the liver, resulting in severe scarring (cirrhosis) or a deadly form of liver cancer. The toll is far worse in afflicted neonates: 90% of those infected with hepatitis B at birth progress to chronic illness, and one quarter of those die from the disease.
The hepatitis B vaccination is 95% protective against infection. In fact, since the CDC’s implementation of universal immunization at birth in 1991 — the first of four doses by the age of 18 months — the number of chronic hepatitis B infections in children and adolescents has fallen by 99%. (There are still 1,000 perinatal cases annually.)
According to the CDC, no child has died from a hepatitis B vaccination, and severe allergic reactions occur in only 1.3 times per 1 million doses — as compared with one case in 1 million doses with the flu shot.
For those born before 1991, disease rates are up 45% in the past decade, a direct result of the previously low vaccination rates. Only 30% of Americans 40 and older are currently immunized against hepatitis B, which experts blame on low awareness of the disease and unfounded safety concerns and beliefs.
Why has the CDC recommended changes to hepatitis B vaccination guidelines?
Anti-vaccination sentiment has spread to federal agencies designed to keep the public safe from preventable disease such as hepatitis B.
In June, Health and Human Services Secretary Robert F. Kennedy Jr. fired all 17 members of the Advisory Committee on Immunization Practices (ACIP), replacing at least seven of them with vaccination skeptics, according to the American Journal of Managed Care, a peer-reviewed health policy journal.
One committee member, Dr. Retsef Levi, who holds a Ph.D. in operations research, a branch of applied mathematics, has made public statements raising questions about adverse effects of mRNA vaccines. (Clinical studies have confirmed the safety of these immunizations, used globally since the 2020 COVID-19 epidemic.) Kennedy himself declined to acknowledge the overwhelming scientific consensus that vaccinations do not cause autism during his January 2025 Senate confirmation hearing.
Apart from vaccine skepticism, the ACIP recommended the hepatitis B vaccination schedule change to model several European countries, like Denmark, that hold the first dose until age 2 months. But 60% of the 194 World Health Organization members give the hepatitis B immunization at birth.
Despite warnings of serious health consequences voiced in a joint statement by the American Public Health Association and 72 public health experts in November, the ACIP voted to suspend universal immunization at birth. It recommended neonatal vaccination only for those whose mothers either tested positive for hepatitis B or hadn’t been tested at all. For all others, parents and health care providers are left to decide when and if their child will begin the hepatitis B vaccine series — no earlier than two months of age.
The ACIP also recommended that the need for further hepatitis B vaccinations in children (usually a series of three injections: birth, 1 to 2 months, and 6 months) can be decided by parents and providers, too, based on viral antibody blood levels to evaluate adequacy of protection. But hepatitis B antibody testing does not identify all infected children and adults: Positive results can be missed due to low levels of viral particles in blood, false negatives, or human error. Infants infected with hepatitis B are just as contagious as any other age group.
The acting director of the CDC, Jim O’Neill, is expected to make a final decision about accepting the committee’s recommendations in the coming weeks.
Officials and medical societies reaffirm strong support for early vaccination
In response to ACIP’s new recommendations, states are scrambling to publish and protect their own immunization schedules. For example, New York State Senator Michelle Hinchey, who introduced the Vaccination Integrity Act in September as a direct response to Kennedy’s reshaping of the ACIP, reiterated the importance of its passage in a recent press release: “Abandoning newborn protections against Hepatitis B is indefensible and elevates conspiracy over science,” she said. “The Vaccine Integrity Act is to ensure that we can protect the health of New Yorkers through proven science.”
The American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the Infectious Diseases Society of America continue to recommend giving newborns the hepatitis B vaccination within 24 hours of birth. They maintain that unvaccinated children and adults to age 59 should be immunized, as should those over age 60 if at high risk.
The ACIP still recommends that all adults get screened for hepatitis B at least once in their lifetime and more often if pregnant or at high risk for the disease, which includes those that have unprotected sex with multiple partners, intravenous drug users, and health care workers.
There is no cure for hepatitis B, but if started early, lifelong antiviral therapy can reduce overall morbidity and mortality by as much as 79%. The viral load is not fully eliminated, though, so the victim remains contagious.
For individuals without Medicaid, Medicare, or health insurance, low cost hepatitis B screening and vaccinations are available through the Dutchess or Columbia county health departments.
Dr. Mary Jenkins, a contributor to the Herald and member of its board of directors, retired after nearly 40 years as a family practice physician in New York state.
Thank you so much for the timely and much need review on the damage hepatitis B can do and the importance of vaccinations for modern human health. These are troubling times for science based medicine.