Selected and summarized by Ronald O. Valdiserri, MD, MPH, Professor, Department of Epidemiology, Rollins School of Public Health, Emory University, and Co-Chair of HepVu.
Dr. Valdiserri reviews significant articles on prevention, public health, and policy advances in viral hepatitis. This month, he highlights “Striving for universal birth dose hepatitis B vaccination in Canada: data from Ontario make a compelling case.”
What question(s) does this study address?
The Centers for Disease Control and Prevention’s (CDC) Division of Viral Hepatitis (DVH) 2025 Strategic Plan as well as the National Strategic Plan to Eliminate Viral Hepatitis in the U.S. call for increasing Hepatitis B birth dose vaccination as a critical step in preventing the perinatal transmission of HBV in the United States. Since 1991, the Centers for Disease Control and Prevention has recommended universal HBV vaccination for all infants beginning at birth as part of a comprehensive strategy to eliminate the transmission of Hepatitis B virus.
Three years earlier, in 1988, the CDC had recommended that all pregnant women be routinely screened for HBV during an early prenatal visit and that infants born to Hepatitis B surface antigen (HBsAg) positive mothers receive Hepatitis B vaccine and Hepatitis B immune globulin within twelve hours after birth. However, in light of failures to identify all infected mothers prior to birth (including mothers who became infected with HBV after prenatal screening had taken place), as well as errors resulting from misinterpreting or incorrectly transcribing HBV screening test results, CDC subsequently recommended HBV vaccination of all newborn infants—regardless of the birth mother’s HBV serostatus.
These long-standing recommendations were changed in late 2025 when the Advisory Committee on Immunization Practices (ACIP) recommended that vaccinating infants born to women who test negative for HBV should no longer be routine but, instead, determined case-by-case through individual-based decision making, i.e. parents are advised to consult with their health care providers to discuss risks and benefits of HBV immunization and determine whether, and when, to vaccinate against HBV. Several days later, the acting Director of the CDC approved the new ACIP recommendations.
Given this recent US policy change, a commentary published by Biondi and her colleagues in the May 2025 issue of the journal Paediatrics & Child Health is of timely interest. The authors are Canadian, a nation where only 3 provinces and territories out of thirteen, recommend universal HBV birth dose vaccination. The commentary provides data from the province of Ontario, making the case that it’s time for Canada to adopt universal birth dose HBV vaccination nation-wide—a recommendation that’s practically the reverse of what has recently taken place in the United States, where routine HBV birth dose vaccination is no longer recommended by the CDC.
What are the major findings of this report/article?
- Ontario and 4 other provinces/territories in Canada currently recommend HBV vaccination during adolescence; only infants born to known HBV positive mothers receive the HBV birth dose.
- Although universal HBV screening in pregnancy is the standard of care in Canada and screening rates in Ontario are high (93%), not every pregnant woman is tested.
- 139 children born in Ontario between 2003 and 2013, were infected with HBV before being eligible for adolescent vaccination. The researchers do not know how many of these infections were acquired at birth (vertical transmission) or later, as a result of horizontal transmission (e.g., infection resulting from close contact with an infected relative or caregiver.)
- Some two decades after Nunavut (Canada’s northernmost territory) adopted routine HBV vaccination at birth, the prevalence of Hepatitis B in the adult population fell from 2.5% to 0.3%.
- A separate modeling study conducted by Biondi and her colleagues showed that birth dose HBV vaccination is cost-effective and could prevent an estimated 550 acute and 160 chronic pediatric HBV infections during the space of 30 years.
What are the implications for the prevention and control of viral hepatitis?
- The authors of the commentary conclude that the HBV birth dose should be routinely administered across Canada because children born in Canada are becoming infected with hepatitis B virus while awaiting adolescent HBV vaccination. They point-out that Canada is “out-of-step” with World Health Organization (WHO) recommendations calling for universal birth dose vaccination, even in regions with low HBV incidence.
- The recent shift in US policy from universal HBV birth dose vaccination to individual-based decision making for infants born to mothers who test negative for HBV has raised concerns that failure to vaccinate at birth and/or delays in receiving the HBV vaccination will lead to increases in preventable HBV infections. Clinicians, public health practitioners, and people living with HBV have expressed fears that this policy change will degrade the progress that the US has made in preventing HBV infection and its serious, and often deadly, consequences.
- In 2023, prior to the recent policy change, (i.e., a time when universal HBV birth dose vaccination was recommended for all US newborns), the CDC reported only 7 confirmed cases of perinatal HBV transmission in the US and the rates of acute cases of Hepatitis B infection reported among persons aged 0-19 years, from 2005 through 2020, remained extremely low —a consequence of the immunity conferred by initiating Hepatitis B vaccination at birth.
- It is imperative that health care providers continue to educate the parents of newborns on the importance of the Hepatitis B birth dose and that state, local and territorial public health programs prospectively monitor rates of perinatal HBV transmission and HBV infection among children so as to evaluate the long-term consequences of the recent US policy change. It must be noted, however, that given current shortfalls in viral hepatitis surveillance capacity reported by state and local health departments, providing these vital indicators in a timely manner may present real challenges in many U.S. jurisdictions.
