CDC Awards $1.6 Million Grant to Study Hepatitis B Vaccination in Newborns
- by Amber Baker
- Published
- Vaccines
The U.S. Centers for Disease Control and Prevention (CDC) has awarded a $1.6 million federal grant to Danish researchers to study hepatitis B vaccination in newborns, with a stated focus on determining the optimal timing and delivery of the vaccine routinely administered in the U.S. to infants on their first day after birth. Researchers from the University of Southern Denmark (SDU) will conduct a single-blind clinical trial involving approximately 14,000 newborn babies in Guinea-Bissau, a small West African nation with elevated rates of maternal and infant mortality and a higher prevalence of hepatitis B than in the United States.1
The study will compare outcomes between infants who receive the hepatitis B vaccine at birth and those who receive it later. According to a blog post about the study, the researchers plan to administer the first hepatitis B dose at birth to some of the 14,000 enrolled infants, while the remaining participants will serve as a control group. A Science news report notes that the control group is presumed to follow Guinea-Bissau’s existing vaccination schedule, which begins at approximately six weeks of age; however, the article acknowledges that “neither the CDC notice nor the SDU researchers’ blog post says so explicitly.”2
Critics of the project say the study raises ethical concerns and will be unproductive as the vaccine—which carries a black-box warning, the most serious safety designation issued by the U.S. Food and Drug Administration (FDA)—is “already known to be efficacious and safe.” “I’m deeply skeptical that this is a good use of taxpayer money,” says Arthur Reingold, an epidemiologist at the University of California, Berkeley School of Public Health. Concerned that the CDC’s grant notice shared “few” details and recipients of the funding did not share the proposal with Science, he says, “there are reasons to be concerned about whether anything useful will be learned.”2
Grant Announced After ACIP Voted to End Universal Hepatitis B Birth-Dose Recommendation
The CDC grant was announced on Dec. 17, 2025, just days after the Advisory Committee on Immunization Practices (ACIP) voted on Dec. 5 to no longer universally recommend the hepatitis B birth dose for all U.S. newborns, marking a significant shift in federal vaccine policy first adopted in 1991, when the CDC recommended that all newborns, regardles of whether a mother tests negative for hepatitis B infection, receive the hepatitis B vaccine within hours of birth.3
The White House, also issued a memorandum on Dec. 5, 2025 directing federal health agencies to align “U.S. core childhood vaccine recommendations with best practices from peer, developed countries.” The memo cited concerns that the U.S. is a “high outlier” in the number of vaccines administered during early childhood.4
As a result of the ACIP vote, infants born to mothers who test negative for hepatitis B are no longer subject to a universal birth-dose policy—one that has effectively operated as a requirement in hospital settings unless parents actively opted out, where permitted by state law. Instead, the CDC now advises “individual-based decision making,” allowing parents to delay vaccination until later infancy.3 5
“The Centers for Disease Control and Prevention (CDC) today adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus,” the agency said in a Dec. 16, 2025 press release. “For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.”5
U.S. Is “High Outlier” in Number of Childhood Vaccines Compared to Peer Nations
The White House memorandum specifically referenced Denmark and other peer nations—including Japan and Germany—which administer fewer routine childhood vaccines and consistently outperform the United States on key population health outcomes. “The Memorandum directs the Secretary of Health and Human Services and the Acting Director of the CDC to review best practices from peer, developed countries for core childhood vaccination recommendations—and the scientific evidence that informs those best practices,” the document states.4
According to international health rankings, countries such as Japan and Denmark regularly rank among the world’s healthiest nations, based on metrics including life expectancy, environmental quality, chronic disease burden, and overall well-being. The U.S., by contrast, continues to lag behind most high-income peers despite spending significantly more per capita on healthcare. Germany also reports longer life expectancy and lower infant mortality than the U.S., which continues to rank below most peer nations on both measures.6
Hepatitis B Policy Not Supported by Science
The newly funded study follows decades of criticism from experts who argue that the dominant narrative used to justify universal newborn hepatitis B vaccination—that the birth dose dramatically reduced hepatitis B transmission in the United States—was not supported by robust epidemiological evidence.7
Information presented during the Dec. 4, 2025 ACIP meeting directly challenged that assumption. The steepest decline in hepatitis B incidence occurred between 1990 and 2007 among adults aged 20 to 49; not among infants or young children. Case rates among infants were already extremely low before the birth dose was introduced, making it hard to attribute later declines to newborn vaccination.7
Similar declines have been seen in countries that never adopted a universal birth-dose policy, further complicating longstanding public health claims of causality. Data presented to ACIP showed that the overall drop in hepatitis B cases was driven largely by reductions among high-risk adults—such as people who inject drugs and those exposed through blood or sexual contact—and that this downward trend was already underway before the birth-dose recommendation was introduced in 1991.7
The policy debate has recently incited new public discourse among some in the scientific community, including epidemiologist Nicolas Hulscher, MPH, who shared historical CDC data and archival media coverage in a series of X posts in early December.
In one post, Hulscher cited CDC figures indicating that mass hepatitis B vaccination of infants and children was “a complete DISASTER” and “resulted in mass casualties.” In another, he referenced a 1991 New York Times article quoting public health officials as saying, “If adults won’t go for the shots, then give them to babies.” 8 9
Hulscher argued that the statement reflected the underlying motive behind the ACIP’s decision to add the hepatitis B vaccine to the newborn schedule: “Big pharma targets the babies when consenting adults refuse,” he wrote.9
Historical Hepatitis B Vaccine Safety Concerns Raised in 1999 Congressional Testimony
More than two decades earlier, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), raised similar warnings during a 1999 congressional hearing. “Serious questions remain about the quality and quantity of the scientific evidence used by federal health agencies to license this vaccine for use in children and, in 1991, to recommend that all newborns receive their first dose just 12 hours after they take their first breath,” Fisher testified.10
Fisher also warned of severe outcomes reported following vaccination in very young infants. “Tragically, for newborns and babies under two months of age, a hepatitis B vaccine reaction can end in death,” she said, citing reports collected by NVIC. “There is no reason why we can’t protect children from vaccine injury and death while we create public health policies designed to protect them from the ravages of disease—if we embrace the principle that every child’s life is important and no child is expendable.”10
The U.S. Department of Health and Human Services (DHHS) defended the grant, saying it aims to address unanswered questions about the broader health effects of the hepatitis B birth dose. “This award supports an independent study designed to answer important questions about the broader health effects of the hepatitis B birth dose,” said DHHS spokesperson Andrew Nixon. “This research aims to fill existing evidence gaps to help inform global hepatitis B vaccine policy, and we will ensure the highest scientific and ethical standards are met.”1
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