The Cost of a Delay
The ACIP’s hepatitis B vaccine vote could reverse decades of hard-won progress
Hi Community,
This week’s ACIP meeting (the advisory committee that informs the CDC on vaccine guidance) is shaping up to be a wild ride. But this is more than theatre. This committee influences not only public trust in vaccines but also access to and availability of vaccines.
Together with incredible colleagues at The Evidence Collective, we published a brief (link HERE), outlining the rumors, distortions, and misleading claims that may circulate during and after the meeting, as well as how to communicate about them clearly and effectively.
Today, I would like to revisit one major issue on the agenda: the hepatitis B vaccine birth dose, which is first up for discussion (again) and the only item scheduled for a vote.
Beyond already-refuted claims about safety that are likely to emerge, the central argument likely to surface is this:
“There’s no reason to give the hepatitis B vaccine at birth to low-risk newborns whose mothers screened negative during pregnancy.”
Some may argue that maternal screening provides sufficient protection for infants in the U.S., but experience shows that screening gaps and early infant exposures make this approach dangerously incomplete.
A number to sit with: 620
According to a new modeling tool from the Vaccine Integrity Project, based at the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), if the ACIP removes the universal birth dose recommendation and “low-risk” newborns no longer receive the vaccine at birth an estimated 620* additional infants will become infected with hepatitis B at birth over the next decade, even though their mothers screened negative during pregnancy.
Of those infected infants, 558 (90%) would develop chronic, lifelong hepatitis B, and 155 (25%) would die prematurely from liver cirrhosis or cancer.
These are preventable infections in newborns who had no chance to protect themselves.
(Note: This number does not account for infants who are infected between birth and protection from their first dose if given at 1-2 months.)
A second number: 0
That is the number of newborns expected to experience severe harm from receiving the hepatitis B vaccine at birth.
A new review from the Vaccine Integrity Project, released alongside the modeling tool, confirmed that:
The birth dose has an outstanding safety profile
Randomized controlled trials, case series, and extensive cohort studies show only short-term, mild reactions (tenderness, fussiness, transient fever)
There is no increase in life-threatening adverse events
Across decades of use and tens of millions of doses, no newborn deaths have been causally linked to the hepatitis B vaccine in published literature or safety surveillance systems.
Put plainly:
The risk of serious harm from the birth dose is effectively zero.
The risk of harm from not giving it is predictable and deadly.
What we learned before 1991
The policy of selective vaccination at birth only for high-risk newborns has already failed once. A vote to remove the recommendation for a hepatitis B dose at birth and rely on targeted screening would effectively set back the clock to 1991, when:
Roughly 16,000 children became infected with hepatitis B every year, many of them at birth or in the first few months of life
90% of infected newborns and infants developed chronic disease
1 in 4 chronically infected children eventually died from cirrhosis or liver cancer
Today, because of universal newborn vaccination:
Fewer than 1,000 U.S. children or adolescents contract hepatitis B each year
Fewer than 20 babies are reported to be infected at birth annually
This represents a 95% reduction in early childhood hepatitis B. In other words:
The birth dose worked.
Why we vaccinate at birth
Hepatitis B spreads through blood and bodily fluids, and infants can be exposed in far more ways than many people realize.
Infection can occur at delivery, of course, but it can also happen in the first weeks and months of life from routine contact with infected household members, caregivers, or even other children. Even tiny exposures, a bite that breaks the skin, shared items like nail clippers, or microscopic traces of blood on surfaces, can transmit the virus. Hepatitis B can survive for up to a week outside the body, and many adults who carry the virus have no idea they are infected.
The first months of life are especially dangerous. Newborns have immature immune systems that are more susceptible to infection and far less capable of clearing hepatitis B.
This is why the selective, “high-risk” newborn vaccination strategy employed in the 1980s failed. Many people were not properly screened during pregnancy. Others screened negative early but later became infected. Household members who were unaware of their infection transmitted the virus. And because these exposures happened early, many infants were infected long before a delayed vaccine could have helped.
The CDC adopted universal newborn vaccination in 1991 because targeted programs were unable to protect all infants.
Today, approximately 80% of U.S. parents opt for the birth dose of the vaccine. If ACIP delays the recommendation for all “low-risk” infants, millions of babies will be left unprotected during the most dangerous window of their lives, and a predictable, preventable rise in chronic hepatitis B will follow.
Delaying the first dose leaves infants vulnerable to infection at birth and in the months before their first dose.
Why this matters
This decision is about whether we maintain a highly effective, low-cost, evidence-based strategy that has protected millions of children or dismantle it based on no new evidence, during the tenure of a reconstituted advisory committee that is not following the evidence and longstanding review process.
More updates soon. Stay tuned.
Thanks, as always, for being part of this community.
-David
*This estimate compares the current recommendation that 100% of babies born to “low-risk” HBsAg-negative mothers receiving the birth dose with a scenario in which none receive it. The model assumes 3,591,328 births per year, a 0.38% maternal HBV prevalence, and an 85% first-trimester screening rate. This does not account for infants who are infected between birth and protection from their first dose if given at 1-2 months.
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