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The Hep B change: Explaining the update, context, and concerns

A clear look at the updated recommendations and why this change matters

Today the ACIP announced a big update, and I know many parents are already trying to make sense of it. The committee voted to remove the universal Hepatitis B birth dose recommendation. I expected this discussion might surface and I even predicted it the day before, but the way the decision was made created an extra layer of confusion for families and clinicians.

Parents deserve clarity, not chaos, especially when decisions this important happen quickly and without clear explanations. Let’s cover what changed today and what it means so you can feel informed, supported, and confident in the decisions you make.

The new Hep B recommendations

The ACIP voted 7-3 to remove the universal recommendation for the Hepatitis B birth dose.

Instead of one clear standard for every newborn, the recommendation now depends on the parent’s hepatitis B status and overall risk. Here’s the breakdown:

  • If the mother is Hep B positive, the baby gets the shot right away, along with other testing.

  • If her status is negative or unknown: the decision is shared between the family and the clinician.

Shared decision-making is not new for low-risk families. Many parents have chosen to wait until a two-week or two-month visit, and those conversations have always centered on timing, follow-up, and how to keep protection on track. These choices should never come with pressure, especially when the parent is Hep B negative and has a plan to receive the vaccine soon after birth. Even for those who don’t choose to vaccinate, our role is to provide education and context, and ultimately, it is their decision. When a family decides not to do the birth dose, I often give the first Hep B shot at the two-week appointment or at the routine two-month visit when it is included in combination vaccines. Waiting can be reasonable when a parent is negative, but I am always clear that the vaccine should be given by the two-month mark to ensure early protection.

The shift ACIP voted on today changes how these conversations may unfold in the birth setting. Without a universal recommendation, hospitals and families may need to make nuanced decisions quickly, sometimes in busy environments where records are incomplete or where there is limited time to review results and discuss risks. This creates more variability in how newborns are protected. It also places more weight on families who already face challenges, such as limited prenatal care, inconsistent follow-up, transportation barriers, or difficulty navigating medical systems. When the structure becomes less consistent, these are the babies most likely to miss timely protection.

Why the Hep B birth dose matters

On the surface, this may look like a small adjustment. In reality, it shifts away from one of the most reliable protections in newborn care.

The Hepatitis B birth dose was created to close real gaps in protection, beginning at birth but extending far beyond the newborn period. Hepatitis B is often silent in adults, but when a baby is infected at birth, it can lead to lifelong infection. Over time, that can result in cirrhosis, liver cancer, or even the need for a transplant. The birth dose, especially when paired with hepatitis B immune globulin for infants born to positive parents, prevents nearly all cases of newborn transmission.

Before universal infant vaccination, more than 20,000 infants and young children were infected with hepatitis B each year in the United States. The reason those numbers look so much lower now isn’t because the risk disappeared, it’s because the vaccine works. The birth dose has always been a key part of that success.

The universal birth dose also filled gaps in prenatal care. Not all parents have early or consistent prenatal visits. Lab records can be missing, incomplete, or misfiled. A parent may test negative in early pregnancy and acquire the infection later.

Many parents have reasonably asked why a birth dose was recommended for every baby if the parent tested Hep B negative during pregnancy. The answer is simple. Universal dosing was designed to close these gaps. Lab results can be delayed or entered incorrectly. A parent who tests negative early in pregnancy can acquire hepatitis B later on. Some families have limited or late prenatal care, and records are not always complete when a baby is born. And because hepatitis B infection in infancy can lead to lifelong liver disease, the cost of missing even one case is significant. Universal dosing was created to eliminate that risk and protect the children most vulnerable to gaps in care.

The birth dose also has a strong and reassuring safety record. The hepatitis B vaccine has been used for decades around the world. Most babies experience only mild, short-lived side effects, such as soreness at the injection site. This is why many clinicians, including me, continue to recommend the birth dose even for low-risk families. The benefit of early, reliable protection has always outweighed the very small risk.

Understanding this history is important because it explains why today’s vote is raising concern. The birth dose was never about assuming risk. It was about ensuring that all babies had protection against a virus that can shape their health for the rest of their lives.

Why this shift is concerning

What stood out today was not just the update but the process behind it.

No new evidence was presented to question the safety or effectiveness of the universal birth dose. There were no new risks, no change in disease patterns, and no new data to justify the shift. Yet the recommendation changed anyway.

For a decision that affects every newborn, families deserve a clear explanation backed by updated research. That did not happen today.

The meeting itself raised concerns. Several members said they were unsure what they were voting on and abstained due to unclear language. When the process feels muddled, it becomes harder for parents to trust the outcome.

Updates like this can also create unintentional doubt. When a long-standing recommendation is removed without a clear scientific reason, some may assume something was wrong with the vaccine. That is not true. Nothing about the vaccine or its safety has changed.

This is why the process matters. Families rely on clear, evidence-based guidance, especially when it comes to newborn care. When the reasoning is unclear or the vote is difficult to follow, it leaves room for confusion at a time when parents need clarity the most. It also places the greatest burden on families who already face barriers to care. Parents with limited prenatal visits, babies without reliable follow-up, and communities navigating access challenges are the ones most affected by sudden shifts in recommendations. These families depend on straightforward, consistent guidance, and today’s vote makes that more difficult.

The titer vote

Another part of today’s meeting was a recommendation that parents consider antibody titer testing discussions with their child’s clinician after the first Hepatitis B dose to help decide future doses (Vote: 6-4)

On paper, that might sound reasonable. In practice, it raised real concern for clinicians. Here’s why:

1. The 10 mIU/mL threshold is an established marker in adults and high-risk infants, but it has never been used this way in healthy newborns. Yes, we do have a known protective level. We’ve used ≥10 mIU/mL for decades in very specific situations, infants born to Hep B positive mothers, health care workers, people who are immunocompromised. But applying this standard to every baby after the first dose is brand-new territory. A single dose often doesn’t reach that level, even though the series works very well. So you end up with a test that tells you nothing useful, and a family who now thinks something is wrong when it isn’t.

2. It adds procedures that don’t improve care. Blood draws in newborns, extra visits, extra cost, and more stress. For families with limited access to care, this creates one more barrier.

3. It complicates a system that already works safely and reliably. The standard three-dose series has decades of data showing strong protection. We don’t need a titer to confirm what the evidence already tells us.

4. It increases confusion instead of helping informed decisions. Shared decision-making can absolutely help families talk through timing and benefits. But introducing testing that has no clear role in healthy newborns doesn’t support that. It makes parents second-guess a vaccine with an excellent safety record, and it adds unnecessary noise to a process that should stay simple.

What parents should know

With all the noise surrounding today’s vote, it is important to stay grounded in what has not changed.

The hepatitis B vaccine itself has not changed.
Its safety profile has not changed.
The risk hepatitis B poses to children has not changed.

The only change today was the wording of the recommendation.

The Hepatitis B vaccine remains a safe and effective way to protect children from a virus that can cause lifelong liver disease. It has been used around the world for decades with one of the best safety records in pediatrics.

Access has not changed either. Families who want the birth dose can still receive it. Families who prefer to start later will continue to have that option.

Shared decision-making can be helpful when it is paired with clear guidance, time to ask questions, and a plan for follow-up. What matters most is that families have reliable information and a clear path forward.

My guidance as a pediatrician

Even with today’s change, the birth dose remains the strongest safety net. It protects babies early, at a time when records may be incomplete, follow-up may be unpredictable, and real risks can be easy to miss in the moment.

For Hep B negative families who prefer to wait, I recommend giving the first dose no later than the two-month visit. The combination vaccines given at that age, like Pediarix or Vaxelis, include Hep B and help keep protection on track. Delaying past two months increases the chance that early coverage may be missed.

If you are pregnant or preparing your birth plan, now is a good time to talk with your clinician about how your hospital plans to implement the updated guidance. Ask about how records will be reviewed, how follow-up will be handled if you choose to wait, and what support is available to ensure your baby receives the full series on time.

I do not recommend checking antibody titers to guide future doses. Titer testing is not standard care for newborns, and we do not have clear thresholds that define full protection in healthy newborns.  Introducing blood draws and additional appointments creates unnecessary barriers and increases the risk that protection may be delayed or missed.

My goal is always to support informed decisions. Low-risk families have long had flexibility in timing, and thoughtful conversations can help parents feel grounded in their choice. The broader concern is not about options. It is about maintaining protection in a system where access and follow-up already vary widely.

Final thoughts: What comes next?

A change like this can feel unsettling, especially when the reasoning is unclear. But here is what matters most.

The core science has not shifted.
The vaccine will continue to be available and covered by insurance. 
The vaccine is the same.
Its protection is the same.
Its safety is the same.

The concern lies in how the recommendation was made and how it will be interpreted. Families deserve transparency and policies that reflect real differences in access, not decisions that widen gaps.

This update may also be misrepresented. Some groups are already claiming the vote signals a safety concern. That is not true. The vaccine remains one of the safest and most effective tools in pediatrics. Confusion about the process does not change the science.

Another part of this that sits heavy for me is who gets the mic in these meetings. We heard from medical teams who care for newborns every single day, laying out why the universal birth dose has protected the babies most at risk. Their messages were calm, steady, and grounded in real practice.

But we also watched political activists and lawyers like Aaron Siri take up space. That changes the tone of the room in a way that doesn’t line up with what most clinicians see in their actual work. The majority of us know vaccines save lives. So when decisions tilt toward a small group whose messaging often creates more confusion than clarity, it’s worrying.

This isn’t about shutting down choice. It’s about making sure policy comes from people who understand newborn care, follow-up gaps, and how easily families can fall through cracks when systems get messy.

Over the next few months, we’ll learn more about how hospitals and professional groups interpret this update. I’ll keep sharing what we know so you can stay informed with steady, reliable guidance.

My other systemic concern regarding this decision: If hospital uptake drops low enough, some hospitals may stop stocking the Hep B vaccine altogether. That creates real access issues, especially for smaller hospitals where supply is already tight.

If you know someone who is pregnant or planning a birth or just has questions about vaccines, feel free to pass this along so they have facts, not noise.

If you enjoyed this newsletter, I’d love for you to share it with others! Screenshot, share, and tag me @pedsdoctalk so more parents can join the community and get in on the amazing conversations we're having here. Thank you for helping spread the word!

— Dr. Mona

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