Q&A: ‘When Death is Preventable, ACIP’s Decision is Unforgivable’’: Pediatric infectious disease expert sounds alarm over CDC’s new guidance for hepatitis B vaccination

Last week, the US Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to remove the universal recommendation for all newborns to receive the hepatitis B vaccine. The decision upends a decades-old precedent that nearly eliminated the virus in kids and kept communities safe and protected. Now clinicians, researchers, and policy makers fear a potential resurgence of this dangerous viral infection. 

Michael Koster F’10, MD, director of the Pediatric Infectious Diseases division and a professor of pediatrics at Brown, discusses the risks associated with the new recommendation and offers advice to help parents navigate through uncharted territory.

This interview has been edited for length and clarity.

What is hepatitis B?

Hepatitis B is a terrible virus. It is not a cold. It is not something like COVID or flu that lasts a few days and goes away. It carries with it serious risks of liver cancer and death. Moreover, it is a lifelong infection, and the difference between getting it as an infant and getting it later in life as an adult can be enormous. 

About 5 percent of adults who get hepatitis B go on to have chronic hepatitis B, whereas 90 percent of infants who are infected with hepatitis B go on to have chronic infections, which can lead to cirrhosis, hepatocellular carcinoma, and death in 25 percent of infant-acquired infections. It's a virus that we have to take very seriously, and it’s one that we want to protect ourselves against for as long as we can. The earlier we can train the immune system to recognize and resist that infection, the safer our kids and communities can be.

Another challenge is that about 50 percent of the people who have hepatitis B don't even know they have it, so that means that it's difficult to prevent transmission between people. While something like HIV dies within hours of exposure to air and the elements, hepatitis B can live on surfaces, including items like toothbrushes, for up to seven days. The transmission of hepatitis B can be through many different routes—it’s more than just drug use or sexual activity.

Why is it important to vaccinate babies so early?

What we're most concerned about in pediatrics is interrupting the maternal-to-child transmission so that we can keep kids healthy and safe. When we immunize infants, we help their immune system learn to recognize and resist infections quickly, and this allows children to be free to live their best life. Just like our kids learn to read from their ABCs and learn to count to three, the vaccines are training the immune system to recognize the virus so they can identify it later on as well. It creates long-lasting immunity as well, which means that childhood vaccines allow us to live well into our adulthood, providing near-lifelong immunity for at least 35 years.

As a kid, I wanted to become a doctor to cure cancer, so in medical school I found it intriguing that this particular vaccine prevents cancer. And as a resident, I fulfilled my dream by personally administering this vaccine and not just preventing hepatitis B, but actively participating in the prevention of hepatocellular carcinoma. Studies have shown that an estimated 22 million deaths have been prevented globally because of this vaccine.

Delaying the vaccine by two months may not sound like a big deal, and yet when you consider nearly 4 million children are born each year in the US, that’s 224 million days per year that infants will be put at unnecessary risk of infection.

What have been the effects of the birth dose policy that was adopted in 1991?

The vaccine first arrived in 1981, and 1988 was when we began moving toward more doses being given to babies around the time of birth. For the first 10 years of the vaccine's history, we didn’t see the needle move in terms of pediatric hepatitis B infections. Even after vaccinations began, close to 18,000 kids got hepatitis B each year. During those years, they really couldn't budge that number until 1991, when they introduced the recommendation for a universal hepatitis B vaccine at birth. Following this, the rates of hepatitis B went down dramatically with considerably improved vaccine coverage. 

Later on, in the early 2000s, they altered the recommendation to vaccinate within 24 hours and changed the language from “consider” to “recommend.” There was no longer any permissive language and we saw an additional increase in hepatitis B vaccines administered in the hospital setting. According to a study in 2023, we’ve seen infant infections fall to around seven cases a year. Getting to this low rate of hepatitis B was through an iterative process built on evidence observed over time. We learned what worked and what wasn’t working, and it is insane to go back to something that we know and have evidence was not working. 

What does the ACIP’s new recommendation entail?

They essentially removed the universal recommendation that all kids should get it. It's important to understand that the language here is a little softer than fully removing hepatitis B vaccine, but if you fully remove the universal recommendation then over the next few years, it would incur $313 million in health care costs and reduce our overall public health by incurring more hepatitis B infections. This includes those that go on to develop cirrhosis, hepatocellular carcinoma, and other illnesses. They are still recommending a birth dose to those who are born to mothers with hepatitis B infections—who should receive hepatitis B immunoglobulin as well—or those with unknown status. They also voted on getting a blood test for hepatitis B titers to determine if the full series is needed, which is first out of scope, and second completely ungrounded in any evidence, further putting infants at serious risk.

It’s important to note that this vaccine was never required, nor a mandate, and now we're going to miss so many kids who could be getting the hepatitis B vaccine in birthing centers. The universal birth dose was a strong recommendation, based on decades of experience. It has been the best way to keep all children healthy by training their immune system to recognize and resist infections before they are exposed.    

What could the potential outcomes be from this change?

People are going to die unnecessarily. Changes like these not only alter human behavior, but practice and policy at the system level. We're absolutely going to see increased rates of hepatitis B infections, and that's not acceptable. In a lot of ways, the recommendation existed as a way in which we capture false negatives in women and pregnant people who actually have hepatitis B. In addition, it’s only screened for at the beginning of pregnancy, and we still miss screening close to 12 to 15 percent of people altogether, creating unreliable information on which to base a lifesaving decision. And now, essentially, you've made it permissive to not have to give a protective dose of vaccine. This is something that was happening in the pre-1991 era, where we saw tens of thousands of cases of pediatric hepatitis B infections. We’re going to miss a lot of kids, and it's not fair to them, their parents, their siblings, or their communities. 

What has been the response among national and regional groups?

Unfortunately, clinicians and researchers can no longer trust the ACIP and the CDC for vaccine recommendations, so we have to shift our focus to trusting other arenas. These include the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Infectious Diseases Society of America. There's also been a national movement around the Vaccine Integrity Project, established by the Center for Infectious Disease Research and Policy, to help make evidence-based decisions around who should get which vaccine and when.

I’ve been in communication with the Rhode Island Department of Health and they'll come out strongly to endorse the American Academy of Pediatric’s vaccine schedule, which includes an at-birth universal birth dose of hepatitis B vaccine, along with the rest of the members of the Northeast Public Health Collaborative. We also have to be mindful of how ACIP recommendations inform insurers and payers, but I can guarantee you insurers want kids to get their vaccines at birth because it is a cost-effective intervention for a costly and deadly disease that's fully—and safely—preventable.

What should the general public keep in mind with this new recommendation?

Personally, I want all expectant parents to know that I strongly recommend the birth dose of hepatitis B vaccine, and all three of my children were immunized in the hospital. There are a few websites people can turn to, including HealthyChildren.org, which is run by the American Academy of Pediatrics. There is also the Vaccine Education Center at the Children’s Hospital at Philadelphia, which is another great resource for questions that people have about vaccines.

I also want parents to know that immunizations allow kids to remain healthy with every opportunity to grow and develop free from the threat of serious illnesses. Our bodies learn from vaccines like children learn to read from beginner books. Their immune systems are not weak, they just haven’t the opportunity to develop and vaccines give them the text they need to recognize and spring into action when they encounter a disease. It's never too early to learn your ABCs.