This week, a Centers for Disease Control and Prevention (CDC) committee voted to end the CDC’s recommendation that all babies in the U.S. receive their first hepatitis B vaccine within 24 hours of birth. The decision all but ends a 34-year-old policy that has reduced the incidence of an incurable liver disease in infants by 99%.
While a change in the recommended vaccine schedule, as proposed by the CDC Advisory Committee on Immunization Practices, must be approved by the CDC’s interim director, the committee’s vote to change the three-dose series for hepatitis B recommendation has local public health leaders and medical providers concerned. Not only are they worried about potential exposure to the disease among babies and the broader community, but also about increasing parent confusion about the safety and efficacy of vaccination in general.
Washington state and local health departments, part of the new West Coast Health Alliance, are clear where they stand on the advisory committee’s vote. They “strongly support that hepatitis B vaccination continue to be routinely offered to all newborns, with the first dose of the vaccine given within 24 hours of birth for newborns weighing at least 4 pounds, 7 ounces, followed by completion of the vaccine series.”
Confused by conflicting vaccine news? We asked Dr. Sandra Valenciano, Public Health-Seattle & King County’s (PHSKC) new health officer, to explain the CDC committee’s suggested hepatitis B vaccination changes, to lay out the potential consequences of such changes, and to advise parents on where to turn for evidence-based information when making decisions about vaccination. Following is that converssation:
Q: What is hepatitis B?
Dr. Sandra Valenciano: Hepatitis B is an incurable disease caused by a virus, and it can affect your liver. Some people might get exposed to it and only be sick for a few weeks. But others can go on to develop a chronic illness and experience serious complications, such as liver cancer, liver failure, and chronic liver disease.
Q: But isn’t hepatitis B a sexually transmitted disease? Why not wait until a child is older or becomes sexually active to vaccinate?
Dr. Valenciano: It is a misconception that hepatitis B is only transmitted sexually. The virus is transmitted through body fluids, including blood, and even a microscopic amount of blood can infect an infant. It can be transmitted through the mother at birth. Caregivers and family members can also transmit it. It can be on household items. That’s why vaccination is so critical.
What’s more, unvaccinated babies can become infected but not show symptoms for a long time. That means they’re not receiving treatment for hepatitis B but the virus could be damaging their livers without anyone knowing.
Q: What was the former recommendation that the committee decided to change?
Dr. Valenciano: Since 1991, the CDC has recommended that all infants receive the hepatitis B vaccine within 24 hours of birth. It is actually a three-dose series, so infants would then receive a second dose (at one to two months) and a third dose (between six and 18 months).
The reason for that universal recommendation to start vaccines at birth is really important: pregnant individuals can pass hepatitis B on to their infants if they’re infected and don’t know that they’re infected. We do screen for Hepatitis B during pregnancy, but some women go undetected for a variety of reasons—they didn’t have access to prenatal care, they were exposed after they had already been screened, the test didn’t detect it correctly. It can be passed on to a baby from the mother during birth.
Infants and children can also be exposed to Hepatitis B by family members and caregivers who have the infection and don’t know that they’re infected. We have millions of people living in the United States with chronic hepatitis B.
Q: What difference, if any, has the recommendation of the 3-dose hepatitis B vaccine made since 1991?
Dr. Valenciano: Prior to the universal recommendation, the United States was seeing anywhere between 16,000 and 20,000 Hepatitis B infections among children a year. The vaccine has been so successful that those numbers have been reduced by 99%. Since the recommendation to give all infants the hepatitis B vaccine at birth was implemented, we’ve had fewer than 20 cases of hepatitis B in infants per year in the United States. Here in King County, we’ve only had two cases in infants over the past decade. That is just remarkable and a huge success for a vaccine.
What we also know, since this vaccine has been used for over three decades, is that it is incredibly safe, and given the reduction in infections, very effective. In terms of side effects, it most commonly causes soreness at the site of the injection and can cause fussiness and mild fever in a baby. It’s a really safe vaccine.
Q: Does that mean we really don’t see hepatitis in babies these days?
Dr. Valenciano: We still see thousands of babies who are exposed to hepatitis B because the pregnant individual went undetected or the infant was born to a birth parent with known hepatitis B. Those babies receive the hepatitis B vaccine at birth and hepatitis B medicine, and then get monitored under a perinatal Hepatitis B monitoring program to see if they go on to develop a chronic infection. Like I said before, this immediate vaccine and treatment approach is really successful and is why so few infants in the U.S. become infected with hepatitis B.
In the United States, we have a lot of people who come from countries where hepatitis B infection is endemic, meaning it’s widely present in the community. We also see hepatitis B in US-born mothers, and it can be missed during pregnancy.
Q: What is the change that the CDC vaccine committee approved last week, and what does it mean?
Dr. Valenciano: First, the advisory committee voted to remove the long-standing universal recommendation that all newborns receive a birth dose of the hepatitis B vaccine. Instead, what they’re recommending is a shared clinical decision approach for infants born to mothers who test negative for hepatitis B during pregnancy, and for the first dose to be given no earlier than 2 months of age. The committee still recommends babies born to mothers who are positive or whose status is unknown get the birth dose along with hepatitis B medication.
The second thing that they voted on is recommending that after babies receive the first dose, they get an antibody test, and use those results to determine whether or not to continue with the rest of the hepatitis B vaccine series.
Q: The American Academy of Pediatrics (AAP), Public Health—Seattle & King County, and numerous other organizations support giving all infants the full hepatitis B vaccine series. Why does relying on an antibody test after the first dose worry you?
Dr. Valenciano: Because there’s no data on it—it has not been studied. The antibody test is supposed to show if your body has developed an immune response to the virus. But, it’s not a “yes or no” test, and because it hasn’t been studied, we don’t know what level of antibody response is sufficient for a baby to actually be protected from hepatitis B infection for their lifetime.
This is really alarming for those of us in public health and the medical community, because this new recommendation is not based on science.
Ultimately, I think our other concern is that this may widen disparities. We might see babies who don’t get the full vaccine series and therefore are at higher risk of hepatitis B infection. We might see an increase in hepatitis B infections. We might see communities that really would benefit from the vaccine series not get it, causing inequities.
Q: Can a baby get hepatitis B from the vaccine?
Dr. Valenciano: No. There’s no live virus in the hepatitis B vaccine. It can’t cause infection in the body. It has one of the longest and strongest safety records of any vaccine in pediatrics. Hundreds of millions of doses have been safely given. At the same time, no vaccine is 100% effective. And so could you get a vaccine and still get an infection? Yes, that is always possible. But the numbers speak for themselves, in terms of the 99% reduction in Hepatitis B infection in infants and children in the U.S. since the hepatitis B vaccination recommendation was implemented.
I urge parents to talk to their child’s pediatrician to learn from them directly about the recommendations. The fact that the American Academy of Pediatrics, along with many other medical societies, continues to recommend the universal hepatitis B vaccine at birth, along with the full series, is really, really important.
Q: When the CDC recommends a vaccine, does it mean parents are legally mandated to give their baby the shots?
Dr. Valenciano: It’s always been a recommendation, not a mandate. Parents have always had a choice to accept or decline the birth dose or the series or use an alternative schedule.
Q: Do you think local doctors are giving enough information about vaccines to parents and answering their questions?
Dr. Valenciano: There should be informed consent for everything that we do in medicine and public health. If you don’t feel like you’re getting the information you need at your child’s appointment, speak up! Ask questions of your provider. It’s their job to discuss vaccine recommendations with patients and parents and to practice informed consent. Even for me, as a doctor, I have two kiddos, and when I take them to their pediatrician, I’m still asking questions.
Q: I’ve heard many parents question whether they should go to the CDC for vaccine information, given the U.S. Health Secretary’s efforts against vaccination. Is there a single source you would recommend for parents seeking evidence-based information and recommendations on vaccines?
Dr. Valenciano: I suggest going to the American Academy of Pediatrics (AAP), although many other professional medical societies, like the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American Public Health Association, and the Infectious Disease Society in America, are all putting out the same recommendations.
On the West Coast, our department is aligned with the Washington State Department of Health, which is part of the new West Coast Health Alliance that includes Washington, Oregon, California, and Hawaii. So, all of these professional societies and these alliances are aligned to make sure that what we’re sharing with the community and the public is evidence-based, data-driven.
Still, before the CDC Advisory Committee on Immunization Practices was developed, it was the American Academy of Pediatrics that put out vaccine recommendations. They have a long-standing history. They look at the data, and what they put out is evidence-based and science-based. That’s where I go when I have questions for my children.
Q: Give me your thoughts on what’s happening right now at the federal level in terms of public health concerns.
Dr. Valenciano: Many of us in the public health and medical community are concerned about what’s happening at the federal level. I think that the biggest concern is about decisions being made without following the standardized process that has always been used. There was a very strong adherence to the recommendation framework that the committee followed previously, where they really examined the data presented and went over the implications of recommendations from a health standpoint, safety standpoint, cost standpoint, as well as an equity standpoint. We’re not seeing those things happening.
Many of the professional societies used to formally sit on the CDC advisory committee, and they got to be involved in the work groups. Their not being a part of these decisions is concerning, as well as their not being able to review the data and the information presented.
Q: By way of example, in justifying their decision to no longer recommend the hepatitis B vaccine for all infants, advisory committee members pointed to Denmark, which does not recommend a birth dose. Is it fair to compare the U.S. to Denmark in terms of needed protection from hepatitis B?
Dr. Valenciano: I think it’s important to talk a little bit about that. The comparison to Denmark is misleading. Denmark has extremely low hepatitis B prevalence, which is a big difference from the United States. Denmark has a small immigrant community compared to the United States, and as a result, we have a much higher prevalence of hepatitis B in the general population—millions of people. Denmark has universal access to prenatal care and a unified medical record system. As a result, pregnant people in Denmark are much more likely to have received screening for hepatitis B, and if they ever tested positive, that information is easily available for their doctors. Here in the United States, that is not the case – many pregnant people don’t receive prenatal care, and doctors don’t always have access to a patient’s disease screening history.
It’s also important to note that the World Health Organization recommends that countries with a certain level of hepatitis B in their community recommend that the universal hepatitis B vaccine be given at birth. Here in the United States, the rate of hepatitis B in the community is high enough that we meet this threshold.
Q: All this conflicting information confuses parents. You’re a parent. What do you think parents need to hear? If I were pregnant and going into a hospital right now, what would you tell me?
Dr. Valenciano: My sister is pregnant. She’s actually due to have her baby on December 25, and she’s hearing all of this. I would say that right now, there’s a lot of noise when it comes to vaccines, what you should and should not do. The biggest recommendation that I could give as a doctor and as a parent is to talk with your trusted healthcare provider, whether that’s your pediatrician, whether that’s your family medicine doctor, or for individuals who are pregnant, talking to their OBGYN. Get the information and the guidance directly from a healthcare provider you trust.
And you can always reach out to us at Public Health—Seattle & King County. We have vaccination information online at kingcounty.gov/immunization, and you can contact our team at vaccineinfo@kingcounty.gov.
Q: Is there anything else you’d like to say to parents?
Dr. Valenciano: I know it’s a confusing time, but here in Washington, we are sticking with what works. We recommend that parents consult a trusted source for evidence-based healthcare information.
