One of the first decisions you will make as a new parent is whether to vaccinate your newborn against hepatitis B. The first dose of this vaccine is recommended within 24 hours of birth, and most babies receive it before leaving the hospital. Hepatitis B is a serious viral infection that affects your liver. It can become chronic and, over time, lead to cirrhosis, liver failure, or cancer. Although the vaccine is effective, many parents have questions about safety, the timing of administration, and whether it is truly necessary for newborns. You have multiple options, including choosing to vaccinate, delay, or decline. This episode explores the evidence on the risks and benefits so you can make an informed decision and feel confident in your choices as a parent.
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Today’s episode comes from a request from a listener who is expecting her first baby and has questions about the hepatitis B vaccine. Although this is standard in hospitals in the United States, there are some mixed opinions on whether it should be given to newborns. She requested more information about why it is recommended, and the risks and benefits of newborns getting it vs the risks and benefits of parents declining it.
The Controversy Surrounding Vaccines
Vaccines are a complex, controversial topic that many people feel very strongly about. As a result, researching vaccines is challenging. It is easy to come across information that appears unbiased but may ultimately push a pro- or anti-vaccine agenda. This episode focuses specifically on the hepatitis B vaccine given at birth.
The Role of the Public Health Organizations
In the United States, the Advisory Committee on Immunization Practices (ACIP) develops recommendations for vaccines. These recommendations are based on multiple factors, including how safe and effective a vaccine is, the severity of the disease it prevents, and how common the disease is without vaccination. When determining vaccine timing, the ACIP considers when a baby’s immune system will respond most effectively while also ensuring protection as early as possible. The Centers for Disease Control and Prevention (CDC) then uses these recommendations to create the official U.S. immunization schedules.
These organizations focus on protecting public health at a national level. Their guidelines influence recommendations made by professional bodies such as the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG). These recommendations, in turn, shape the advice you receive from your healthcare provider. Understanding how these recommendations are developed helps you have informed conversations with your doctor, midwife, or pediatrician and make the best decisions for you and your baby.
Vaccines During the Current Administration
Recent comments from President Trump have raised questions about potential changes to vaccine policies, including the number and combination of doses. While guidance has already evolved for COVID-19 vaccines, recommendations for other vaccines may also change in the future. Typically, once a vaccine is added to the CDC schedule, it is universally recommended. If a vaccine is removed from the schedule, then the attitudes of physicians may change.
Evaluating Vaccines
I take a systematic and evidence-based approach when evaluating any vaccine. My goal is to understand both the science and the context. I start by asking several key questions:
- What are the risks of the illness the vaccine prevents?
- What is the history of the vaccine?
- What ingredients are in it?
- How effective is it?
I also encourage you to consider other personal factors. This includes questions like:
- What is the likelihood of exposure where you live or places you plan to travel?
- What is the overall health of you or your child?
- Is the illness more common during certain seasons?
Answering these questions requires a lot of research and critical thinking. Researching vaccines can feel very overwhelming. The CDC’s vaccination schedule includes a long list of vaccines, which can be daunting for new parents. There is a lot of nuance in vaccination decisions, and it does not have to be all or nothing. One way to make this more manageable is to evaluate vaccines individually. Focus on the ones that are recommended at your baby’s upcoming appointment. If you follow this approach, the first vaccine on your list would be hepatitis B since it is given shortly after birth.
Hepatitis B
Hepatitis refers to inflammation of the liver, and there are three main types of viral hepatitis: A, B, and C. Hepatitis B is caused by the hepatitis B virus (HBV). An acute infection is short-term, usually lasting less than six months. If the immune system cannot fully clear the virus, the infection can become chronic. Chronic hepatitis B can lead to ongoing inflammation that, over time, may cause scarring of the liver (cirrhosis), liver failure, or liver cancer. According to the CDC, up to 90% of infants infected with hepatitis B at birth develop chronic infection. While treatments are available to manage chronic hepatitis B, there is currently no cure.
Hepatitis B spreads through blood, semen, and other body fluids. Transmission most commonly occurs through sexual contact, sharing needles, or sharing personal items like toothbrushes or razors with someone who is infected. If a mother has hepatitis B, they can pass the virus to their baby during birth. ACOG recommends universal screening for hepatitis B early in every pregnancy.
Hepatitis B Vaccination Recommendations
The CDC and the American Academy of Pediatrics recommend that all newborns receive the first dose of the hepatitis B vaccine within 24 hours of birth, followed by a second dose at 1 month and a third dose at 6 months of age.
Hepatitis B Vaccine
The FDA licenses two hepatitis B vaccines that can be given at birth. For each vaccine, let’s cover the manufacturer, approval date, and key ingredients. There is also a link to the package insert. This is the official document from the manufacturer and includes clinical trial results, possible side effects and adverse reactions, all ingredients, and other details. Both vaccines are approved for use from birth through 19 years and are given as a three-dose series on a 0, 1, 6-month schedule.
- Manufacturer: Merck
- Approved: 1986
- Ingredients: Each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen, 0.25 mg of aluminum (amorphous aluminum hydroxyphosphate sulfate), and <1% yeast protein. It also contains <15 mcg/mL residual formaldehyde.
- Manufacturer: Glaxo Smith Kline
- Approved: 1989
- Ingredients: Each 0.5 mL dose contains 10 mcg of hepatitis B surface antigen, 0.25 mg aluminum (aluminum hydroxide), and <5% yeast protein. It also includes 4 mg sodium chloride to make the vaccine isotonic and phosphate buffers (0.45 mg disodium phosphate dihydrate and 0.35 mg sodium dihydrogen phosphate dihydrate) to keep the vaccine’s pH stable.
Comparing Your Vaccine Options
In comparing the two vaccine options available at birth, they are very similar. Both use aluminum in the same amounts as an adjuvant to enhance the immune response. Although the aluminum compounds used by each manufacturer are slightly different. Both contain trace amounts of yeast protein. Neither contains a preservative. The remaining ingredient differences are a result of the differing manufacturing processes. Engerix includes sodium chloride and phosphate buffers. Recombivax contains residual formaldehyde.
Both options provide long-lasting protection and produce protective antibody levels in about 90 to 95 percent of healthy infants. If you prefer one brand over another, check with your hospital or pediatrician to find out whether that is the brand they carry or if they can order it. Choosing a specific brand of vaccine may make more sense when comparing vaccines for other illnesses. In the case of Hep B, they are very similar.
If you choose to delay administration of the Hep B vaccine, there are two additional vaccine options available after 6 weeks. These are combination vaccines that include Hep B along with immunization for other illnesses. This episode focuses on the vaccines available at birth. You can check out the package inserts linked below for more information on the Hep B vaccines from 6 weeks.
- Pediarix includes immunization for hep B, diphtheria, tetanus, pertussis, and polio.
- Vaxelis includes immunization for hep B, diphtheria, tetanus, pertussis, polio, and Hib, which is a bacterium that can cause infections like meningitis.
Risks and Side Effects
All vaccines can cause side effects, though most are mild and temporary. A severe allergic reaction is possible but very rare. The most commonly reported reactions for both hepatitis B vaccine options include irritability, fever, diarrhea, fatigue or weakness, decreased appetite, runny nose, and pain or swelling at the injection site. In clinical trials, episodes of apnea (temporary pauses in breathing) were observed in some premature infants after vaccination. For this reason, if your baby is born prematurely, your healthcare provider may recommend waiting before giving the first dose. Similarly, if your newborn weighs less than 2,000 grams, or about 4.4 pounds, the hepatitis B vaccine is typically delayed for a month or longer.
Considerations
Now that you have a clearer understanding of hepatitis B and the vaccine, there are a few additional factors to consider as you decide what is best for your baby.
Risk Exposure
In some regions, such as parts of Asia and sub-Saharan Africa, hepatitis B is considered endemic, meaning a large portion of the population is chronically infected. In the United States and most other developed countries, hepatitis B is not endemic and occurs much less frequently. If you plan to travel internationally or live in an area with higher rates of hepatitis B, that’s an additional factor to consider when making your vaccination decisions.
Hepatitis B is primarily transmitted through sexual contact or by sharing needles. One argument against vaccinating at birth is that a newborn’s risk of exposure is extremely low. However, if the mother has hepatitis B, the situation changes significantly. ACOG recommends routine, universal screening for hepatitis B early in pregnancy. Even with early screening, it is possible for a mother to become infected later in pregnancy before giving birth. If a mother does not have a Hep B infection, there is no risk of transmitting the virus during delivery. For additional reassurance, you could potentially request repeat testing closer to your due date to confirm that you have not developed an asymptomatic infection that could be passed to their baby at birth.
Vaccine Mandates
Another consideration is how vaccination policies may affect your family depending on where you live. In the United States, every state has legislation in place regarding vaccination requirements. States enforce these laws by requiring proof of vaccination for children to attend public or private daycare or school. In states with vaccine mandates, a child may be denied school entry if their vaccination records are not up to date.
Currently, twenty-nine states and Washington, D.C. allow exemptions for individuals with religious objections to vaccination. Fourteen states permit exemptions for either religious or personal, or philosophical reasons. Five states do not allow any type of non-medical exemption. In September 2025, the governor of Florida announced the state would eliminate vaccine mandates. You can view each state’s specific requirements and available exemptions here.
Depending on the state you live in, declining vaccines may affect whether your child can attend school or daycare. In states like California, where vaccination requirements are strict, you will have a difficult time enrolling your child in school if they are not up to date with the CDC vaccination schedule. Families who choose to homeschool are generally not impacted by these restrictions.
Evaluating Your Options
When it comes to the hepatitis B vaccine, you have three options: you can decline it, you can move forward with it, or you can delay it. Remember that public-health guidelines are designed to protect the population as a whole. Your role as a parent is to make the best choice for your baby.
There is an argument that widespread vaccination benefits the community through herd immunity. For some families, that is an important factor. For others, the decision is more personal. Vaccines can feel intimidating, but it is best to make your decision based on solid information rather than fear. Whether that fear is about possible vaccine risks or the disease itself. The goal is to make the best decision you can with the knowledge you have right now.
Talking to Your Pediatrician
Your pediatrician is a great resource for questions or concerns about vaccines. You do not have to accept every vaccine exactly as scheduled or reject them all. You can take an individualized approach that feels right for your family. If you plan to follow an alternative schedule or delay certain vaccines, it is essential to confirm that your pediatrician is supportive of that plan. Some providers may not work with families who choose to delay or decline vaccines, while others are more flexible. The CDC vaccination schedule aligns with the timing of well-baby visits during your child’s first few years. Having open communication and alignment with your pediatrician can make those appointments smoother.
Parenting Together
Parenting will bring many decisions where you and your partner may not always agree, and vaccines can be one of those topics. It is normal for this to create tension, especially when you both care deeply about doing what’s best for your baby. Keeping open communication and listening to each other’s perspectives can help you find common ground. If you’re still having trouble reaching an agreement, consider talking with your doctor, midwife, or pediatrician for additional information and guidance. Ultimately, it’s about coming together and making decisions that feel right for your family.
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