Hepatitis B is a serious liver infection caused by the hepatitis B virus. While typically transmitted through contact with infected bodily fluids, mothers with chronic hepatitis B infection can also transmit the virus to their babies during pregnancy, childbirth or breastfeeding.
While the U.S. Centers for Disease Control and Prevention (CDC) recommends a new hepatitis B vaccine be administered to pregnant women, the safety and necessity of vaccinating pregnant women with this shot has become a topic of debate. It’s important to note that casual contact, like sharing utensils or being around someone who coughs or sneezes, does not transmit hepatitis B.
Examining the Risks of the Hepatitis B Vaccine in Pregnancy
Recent changes in recommendations and concerns raised by experts warrant a closer look at the risks associated with the use of the hepatitis B vaccine during pregnancy. One significant point of concern is the limited safety data specifically for pregnant women.
As noted by Children’s Health Defense, in 2024 “the CDC added a new brand of Hepatitis B vaccine, Heplisav-B, to the list of vaccines that can be administered to pregnant women — after removing language that said Heplisav-B was not recommended in pregnancy ‘due to lack of safety data in pregnant persons.’”1
As stated in the Heplisav-B label, “there are no adequate and well-controlled studies of Heplisav-B in pregnant individuals.”2 This lack of robust data makes it difficult to fully assess the risks to both the mother and the developing fetus. Claims of safety are often based on studies in animals or small post-licensure studies, which don’t accurately reflect the effects on pregnant women.
Furthermore, as noted, the CDC removed language stating that Heplisav-B was not recommended in pregnancy due to this lack of safety data. This change, along with the addition of Heplisav-B to the list of vaccines administered to pregnant women, has raised concerns among health care providers. Some providers have expressed surprise and unease about these changes, particularly given the absence of strong evidence supporting the vaccine’s safety in this population.
The timing of the hepatitis B vaccine within the context of other recommended vaccines during pregnancy also raises questions. The CDC now recommends multiple vaccines during pregnancy, including flu, COVID-19, Tdap (tetanus, diphtheria, pertussis) and respiratory syncytial virus (RSV).3
Experts have expressed concern about the cumulative effect of administering multiple vaccines during pregnancy, as there is limited research on the combined impact of these vaccines on maternal and fetal health. This lack of data makes it difficult to fully understand the risks and synergistic adverse effects.
Experts Highlight Risks of Vaccines for Pregnant Women
Experts who spoke with Children’s Health Defense expressed serious concerns about the safety and effectiveness of vaccines recommended for pregnant women. They stated, “The vaccines recommended for pregnant women are often risky and ineffective and long-term safety data are lacking.”4 Despite these warnings, the CDC has continued to update its vaccination schedule. Children’s Health Defense reported:5
“The CDC now recommends more than 200 shots over an individual’s lifetime. In 1983, the CDC recommended just 11 doses of seven vaccines for children. There were no vaccine recommendations for adults, including pregnant women, before 1986, when the National Childhood Vaccine Injury Act of 1986 granted vaccine manufacturers protection from liability for vaccine injuries.”
Historically, up until 2012, pregnant women were advised against receiving most vaccines due to concerns about harm to the fetus.6 The shift in recommendations to now include these vaccines comes without substantial evidence to validate their safety for both mother and child.
“The rising number of recommended shots for pregnant women is concerning, particularly because of the lack of randomized controlled trials large enough to identify safety issues and because long-term safety data are lacking,” Children’s Health Defense noted.7 Experts emphasize that without comprehensive studies, the safety profile of these vaccines remains uncertain.
“Vaccine safety data are scarce,” states Karl Jablonowski, Children’s Health Defense senior research scientist. “In pregnancy, it’s even more scarce. And it’s almost nonexistent in situations where multiple vaccines are administered during pregnancy — which is the clinical reality.”8
This scarcity of data means that the risks have not been adequately studied or communicated, leaving pregnant women and their health care providers in a precarious position. Further complicating the issue, the CDC has added new vaccine brands despite insufficient safety data for pregnant women.
Further, hepatitis B’s mode of transmission — primarily through high-risk adult behaviors like unprotected sex or intravenous drug use — contrasts with other infections that have broader impacts, questioning the necessity of universally vaccinating pregnant women who aren’t at risk.
In the early 1990s, the hepatitis B vaccine was incorporated into the childhood vaccination schedule with limited safety investigation, despite the fact that only infants born to mothers with Hep B are typically at risk.9 This decision points to a pattern of rushed vaccine approvals without thorough safety analyses, especially concerning vulnerable populations like pregnant women and infants.
More Concerns Surrounding Vaccines Recommended to Pregnant Women
Vaccines such as Tdap not only subject both the mother and baby to multiple pharmaceutical agents, but “the bacteria that causes whooping cough (pertussis) contained in the Tdap likely no longer provides protection, as it’s outdated,” Children’s Health Defense notes.10 Critics argue that this exposure to numerous drugs leads to over-vaccination, further increasing the risk of adverse effects without clear evidence of benefit.
The influenza vaccine has also been scrutinized for low efficacy rates and concerning safety data. Even advocates acknowledge that the flu vaccine is only between 22% and 56% effective in any given year.11 Moreover, the presence of thimerosal, a mercury-based preservative in many flu vaccines, raises additional safety concerns.12
An analysis published in the journal Vaccine also found that women who received the flu vaccine had twice the odds of spontaneous abortion compared to those who didn’t.13,14 This alarming finding underscores the need for more rigorous safety evaluations before recommending such vaccines to pregnant women.
The COVID injection’s recommendation for pregnant women has also been contentious. While it’s recommended in the U.S., other countries have not adopted the same stance, highlighting discrepancies in safety assessments across different health authorities.15 Reports of high rates of adverse events, including miscarriages and preterm births, have been associated with the COVID shot,16 intensifying the debate over its safety for pregnant women.
Lastly, clinical trials for RSV vaccines revealed elevated rates of preterm birth, suggesting that these vaccines carry significant risks for pregnant women.17 These findings further question the wisdom of adding more vaccines to the already extensive list recommended for pregnant women, especially in the absence of robust safety data.18
Making Informed Choices About Vaccination During Pregnancy
Research has revealed concerning safety issues with vaccination during pregnancy, but there are practical ways to make informed decisions about your health. The data shows that vaccine manufacturers themselves acknowledge safety and effectiveness have not been established for pregnant women.
When it comes to the hepatitis B vaccine, it’s crucial to understand that transmission from mother to child occurs only if the mother is actively infected with the hepatitis B virus. Therefore, a simple blood test determines a pregnant woman’s hepatitis B status.
If the test is negative, meaning she does not have the infection, there is no risk of transmitting it to her baby, and therefore, vaccination to prevent mother-to-child transmission is unnecessary. This screening option empowers women to make informed choices based on their individual risk.
It is essential for women to have open discussions with their health care providers about the benefits and risks of any vaccination during pregnancy. Every medical intervention carries risks, and vaccines are no exception. While vaccines sometimes offer protection against certain diseases, it’s necessary to weigh potential benefits against the risks, especially during pregnancy, a time of heightened vulnerability for both mother and child.
Women should ask detailed questions about the available safety data, particularly regarding pregnancy, and discuss any concerns they have. This shared decision-making process ensures that women are actively involved in their health care and make choices that align with their individual circumstances, health background and values.
Ultimately, the decision to vaccinate during pregnancy is a personal one. It’s important to understand the risks and the limitations of current research on vaccine safety in pregnancy, implement strategies to support your immune system, and work with your medical providers to create a personalized health care plan for a healthy pregnancy.
