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Hepatitis B Vaccine Q&A: Why Do Babies Need The Shot?

The people at highest risk for contracting hepatitis B include health care workers, IV drug users and people having sex.

So why do babies get vaccinated for hepatitis B as soon as they are born? It's a fair question, and health care providers have compelling answers. 

Hepatitis B is a virus that can do serious, sometimes fatal, liver damage. Although groups that are more exposed to swapping bodily fluids are at greater risk, anyone can get infected.

Getting infected with hepatitis B as a baby is extra dangerous. Infected infants have a 90% chance of developing the disease's more dangerous chronic form. And a quarter of those babies will go on to die prematurely from the disease when they become adults, according to the American Academy of Pediatrics. 

When the vaccine was invented in the 1980s, doctors initially vaccinated only the highest risk individuals. Cases didn't meaningfully decline. 

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In 1991, the Centers for Disease Control and Prevention began recommending vaccinations for everyone at birth. 

The protocol produced results: New infections dropped significantly, especially among children and adolescents.

"Now it's a very uncommon disease in young children because of that vaccine," Dr. Paul Offit, Children's Hospital of Philadelphia pediatrician and infectious disease expert, said. "It was a remarkable, remarkable achievement."

Today, infants get their first dose within 24 hours of birth and receive two to three more doses by the time they are 6 months old. 

But the CDC's independent vaccine panel is scheduled to reevaluate the vaccine schedule at its Sept. 18 meeting. KFF Health News reported that the panel is expected to vote on whether to delay the vaccine until children are 4. 

Here's what you should know about hepatitis B and what is behind the CDC's longstanding "at birth" hepatitis B vaccine recommendation.

What is hepatitis B? 

The hepatitis B virus attacks the liver. Some people become very sick upon initial infection. Others have only mild symptoms or none at all. Acute cases can resolve on their own, but sometimes they develop into chronic infections. 

Long-lasting infections can be asymptomatic, and dangerous. They develop more slowly and symptoms may not show up until much later in life, sometimes decades after the first exposure. 

"It's a stealth infection," said Dr. William Schaffner, Vanderbilt University School of Medicine professor and infectious disease expert. "After you get over the acute infection, you can have this smoldering infection and be contagious to others and feel perfectly normal."

Untreated, chronic hepatitis B infections can cause cirrhosis and death. It is also one of the leading causes of liver cancer. Patients can seek treatments to reduce the virus' worst effects. But there is no cure. 

The CDC estimates about 640,000 adults have chronic hepatitis B, but because of its asymptomatic nature, about half of people with the virus do not know they are infected and contagious.

Who gets hepatitis B and how? 

Anyone can get it. 

Hepatitis B is transmitted through bodily fluids like blood, semen and vaginal fluids. It is usually transmitted through sexual activity, direct contact with blood, or from mother to child during delivery due to contact with bodily fluids.

Because hepatitis B is an especially tough virus, it can live outside the body on surfaces for up to seven days. Even a small amount can be infectious.

That means that although you can get it through sexual contact or health care work, mundane contact can also result in transmission. Small amounts of dried blood on innocuous household items like nail clippers, razors or toothbrushes could be enough.

Many hepatitis B patients are never sure how they contracted it.

"Those environmental routes of transmission of hepatitis B undoubtedly play a small but notable role," Schaffner said. 

Because so many people are unaware they are infected, preventing transmission was much more difficult — until the vaccine. 

How do babies get hepatitis B?

The fact that so many infected people have no idea they have it makes it nearly impossible to guarantee a child will never come into contact with a hepatitis B-positive individual.

Babies can get infected from their mothers during childbirth. Testing for hepatitis B during pregnancy is recommended, and patients who receive regular prenatal care are highly likely to be tested at some point. But not all expecting mothers receive regular medical care. In some cases, those at highest risk for contracting hepatitis B are also less likely to access prenatal care, Schaffner said.

The vaccine works well to prevent infection in babies born to mothers with hepatitis B. 

But even if a mom tests negative, the child's risk of contracting hepatitis is not zero. The reasons are varied: The test produces some false negatives. Pregnant patients can contract hepatitis B after being tested. Children may become infected simply by being in contact with the world at large.

Offit said that prior to the vaccine being recommended for all infants, around half of children under 10 were infected from their mother during birth. The other half contracted it somewhere else. 

How does the vaccine work and has it been effective at reducing cases? 

The hepatitis B vaccine was first introduced in 1981; the version in use today was put in place in 1986. 

It uses proteins from the surface of the hepatitis B virus to provoke an immune response that gives the body a defense against future infection. It is not a live virus, and the vaccine can't infect someone with hepatitis B. 

Doctors expect the vaccine may provide lifelong protection, but they are still monitoring results of the 39-year-old vaccine.

Prior to the vaccine, around 200,000 to 300,000 people were infected with hepatitis B each year, including approximately 20,000 children, older CDC reports show. 

Since hepatitis B vaccines began being universally administered to babies, overall cases are down to around 14,000 annually. The change is especially dramatic among young people. In 2022, the CDC reported 252 new chronic hepatitis B infections among people up to age 19, or 0.4 out of every 100,000 kids. 

Dr. James Campbell, a University of Maryland pediatric infectious disease doctor, said the low rate is directly related to the recommended hepatitis B vaccine schedule: "Because we've been vaccinating nearly the entire population since 1991 those people are now 30 something years old." New infections are largely among older Americans. 

All the doctors we spoke with, the CDC and the American Academy of Pediatrics describe the vaccine as safe and effective. 

But why not delay the vaccine until a child is a little older?

When it comes to hepatitis B, that first year of life is critical.

Whereas the Department of Health and Human Services reports that 90% of infants who become infected go on to develop a chronic hepatitis B infection, that rate is 2% to 6% for adults. And with research showing that 25% of infected infants die prematurely from the disease, public health officials have long held that early delivery is crucial. 

"Think about it," Campbell said. "We used to have 18,000 or 20,000 kids a year being born with this, a quarter of them going on to have liver cancer. We now have almost none."

Delaying administration by even a few months increases a baby's risk should they come into contact with the virus, Offit said. And Schaffner said delaying a vaccine can easily lead to never getting it: An unvaccinated child can become an unprotected adolescent or young adult with sexual partners, "and boom, then they get infected," he said.  

What are the hepatitis B vaccine's safety risks?

The most common side effects are mild and short term including pain or soreness where the shot is given, headache, fatigue or fever, according to the CDC. Very rarely, some people have a severe allergic reaction to the shot called anaphylaxis, which can be treated. 

The vaccine contains small amounts of aluminium, an additive used to enhance the body's immune response. Although large amounts of aluminum can be harmful, the vaccine contains less aluminum than infants get from their natural surroundings. 

According to the Children's Hospital of Philadelphia, babies get about 4.4mg of aluminum from vaccines in their first six months; they get around 7mg from breastmilk and around 38 mg from formula in the same time. 

I heard that the risk of a baby dying from hepatitis B is 1 in 7 million. Is that wrong?

Health and Human Services Secretary Robert F. Kennedy used that statistic during recent Senate testimony. "That means you need to give 7 million hepatitis B vaccines to prevent one death," he said.

The vaccine is not administered to prevent babies from dying as babies. It aims to prevent them from developing the more harmful chronic hepatitis B, which can be fatal when they get older. It also prevents severe illness. 

Kennedy's statistic for babies who will eventually die from hepatitis B is still missing a lot of context.  

It's based on a 2020 research paper that tried to quantify how many people would have died of hepatitis B in 2014 had there never been mass vaccination. 

The study estimated that 1,740 children ages 10 or younger would have contracted a deadly case of hepatitis B in a single year, 2014. 

But to make his "1 in 7 million" calculation, Kennedy left out 99% of those deadly cases — any considered to be due to "elevated risk" of exposure, including among children born to infected mothers, children living with infected individuals, or those in communities with large numbers of infected people. 

Since many people do not know they are infected, it can be hard to know if you are at elevated risk or reside in a community with infected individuals. 

Vaccines given at birth "protect not only infants and children in their infancy and childhood, but throughout their lives," Schaffner said. "It's a larger series of issues that we're trying to address. We're trying to protect not only babies, but the transmission of the virus to the next generation."

CDC Advisers Punt On Hepatitis B Vaccine Vote, After Changing Guidance On MMRV

Martin Kulldorff, chairman of the CDC's Advisory Committee on Immunization Practices, speaks during a Thursday meeting of the panel in Chamblee, Ga. Elijah Nouvelage/Getty Images hide caption

toggle caption Elijah Nouvelage/Getty Images

A panel of vaccine advisers to the federal government —now embroiled in controversy under the leadership of Health Secretary Robert F. Kennedy Jr. — has voted in favor of changing the childhood vaccine schedule for one vaccine — and deferred a proposed change to another.

On Thursday afternoon, the Advisory Committee on Immunization Practices, or ACIP, voted 8-3 to change the current recommendations that allow children under 4 to receive the MMRV vaccine, a combination shot for measles, mumps, rubella and chickenpox (or varicella).

The vast majority of children in the U.S. — about 85% — get separate shots for MMR and chickenpox, though parents currently have the option to give their children the single shot to cover all four diseases.

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The panel, which advises the Centers for Disease Control and Prevention, also debated changes to the current recommendations for the hepatitis B vaccine. Although some on the panel seemed enthusiastic about pushing the first dose recommendation later in life, after some discussion on Friday morning, there was a small revolt against tackling this issue at all.

"I move to postpone the question indefinitely," Dr. Robert Malone, a close Kennedy associate, said early in the day. "I believe that there's enough ambiguity here and enough remaining discussion about safety, effectiveness and timing that I believe that a vote today is premature."

The panel overwhelmingly agreed, voting 11 to 1 — the only member who disagreed was chair Martin Kulldorff.

Later on Friday, the panel will vote on recommendations on who should be eligible for the latest COVID-19 vaccines.

On Thursday, amid a lot of confusion, the panel voted to allow the MMRV vaccine for children under 4 to continue to be paid for by the Vaccines for Children program. But on Friday morning, they reversed course. After a second vote on the same question, they removed the vaccine from that program, which covers vaccines for many low-income children. Coverage by Children's Health Insurance Program and Medicaid will also be affected by the vote and may not cover these shots anymore.

The moves to overhaul the children's vaccine schedule represent the latest victory in Secretary Kennedy's long-running campaign to reshape policy. There was vocal opposition to the proposed changes from representatives of major medical groups who were present at the meeting.

"A question I've had all along through these discussions is why? Why are we addressing this hepatitis B vaccine recommendation? Is there really a reason?" asked Dr. Flor Muñoz, a pediatric infectious disease clinician who spoke at the meeting.

The proposed changes to the vaccine schedule also run counter to the hours of data presented by the CDC's own scientists throughout the meeting on the rationale for these recommendations.

Many in public health had warned that Kennedy was aiming to retool the vaccine schedule, after he replaced all 17 members of ACIP with his own handpicked roster, including five members he added this week. Many of those he chose have a history of being critical of vaccines.

The panel's votes still require final approval from the acting CDC director Jim O'Neill, an ally of Secretary Kennedy's who's expected to greenlight their recommendations.

MMRV no longer recommended for kids under 4

Tension between the committee and the medical establishment surfaced throughout the discussion over changes to the MMRV vaccine guidance.

At issue was evidence, presented by CDC staff, showing a slightly increased risk of fever-related seizures in children ages 12-23 months after receiving the MMRV shot compared to the MMR, which concerned some committee members.

"I would go with the option that seems to be safer," said ACIP member Retsef Levi, an MIT professor of operations management who gained prominence during the pandemic for criticizing COVID vaccines.

But Dr. Cody Meissner, a pediatrician at Dartmouth College and ACIP member, pointed out that fever-related seizures, while "frightening" for the family, are not uncommon. They occur in 3% to 5% of all children.

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"Every pediatrician is experienced in febrile seizures. We know that the prognosis is excellent," he said.

Removing the MMRV shots from the vaccine schedule for children under age 4 would spark more public confusion, compromise insurance coverage and potentially lead to fewer kids being vaccinated, said Dr. Jason Goldman, president of the American College of Physicians who is acting as a liaison to the committee.

"I urge this committee not to change the recommendations if they truly want to give the power to the parents to decide what is best for their child," he said.

Several liaisons from major medical groups criticized the committee's process.

Goldman said it failed to bring in the voice of subject matter experts, clinicians and patients, noting that the representatives from medical groups had been removed from ACIP workgroups.

A potential break with existing policy on hepatitis B

The proposed changes to the hepatitis B vaccine schedule would have marked a major departure — one that pediatricians and medical groups caution could reverse decades of progress in lowering rates of illness in the U.S.

Existing policy is to give the vaccine to all babies at birth regardless of the mother's hepatitis B status. The new recommendations would have upended this, instead guiding doctors to screen all mothers and offer the vaccine only to those who do not test negative in an initial screening.

Several new ACIP members questioned why a universally given birth dose was necessary, if mothers could be adequately screened ahead of time.

"Are we asking our babies to solve an adult problem?" said Dr. Evelyn Griffin, an OB-GYN and ACIP member, "Are we trying to lower the prevalence of hepatitis B in a high-risk population by vaccinating them on day one?"

But CDC scientists explained that gaps in prenatal screening could leave many babies vulnerable to catching a debilitating, sometimes fatal illness. And an infant could be infected by exposure to someone else in the household who is infected — around half of people with hepatitis B don't know they have it.

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"I have not seen any data that says that there is any benefit to the infant of waiting a month, but there are a number of potential harms to the infants of waiting," responded Dr. Adam Langer, a CDC scientist who was presenting on the data.

Meissner echoed these sentiments, pointing out that efforts to identify high risk groups had failed in the past, which is why the recommendations were made in the first place.

"It's an extremely safe vaccine," said Meissner, "If we change the recommendations, we will increase the risk of harm based on no evidence of benefits because there will be fewer children who get the full hepatitis B series."

"We will be creating new doubts in the mind of the public that are not justified," he added.

Political tensions around the vaccine guidance process

The meeting comes on the heels of a contentious Senate hearing on Wednesday with the recently-ousted CDC director Susan Monarez.

Monarez testified that she was fired after clashing with Kennedy over his demands that she preemptively agree to approve vaccine recommendations from ACIP, and fire career scientists.

"He said the childhood vaccine schedule would be changing starting in September and that I needed to be on board with it," she said.

Kulldorff, an epidemiologist, acknowledged the "controversy" at the outset, with pointed comments against his critics — among them a slate of former CDC directors who have said the new members, selected by Secretary Kennedy, are "unqualified" and "share his dangerous and unscientific views. "

Kulldorff rebuffed the idea that he or others on the panel were "anti-vaxxers" and challenged the former directors to an "open public debate."

"If they want to be trusted, they should all accept," he said.

Another sign of the increasingly polarized nature of vaccine policymaking was the notable absence at this week's meeting of a liaison from the American Academy of Pediatrics — the leading national group representing pediatricians in the U.S. That would usually collaborate with the panel.

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The AAP had decided to boycott the meetings, arguing federal vaccine policymaking is no longer a "credible process." Kennedy has barred professional medical groups such as the AAP from serving in their traditional roles as expert liaisons to workgroups of the advisory committee.

ACIP member Meissner said the AAP was making a "grave mistake not to participate" and "moving itself to irrelevance."

Dr. Susan J. Kressly, president of the AAP issued a statement Thursday noting the group had published its own immunization schedule "to ensure providers and families have evidence-based guidance rooted in the best interests of children's health."

The group continues to recommend that the combination MMRV shot "should remain an option for families," Kressly said.

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