Dr. Patricia Tibbs said her pediatric practice in Laurel has gotten “so many rejections” for newborn hepatitis B vaccines in the last year, and she suspects some of those infants may end up with debilitating conditions as a result. 

“The problem with that is that if you are in the process of turning positive for hepatitis B and you did not know you were exposed, and if we don’t give the baby the vaccine at birth, then your baby has acquired it,” said Tibbs, president of the Mississippi chapter of the American Academy of Pediatrics, told Mississippi Today. “You can’t stop the process once it’s acquired.”

This shift among how parents choose to protect their children against infectious disease was underway even before a group of advisers convened for the Centers for Disease Control and Prevention this week. Universal hepatitis B vaccines for infants are no longer recommended by the Advisory Committee on Immunization Practices, a panel that advises the federal government on vaccination policy, as a result of a controversial vote Friday. 

The 8-3 vote brought an end to a longstanding recommendation to vaccinate all healthy newborns against hepatitis B, regardless of whether the mother tests positive for the virus. The current committee was hand-picked by U.S. Health Secretary Robert F. Kennedy Jr. after he fired 17 former members. In June, Kennedy called his move a “clean sweep” that represents a broader movement to prioritize parental autonomy. Committee members also discussed the childhood immunization schedule but only voted on the recommendation for hepatitis B. 

Several national health associations, including the American Academy of Pediatrics and the Infectious Diseases Society of America, have come out with statements reiterating the importance of continued recommendation of universal birth doses of the vaccine. On Friday, the American Medical Association called the panel’s decision “reckless.” 

Hepatitis B can spread through sexual contact and drug use, but it can also be transmitted from mothers to infants during childbirth. In infancy, the disease can be transmitted through contact with an infected person’s body fluids, such as their blood. The committee now recommends the vaccine only for babies whose mothers test positive for the virus. For other babies, it will be up to parents and doctors to decide whether a birth dose is appropriate. 

The virus attacks the liver, is often asymptomatic for years, and can present in adulthood as liver cancer, cirrhosis and death. The risks of these outcomes are much higher for people who get infected as infants. There is no cure.

Babies born to mothers who are negative at the time of birth are very unlikely to get the virus. However, if a mother tests negative before birth, she could still contract the virus between the time of testing and birth. Testing at birth is a mostly-effective alternative to immediate vaccination in large hospitals that do speedy in-house testing, but not in smaller, rural hospitals where tests can take days to come back, Tibbs said, adding that there is always a chance of a false negative or infection from someone other than the mother. The newborn vaccine is most effective when administered within 12 hours of birth, experts say. 

The recommendation changes will likely have a greater impact in rural areas. There, mothers are more likely to get tested for the first time at birth, the results may take a while to come back, and infants can miss the 12-hour window, Tibbs said.

“This particular decision is going to impact Mississippi especially a lot,” Tibbs said. “Because we already have issues with adequate prenatal care and places where people travel for hours to get good care.”

Panelists say the vaccine has come up now because the committee is required to periodically review vaccine safety. They say they deemed the hepatitis B vaccine the most important to examine since it is the earliest vaccine given to infants and contains aluminum adjuvants – salts that make some vaccines more effective by stimulating an immune response. 

“We have to be cognizant of the fact that the past several decades have seen an explosion in chronic disease, especially the highest rate in our children,” said ACIP member Dr. Evelyn Griffin, an obstetrician and gynecologist in Baton Rouge, Louisiana, Thursday. “Something is happening, and we have to address that … I’m not saying it is vaccines that is causing this, but vaccines is what we are tasked to explore, so we have to investigate these topics.” 

The new recommendations will not affect access or availability of the vaccine currently available, Andrew Johnson of the Centers for Medicare and Medicaid Services said during the meeting. The vaccine will continue to be covered by insurance at no out-of-pocket cost for all beneficiaries. 

“This vote to weaken the hepatitis B dose recommendation will be the first time in my 21 years of experience as a liaison to ACIP that ACIP is voting on a policy that based on all of the available and credible evidence regarding benefits versus harm, it actually put children in this country at higher risk rather than lower risk of disease and death,” said Dr. Amy Middleman, a professor of pediatrics at the University of Oklahoma’s College of Medicine, during the hearing.

Why this, why now?

In 1991, the U.S. pioneered its recommendation that all infants receive a dose of the hepatitis B vaccine on the day of birth. Between 1990 and 2019, reported cases of acute hepatitis B among children declined by 99%. 

Most parents today choose a birth dose of the hepatitis B vaccine, with only 9% choosing to forego or delay it, according to the KFF/Washington Post Survey of Parents conducted last summer. 

About 30 vaccines, excluding flu and Covid shots, are recommended in the U.S. for children. The debate on childhood vaccination has become increasingly contentious as the country becomes more divided. Liberals are more inclined toward vaccination, seeing it as a matter of public health, and conservatives are less inclined toward vaccination, seeing it as a matter of individual freedom. Seventy-four percent of Democrats or those who lean Democrat feel confident that vaccines have been tested enough for safety, while only 35% of Republicans or those who lean Republican believe the same, according to an Oct. 20-26  survey conducted by the Pew Research Center.

Some of the people Kennedy replaced former committee members with are considered controversial for being vaccine skeptical. During this week’s meeting, members pushed back against decades-long practices in disease prevention.

“My personal bias is to err on the side of enabling individual decision making and individual rights over the rights of the collective,” said the committee’s vice president, Dr. Robert Malone, who has said he is not anti-vaccination and has worked in mRNA technology for years, during Friday’s deliberations over when to administer the hepatitis B vaccine. “This is not a trivial thing, and it reflects fundamental, frankly philosophical, disagreements about the role of public health and medical practice.”

“Your role is population health, not the individual,” shot back Dr. Jason Goldman, who has served as a liaison to the committee for the American College of Physicians for almost a decade. “We are looking at what are the population risks and how do we make those recommendations.”

In the two-day session, committee members called for more long-term vaccination studies, including placebo-controlled trials to look at causation with conditions such as asthma, allergies, ADHD and autoimmune disorders. Virologists have long considered it unethical once a vaccine is authorized for use to perform additional studies that withhold the vaccine from placebo patients. 

“Many vaccines have been in existence for decades. When the newer, next-generation vaccine comes along, we are obligated to use the standard of care as the control – not a placebo,” Dr. Wilbur Chen, an infectious disease physician-scientist at the University of Maryland Medical Center, told Mississippi Today. Chen was one of the 17 former committee members dismissed in June. 

Before Friday’s vote, the hepatitis B vaccine was recommended for all newborns but not mandated. However, in schools and some pediatricians’ offices, the vaccine is required. More than half of pediatricians’ offices in the U.S. included in a study published in the medical journal JAMA reported having a dismissal policy for families who do not vaccinate their children according to the immunization schedule. 

“I was trained in bioethics that these are things that are not acceptable,” said Malone. “The absence of coercion, compulsion and enticement is the essence of informed consent.”

Mississippi recently added religious exemption, allowing children who do not comply with the recommended immunization schedule to attend school. Before 2023, Mississippi was one of six states that did not allow religious exemption for childhood vaccines. 

Since the exemptions became allowed two years ago, Mississippi went from first in the nation for its rate of childhood immunization to third. 

“Historically, parents all got vaccines,” said Tibbs. “It’s not in my memory for people to reject vaccines until recently.”

The way forward

Two-thirds of Americans don’t trust the health care system today, according to a study from Johns Hopkins University study. That’s up 10 percentage points from 2021, the height of the Covid pandemic. 

Panelists who voted to pass the new hepatitis B recommendations said that increased parental autonomy is necessary to rebuild public trust in the medical industry. They also said that it has never been socially acceptable to talk about adverse effects of vaccines, leading to parents and individuals feeling gaslit and silenced. 

MaryJo Perry, co-director of Mississippi Parents for Vaccine Rights, called the new recommendations a win after she tried to bring these changes to Mississippi in 2017 through a bill authored by Rep. Becky Currie, a Republican from Brookhaven. The bill would have prohibited the state’s Health Department from requiring the hepatitis B vaccine for all infants at the time of birth. 

“I think it’s a shift in the integrity behind the government and the way they represent vaccine science,” said Perry, whose group now has 14,000 followers on Facebook. Perry said most of the families she works with report feeling that their concerns are not taken seriously and are judged or penalized for exercising their right to choose. 

“They get shamed, they get bullied, they are fear-mongered and coerced,” Perry said. “When you have a brand-new baby, it’s supposed to be a wonderful time. And parents just are tired of that, and today’s young mamas are not putting up with it.”

Some doctors who spoke during the hearings expressed concerns that public distrust might grow, since there is now a rift between what ACIP now recommends and what various medical and pediatric associations recommend. They also described the hearings as chaotic and overly anecdotal. 

“These decisions really affect a lot of people’s lives, and we really are obligated to our countrymen to make sure that we do this in an organized process,” said Middleman, the ACIP liaison. “We can’t just dump a pile of unfolded laundry on the floor and then try to determine from that whether or not we need more T-shirts or more pants.”

Pediatricians also expressed their own confusion over how the new recommendations will change practice, if at all, considering the decision has always been up to parents. 

“Is it not going to change anything because people have always been able to opt out?” asked Tibbs, of the Mississippi chapter of the American Academy of Pediatrics. “I won’t stick your baby if you don’t want the hepatitis B vaccine, right? So, is nothing changing?”

As of now, the hepatitis B vaccine will continue to be covered by insurance for all families who choose to receive a birth dose. But Tibbs worries about the possibility insurance companies will stop covering the vaccine down the road. 

“We as pediatricians will continue to follow the American Academy of Pediatrics recommendation,” said Dr. Anita Henderson, past president of the group’s Mississippi chapter. “… We are not planning to make any changes to our recommendations, any changes to our policies. We will continue to recommend the vaccine.”