The Centers for Disease Control and Prevention's vaccine advisory panel was poised to vote Friday to eliminate the recommended birth dose of the hepatitis B vaccine. major renovation by Secretary of Health and Human Services Robert F. Kennedy Jr. in June.
The hepatitis B vaccine has long been a major target of anti-vaxxers. But changing a decades-old recommendation proved challenging even for Kennedy's handpicked Advisory Committee on Immunization Practices.
The vote, scheduled for September, was called after bitter disagreements among members, whose arguments on Thursday repeatedly escalated into shouting matches.
“We're trying to evaluate a moving target,” Dr. Joseph R. Hibbeln, one of the move's strongest opponents, said during the meeting.
While changing current recommendations would not prevent newborns from receiving the vaccine, Medicaid and other public insurance programs would no longer be required to cover it, making the birth dose unaffordable for millions of poor families and complicating access for many more.
Unlike most vaccine-preventable diseases, such as whooping cough and chickenpox, hepatitis B is usually asymptomatic and often spreads undetected until middle age, when one in four infected people develops liver cancer or cirrhosis.
“It's one of the cancers with the highest mortality rate in the United States,” said Dr. Su Wang, medical director of the viral hepatitis programs and the Center for Asian Health at Cooperman Barnabas Medical Center in New Jersey, who lives with the disease. “The life expectancy we give people is on average six months.”
Opponents of current vaccine leadership include Kennedy, Surgeon General nominee Casey Means and President Trump—characterize the virus as a result of risky “adult” behavior, including sex and intravenous drug use.
“Hepatitis B is sexually transmitted,” Trump said at a White House news conference in September. “There is no point in infecting an almost newly born child with hepatitis B.”
But experts say that's not how most people get sick.
“The virus is primarily transmitted from mother to child,” said Dr. Chari Cohen, president of the Hepatitis B Foundation.
Most infected mothers are immigrants, especially from Philippines, China and Vietnam — Make birth vaccination an urgent priority for many California families.
For some administration officials and commissioners, the disease's prevalence among immigrants is a talking point.
“The elephant in the room is immigration: We've had years of illegal immigration, undocumented people coming from countries with higher endemicity,” said Dr. Evelyn Griffin, one of the group's most vocal proponents of change.
“We have problems that adults need to solve with our resources, rather than asking children to solve the problem for us,” she said.
Griffin and other opponents of the current vaccination schedule say vaccinating everyone puts an unfair burden on healthy newborns from nonimmigrant families whose mothers either screen negative or have few risk factors for the disease.
But experts say the proposed alternative to universal prenatal testing and aggressive risk assessment is unrealistic in the current American health care system. Today, fewer than 85% of mothers are screened—a number that experts say will plummet if health care subsidies disappear and Medicaid enrollment declines in the coming months.
“Our previous risk-based vaccination strategy failed,” said Catherine Werner Perez of the Alliance for Aging Research. “Before the transition to universal vaccination in 1991, nearly 20,000 infants and children were infected annually in the United States.”
For infants exposed to a blood-borne virus in utero or during birth, every minute a vaccination is delayed increases the risk of transmission. That reality has prompted U.S. public health officials to increase the first dose from early childhood, when it was administered in the 1980s, to the first 24 hours of life, a recommendation the CDC has followed since 1991.
“[The vaccine] saved thousands, if not millions of lives in the US alone,” Cohen said. “There is more data on the safety and effectiveness of the hepatitis B vaccine than on anything else we put into our bodies.”
Data shows that those who contract hepatitis as infants are much more likely to develop chronic and ultimately fatal infections than those who contract it as adults.
Because the virus can live on surfaces for up to a week, doctors and public health experts stress that children can become infected with it even from seemingly minor exposure. Caregivers may not know they have the disease and are unlikely to get tested, making dosing at birth more relevant, they said.
“The mother is not the only person around the child,” said Wang, who told the commission Thursday that she likely contracted the disease from her grandparents. “There are grandparents, caregivers, other young children. Essentially, you're leaving that child vulnerable.”
Evidence shows that even a small cut caused by common nail clippers runs the risk of becoming infected.
Kennedy and his allies on the panel counter that most babies don't need the vaccine and that delaying it would give parents the opportunity to engage in “shared clinical decision-making” about whether and when to get the shot.
However, the commission has so far struggled to unite around an alternative recommendation. Thursday's scheduled vote was tabled in part because the proposed language remained in flux even during the meeting.
“This is the third version of questions that most of ACIP received in 72 hours,” Hibbeln said.
Hibbeln and fellow panelist Dr. Cody Meissner were vocal opponents of changing the birth dose recommendation when it was first discussed in September.
“We will create new unjustified doubts in the public mind,” Meissner said.
Others said the move would not go far enough.
“I don’t see any argument at all for vaccinating young children living in normal environments,” panellist Dr. Retzef Levy said in September.
Experts have warned that in addition to limiting public coverage of the vaccine, the change in recommendations could also force privately insured parents to go through layers of complex authorizations to access the birth dose.
Many feared the decision could further stigmatize the vaccine at a time when many parents are refusing it simply because the recommendation is pending.
“States and hospitals are reporting declines in hepatitis B vaccination rates,” said Kayla Intabandit of the Center for Health Equity in Rural and Underserved Communities. “Even some mothers living with hepatitis B refuse doses at birth, putting their babies at greatest risk of infection.”
Experts have warned that moving the recommendation from the first day of life to the second month could lead to 1,400 new infections a year.
“Any child who gets hepatitis B because we changed the policy is one too many,” said Dr. Judith Schlay. “I want us to make sure that no child gets hepatitis B.”
