The centers for disease control and prevention are not expected to change the recommendations for hepatitis B vaccines in newborns, after their advisory panel presented a highly anticipated vote on Friday on the subject.
The panel was expected to recommend delaying the use of the vaccine in babies, currently administered shortly after birth, but some members expressed their frustration due to lack of evidence on side effects and said more discussion was needed. A member also said that the voting language was not clear and could lead to a confusing orientation.
The unorthodox decision follows a chaotic and unconventional voting process for the Immunization Practices Advisory Committee (ACIP), whose 12 members were appointed to the Secretary of Health Robert F. Kennedy Jr. in recent months. Many have expressed skepticism about the safety and efficacy of vaccines.
The members had to vote on Friday about whether to delay the first dose of the hepatitis B vaccine until a child has at least 1 month of age, provided that the mother tries negative for the virus. Currently, the first dose is administered within 24 hours after birth because hepatitis B, an incurable infection that can cause liver disease, cancer and death, can be transmitted from mother to child during childbirth.
The hepatitis B vaccine has become the target of Republican legislators, including Rand Paul in Kentucky, who questions the medical need to protect newborns if their mothers have tried negative for the virus.
The member of the ACIP member, Dr. Robert Malone, said Thursday that the Committee assumed the issue because “a significant population” in the United States has concerns about vaccine policy, including the hepatitis B vaccine at birth.
However, many public health experts questioned the need to vote without new data to analyze.
Minutes before presenting the subject, the ACIP voted unanimously to recommend trying all pregnant women for hepatitis B. A spokesman for the Department of Health and Human Services said that the test is covered between insurance programs and the objective of the vote was to encourage suppliers and health systems to increase test rates.
At Thursday’s meeting, CDC employees summarized the results of 17 studies, which found that the hepatitis B vaccine is overwhelmingly safe and has helped virtually eliminating hepatitis B infections among newborns. The agency also pointed out that many pregnant women are not examined by hepatitis B in the US. According to CDC, 12-16% of pregnant women in the US are never analyzed by hepatitis B during pregnancy, and even if they are, some cases can be lost.
Several members of ATPIP backed up what they said were omissions in the presentations of the CDC, pointing out individual studies and anecdotes they said they asked questions about the neuro-development side effects.
Two members of the Committee, Malone and Vicky Pebsworth, who have a history of sharing erroneous information about vaccines, said the CDC presentations omitted a 2012 report from the Institute of Medicine. The report said he could not determine if hepatitis B vaccines were associated with brain inflammation because no study had properly analyzed that research question.
“The absence of data that demonstrates statistically lack of security does not mean that the product is safe,” Malone said Friday morning.
Pebsworth also raised concerns about CDC data that show irritability or irritability in some babies who received the hepatitis B vaccine.
“These are not trivial reactions,” said Pebsworth.
However, such symptoms are difficult to attribute to vaccines because babies can be irritable or felling regardless of vaccination.
Dr. Cody Meissner, a pediatrician and the only current member of ACIP that has previously served in the Committee, delayed Pebsworth’s concern, pointing out that irritability or concern “are certainly not objective parameters that should be used to evaluate security.”
He added that no vaccine is 100% safe or effective, but that the Committee was destined to decide whether vaccine protection exceeds possible risks.
“When you apply that to a hepatitis B vaccine of the newborn, I do not think there is any questions that the benefit far exceeds any adverse side effect,” he said.
The cases of acute hepatitis B infections among the children collapsed after the CDC began to recommend a universal dose at birth in 1991.
It is not clear if Acip will visit the issue again in the future. If they do, the links of the National Foundation for Infectious Diseases, the American Medical College and the Adolescent Health and Medicine Society asked the committee to return to a framework for vaccine recommendations that for a long time has guided the decisions of the advisory panel. The framework considers the risk and benefits of a vaccine, whether a recommendation is feasible and how health equity would affect.
Dr. Amy Middleman, a link for the Adolescent Health and Medicine Society, said it is easy to be distracted by contradictory studies.
“I would urge the committee to use the methodical and scientific method to weigh the risks and benefits properly,” he said.
