By Zachary Stieber
Contributing Writer
The Centers for Disease Control and Prevention’s vaccine advisory panel postponed a vote on delaying the first dose of the hepatitis B vaccine to weigh whether the vaccine should be removed from the childhood schedule altogether, one of the advisers said last week.
“A lot of people don’t understand what transpired there, but for me, I was faced with a decision of either voting to delay it for one month or voting against that motion and functionally endorsing administering hepatitis B vaccine at birth, continuing the standard,” Dr. Robert Malone, a member of the CDC’s Advisory Committee on Immunization Practices, said in remarks during a call held by MAHA Action, a nonprofit that says it helps advance the Make America Healthy Again agenda.
“And instead what I did was make a motion and … virtually all committee members except for the chair endorsed that: ‘No, we’re not ready to make that decision. We need to postpone that because we need to really have the data to address whether or not hepatitis B vaccine should be administered to children at all,”” Malone said.
Hepatitis B is a liver disease that can, in some cases, result in serious complications, including death. It can spread in multiple ways, including through bodily fluids from infected people or from an infected pregnant woman to her baby.
During their mid-September meeting, ACIP members pored over data on hepatitis B and the first dose of the vaccine, which is recommended by the CDC shortly after birth and is often administered in the hospital following delivery.
ACIP had been slated to vote on changing the first dose recommendation from within hours of birth to a minimum of one month after birth, for children born to mothers who test negative for hepatitis B.
That timing was decided because the second dose is recommended at one to two months of age, Martin Kulldorff, the chair of ACIP, said during the meeting.
Just before the vote was held, Malone introduced a motion to table, which passed 11-1.
Malone and another member, Vicky Pebsworth, stated that they were concerned with the CDC’s claim that the Institute of Medicine — now known as the National Academy of Medicine — had found the vaccine to be “safe and effective.”
The academy stated in its most recent report — in 2012 — that due to insufficient evidence, it could not determine whether the vaccine causes or does not cause 26 conditions, including Guillain-Barré syndrome.
The only condition for which it issued a conclusion was anaphylaxis, stating that the available evidence indicated the vaccine causes allergic shock in individuals sensitive to yeast.
Other advisers said they opposed changing the hepatitis B schedule at all.
The full schedule in the United States is three doses, with the third recommended between 6 months and 18 months of age.
“Any potential changes to the childhood vaccine schedule will be based on the latest available science and only after the ACIP recommends it and the acting CDC director reviews and approves those recommendations,” a Department of Health and Human Services spokesperson previously wrote in an email.
President Donald Trump last week called for spacing out vaccines and delaying the hepatitis B vaccine to 12 years of age.
Trump “endorsed that the hepatitis B vaccine as a dose to be administered to children and newborns made no sense at all, which many of us have been saying forever,” Malone said on the call.
Many other countries that recommend the hepatitis B vaccine advise starting the regimen at two or three months of age, or even later. Others, including Denmark, do not recommend it at all, outside of at-risk populations, such as children born to hepatitis B-positive mothers.
A 2003 Danish assessment of the possible introduction of the vaccine as a routine vaccination “did not give a clear recommendation for or against vaccination against hepatitis B, but highlighted both potential benefits and disadvantages,” a spokesperson for the Danish Health Authority wrote in an email.
Based on the assessment, the authority decided on “strengthening the existing risk-based strategy, focusing on testing, vaccination, and information targeted at vulnerable groups, instead of introducing the vaccine to the national vaccination program for children.”