What’s Happening with the Hepatitis B Vaccine?

The Advisory Committee on Immunization Practices (ACIP) met again on December 4 and 5 to discuss its stance on the hepatitis B vaccine, the childhood vaccine schedule, and aluminum adjuvants. They previously met in September when they discussed the MMRV, hepatitis B, and COVID vaccines. At that time, they did not make significant changes to the vaccine schedule; they tabled a vote on hepatitis B.

Since September, the landscape of vaccines has become even more confusing. The CDC updated its website on vaccines to suggest that they do cause autism (they do not). The AAP has issued its own vaccine schedule, which some practices are now following. It’s too much to address all of this here, but below is a brief update on the most recent changes and what it means for vaccines right now.

Hepatitis B vaccine

Hepatitis B is a significant cause of liver cancer and liver failure. It’s much more serious if it is acquired early in life, since at that stage, infection is very likely to lead to becoming a carrier.

Transmission from mother to child is very likely if the mother is a hepatitis B carrier and the infant is not vaccinated. This is why hepatitis B vaccines are given at birth; this policy of universal vaccination at birth has proved highly effective at reducing hepatitis B rates.

ACIP voted on two questions. First, they voted to move away from the universal at-birth vaccination recommendation. More specifically, they voted to recommend that if a woman has tested negative for hepatitis B, the decision about giving a birth dose should be made in consultation with their doctor. Second, they voted to recommend that babies be tested to see if they responded to the vaccine before giving additional doses later in the first year.

The first of these decisions is the more consequential. The second recommendation is likely to be difficult to implement, and it’s unclear whether anyone will follow through on this.

There was considerable discussion of this first decision. On the one hand, many other countries do not give this vaccine at birth to women who are negative for hepatitis B. On the other hand, there is no reason to make this change. The committee wasn’t reacting to any safety signal or anything else, so it’s unclear why this would be changed. During the discussion, many members of the committee were visibly and audibly angry.

The individuals who favored the vote argued that the immediate transmission risk for babies whose mothers are known to be negative is vanishingly small, so a shared decision-making model makes more sense. Those who opposed it felt that this would put people at risk unnecessarily — some babies might never get vaccinated if it wasn’t done at birth, for example. They also felt clearly that there was no point in this change because there are no downsides to giving a baby the hepatitis B vaccine at birth.

Many people will wonder whether this change affects their access to this vaccine. The answer is for now, no. The new recommendations indicate that vaccines should be available to everyone as long as they want it, and they should be universal for women who are positive for Hepatitis B or whose status is unknown. The big concern here is for people with more limited access to healthcare, who may simply fall through the cracks.

Decision: If a woman has tested negative for hepatitis B, the decision about giving a birth dose should be made in consultation with their doctor. There is a suggestion that babies may be tested to see if they responded to the vaccine before giving additional doses, but limited information on how this will be implemented.

Childhood vaccine schedule

The second part of the meeting was taken up with two broader presentations on the childhood vaccine schedule. One was by Aaron Siri, a vaccine injury lawyer; the second was by Dr. Tracy Hoeg, an FDA scientist. The former caused the most consternation.

Mr. Siri presented a laundry list of vaccine skeptic talking points — that vaccines are not placebo-tested, that there are too many vaccines, etc. His core argument was that there should be no vaccine mandates at all, and all vaccine decisions should be made with individual consultation with doctors. I have talked through many of these issues before. Several committee members pushed back on this presentation, but there was limited time to do so.

Dr. Tracy Hoeg discussed the comparison between the childhood vaccine schedules in Denmark and the U.S. Point: There are fewer vaccines given in Denmark. There was limited time for discussion on this one. One issue raised in the discussion was the issue that the health care system and population of Denmark are different, and this may drive the necessity of different approaches.

Decision: No vote was planned on either of these.

Aluminum adjuvants

Finally, there was a presentation on aluminum adjuvants. Many vaccines (not all) contain a form of aluminum as an adjuvant – this improves the response of the immune system and makes the vaccines work better. This has been a concern for some people for many years, despite a fair amount of evidence that it shouldn’t be.

The presentation was short and argued that these concerns should be discussed more carefully in a working group to decide if ACIP should be recommending against the use of these products. This change would be very significant — it would require reformulating a lot of existing vaccines, which would clearly reduce access, at least in the short term.

The proposal here was to create a working group to discuss this. Some committee members felt this was a waste of time, given the data we already have.

Decision: There was no planned vote on this.

Closing thoughts

The practical change to hepatitis B vaccination at this meeting was fairly small. What is far more concerning is the tone of the meeting — many presentations made questioning vaccine safety, giving light to discredited and problematic evidence. One has the feel of a start of something larger — an attempt to dramatically limit the use of vaccines in children. The committee meets again in February, at which point they may take up some of these broader changes.

In this, the first step is to reduce trust in these products, despite decades of safety data. Unfortunately, that is already happening.