Part II: The Hepatitis B Vaccine (birth dose)
The Issue – Whether the first dose of hepatitis B vaccine (a three-dose series) should continue to be administered in the hospital within 24 hours of delivery to the newborns of mothers who test negative for hepatitis B infection (specifically, when the laboratory returns a negative test on the mother for hepatitis B surface antigen (HBsAg)) or whether the childhood vaccination schedule should be revised to move the date for the first vaccine of the 3-shot series for these children to 1 month.
Why is the vaccine recommendation being revisited?
That was the key question that went largely unanswered. The current recommendation for all newborns to receive their first dose of vaccine within 24 hours of delivery has been in place since 2018. More and more countries around the world are moving towards this practice, and no country that has had a universal (meaning that all newborns are vaccinated regardless of the mother’s hepatitis B infection status) vaccination policy has moved to more selective vaccination as was the proposed motion before the committee. Further, the results of U.S. hepatitis B vaccine policy and practice have led to dramatic reductions in hepatitis B infections and resulting chronic hepatitis B with its various complications (see below) to the point that the U.S. could now consider the possibility of eliminating hepatitis B.
No one suggested that there was new data that showed any concerns over the same data that has been reviewed in the past and for which the current recommendation was based.
Why do we vaccinate newborns?
In 2022, there were 254 million cases of hepatitis B infections in the world, many of which progress to becoming chronic infections that ultimately lead to the development of cirrhosis with the need for liver transplantation to save the person’s life, to hepatocellular cancer (cancer of the liver), and even death. More than $1 billion dollars is spent in the U.S, on hospital care each year for the treatment of hepatitis B related complications. The annual costs of treating a patient with hepatitis B without severe complications ranges from $25,308 to $93,935 and for treating a patient who requires liver transplantation, those annual costs increase to $174,282 to $324,849.
Many people realize that in adults, the major modes of transmission of hepatitis B infection are through intercourse or intravenous drug abuse (it can be transmitted through blood transfusion, but this has become negligible due to screening of blood prior to transfusion), so they don’t understand the need to vaccinate infants given that they would not have either risk factor. It is important to note that half of those who are infected and contagious with hepatitis B do not have symptoms or know that they are infected.
The reason for vaccination of infants in the first 24 hours following birth is related to the fact that infants become infected in much different ways than do adults; in fact, babies become infected from adults. The major risk is a mother transmitting the virus to the infant during the pregnancy or following birth. If no intervention is taken (vaccination of the infant and treatment of the infant with hepatitis B immune globulin), up to 85 percent of infants born to a mother with hepatitis B infection (recall that half of adults don’t realize or know that they are infected) will develop hepatitis B infection. Unfortunately, 90 percent of infants who are infected by their mothers will develop chronic hepatitis B with risk for development of cirrhosis, cancer and/or death (25 percent die from the infection) or the need for liver transplantation.
Another thing that can be difficult for people to understand is then why not just test the mothers for hepatitis B and just vaccinate the children whose mothers test positive. There are lots of reasons why we fail to identify the mothers who are infected. First, as more women have challenges with access to prenatal care, a lot of times, women don’t receive the recommended screening during the early parts of their pregnancy. Second, we are not good at identifying women who are at increased risk for hepatitis B, and while the mother may initially test negative, there are some of these women who will become infected in the interval between the hepatitis test and delivery. Further, women can receive their pregnancy care from a wide range of providers, and screening doesn’t get done in 100 percent of these cases. Also, there are a number of viral hepatitis tests that tell us different things, and sometimes the results may not be understood correctly, transcribed correctly or communicated correctly resulting in the infant not being vaccinated based on this misunderstanding even though the mother is infected. This has led to some recommending that we just test women at the time of delivery. That can address some of these challenges, but not necessarily all. One factor is that these days, if the birth is a normal, uncomplicated vaginal delivery, the patient could end up being admitted and discharged before the hepatitis test result is ready, especially at rural, critical access, and small hospitals that may not be able to run these tests 24 hours a day.
So, the reality is that we end up with about 12 – 16 percent of pregnant mothers not getting the screening hepatitis B test.
Thus, the three-dose series has been recommended to be given within 24 hours of delivery (“the birth dose”), at 1 – 2 months of age, and at 6 – 15 months of age. The protection from hepatitis B infection in the child increases with each dose (protective antibodies in ~25 percent of infants following dose #1, ~ 63 percent of infants after dose #2, and ~95 percent of infants after dose #3 (it is 98 percent if the infant was born healthy and at full term)). Further, while up to about 5 percent of infants will develop fever following the first dose, the vaccine has been determined to be very safe (the risk of fever, irritability, redness at the injection site, etc. vs the risks posed by hepatitis B infection) and the durability of the vaccine has been amazing with protection lasting more than 30 years in more than 90 percent of those vaccinated, with the likelihood of life-long protection.
If perinatal (around the time of birth) exposure from an infected mother was the only mode of transmission to the infant, then not vaccinating children whose mothers are negative on testing would make complete sense, so long as we could ensure that all mothers were tested and that we had the correct results in time before hospital discharge. However, household members and others who will be in contact with the infant (nannies, babysitters, extended friends and family, day care workers, etc.) also can pose a risk because the virus can be transmitted through exposure to body fluids (e.g., saliva) and a family member who is also infected with hepatitis B but unaware could have a scrape, cut or other injury in the house, and the virus is known to be able to remain viable on surfaces in the home for as long as 7 days and only a miniscule amount of that blood is necessary to cause infection in the infant. An unvaccinated child living in the same household as an infected member of the family can account for 7 – 11 percent of those children becoming infected.
What was the recommendation put before the committee by the chair to be voted upon?
“The pediatric vaccine schedule should be updated to reflect the following change:
If the mother tests hepatitis B surface antigen (HBsAg) negative:
- The first dose of hepatitis B vaccine is not given until the child is at least one month old.
- Infants may receive a dose of hepatitis B vaccine before 1 month according to individual-based decision-making.” (shared clinical decision-making).
What were the arguments against the recommendation?
- We already know from experience before the recommendation was changed to universal vaccination (i.e., when only those infants whose mothers tested positive or their hepatitis B status was unknown), that cases were missed, compliance with the three-dose series was decreased and on-time vaccination was decreased.
- The longer the interval between birth and vaccination in those children who are infected, the worse the outcomes.
- Changing the recommendation when there is no new evidence of compelling reason to do so will lead to provider confusion and confusion on the part of parents, and potentially erode vaccine trust further.
- The consequence of the change would be that the Medicaid, the Children’s Health Insurance Program, (CHIP), and individual and small market health plans would no longer pay for the birth dose vaccines in children whose mothers test negative and the Vaccines for Children Program (VFC) (which pays for vaccines for a little over half of all children in the U.S., including the uninsured, American Indians, Alaska natives and the underinsured who receive their care at federally qualified health centers) would no longer pay for the birth dose vaccine unless ACIP specifically voted against VFC aligning their coverage with the new recommendation.
What was the vote?
This is where things got wild, surprising, and nearly devolved into chaos. The votes on the MMRV vs. MMR + V that I wrote about yesterday and the votes on the hepatitis B birth dose were on the agenda for yesterday. However, after a long day with fatigue setting in, the votes were postponed to Friday. The votes on the MMRV vs MMR + V issue were taken and were as I wrote about yesterday. However, when the vote to modify the childhood vaccination schedule passed, it required a vote to be taken to determine whether the VFC should align their coverage with that new recommendation. It was clear that few understood that while CMS automatically changes coverage in accordance with the new recommendation, the committee must vote as to whether VFC should align coverage with the new recommendation. The motion to vote on didn’t explain any of this, and as members were told that a “yes” vote would mean that parents would have to pay for MMRV if they elected that for their child’s first dose in order to reduce the number of shots the child received and a “no” vote would mean that the VFC, but not CMS, would continue to pay for the MMRV vaccine if a parent elected for their child to receive it, almost no one could wrap their heads around it and there was extensive discussion and questions in an effort to try to understand this, with two members ultimately abstaining from the vote just on the basis that they could not understand the implications of their vote. The motion to align VFC coverage with the new recommendation failed on a 1 – 8 – 3 vote, which I took to mean that members realized that they were effectively taking the medical decision-making away from parents, especially parents that could not afford to pay for the MMRV vaccine, and so while their new recommendation was symbolic, they wanted the vaccine to be covered for if those parents still opted for it, but I was wrong.
Once a speech was given and members realized the confusion that was being created for everyone, there was a motion that passed for reconsideration and a new vote took place in which there remained three abstentions, but 8 of the members changed their vote from no to yes.
Now, all of that was just the votes on the MMRV vs MMR + V issue. While the committee did vote unanimously to recommend that all women be tested for hepatitis B infection during pregnancy (this is what is already in place), I braced myself for what I anticipated would be a vote in favor of changing the birth dose of hepatitis B for infants of mothers who test negative to one month. To my surprise, and based in large part on a complete misunderstanding as to how we assess medication and vaccine safety, the committee voted 11- 1 to table the issue.
What is my take?
Had the issue not been tabled, I would have voted against the new recommendation. There was no new data, no new concerns, and no reason offered as to why a change was needed. Changes to the childhood vaccine schedule are disruptive and require a lot of communication and explanation to a massive health infrastructure across the country. When those changes are needed, they should be made. However, tinkering with the schedule, especially when the lack of expertise on the committee was pretty apparent and multiple liaison organizations expressed grave concerns that there is certain to be more children developing chronic hepatitis B infections is not only deeply concerning, but inconsistent with the supposed MAHA agenda. Unlike many of the vaccine-preventable illnesses, I have seen plenty of cases of chronic hepatitis B disease and I understand its ravages to the human body. It is always difficult to care for patients with severe diseases that threaten their lives; it is a 100-times worse when the disease could have been easily prevented.
Nevertheless, I remain extremely concerned about the potential for ACIP to revisit and alter this well-established universal hepatitis B vaccine recommendation at some point in the future. Today’s decision avoids, at least temporarily, interruptions toward the elimination of this horrible disease in the U.S.
The success of the hepatitis B vaccine is backed by 40 years of evidence. With 1 billion doses administered globally, and a reduction of 99% in acute infections in children 19 and younger in the U.S., the benefits of the vaccine are irrefutable. Weakening the birth dose recommendation would risk reversing decades of progress and undermines public confidence in a vaccine that prevents a leading cause of liver cancer.
I indicated above that the question as to why the birth dose was being revisited was “largely” unanswered. I qualified that because on the second day, and my personal guess is that it was related to all the consternation this issue raised from the public health and medical communities, one committee member (Dr. Malone) offered a “reason” indicating that it was incumbent upon the newly constituted committee to revisit these matters to restore the public’s trust. In fact, he went so far as to suggest that the very question being raised by many of the liaison groups was disingenuous, which I find extremely disingenuous in itself given that I don’t believe that Dr. Malone has been the most prominent, influential, and effective purveyor of COVID-19 vaccine disinformation, but he would certainly be on my top 10 list. I find it ironic when those who are setting fires to houses are the ones alleging that the police need to get the arsons under control.
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