The CDC’s Advisory Committee on Immunization Practices voted Friday morning to change its recommendation on hepatitis B vaccines for newborns.
For more than three decades, the agency has recommended that all infants receive a hepatitis B vaccine, regardless of their risk status. Now, the vaccine will only be recommended for infants born to mothers who test positive for the infection or whose status is unknown. The committee’s decision still needs approval from the CDC’s acting director.
A group of researchers conducted a modeling study to assess the impacts of delaying the vaccine. The study has not yet been peer reviewed, but it found that delaying the vaccine by even two months could lead to more than 1,400 preventable hepatitis B infections and more than $222 million in additional health care costs.
Eric Hall is an assistant professor of epidemiology in the OHSU-PSU School of Public Health. He led the study and joins us with more details.
Note: The following transcript was transcribed digitally and validated for accuracy, readability and formatting by an OPB volunteer.
Dave Miller: This is Think Out Loud on OPB. I’m Dave Miller. The CDC’s Advisory Committee on Immunization Practices voted this morning to change its recommendations for hepatitis B vaccines for newborns. For more than three decades, the agency has recommended that all infants receive a hep B shot shortly after birth. Under the new guidelines, the vaccine would only be recommended for infants born to mothers who test positive for the infection and maybe for those whose status is unknown. But even after the vote, that’s not totally clear right now. The change was made after Health and Human Services Secretary Robert F. Kennedy Jr., got rid of members of the existing advisory committee and replaced them with a number of vaccine skeptics.
Meanwhile, a group of researchers recently conducted a modeling study to assess the impacts of delaying the hep B vaccine. Their study has not yet been peer reviewed, but it found that delaying the vaccine by even two months could lead to more than 1,400 otherwise preventable hepatitis B infections and more than $220 million in additional health care costs.
Eric Hall is an assistant professor of epidemiology in the OHSU-PSU School of Public Health. He led the study and he joins us now. It’s great to have you in the studio.
Eric Hall: Thank you. I’m happy to be here and thank you for having me today.
Miller: What is hepatitis B?
Hall: Yeah, so hepatitis B is a virus. It’s an infectious disease that can be transmitted from person to person. And it is transmitted when people come into contact with contaminated body fluids – typically blood, but it could be other types of body fluids as well. We know a lot about transmission and we know there are a few key ways that transmission typically occurs. And one of those ways is when an infected birth parent or mother has hepatitis B and gives birth to a newborn infant, there’s a high risk of transmission to that infant, if there are not any interventions at that point in time.
Miller: What does hepatitis B do to people?
Hall: Hepatitis B leads to inflammation of the liver. In some people it will just be kind of a short acute infection that will spontaneously clear. But in others it develops into a long term chronic health problem, and that long-term problem can lead to much more severe consequences such as cirrhosis, liver cancer and unfortunately early death. It’s important to note that hepatitis B cannot be cured. So when someone becomes infected and develops these chronic conditions, they will be living with and trying to manage this disease for the rest of their life.
Miller: How prevalent is hepatitis B in the U.S. right now? And how has that changed over the decades?
Hall: That’s a great question. In the U.S. right now, hepatitis B is – I would need to look up the exact prevalence – a pretty low prevalence and that has primarily been driven by a lot of our prevention efforts over the past three to four decades.
As I mentioned, the disease cannot be cured. So in public health, our best tool for ensuring people are protected and not experiencing the poor health outcomes that are a result of hepatitis B, we really try to focus on prevention. And in preventing new infections, our best tool for that is vaccination. So our vaccination strategy has evolved over time, but the key cornerstone to that has been the infant vaccination program here in the United States that has really driven down the number of infections that we see, not only among children but among all people as those children grow into adults.
Miller: How much do we know about the impact that universal newborn vaccination has had?
Hall: We know a lot. As I mentioned, our national vaccination strategy has evolved over time. And in 1991, that strategy evolved to recommend vaccination for all newborns shortly after birth. We can look at data on the number of new infections that have occurred among infants and children from that time frame till now. And since 1991 up until now, there’s been a 99% decrease in the number of infections that occur among children.
Miller: The question of hep B vaccine recommendations was supposed to be voted on at this committee’s meeting three months ago. What happened?
Hall: To my knowledge, the first time the advisory committee on immunization practices began discussing delaying the infant hepatitis B vaccination schedule was at the September meeting that you’re talking about. I attended that meeting. I watched very closely. This is an interest of mine both professionally and personally. And it became clear as that meeting was unfolding that there was some confusion around the exact implications of the policy that they were voting on, the wording and how that policy would play out. So, at that meeting, they ended up kind of delaying their process, delaying the vote and pushing it to the meeting this week.
Miller: Can you give us some context here? And we should say, just for the big picture of how this works, that they give these recommendations to the CDC, and then the CDC is the one that actually puts out the official guidance or official federal recommendations for the rest of the country. But how has this committee proceeded in the past when it would consider questions like who should get a particular vaccine, when?
Hall: The first part of what you were saying there, the recommendations that come from the advisory committee on immunization practices, historically, essentially serve as our federal policies around vaccination and how to use vaccines here in the United States. So as you mentioned, the recommendations then go to CDC and the CDC director typically signs off on them, and then that becomes our federal policy here in the United States.
Now, the way that plays out is different states have different laws and statutes that are tied or could potentially be tied to these federal recommendations and federal policies. So the actual ramifications in any given state can differ based on these recommendations, but they’re very influential and they’re very important in vaccine access here in the United States.
Miller: That’s what happens after ACIP makes its recommendations. I’m curious about what’s changed in terms of the way they consider data, the kind of data they consider, the kinds of conversations they have, the makeup and curriculum vitae of the people on the committee. How has that changed in the last few months?
Hall: Yeah, another excellent question. So historically, the ACIP uses a very rigorous and thorough process in which they evaluate evidence and data across a variety of domains. And they’ve actually outlined and documented this process through something called the evidence to recommendations framework. Now, this framework involves looking at different pieces of evidence and data across many domains. Some of those include thinking about what are the potential benefits of a policy change, what are the potential harms of this policy change? Is this policy change an efficient and responsible use of financial resources? Does this policy change have an impact on health equity? What is the magnitude of the health problem that this policy change is trying to address?
Historically, they evaluate evidence across all these different domains and they use something called grade, which is a way of kind of grading and looking at how strong the evidence is in each of these domains. Then when they make a recommendation, they publish all the evidence that went into their evaluation of each of these different domains. And that is a very transparent way for us to understand how they arrive at their decisions.
Miller: How much of that happened yesterday or this morning?
Hall: I would say not a lot. And I would say it hasn’t been happening at least since the September meeting. That’s where my work entered the equation here. I was watching the September meeting. And I have previous experience conducting analysis that I’ve presented to previous versions of ACIP. And I know lots of people that have experience either with work groups or on the voting committee in previous iterations. So we’re watching the September meeting and we noticed that they were missing key pieces of evidence across some of these domains. In particular, for this vote, they were missing evidence on potential harms, potential benefits, and the use of financial resources or economic analysis.
So my team, we came together and we quickly realized that we could leverage our expertise. We could leverage our knowledge of the evidence to recommendation framework. We could build upon our previous modeling work to help provide some of this evidence for them to use at this meeting here. And that’s what led us into starting our work.
Miller: OK. So what did you learn? I gave sort of the one-sentence version in my intro, but what did you find specifically when you looked at the impact that delaying the hep B vaccine for newborns would have?
Hall: In our study, again, we started after the September meeting when it was unclear exactly what policy or how long of a delay this committee was considering. So we modeled several different scenarios and what we found is that delaying the infant hepatitis B vaccination schedule at all would result in additional preventable hepatitis B infections, additional severe health complications and sharp increases in health care spending.
Specific to the conversations that they’ve been having at this meeting, we looked at and we modeled delaying infant hepatitis B vaccination to two months, and we found that delaying the current recommended birth dose two months among all infants whose mothers are not known to be living with hepatitis B, there could be at least 1,400 preventable hepatitis B infections among children, which could result in over $222 million in health care spending. Now, even if these delays are only restricted to children that are born to birth parents that have been confirmed or tested negative for hepatitis B, we would still see an additional, at least, 230 infections and an additional $21 million in health care costs for each year that this recommendation would be in place.
Miller: And that’s just two months. So, that assumes that after two months, those kids did get those shots?
Hall: So yeah, so in our modeling study, those numbers that I just presented assume that all those children would receive vaccination at two months in time. The further vaccination is pushed out, the larger those numbers would be.
Miller: Now, when I did my intro, I said that for kids whose mothers test positive for hepatitis B, the recommendations stay the same, that those kids should get the hep B vaccination if the CDC takes this committee’s recommendations. But I have seen, this morning, conflicting reports about what the committee is recommending for mothers whose hep B status is unknown, for whom there was no testing. Some places have reported that the committee says that they should get the shot. Some have said no, they should talk to their doctor first. Why is there such confusion?
Hall: Confusion in terms of the resulting vote?
Miller: Yeah, of what this vote means? It’s an important question.
Hall: Yeah. It is a very important question. And I think the confusion arises … I mean, I still have some confusion myself. This vote just happened a couple hours ago and it’s hard to understand exactly what the final signed-off recommendation and policy is going to look like. All of the language that they voted on today was centered around changing the recommendation for infants born to birth parents who have tested negative for hepatitis B. In the meeting, they declared that they are not going to change any recommendations around infants born to birth parents who have tested positive for hepatitis B. But it was unclear what will happen to the existing recommendation for infants born to birth parents whose hepatitis B status is unknown.
And I just want to add in, that’s a very, very important group when thinking about the idea of risk-based recommendations versus universal recommendations. Unfortunately, here in the United States, our health care system is not perfect. Our prenatal care is not perfect, and we have many people who are pregnant who either don’t access prenatal care, don’t access consistent prenatal care and might not be tested for hepatitis B in their pregnancy. It’s estimated up to 1 in 5 infants are born in a situation in which we don’t know the birth parents’ status. So this is a very significant group and the way we design our public health strategies to make sure we take care of the infants born in this group is important.
Miller: So as you said, you and your colleagues saw that this was going to be taken up by this committee back in September. They delayed it, so you quickly got yourselves into gear and put this report together to look at the likely impact of delaying hep B vaccinations. Do you know if the members of the committee actually read your report?
Hall: I know at least one of them did because he mentioned in the meeting that he did. I can say we …
Miller: Was he one of the ones who voted for the changes, or was he one of the three who said no, we should keep things the way they are?
Hall: This person voted for the change.
Miller: After reading your report?
Hall: Yes.
Miller: I can imagine someone saying these are just recommendations. If someone wants their kid to be vaccinated for hep B at birth, they can just ask for it. I think there is little reason to assume that RFK Jr.’s acting CDC director is not going to accept these recommendations. So everyone assumes at this point this is going to be the new federal recommendation, but what role do they play in practice?
Hall: Yeah, great question. You make a very important point that they are indeed recommendations. They always have been recommendations and they’ve never been requirements or mandates.
Miller: School is a different question.
Hall: School is a different question, but in terms of the ACIP recommendations, that’s not the case. And even our, I guess, now previous version of recommended universal infant vaccination, it was a recommendation and there has always been an individual choice for the infant to receive vaccine or not.
Now, the reason these are important – we’re talking about the recommendations – is that states end up controlling their own vaccination policies and those policies can range from everything to what vaccines are covered either by insurance or by different types of public funding. They can determine who is allowed to administer a vaccine, so scope of practice laws. And it can determine a variety of other things like school requirements. These all differ a little bit from state to state and many of these laws and statutes are tied in directly to the ACIP recommendations. So when ACIP recommendations change, they can automatically trigger changes in some of these state laws and statutes.
Miller: What’s next in terms of your best understanding of what RFK Jr.’s essentially handpicked vaccine recommendation committee will be looking at and might be changing?
Hall: That’s a tough question because I don’t think many of us in the public health community thought six or eight months ago they would be looking at changing the infant hepatitis B vaccination schedule. This has been a great public health success. There has been no new evidence to arise that would indicate there’s any type of risk around hepatitis B vaccination for infants. Honestly, that was originally surprising that this was part of the conversation.
So with that in mind, I’m not entirely sure what’s next. I know today at the meeting, that’s probably still going on, they are talking about looking at the whole childhood immunization schedule together and having conversations around that. They haven’t mentioned any type of votes, proposed policy changes or language around that. So I don’t necessarily know where they’re going with that, but it’s kind of to be seen.
Miller: Eric Hall, thanks very much.
Hall: Thank you.
Miller: Eric Hall is an assistant professor of epidemiology in the OHSU-PSU School of Public Health. He led a recent study that modeled the risks of delaying the hepatitis B vaccine.
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