Special Update: Dysfunction at ACIP

Chris Dall: Hello and welcome to the Osterholm Update, a podcast on COVID-19 and other infectious diseases, with Doctor Michael Osterholm. Doctor Osterholm is an internationally recognized medical detective and Director of the Center for Infectious Disease Research and Policy, or CIDRAP, at the University of Minnesota. In this podcast, Doctor Osterholm draws on nearly 50 years of experience investigating infectious disease outbreaks to provide straight talk on the latest infectious disease and public health threats. I'm Chris Dall. Reporter for CIDRAP news. And I'm your host for these conversations. Hello, everyone, and welcome to a special episode of the Osterholm Update Podcast. We're here today to do what we promised we would do in our last episode, give you a quick recap of last week's meeting of the Advisory Committee on Immunization Practices, or ACIP, which meant to discuss recommendations for updated COVID-19 vaccines, as well as two vaccines that are on the childhood immunization schedule. We're going to start with the recommendations that were made for COVID-19 vaccines on Friday, the second day of the ACIP meeting. So, Mike, can you lay out for our listeners what ACIP recommended and what this discussion was like on Friday?

Dr. Osterholm: Thanks, Chris. As we promised last week, we would give you an update today. And I must say, in sharing this update with you, I have never seen a federal agency meeting like I saw on Thursday and Friday in my 50-year career. It was remarkable in a number of different ways. First of all, I have actually seen student council meetings of high school students run with more efficiency and effectiveness that I actually saw this meeting on Thursday and Friday. Again, I don't say that to in any way impugn any of the individuals, but it just showed how little preparation really had gone into the meeting in terms of understanding what was before them. A good example was, in fact votes that were taken in which on a hot mic, members actually said, I don't know what we just voted for. I mean, that actually happened. You can't make that up. And the questions were often when posed to the members to vote on every individual rather than answering yes or no, said, well, yes, if this, this, this and this, but this, this and this were never discussed as part of the actual question that was being called. So, I can't tell you for sure what it all means. In addition, I just want to add that as much as that meeting came to a conclusion with certain votes, which I'll talk about today, please don't forget, in the end it's up to the acting director of the CDC, or likely the Secretary of Health and Human Services, who will ultimately decide what in fact these questions actually meant in terms of a vote.

Dr. Osterholm: What I mean by that in the past, there have been rare examples where the director of the CDC did not accept an ACIP recommendation and reversed that. I will today highlight 1 or 2 questions I think is very likely yet to be called by the acting director of the CDC or the head of HHS, i.e., Mr. Kennedy. But let me just highlight, Chris, the point that you asked about, and that's Covid. The Covid vaccine discussion on Friday was steered by lines of questioning that came from a working group led by Retsef Levi, professor of operations management at the MIT Sloan School of Management and a known critic of Covid vaccines. Throughout the course of the meeting, it was clear and apparent his lack of understanding of basic principles of infectious diseases and immunology. Levi focused heavily on safety concerns, the effectiveness of the vaccines, a purported lack of research, and several uncertainties, including whether the vaccine causes long term health problems that are similar to long Covid. He also said that mRNA vaccines need more rigorous purity studies. The ultimate takeaway from this presentation was that the CDC had not adequately acknowledged safety concerns, and many of the ACIP members seem to share this view. I might add that there were a number of real experts on mRNA technology who have commented in the media in the past two days demonstrating how these comments held no merit whatsoever.

Dr. Osterholm: A very thoughtful piece in STAT news, Drew Weissman, the Nobel Prize laureate co-winner for his work on mRNA, actually had a very pointed comment about the lack of understanding by this group of what mRNA technology is all about. Some CDC staff did their best to provide the most accurate information possible on the safety and efficacy of COVID-19 vaccines to all the members of the committee, only to have Levy suggest that the data they presented was low quality. Well, I will just tell you right now that the data that he presented was of almost zero quality. So, in fact, it gives you a comparison here as to what this was all about. After a long day discussion, ACIP voted unanimously for a more limited recommendation for COVID-19 vaccines than in previous years. For 65 years of age and older, they recommended vaccination based on individual based decision making. With shared decision making is meant to imply is that you have to have this discussion with your healthcare provider, and yet it's still unclear completely what that means. And what I mean by that is who in healthcare actually can be considered a consult in terms of shared decision making? Can a pharmacist actually qualify for that? And in some states, it's likely they don't. Fortunately, the committee rejected a proposal to recommend the states and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine, which would limit access even further.

Dr. Osterholm: Note that this particular vote was 6 to 6, with the tie going to the chair's vote, which was not to recommend prescriptions. This is one that I really, honestly believe is going to be reconsidered by the Department of Health and Human Services. Don't be surprised if in the end, a prescription is actually required. And let me also say that if that happens, that will again just create another barrier to obtaining a Covid vaccine, because how many of us can readily get in to see a healthcare provider to get a prescription? How many of us do not have a healthcare provider that can provide such a prescription? How will we in fact interpret what shared decision making actually means? Does that mean that a healthcare provider has to spend ten, 15, 20 minutes with you going through all the aspects of the vaccine? Well, we know that's never going to happen. So, talk about barriers. Again, remember this is the issue of vaccines versus vaccination. We may have vaccines available, but to get them as a vaccination could be very very difficult. And two other separate votes, the group recommended that the CDC add more language about risk and uncertainties of COVID-19 vaccines to vaccine information statements and that healthcare providers, as I just noted, talk to patients about risk and benefits of vaccination and known risk factors regarding Covid.

Dr. Osterholm: Well, many of the aspects of vaccine risk that they discussed at this meeting simply do not have a valid scientific place. So, at this point, all I can say is that there's still a lot that we don't really understand in terms of what the results of this Friday meeting actually mean. HHS wrote in a press statement released shortly after the vote. Quote, individual decision making is referred to on the CDC's adult and child immunization schedules is vaccinations based on shared clinical decision making, which references providers including physicians, nurses and pharmacists. It allows for immunization coverage through all payment mechanisms, including entitlement programs such as the vaccine for Children's Program, Children's Health Insurance Program, Medicaid and Medicare, as well as insurance plans through the federal health insurance marketplace. Now, however, there is a challenge here in that in a number of states, if you use a vaccine off label, you may need, in fact, to have a medical care provider other than a pharmacist to provide you with the approval for you to get the vaccine. As was noted by a number of our colleagues after the Friday meeting, it's very clear that shared clinical decision making means different barriers in different states. Some will require a prescription, some won't. Previous ACIP members have clearly tried to move us from shared clinical decision making because of the barriers that it presents.

Chris Dall: Mike, traditionally, ACIP has clarified the vaccination recommendations. It seems like in this case, what's happened is they've made a muddy picture even muddier.

Dr. Osterholm: Chris, I don't know how many ways you can screw up a meeting in terms of actions taken, what votes mean, how votes were taken, or what was shared and not challenged when it was clear to experts there that in fact, it was misinformation that was being shared. So, you're absolutely right. There was more clarity to this situation prior to the meeting. And already many of you know, it was not clear before the meeting. But what this meeting has done has only further muddied the waters, as you've said.

Chris Dall: As I noted, there were also discussions and votes on two childhood vaccines. The measles, mumps, rubella and varicella vaccines and the hepatitis B vaccine. What happened there, Mike?

Dr. Osterholm: Well, Chris, I can unfortunately report it was more of the same. Thursday's discussion began with the topic, as you noted, of a combined measles, mumps, rubella and varicella vaccine and the increased risk of febrile seizures with that first dose that is given in the two-dose series. The slightly increased risk of febrile seizures is well known in the MMRV compared to the MMR, and is one that in fact has already been noted that healthcare providers should discuss with parents, do they want to have two separate injections at the time of the first doses, or do they want to actually go with the single dose combined vaccine? These febrile seizures do not cause severe or long-term health consequences, but they can be at the moment, very scary for parents. Currently, providers and parents have the option to discuss. Do I want the MMR and the VIH separately to injections, or do I want to go with MMRV of the single dose vaccine. The final vote from the ACIP was to no longer recommend MMR vaccine under the age of four, and only recommend MMR and varicella vaccine separately between 12 to 15 months of age. This is really not any different than we had before, except instead of previously recommending again, it was the opportunity for the healthcare provider to have that discussion with the parent. It became clear during the ACIP meeting that many of the members did not understand the significance of voting on coverage of MMR under the vaccines for children program, a federally funded program that allows for uninsured, underinsured, and other vulnerable children to receive affordable vaccines.

Dr. Osterholm: This is why having subject matter experts on committees like this is so important. And to me, another jarring moment where the lack of expertise of the committee was incredibly clear was Doctor Malone's question on adjuvants in MMRV vaccines MMRV is a live attenuated vaccine and therefore does not contain adjuvants. While this may not be general knowledge that most of the public is aware of, it is something that people voting on vaccine availability should understand. In a confusing turn of events, an unprecedented in my experience in public health, the committee voted on Thursday to maintain coverage for the MMRV vaccine under the vaccine for children's program, i.e., for those younger children. However, that would be inconsistent with the vote that they took earlier to in fact limit that MMR vaccine to only those for second dose. Because of this inconsistency, they then had to revote again on Friday to reverse their previous decision to align with the general recommendations for children under four. This chaos and disorganization was simply incredible. This was also at the point where that hot mic picked up one of the members actually saying, what did we just vote for? The other vaccine discussed on Thursday's meeting is the hepatitis B vaccine, which has received a lot of scrutiny from anti-vaxxers despite its incredibly strong safety profile.

Dr. Osterholm: The first dose of hepatitis B vaccine is typically given within 24 hours of birth, and the second 1 to 2 months of age. The Secretary of Health and Human Services and his supporters have cast doubt on the safety and utility of this vaccine, especially for newborns, despite this being a very vulnerable age for hepatitis B infection. Prior to the universal hepatitis B recommendation, we still saw up to 20,000 new infections in children in this country every year. With this particular new universal recommendation, women who are not previously screened, who may be infected, or those who children who are in high risk family situations where limited blood contact, even something as simple as sharing toothbrushes could result in transmission. Until this universe recommendation came in place, we were not doing what we could to control hepatitis B transmission in kids. So, this is really an important message to get across. Does every child need to be vaccinated exactly at birth to prevent transmission? No. But the only way to catch all of the kids coming through that safety net system is, in fact, to do that. And because of the incredible safety profile of this vaccine and its long-term effectiveness in terms of protection, even into adulthood after having been vaccinated as a child is really remarkable.

Dr. Osterholm: So, the conversation at the meeting revolved around whether to rely on test results of the birth mother during pregnancy as a strategy to delay the dose given to babies. While this may seem like a reasonable suggestion, as I just noted, it is impractical and is not taking into consideration the fact that in our country, a country that has a health care system very different than we've seen in countries in Europe or Asia, where they do assure that every mother is adequately screened before delivery. Fortunately, the hepatitis B vote was tabled for now and will be determined at a future meeting. I'm very concerned about this. I don't want to see us go back to 20,000 new cases of hepatitis B in children a year in this country. It just simply is unnecessary and should be unacceptable. So, we'll see what happens. But in short, Chris, all I can tell you is that this was by far the most difficult professional meeting I've ever participated in or listened to. And all I can say is, I can imagine what's coming down the pike. And again, everyone be aware that all the recommendations I just talked about could be totally undone in just a moment. If, in fact, the acting director of the CDC or the Secretary of Health and Human Services decides to go in a different way.

Chris Dall: Well, we hope this has been helpful to you, our listeners. As Doctor Osterholm noted, we will likely have more information, maybe different information, for our next episode on October 2nd. Thank you. Thanks for listening to the latest episode of the Osterholm update. If you enjoyed the podcast, please subscribe, rate, and review wherever you get your podcasts, and be sure to keep up with the latest infectious disease news by visiting our website CIDRAP.umn.edu. This podcast is supported in part by you, our listeners. If you would like to donate, please go to CIDRAP.umn.edu The Osterholm Update is produced by Sydney Redepenning and Elise Holmes. Our researchers are Cory Anderson, Meredith Arpey, Leah Moat, Emily Smith, Clare Stoddart, Angela Ulrich, and Mary Van Beusekom.