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A summary of presentations from the weekly Summit partner webinars

July 11, 2024 – The latest Summit Summary

Advisory Committee on Immunization Practices (ACIP), Updates from the June 2024 ACIP Meeting – Melinda Wharton, MD, MPH, CDC & Executive Secretary, ACIP

Melinda Wharton, MD, MPH, CDC & Executive Secretary, ACIP, gave updates from the June 2024 ACIP meeting.

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Respiratory Syncytial Virus (RSV) Vaccines – Adults

ACIP approved the recommendation for a single dose RSV vaccination for adults 75 years of age and older and a single dose RSV vaccination for adults 60-74 years of age who are at increased risk of severe RSV disease. These recommendations were adopted by the CDC director on June 26, 2024. The work group did not make a recommendation for adults 50-59 years of age, choosing to postpone that decision until more data become available.

Background & Details
In June 2023, ACIP recommended RSV vaccine for adults 60 years of age and older using shared decision making (SCDM) for a variety of reasons, including existing data gaps, uncertainties regarding effectiveness and risk for certain groups, and limited information about duration of protection and potential need for revaccination.

FDA licensure in 2024

  • In May 2024, Moderna’s RSV Vaccine was licensed for use in persons 60 years of age and older.
  • In June 2024, GSK’s RSV vaccine age indication was lowered to include people 50 to 59 years of age who were at increased risk for lower respiratory tract disease caused by RSV.

Vaccine Effectiveness
There were data presented at the meeting that showed that, under real world conditions, RSV vaccination does provide protection against severe RSV disease among adults 60 years of age and older. There were also data that showed evidence of…

  • Vaccine effectiveness against RSV-associated emergency department visits, hospitalization, and critical illness.
  • Protection for those at high risk of severe RSV disease, including older adults and adults with immunocompromising and underlying conditions.

One remaining area of uncertainty is the risk of Guillain-Barre syndrome post-vaccination. The FDA provided an update on this issue with their study among Medicare beneficiaries, but it will be some time before their analysis of the 2023-2024 season will be complete.

Feedback about Shared Clinical Decision Making (SCDM)
ACIP and CDC have heard that SCDM is difficult to implement, specifically with standing orders. With SCDM conversations, providers are not comfortable with the conversation or feel it is not within their scope of practice (e.g., pharmacists). Providers also have concerns about their ability to complete the particular risk-benefit discussion intended.

Summary of Available Evidence, adults 60 years of age and older
The annual rate of RSV-associated hospitalization rises with increasing age, with a steep surge at 75 years of age. Certain chronic medical conditions also increase the risk, independent of age. Among older adults, RSV can be severe and there can be significant post-hospitalization sequelae.

The work group worked under considerations that suggest that, even with the initial uncertainty about estimated benefits and potential risks of RSV vaccination, there is now evidence of robust protection against RSV-associated hospitalization during the first season for adults 60 years of age and older. There is still uncertainty about the risk of Guillain-Barre syndrome, which warrants attention. The ACIP recommendation is intended to maximize vaccination among people most likely to benefit and minimize vaccination among people least likely to benefit.

DTaP-IPV-Hib-HepB (Vaxelis®) Vaccine

ACIP recommends DTaP-IPV-Hib-HepB (Vaxelis®) should be included with PRP-OMP (PedvaxHIB) in the preferential recommendation for American Indian and Alaska Native infants. The recommendation was also adopted by the CDC director on June 26, 2024.

Background & Details
The PRP-OMP (PedvaxHIB) is preferentially recommended for American Indian and Alaska native infants (who have historically had higher levels of Hib meningitis and at younger ages than the general U.S. population) for its protective antibody response after the first dose. Vaxelis,® the pediatric combination vaccine for DTaP-IPV-Hib-HepB, did not have that preferential recommendation for that population. However, a recent clinical trial showed a comparable immune response after the first dose in American Indian and Alaska native infants.

Chikungunya Vaccine

The work group will continue to discuss considerations and options for use of vaccines in U.S. territories and states with risk of transmission, including acceptability and feasibility. The Bavarian Nordic vaccine is expected to be a topic of discussion at the October ACIP meeting.

Background & Details
The first chikungunya vaccine in the world, Valneva’s live, attenuated vaccine, was licensed in November 2023 as a single dose for adults 18 years of age and older.

  • In February 2024, ACIP recommended the chikungunya vaccine for travelers to outbreak areas and for laboratory workers at risk of exposure.
  • The work group is discussing use in the U.S. territories and states with risk of transmission.
  • There have been chikungunya outbreaks in Puerto Rico, the U.S. Virgin Islands, American Samoa, the Federated States of Micronesia, and the Marshall Islands since 2013.
  • The outbreaks were explosive (e.g., in Puerto Rico, an estimated 30% of the population was likely infected and the majority of those infected had clinical illness). The outbreaks leave a lot of uncertainty in their wake regarding whether and when they will come back, so development of recommendations for use of vaccine will likely be challenging.

There is another chikungunya vaccine, a virus-like particle vaccine, manufactured by Bavarian Nordic. An application for this vaccine has been submitted to the FDA and could be licensed next year.

Dengue Vaccine

ACIP has previously recommended the U.S.-licensed vaccine for prevention of dengue, Dengvaxia, in children 9 to 16 years of age with laboratory confirmation of previous dengue infection AND living in endemic areas.

Background & Details
According to the World Health Organization (WHO), there has been an increase in dengue cases reported globally in the last 5 years – and a pronounced increase in the Americas, where more than 7 million cases were reported during the first four months of 2024. There has also been a 10-year outbreak in Latin America.

  • There has been an ongoing effort to implement Dengue vaccination in Puerto Rico, but requirements for pre-vaccination laboratory testing and the 3-dose series has made implementation challenging.
  • The manufacturer of the vaccine has recently discontinued production due to lack of demand.
  • The CDC website indicates that additional Dengue vaccines are in clinical development and that people can protect themselves by preventing mosquito bites.

COVID-19 Vaccines

ACIP voted to recommend the 2024-2025 COVID 19 vaccines, as authorized or approved by the FDA, for people 6 months of age and older. This recommendation was adopted by the CDC director on June 27, 2024.

Background & Details
The FDA’s advisory committee met on June 5, 2024, to discuss strain selection for the upcoming season. Following that meeting, the FDA advised manufacturers to develop monovalent JN.1 lineage vaccines, with a preference for the KP.2 strain, if possible.

The work group has been discussing recommendations for 2024-2025 COVID-19 vaccines, of which there are three approved by the FDA: two MRNA vaccines for people 6 months of age and older, and one Novavax protein subunit vaccine for people 12 years of age and older.

Alternatives to the age-based recommendations were considered, including risk-based and shared clinical decision making recommendations.

  • A risk-based recommendation would not allow access to COVID-19 vaccines for those not in a defined risk group.
  • Shared clinical decision making would create barriers for vaccination, might not effectively target those at the highest risk, and would likely increase inequities in vaccine access.

The work group also noted that the COVID-19 disease burden continues to be substantial and that consistent recommendations might increase coverage over time. So, along with a universal recommendation, the work group noted that additional implementation efforts should be targeted towards those who will receive the most benefit from COVID-19 vaccination:

  • People over 65 years of age;
  • Those with underlying conditions; and
  • Pregnant people.

Vaccines are expected to be available to ship in late summer or early fall, contingent on FDA authorization or approval, and should be available for administration along with the influenza vaccine.

Influenza Vaccines

ACIP reaffirms the recommendation for annual influenza vaccination of everyone 6 months of age and older without contraindications. This recommendation was adopted by the CDC director on June 27, 2024.

Background & Details
All influenza vaccines marketed in the U.S. for the upcoming season will be trivalent, with H1N1, H3N2, and B/Victoria components, and including an update in the H3N2 component.

ACIP recommended two vaccines, the high dose and adjuvanted influenza vaccines, as acceptable options for people who have had solid organ transplants, without a preference over other age-appropriate, inactivated influenza vaccines or the recombinant vaccine. This recommendation was adopted by the CDC director on June 27, 2024.

Background & Details
ACIP made a recommendation to include both the high dose and adjuvanted influenza vaccines among those vaccines recommended for persons who have had solid organ transplants, who are 18 to 64 years of age. Those who have had solid organ transplants require lifelong immunosuppression, so influenza can be severe in this group.

Update on Current H5 Situation
There was an update on the current H5 situation on dairy farms, including an overview of the three cases that had been identified among farm workers. On July 3, 2024, a fourth case was identified in a farm worker and, fortunately, that caused only mild illness. CDC’s risk assessment is that the overall risk to the public remains low, but there is increased risk with exposure to infected animals or environments and exposed individuals should monitor for symptoms.

Pneumococcal Vaccines

ACIP recommended 21-valent pneumococcal conjugate vaccine (PCV21) as an option for adults who have a current recommendation to receive a dose of pneumococcal conjugate vaccine (PCV). This recommendation was adopted by the CDC director on June 27, 2024.

Background & Details
Merck’s 21-valent pneumococcal conjugate vaccine (PCV21) was licensed by the FDA for use in adults 18 years of age and older on June 17, 2024. This vaccine is very different in composition type from the 20-valent pneumococcal conjugate vaccine (PCV20). PCV21 will likely provide better coverage for prevention of pneumococcal cases because the serotypes included in PCV21 account for a larger proportion of cases of invasive pneumococcal disease among adults, compared to PCV20.

There were policy discussions about lowering the age-based recommendations, but the work group believed that there was insufficient evidence to do so. Several committee members were interested in additional consideration of an age-based recommendation down to 50 years of age due to the higher risk among black adults, and additional discussion of this issue is likely in October 2024.

Meningococcal Vaccines

There is no new recommendation from ACIP for these vaccines.

Background & Details
This work group has two areas of active work: reviewing data on GSK’s combined MenABCWY vaccine, which is expected to be licensed in 2025, and revisiting the adolescent meningococcal vaccine schedule because the combination vaccines don’t work/fit well in the current schedule. The work group is also considering moving from the current shared clinical decision making recommendation for MenB vaccination to a risk-based recommendation.

The work group anticipates presenting the GRADE analysis for the evidence to recommendations framework for these policy considerations, along with cost-effectiveness analysis, at the October 2024 meeting. They will also vote on a revised schedule in February 2025.

Respiratory Syncytial Virus (RSV) Vaccines – Maternal/Pediatric

There is no change in ACIP’s recommendation for use of the maternal and pediatric RSV vaccines for the upcoming season.

Background & Details
There are currently two interventions available to protect infants and young children from RSV: either through maternal RSV vaccination, or the use of nirsevimab in the infant. All infants are recommended to be protected by either maternal RSV vaccination or nirsevimab for the 2024-2025 season.

Post-licensure data from two surveillance platforms indicated that nirsevimab presented effectiveness against RSV-associated hospitalization of more than 90% and also provided high effectiveness against medically attended RSV-associated severe respiratory illness and emergency department visits. ACIP also heard about an effort to vaccinate infants in a remote area of Alaska, which provided nearly complete coverage of newborns and good coverage of other infants. Dramatic impact was demonstrated for infants who received nirsevimab and a report is forthcoming.

At this point, there is no recommendation for repeated maternal vaccination in subsequent pregnancies (after a maternal RSV vaccine in a previous pregnancy), but infants born to persons only vaccinated during a prior pregnancy (not during the current pregnancy) should receive nirsevimab.

Human Papilloma Virus (HPV) Vaccines

An ACIP work group is being formed to consider changes to the existing HPV recommendations, and a first report is expected at the October 2024 meeting.

Background & Details
This vaccine is currently recommended in the U.S. at age 11 to 12 years but can be started as early as age 9. Catch-up vaccination is recommended through age 26, with some adults ages 27 to 45 potentially benefitting, too, with shared decision making. Two or three doses are needed, depending on age.

Anthrax Vaccines

ACIP will be convening an Anthrax vaccine work group to review data and provide recommendations for its use.

Background & Details
In July 2023, CYFENDUS (Anthrax vaccine, absorbed and adjuvanted) was approved by the FDA for post-exposure, prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in people 18 to 65 years of age, when administered in conjunction with recommended antibacterial drugs. It is currently a component of the U.S. government’s strategic national stockpile.

Next Scheduled Meeting
ACIP’s next scheduled meeting is October 23-24, 2024.

QUESTIONS & ANSWERS

Q: With the pneumococcal recommendation and the sliding in of a PCV21, will the clinical considerations from ACIP and CDC probably talk about how to implement PCV21 with someone who has had PCV20?
Melinda Wharton (ACIP/CDC): There is no recommendation for the use of PCV21 in people who previously received PCV20. The current recommendation is that PCV21 is an acceptable vaccine to use along with PCV20 in the context of existing recommendations.

Q: Is there any consideration in the work group that there might be questions from providers about providing that additional benefit to patients?
Melinda Wharton (ACIP/CDC): I can’t comment on what the work group has or hasn’t discussed, but I would be very surprised if there was any permissive guidance about doing that and that has not been discussed. It certainly wasn’t discussed at ACIP.
Kelly Moore (Immunize): As a follow-up to the previous question, because discussion came up with a heavy emphasis on the serogroup 4 prevalence in certain groups where there are outbreaks, and how it was part of the PCV20 vaccine and not PCV21 vaccine. I think there was discussion of that issue, and it raised the question about whether there are policy considerations that are coming. Because I think that may be where people were thinking, “Is there some for certain groups in certain areas based on the epidemiology?”
Melinda Wharton (ACIP/CDC): I expect the clinical considerations might address that to some degree. Certainly, there are communities where there is a lot of type 4, but it’s not a national phenomenon. It seems to be pretty local, so I expect that it will address that, but I don’t know.

Q: For the RSV 75+ routine recommendation, will it be made clearer that this is a one-time vaccination, not annual?
Melinda Wharton (ACIP/CDC): That’s the intent of the ACIP’s recommendation right now. This is recommended on a one-time basis. I can’t speak for what the national communication efforts will be, but certainly that’s what ACIP recommended. And there’s no recommendation for revaccination. I think we’re all really interested in the combination products under development, but there’s no recommendation for revaccination, at this point.

Q: As a follow up, because of the current comprehensive, respiratory viral season effort, RSV seems to be lumped with flu and COVID. So there could be provider confusion.
Melinda Wharton (ACIP/CDC): It’s a great point. It was one thing last year, when it was new and, unless you’re in a clinical trial, you hadn’t gotten it before; but that’s not the case this year. Most people who are age eligible did not receive it last year, but quite a few did, and it will be important that that is communicated to patients.

Q: Did the ACIP or any other group question the inequity of vaccine coverage for those who are now uninsured and will not have bridge access?
Melinda Wharton (ACIP/CDC): The bridge program was wonderful while we had it. It was a bridge. And, until there’s a comprehensive, adequately funded adult immunization program, we will continue to have these inequities in access. And it is tragic, but it’s the way it is right now. Certainly, ACIP frequently comments about the need for a Vaccines For Adults program.
L.J Tan (Immunize): I can also say that, at this June meeting, it was not any different: I heard several members of the committee talk about the importance of access for the uninsured. There’s a lot of advocacy work that’s being done by the Adult Vaccine Access Coalition (AVAC: https://adultvaccinesnow.org/). Look at some of their work, too.

Q: If a person had PCV13 and requests PCV21, is that allowed? Is it covered by insurance?
Melinda Wharton (ACIP/CDC): This is exactly the type of question I shouldn’t try to answer, but I do think in all the baroque complexity of our pneumococcal recommendations there is some guidance about certain people who had received a pneumococcal conjugate vaccine, but not PCV20, being able to get PCV20. ACIP voted to say that if PCV20 was recommended for adults, so either the high risk or the age-based recommendations, PCV20 was an alternative. So, I think the answer is, if they are in a group where PCV20 was permitted, then probably PCV21 is, too, but I should not try to answer a question like that.

Q: Regarding COVID, if someone received that updated 2023-2024 vaccine in the last 4 months, for example, should they wait for the updated 2024-2025? Should they wait 4 months?
Melinda Wharton (ACIP/CDC): The updated clinical guidance isn’t out, yet. It will come out when the vaccines are available. I would anticipate that the recommended minimum interval may very well be included in that clinical guidance. But, since it’s not out yet, I can’t say for sure that it will be, but I think this is one of the reasons there was concern about the timing of the additional dose earlier this year for people over 65: if people get it too late, then it might make it hard for them to get the updated vaccine as soon as it becomes available. So, I expect that that 4-month interval will be there. But, we’ll know when we know.

Q: We’re getting a lot of questions like, “Do I stop using the 2023-2024 version altogether right now?” And the answer I’ve given is, “No, those clinical considerations are in effect until we have new ones published” – is that the correct understanding?
Melinda Wharton (ACIP/CDC): I think that’s right. And regarding the follow-up question, which I expect you’ve gotten from people, “We know there’s an updated vaccine coming, but my 92-year-old mother is getting ready to ‘fill in the blank….” I think those are just difficult individual questions that people are just going to have to wrestle with (i.e., what makes them more, or less, comfortable), because those are not the kind of questions ACIP answers.
Kelly Moore (Immunize): Right, we do our best to help with that. We just want to make sure we’re not clashing. And we’ve gotten exactly that. Folks who are anticipating significant exposures, and they’re quite vulnerable, compromised, or frail and want to know, “Do I get another one now, since I haven’t had one since September?” And our answer has been, “Yes, if you feel like you’re going to be at high risk now, and you haven’t had one since September, and you’re in a group recommended to get another dose, that’s okay. Then we’ll see what the interval is when the new recommendations come out.”

Q: When is the PneumoRecs VaxAdvisor, the CDC app, going to be updated to include PCV21? And when is that going to be available? It’s been a great clinical tool.
Melinda Wharton (ACIP/CDC): I don’t know the answer to that question. I would be very surprised if the team was not going to have it done when the recommendations come out, but I don’t know for sure.

Q: There were some wonderful advances in getting information out more quickly last summer. You know we really appreciated not having to wait for the MMWR publication to get the clinical considerations up online. Do you have any sense of how soon we might see the clinical considerations for the recommendations that have already been accepted by the CDC director, online, as that would help those of us who are writing, say, standing orders, templates, and other resources.
Melinda Wharton (ACIP/CDC): There is probably a lot of variability in terms of when the different things will come out. But, you highlight an important point. It’s something we’re very aware of and I think that’s all I’ll say.

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Announcements
  • The National Adult and Influenza Immunization Summit in-person meeting on August 15-16, 2024 at the Marriott Marquis in Atlanta, GA is full, and the waitlist is closed. NAIIS will continue work to verify expected attendance of registrants and offer opportunities to register based on cancellations to those on the existing waitlist. Those on the waitlist will receive registration emails should a spot open up and should then register as soon as possible.
  • The next National Adult and Influenza Immunization Summit in-person meeting will be May 13-15, 2025 – with anticipated arrivals on Monday, May 12, 2025 and departures on the afternoon of May 15, 2025.

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