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A summary of presentations from the weekly Summit partner webinars

November 7, 2024 – The latest Summit Summary

Updates from the October 2024 ACIP Meeting – Melinda Wharton, MD, MP, Executive Secretary, ACIP

Melinda Wharton, MD, MP, Executive Secretary of ACIP gave an update from the October 2024 ACIP meeting.

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The following is a brief update of the October ACIP meeting.

Pneumococcal Vaccines

The following recommendation was made at the October 2024 ACIP meeting and adopted by the CDC Director.

ACIP recommends a pneumococcal conjugate vaccine for adults 50 years of age and older. This recommendation was adopted by the CDC director.

Background & Details
PCV21, a 21-valent vaccine, contains 11 pneumococcal serotypes not present in PCV20 and has dropped 10 serotypes that are in PCV20; the serotypes in PCV21 account for a larger proportion of cases of invasive pneumococcal disease among adults, compared to PCV20.

  • For adults 19 to 64 years of age with a risk condition, PCV21 included types accounting for 81% of cases, compared to 58% for PCV20.
  • For adults 65 years of age and older, PCV21 included types accounting for 85% of cases, compared to 54% for PCV20.

June Conclusions on Lowering Age-based Recommendation

  • In June, the work group concluded that available evidence supported the use of PCV21 for adults but could not reach consensus on extension of the age-based recommendation down to 50 years of age. The work group did not support lowering the age-based recommendation down to 19 years of age.

Proposal Based on June 2024 Meeting Request

  • A proposal, based on a request from the June meeting to address the higher risk of invasive pneumococcal disease among Black adults 50 to 64 years of age, was presented.
  • The work group discussed the relative weight of the factors, disease burden, and serotype data and, whereas data supported a recommendation for PCV21, it would be difficult to have different age-based recommendations for PCV21 versus PCV20.
  • The cost effectiveness analysis resulted in a recommendation for a pneumococcal conjugate vaccine for adults 50 years of age and older.

Influenza Vaccines

The following vote was made at the October 2024 ACIP meeting.

ACIP voted to align the Vaccines for Children (VCF) influenza vaccine policy with the votes taken in June, allowing use of high dose and adjuvanted influenza vaccines as an option for 18-year-olds with solid organ transplants receiving immunosuppressed suppressive medications.

Background & Details

FluMist

  • There was an announcement about the recent licensure of FluMist for self- or caregiver-administration.
    • For the 2024-2025 influenza season, FluMist is only available for administration by a healthcare provider.
    • For the 2025-2026 influenza season, it is anticipated that FluMist will be available for self- or caregiver-administration.

End-of-Season Vaccine Effectiveness Estimates for the 2023-2024 Season

  • Influenza A(H1N1) was predominant with lower levels of A(H3N2) and B Victoria.
  • Vaccination with a 2023-2024 influenza vaccine reduced the risk of medically attended influenza outpatient visits and hospitalizations among children, adolescents, and the elderly.

H5N1

  • An update on H5N1 included that, as of October 18, 2024, USDA had confirmed HPAI A(H5N1) in U.S. dairy herds in 324 farms across 14 states. There have been a small number of cases identified among farm workers with direct contact with infected animals.
  • There are no indications of unusual influenza activity in people. With testing of more than 50,000 specimens, a single case of H5 influenza has been identified. Overall risk to the public remains low, according to CDC.

Chikungunya Vaccines

There were no new approvals or recommendations from ACIP at the October 2024 meeting for chikungunya vaccines.

Background & Details

The first chikungunya vaccine, manufactured by Valneva, was licensed in November 2023 for use in adults, 18 years of age and older.

  • In February 2024, ACIP recommended the live attenuated chikungunya vaccine for adult travelers to outbreak areas and for laboratory workers at risk of exposure.

Bavarian Nordic presented on the virus-like particle chikungunya vaccine, which could be licensed in February 2025 and is intended for adolescents and adults.

  • The work group’s assessment was that, if licensed, this vaccine will provide an option for adults and for adolescents.
  • There is no vaccine effectiveness data and the need for booster dose is unknown; there are no apparent safety concerns.
  • Assuming licensure, recommendations from ACIP are expected to be developed addressing the same populations for the live attenuated vaccine.

COVID-19 Vaccines

With some caveats based on previous vaccination status, the following recommendations were made at the October 2024 ACIP meeting and adopted by the CDC Director.

  • ACIP recommends a second dose of 2024-2025 COVID-19 vaccine for adults ages 65 years and older.
  • ACIP recommends a second dose of 2024-2025 COVID-19 vaccine for people ages 6 months-64 years who are moderately or severely immunocompromised.
  • ACIP recommends additional doses (i.e., 3 or more doses) of 2024-2025 COVID-19 vaccine for people ages 6 months and older who are moderately or severely immunocompromised under shared clinical decision-making.

Background & Details

In June, ACIP recommended 2024-2025 COVID-19 vaccines as approved by FDA for people 6 months of age and older.

  • A single dose of the 2024-2025 vaccine is recommended for everyone 5 years of age and older, but younger children may need multiple doses, including at least one dose of the 2024-2025 vaccine.
  • The focus of the discussion at the October 2024 ACIP meeting was a recommendation for an additional or second dose of the 2024-2025 COVID-19 vaccine for older adults, and additional doses for people who are moderately or severely immunocompromised.

Vaccine Coverage According to the National Immunization Survey

  • Only ~40% of adults 65 years of age and older got at least one dose of the 2023-2024 COVID-19 vaccine last year, and less than 10% got at least one additional dose.
  • Vaccine coverage for two or more doses was even lower among adults who are immunocompromised.

COVID-19 vaccination provided protection against hospitalization among people who were immunocompromised or over 65 years of age.

  • COVID-19 continues to circulate year-round.
  • Two-thirds of COVID-19 hospitalizations are among adults 65 years of age and older, and almost half were among those 75 years of age and older; most had not received the 2023-2024 COVID-19 vaccine.

RSV Vaccines – Maternal/Pediatric

There were no new approvals or recommendations from ACIP at the October 2024 meeting for RSV maternal/pediatric vaccines.

Background & Details

The current recommendations are that all infants should be protected against RSV disease with either maternal RSV vaccine or nirsevimab.

Clesrovimab

  • Merck presented on this long-acting monoclonal antibody which is not yet licensed and is similar to nirsevimab.
  • The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants who were born or entering their first RSV season.
  • The proposed dosing schedule of clesrovimab is the same for all infants regardless of weight.
  • Clesrovimab was highly effective at preventing severe RSV disease, with efficacy against RSV hospitalization of ~90%.
  • More to come on this potential additional option for RSV protection of the infant.

Safety of the Maternal RSV Vaccine

  • FDA approved and ACIP recommended Pfizer’s RSV vaccine at 32 to 36 weeks’ gestation, which avoids potential risk of earlier preterm births.
  • An update from the Vaccine Safety Data Link on the first season analysis found that maternal RSV vaccination during 32 to 26 weeks’ gestation was not associated with an increased risk of preterm birth or small-for-gestational-age infants.

Meningococcal Vaccines

The following recommendations were made at the October 2024 ACIP meeting and adopted by the CDC Director.

  • ACIP recommends MenB-4C (Bexsero) be administered as a two-dose series at 0 and 6 months when given to healthy adolescents and young adults 16 to 23 years of age based on shared clinical decision-making for the prevention of serogroup B meningococcal disease.
  • ACIP recommends MenB-4C (Bexsero) be administered as a 3-dose series at 0, 1 to 2, and 6 months when given to persons ≥10 years of age at increased risk for serogroup B meningococcal disease (i.e., persons with anatomic or functional asplenia, complement component deficiencies, or complement inhibitor use; microbiologists routinely exposed to N. meningitidis isolates; and persons at increased risk during an outbreak)

Background & Details

The work group discussed two new combination meningococcal vaccines that cover serogroups ABCWY.

  • Pfizer’s MenABCWY vaccine is licensed and, last year, ACIP recommended it as an option at visits where both meningococcal quadrivalent and B vaccines were indicated.
  • GSK MenABCWY vaccine is not licensed yet, but ACIP could vote on it at the February 2025 meeting, if it is licensed in time.
    • The evidence review for GSK MenABCWY was presented and an interim recommendation could mirror the recommendation for the Pfizer vaccine, as an option for those recommended to receive both the MenACWY and MenB vaccines at the same visit.

The work group continues to grapple with revisions to the meningococcal vaccination schedule.

  • There was discussion and a vote about the dosing schedule for GSK’s meningococcal B vaccine, and the new schedule is now aligned with that for Pfizer’s meningococcal B vaccine.
  • The updated label includes a two-dose schedule and a three-dose schedule; the choice of dosing schedule may depend on risk of exposure and individual susceptibility.
  • The committee voted on a two-dose schedule for healthy adolescents and young adults and a 3-dose series for people 10 years of age and older at increased risk of meningococcal disease (see above for complete recommendations).

Proposed CDC Clinical Considerations

  • The three-dose series may be used to optimize rapid protection for those who initiate the vaccine series less than 6 months prior to the period of increased risk – would apply to MenB-4C and MenB-FHbp.

RSV Vaccines – Adult

There were no new approvals or recommendations for RSV vaccines for adults from the October 2024 ACIP meeting.

Background & Details

There are currently three RSV vaccines licensed for use in older adults in the United States.

  • In June, the GSK RSV vaccine was approved by the FDA for adults aged 50 to 59 years of age at increased risk for RSV lower respiratory tract disease.
  • In October, the Pfizer RSV vaccine was approved for people 18 to 59 years of age at increased risk.
  • An updated FDA analysis suggested an increased risk of Guillain Barre Syndrome (GBS) following the protein subunit vaccines (these are the vaccines manufactured by GSK and Pfizer) among adults ≥65 years of age, although the risk is rare. The work group concluded that there is an increased risk of GBS following receipt of the protein subunit vaccines that is comparable to, and possibly greater than, that of currently licensed and recommended adult vaccines.
    • The risk needs to be considered in the context of public health benefits.
    • Co-administration of RSV vaccine with other recommended vaccines continues to be acceptable.

The work group continues to support the current recommendations for RSV vaccines for adults ages 75 years of age and older and those adults who are 60 to 74 years of age with increased risk of sever RSV disease.

Immunization Schedules

The ACIP voted for the following at the October 2024 ACIP meeting, and the recommendation was adopted by the CDC Director.

The Recommended Child and Adolescent Immunization Schedule, United States, 2025 and the Recommended Adult Immunization Schedule, United States, 2025 was approved.

Background & Details

Updated child and adolescent and adult immunization schedules were presented and incorporated updates to recommendations made since last year.

HPV Vaccines

There were no new approvals or recommendations for HPV vaccines at the October 2024 ACIP meeting.

Background & Details

ACIP currently recommends routine HPV vaccination at ages 11 to 12, and as early as age 9. The work group is considering rewording the age for routine vaccination to allow more flexibility. There was a systematic literature review that found, among other things, that vaccination at age 9 was feasible but not necessarily better.

The work group is discussing a reduction in dosing, based on clinical trials that led to the two-dose schedule.

  • There are now data on single-dose schedules and a revised WHO recommendation in December 2022 that included off-label language (the WHO states that a single-dose schedule, referred to as an alternative, off-label single–dose schedule can provide a comparable efficacy and durability of protection to a two-dose regimen). Fifty-eight countries are now using single-dose schedules.

CMV Vaccine

There were no new approvals or recommendations for cytomegalovirus (CMV) vaccine at the October 2024 ACIP meeting.

Background & Details

A brief presentation was given to announce the formation of a work group for cytomegalovirus vaccines.

  • Congenital cytomegalovirus is the most common infectious cause of neurodevelopmental disabilities in the United States, with about 4,000 children born with congenital CMV disease each year.
  • CMV causes substantial morbidity and mortality in people with immunosuppression.
  • Several clinical trials have not moved to Phase 3, but there is one ongoing Phase 3 trial, for Moderna’s mRNA vaccine.

Mpox

There were no new approvals or recommendations for Mpox vaccination from the October 2024 ACIP meeting.

Background & Details

There was a brief overview of the ongoing clade 1 outbreaks.

  • There are several African countries, including the Democratic Republic of Congo (DRC) where clade 1 is known to be endemic.
  • Since last year, there have been outbreaks of clade 1A and clade 1C.
  • Higher mortality rates have been associated with clade 1A, but recently, with supportive care, the case fatality rate has been ~1.7%.
  • Outside of endemic countries, clade 1 has been spread primarily by sexual contact while traveling in countries with sustained transmission.
    • No clade 1 cases have been identified in the United States.
    • The risk of clade 1 is low for U.S. travelers; vaccination and pre-travel counseling is recommended for travelers who anticipate sexual contact during travel.

QUESTIONS & ANSWERS

Q: Regarding the PCV vote, during the discussion there was no discussion of the two-dose series of PCV15 followed by polysaccharide vaccine a year later. But some of the clinical considerations said that, even though the ACIP vote was only to recommend pneumococcal conjugate vaccine for healthy people down to age 50, there appeared to be a reference saying that PCV15 was one of the options and, if so, then a person needed a polysaccharide vaccine a year later. However, there was never a vote on polysaccharide vaccine for healthy people down to age 50. So, it’s been a point of confusion following the meeting, because all the conversation and economic analysis was around PCV20 and PCV21. So there was confusion about whether an equally recommended option is PCV15 followed by a not-voted use for PPSV23.
Melinda Wharton (ACIP): So, I’m not sure but, based on the discussion, my understanding is the committee’s intention was to keep this about PCV20 and PCV21. I don’t think there was any consideration of PCV15 followed by the polysaccharide vaccine as a routine option, as an age-based option down to age 50, even though there are existing recommendations for that use for high-risk groups. I think the whole thing about what we already recommend for high-risk groups versus an age-based recommendation was part of why people felt that PCV20 had to be included because it gets you all tied up in knots, otherwise. So, I’m not completely sure what the final clinical considerations will be, but my understanding is that the intention was for PCV20 and PCV21.
Follow-Up: Okay, so the age-based vote, you believe their intent was PCV20 and PCV21. Do you have any idea when those may be available online for those of us who write standing orders?
Melinda Wharton (ACIP): That’s a good question. I don’t remember it, so I’ll see if I can find out and get back to you by email.
Carolyn Bridges (Immunize): There is a job aid for people 50 years of age and older from CDC [https://www.cdc.gov/pneumococcal/downloads/Vaccine-Timing-Adults-JobAid.pdf], which may provide some clarity as to the clinical considerations.

Q: About the Chikungunya recommendations, there was a lot of information there. I’m wondering if you could reiterate what the decisions were and what decisions are pending. And can you also verify that your slides will be available?
Melinda Wharton (ACIP): Yes, I will provide the updated slides. ACIP has previously recommended the licensed live attenuated chikungunya vaccine for travelers 18 years of age and older to areas at increased risk of exposure because of outbreaks – either active outbreaks or that it could be considered for those in areas where there has been recent disease activity at a certain level, without necessarily the kind of catastrophic outbreaks that have occurred so frequently. That is the recommendation that has already been made for the Valneva vaccine along with the recommendation for laboratory workers at increased risk of exposure. This is not for people working in routine clinical laboratories but for people in specialized laboratories that are actually working with Chikungunya virus. Because laboratory transmission is something that is known to happen and now that there is a licensed vaccine, it seems like that should be prevented. There’s been a little discussion at the ACIP meetings, and probably a lot more in the work group, about potential use of chikungunya vaccine in U.S. territories or states in which there is chikungunya transmission. That’s a really complicated thing because of the nature of these outbreaks, which tend to be really explosive with high attack rates and a lot of healthcare utilization in a short period of time. But then they are greatly attenuated and it’s not clear: Does the virus persist in the mosquito population? How many years would it be before another outbreak occurs? So, to deal with a vaccine strategy for that kind of epidemiology is challenging. And I expect the work group is still wrestling with that. So that’s to come. There’s been no proposal that has come to the full committee. It seems the way this is likely to play out is that there will be recommendations for travelers and laboratory workers for the virus-like particle vaccine, should it be licensed soon. And then those recommendations for use in territories and states would probably be taken on for both vaccines, should they both be licensed.

Q: The job aid from CDC, in October 2024, on pneumococcal vaccine timing says at the very top that one of the options is PCV15 for healthy adults 50 years of age and older. PPSV23 is also an option. So that’s really confusing to me because it was never discussed or voted on for this polysaccharide.
Melinda Wharton (ACIP): Well, then I expect that that is what the clinical considerations will say. I am surprised but I guess I shouldn’t be because it’s pneumococcal.

Q: There was discussion during the schedule discussion and the presentation of the adult schedules about the use of Heplisav-B and PreHevbrio during pregnancy. The background was that Heplisav-B had a label change by FDA because there is now some data supporting its safety during pregnancy. There was no corresponding label change to PreHevbrio, but the discussion got confusing because of the removal of the note from the schedule stipulating that both Heplisav and PreHevbrio should not be used during pregnancy because of a lack of evidence of safety. So we were just confused about where that ended up. And I realize we may have to wait until we see the schedule.
Melinda Wharton (ACIP): I guess that was confusing. What I hope will happen is that there will be some updated clinical guidance from CDC before the schedule is finalized. And then it will allow the schedule team to have some established guidance that can then be the basis for revision to the schedule. That’s what we hope will happen, but we’ll know when we know.
Follow-Up: So it requires both FDA’s label change and then CDC Division of Viral Hepatitis to follow up on that?
Melinda Wharton (ACIP): This is a matter of clinical considerations, and I know they’re working on it. So, I’m pretty sure this is going to get sorted out, I just can’t say for sure.

Q: When do you anticipate online publication of the schedules?
Melinda Wharton (ACIP): I know that the plan was to finalize later this month, but I don’t know when it’s published online. I can try to find that out.

Q: About risk conditions for COVID-19 vaccines, the CDC website talks about high-risk conditions for COVID-19 and lists BMI of greater than 25. And the website also notes that the risk for severe disease increases as BMI increases. Is that still the case? It is still up on the website; do you have any insights? I don’t think that obesity qualifies as an immunocompromised condition, but if you had any insights about how obesity is treated in terms of additional vaccine doses, that would be helpful.
Melinda Wharton (ACIP): I’m not sure. My interpretation, that is the same as yours, is that it seems like the recommendation is not for people with underlying risk conditions and immunocompromising conditions. So, my assumption would be that the additional dose is limited for people under 65 years of age with immunocompromising conditions, at least based on the language that was presented. But I’m not totally sure, otherwise.
Carolyn Bridges (Immunize): That would be my interpretation, too. It’s not an immune-compromising condition, moderate to severe.
Melinda Wharton (ACIP): The clinical considerations are posted now. I should have remembered that.
Kelly Moore (Immunize): If you go to the link to the interim clinical considerations that are updated on the CDC website [https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#immunocompromised] and scroll down, there is a subheading “Description of Moderate and Severe Immunocompromising Conditions and Treatments.” There is a bulleted list there that specifies the conditions that qualify, and obesity is not one of them.

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Announcements
  • A webinar called “Pandemic Influenza Vaccines: Responding to the H5 Outbreak & Preparing for The Future” is coming up on November 15, 2024. The event is co-sponsored by the O’Neill Institute for National and Global Health Law at Georgetown Law, the Global Health Institute, Center for Global Health Science and Security (CGHSS) and Center on Medical Product Access, Safety and Stewardship (COMPASS) at Georgetown University. More information here: https://oneill.law.georgetown.edu/events/pandemic-influenza-vaccines-responding-to-the-h5-outbreak-preparing-for-the-future/.
    • Note: Some interesting information was also published on November 7, 2024 in the MMWR on a paper in Nature about ferret studies of H5N1.
  • On November 1, CMS updated the physician fee schedule for 2025. More information here: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-final-rule.
    • Because hepatitis B vaccine is now recommended for everyone through age 59 and for high risk people ages 60 and older, it can now be roster billed. And because of these expanded indications for hepatitis B, they would no longer require a physician order.
    • CMS is finalizing a policy to set payment for hepatitis B vaccines and their administration at 100%, a reasonable cost in rural health centers and the FQHCs separate from the payment under the FQHC primary payment methodology.

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