ACIP Votes to Recommend Pneumococcal 21-Valent Conjugate Vaccine for Adult Populations

The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously voted to recommend the pneumococcal 21-valent conjugate vaccine (PCV21, CAPVAXIE; Merck) for appropriate adults 65 years of age and older for pneumococcal vaccination, according to a press release from Merck and the CDC’s ACIP committee meeting.^1,2

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ACIP voted to recommend a single dose of the PCV21 vaccine for multiple specific groups, including adults 65 years of age and older who had not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown. Another recommendation includes adults 19 to 64 years of age with certain risk factors who have not previously received a conjugate vaccine or whose vaccine history is unknown.¹

Additionally, the committee recommended that adults 19 years of age and older who have started their pneumococcal vaccine series with pneumococcal 13-valent conjugate vaccine (PCV13), but had not yet received all recommended pneumococcal 23-valent polysaccharide vaccine (PPSV23) doses, receive the PCV21 vaccine.¹

For adults 65 years of age and older who completed their vaccine series with both PCV13 and PPSV23, the working group recommended shared clinical decision-making with a treatment provider regarding the use of a supplemental dose of PCV21.¹

James Loehr, MD, FAAFP, presented introductory evidence at ACIP’s June 27, 2024, meeting. He discussed that this vaccine has “a totally different combination of serotypes” than previous pneumococcal vaccines. He also noted that PCV21 has broad coverage across multiple age groups—stronger than that of the previous vaccine, PCV20.²

PCV21 provides 81% coverage for those 19- to 64-years-old with a risk-based indication, and provides 85% coverage for those who are 65 years of age or older, according to Loehr’s presentation.²

After a presentation of the economic analysis of PCV21 use in adults, Miwako Kobayashi, MD, MDH, presented some of the working group’s interpretation of evidence to recommendation (EtR). Overwhelmingly, the working group favored this recommendation, with them deeming the PCV21 vaccine had “desirable consequences [that] clearly outweigh undesirable consequences in most settings.”²

Once the voting language in the recommendation was agreed upon, the committee voted unanimously, 11-0 with 1 recusal, to recommend the PCV21 vaccine for pneumococcal disease.²

The recommendations are like those approved by ACIP in September 2023. Those recommendations stated that adults aged 65 years or older and adults aged 16-64 with certain underlying conditions should receive either pneumococcal 20-valent conjugate vaccine (PCV20) alone or pneumococcal 15-valent conjugate vaccine (PCV15) in a series with PPSV23.³

“[PCV21] represents an innovative approach to invasive pneumococcal disease prevention in adults, as it is specifically designed to help protect against the strains that cause the majority of severe disease in adults 65 years of age and older,” Eliav Barr, MD, senior vice president, head of Global Clinical Development, and chief medical officer at Merck Research Laboratories, said in a news release. “The ACIP vote recognizes the clinical profile of [Eliav Barr] for adults in the US, and we look forward to the CDC’s final, published recommendations.”¹

Loehr noted that there are PCV24 and PCV31 vaccines being considered for future recommendations that are currently in advanced stages of development.²

References

1. Merck. CDC’S ACIP Unanimously Recommends Merck’s CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal Vaccination in Appropriate Adults. Press release. Released June 27, 2024. Accessed June 28, 2024. https://www.merck.com/news/cdcs-acip-unanimously-recommends-mercks-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-pneumococcal-vaccination-in-appropriate-adults/

2. Centers for Disease Control and Prevention on YouTube. Advisory Committee on Immunization Practices (ACIP) Day 2. Beginning at 6:00:12. Streamed June 27, 2024. Accessed June 28, 2024. https://www.youtube.com/live/DQslT3K9L8Y

3. Kobayashi M, Pilishvili T, Farrar J, et al. Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recommendations and Reports. 2023;72(3):1-39. doi:10.15585/mmwr.rr7203a1