This page summarizes the Advisory Committee on Immunization Practices (ACIP) recommendation of June 27, 2024, as published by CDC. Pneumococcal vaccine recommendations are reviewed over time; check CDC for current guidance.
Streptococcus pneumoniae (pneumococcus) is a common bacterial cause of respiratory infections, bloodstream infections and meningitis. Invasive pneumococcal disease (IPD), infection in a normally sterile site such as the blood, cerebrospinal fluid, bone or a joint, can cause severe illness or death. Adults 65 and older, and adults with certain underlying conditions or risk factors, are at higher risk, and have had IPD case fatality ratios above 10%.
The vaccines
ACIP recommends a pneumococcal conjugate vaccine (PCV) for all adults 65 and older, and for adults 19–64 with a risk condition who have not had a PCV or whose history is unknown. Before this recommendation the options were:
- PCV20 (Prevnar20) alone; or
- PCV15 (Vaxneuvance) followed by the 23-valent polysaccharide vaccine PPSV23 (Pneumovax23).
Separate guidance covers adults who started with PCV13.
On June 17, 2024, the Food and Drug Administration licensed PCV21 (Capvaxive, Merck Sharp & Dohme) for people 18 and older. It leaves out some serotypes found in other licensed vaccines but adds eight new ones.
The recommendation
On June 27, 2024, ACIP recommended a single dose of PCV21 as an option for adults 19 and older who are already recommended to receive a PCV. Who should be vaccinated did not change.
- Where serotype 4 is common. PCV21 does not contain serotype 4. In populations where 30% or more of pneumococcal disease is caused by serotype 4, the earlier options that include it, PCV20 alone or PCV15 then PPSV23, are expected to give broader coverage.
- With other vaccines. Following ACIP's general best practice guidelines, pneumococcal vaccine can be given at the same visit as other age-appropriate vaccines when there is no contraindication.
- Contraindications. Don't give PCV or PPSV23 to anyone with a known severe allergic reaction, such as anaphylaxis, to a vaccine component, and don't give PCV to anyone with a known severe allergic reaction to any diphtheria toxoid–containing vaccine. Check the package insert for precautions.
- Reporting. Report adverse events after vaccination to VAERS at https://vaers.hhs.gov/reportevent.html or 800-822-7967.
The evidence
The disease. Before the COVID-19 pandemic, U.S. adults had about 100,000 hospitalizations a year for noninvasive pneumococcal pneumonia and 30,000 IPD cases. In 2018–2022, serotypes in PCV21 caused about 80% of IPD among adults with vaccine indications, including 20%–30% from its eight new serotypes.
Serotype 4. After the 7-valent PCV was introduced for children, serotype 4 disease fell sharply, but it has recently reemerged in parts of the western United States, including Alaska, the Navajo Nation, Colorado, New Mexico and Oregon. Those affected are typically adults under 65 with a risk condition, a history of substance abuse, or experiencing homelessness.
Disparities. Pneumococcal disease is disproportionately high among Black adults. Vaccinating children with PCV13 narrowed the gap for PCV13 serotypes, likely through indirect protection; remaining disparities are mostly from serotypes not in PCV13.
Immune response, from one phase II and three phase III randomized trials:
- In healthy adults 50 and older never vaccinated against pneumococcus, PCV21 was noninferior to PPSV23 and PCV20 for shared serotypes, and gave significantly higher responses for most of its unique serotypes (for 15C, the response was numerically but not significantly higher than with PCV20).
- In adults 50 and older previously vaccinated with PCV13, PPSV23 or PCV15, and in adults living with HIV, PCV21 was comparable for shared serotypes and immunogenic for its unique ones.
- Given at the same visit as quadrivalent influenza vaccine, antibody levels to both were numerically lower than when given separately; coadministration met noninferiority for all but pneumococcal serotype 23B and influenza A/H3N2.
Safety, pooled from four phase III trials (4,020 PCV21 recipients, 2,018 comparator recipients):
| Solicited adverse event | PCV21 | Comparator |
|---|---|---|
| Any | 63.3% | 63.9% |
| Injection site pain | 55.6% | 54.5% |
| Fatigue | 27.1% | 23.7% |
| Headache | 18.4% | 15.5% |
| Myalgia | 11.3% | 7.5% |
Most events were mild or moderate. Four potentially life-threatening events, all fevers of 104°F (40°C) that resolved, occurred: three with PCV21 and one with a comparator. Across six trials, serious adverse events through 6 months occurred in 74 of 4,963 PCV21 recipients (1.5%) and 49 of 2,472 comparator recipients (2.0%); two in the PCV21 group, bronchospasm and injection site cellulitis, were judged vaccine-related, and both resolved.
Cost-effectiveness. Three models (Tulane-CDC, Merck and Pittsburgh) measured cost per quality-adjusted life-year (QALY) gained. Using PCV21 instead of PCV20 for adults already recommended a PCV ranged from cost-saving to $58,000 per QALY. In the Tulane-CDC model, replacing PCV20 with PCV21 for adults with risk-based indications gained fewer QALYs when serotype 4 made up 35% or more of pneumococcal disease. For adults 50–64, estimates ranged from $3,000 to $270,000 per QALY, and use in adults 19–49 was the least favorable.
What comes next
CDC and ACIP planned to assess whether the evidence supports lowering the age for the routine age-based adult recommendation, and to keep monitoring the safety and public health impact of PCV15, PCV20 and PCV21.
Sources
- Kobayashi M, Leidner AJ, Gierke R, et al. "Use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024." MMWR 73(36). https://www.cdc.gov/mmwr/volumes/73/wr/mm7336a3.htm
- Supplementary figure on serotype distribution: https://stacks.cdc.gov/view/cdc/160379
Licence: CC0 1.0 (public domain) · Adapted from www.cdc.gov
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