Miwako Kobayashi, MD1; Andrew J. Leidner, PhD2; Ryan Gierke, MPH1; Wei Xing, MSTAT1; Emma Accorsi, PhD1; Pedro Moro, MD3; Mini Kamboj, MD4; George A. Kuchel, MD5; Robert Schechter, MD6; Jamie Loehr, MD7; Adam L. Cohen, MD1 (View creator affiliations)
View advised citationSummary
What’s already recognized about this matter?
Ahead of October 2024, a unmarried dose of 15-valent, 20-valent, or 21-valent pneumococcal conjugate vaccine (PCV), used to be really useful for adults elderly 19–64 years with menace prerequisites for pneumococcal illness and for all adults elderly ≥65 years.
What’s added by way of this document?
On October 23, 2024, the Advisory Committee on Immunization Practices really useful a unmarried dose of PCV for all adults elderly ≥50 years who’re PCV-naïve or who’ve unknown vaccination historical past. The chance-based advice for adults elderly 19–49 years is unchanged.
What are the results for public well being apply?
The up to date, expanded age-based advice is anticipated to support pneumococcal illness prevention in adults elderly 50–64 years, specifically amongst demographic teams experiencing upper illness charges.
Summary
Ahead of October 2024, the Advisory Committee on Immunization Practices (ACIP) really useful use of a pneumococcal conjugate vaccine (PCV) for all adults elderly ≥65 years, in addition to for the ones elderly 19–64 years with menace prerequisites for pneumococcal illness who’ve now not won a PCV or whose vaccination historical past is unknown. Choices integrated both 20-valent PCV (PCV20; Prevnar20; Wyeth Prescribed drugs) or 21-valent PCV (PCV21; CAPVAXIVE; Merck Sharp & Dohme) on my own or 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme) in sequence with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme). There are further suggestions to be used of PCV20 or PCV21 for adults who began their pneumococcal vaccination sequence with 13-valent PCV (PCV13; Prevnar13; Wyeth Prescribed drugs). The ACIP Pneumococcal Vaccines Paintings Workforce hired the Proof to Suggestions framework to steer its deliberations on increasing the age-based PCV advice to incorporate adults elderly 50–64 years. On October 23, 2024, ACIP really useful a unmarried dose of PCV for all PCV-naïve adults elderly ≥50 years. Suggestions for PCVs amongst adults elderly 19–49 years with menace prerequisites and PCV13-vaccinated adults have now not modified from earlier suggestions. This document summarizes proof regarded as for those suggestions and gives up to date medical steering to be used of PCV.
Advent
Streptococcus pneumoniae (pneumococcus) is a not unusual bacterial reason behind respiration tract infections, bacteremia, and meningitis. Popular use of pneumococcal conjugate vaccine (PCV) in youngsters diminished the prevalence of pneumococcal illness, each amongst youngsters thru direct results and amongst older youngsters and adults who’ve now not won PCV thru oblique results (i.e., aid in illness prevalence within the inhabitants on account of diminished transmission of pneumococcus from youngsters) (1,2). Then again, individuals with underlying prerequisites or components that building up their menace for pneumococcal illness (menace prerequisites)* and older adults revel in upper pneumococcal illness charges. As well as, racial disparities in pneumococcal illness prevalence persist, together with upper charges amongst non-Hispanic Black or African American (Black) and non-Hispanic American Indian or Alaska Local (AI/AN) adults (3).
Ahead of its October assembly, the Advisory Committee on Immunization Practices (ACIP) really useful receipt of a unmarried dose of PCV for all adults elderly ≥65 years and the ones elderly 19–64 years with a menace situation who’ve now not won PCV or whose vaccination historical past is unknown. Choices integrated both 20-valent PCV (PCV20; Prevnar20; Wyeth Prescribed drugs) (4) or 21-valent PCV (PCV21; CAPVAXIVE; Merck Sharp & Dohme) (5) on my own, or 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme) (6) adopted by way of 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) (7). Further suggestions are appropriate to be used of PCV20 or PCV21 for adults who commenced their pneumococcal vaccination sequence with 13-valent PCV (PCV13; Prevnar13, Wyeth Prescribed drugs) (8,9).
In June 2024, ACIP really useful PCV21 as an possibility for adults who’re really useful to obtain PCV and proposed a overview of to be had proof to decide whether or not information supported decreasing the age-based advice to ≥50 years for all really useful PCVs (8). The approval of PCV21, which used to be particularly evolved to focus on pneumococcal serotypes that regularly purpose illness in adults (Determine), used to be observed as a singular alternative to cut back pneumococcal illness prevalence and well being disparities amongst U.S. adults. This document summarizes the proof regarded as by way of ACIP in regards to the enlargement of the age-based advice to incorporate adults elderly 50–64 years, highlighting issues of pneumococcal illness prevalence and mortality, well being disparities, and useful resource use.
Strategies
All over July–October 2024, the ACIP Pneumococcal Vaccines Paintings Workforce regarded as PCV use amongst PCV-naïve adults elderly 50–64 years throughout the Proof to Suggestions (EtR) framework.† Printed and unpublished information on pneumococcal illness prevalence and mortality, pneumococcal vaccination protection, and financial fashions of age-based PCV use at age ≥50 years had been reviewed; and findings had been summarized by way of race and ethnicity every time to be had (3,10). Earlier Grading of Suggestions, Review, Building and Analysis (GRADE) evaluations for PCV15, PCV20, and PCV21 (8,11,12) had been supplemented by way of an up to date seek of MEDLINE, (the use of PubMed) and ClinicalTrials.gov to spot further literature on protection and immunogenicity. Postlicensure protection information on PCV20 from the Vaccine Opposed Tournament Reporting Device (VAERS) and an research the use of Facilities for Medicare & Medicaid Services and products (CMS) information had been reviewed.
Rationale and Proof
Pneumococcal Illness Occurrence in Adults Elderly ≥19 Years
Pneumococcal pneumonia, accounting for 12%–13% of all hospitalized pneumonia instances, has been estimated to lead to roughly 225,000 U.S. grownup hospitalizations every year (13–15). Amongst adults elderly 50–64 years with invasive pneumococcal illness (IPD) and the ones hospitalized with pneumococcal pneumonia, roughly 90% had a number of menace situation (3,14). Ahead of the COVID-19 pandemic, roughly 30,000 IPD§ instances passed off every year amongst U.S. adults (16). In 2022, adults elderly 50–64 years skilled IPD prevalence and mortality charges of 13.2 and 1.8 according to 100,000 inhabitants, respectively. Those charges had been upper than the ones in all different age teams except for adults elderly ≥65 years, whose prevalence and mortality charges had been 17.2 and a couple of.7 according to 100,000 inhabitants, respectively (1). In step with CDC’s Lively Bacterial Core surveillance (ABCs) information, throughout 2018–2022 (prior to PCV20 used to be extensively used and prior to PCV21 approval amongst adults), 56% and 83%¶ of IPD instances had been because of pneumococcal serotypes contained in PCV20 and PCV21 in adults elderly 50–64 years, respectively (17).
Racial Disparities in Pneumococcal Illness Occurrence and Vaccination Protection
An estimated 32%–54% of adults elderly 50–64 years had no less than one menace situation that qualifies for risk-based pneumococcal vaccination.** Then again, 2022 Behavioral Possibility Issue Surveillance Device information confirmed that simplest 37% of adults elderly 50–64 years with a risk-based vaccination advice won a pneumococcal vaccine, when put next with 70% of adults elderly ≥65 years with an age-based advice; racial disparities in vaccination charges had been obvious†† (3). ABCs information confirmed that IPD charges amongst Black adults peaked at a more youthful age (55–59 years) when put next with charges amongst non-Black adults whose IPD charges larger with expanding age (3). Despite the fact that PCV13 use amongst U.S. youngsters has diminished disparities in PCV13-type IPD prevalence in adults, most likely on account of oblique results; final racial disparities are pushed by way of non-PCV13 serotypes, with non-PCV13 serotype IPD charges amongst AI/AN and Black adults (25 and 10 according to 100,000 inhabitants, respectively) exceeding the inhabitants reasonable of six according to 100,000 (3).
PCV Immunogenicity and Protection from Medical Trials
An up to date literature seek recognized six PCV15 trials (18–23), 3 PCV20 trials (24–26), and 7 PCV21 trials (27–32) that integrated immunogenicity and protection information for adults elderly ≥50 years. Abstract of proof from the up to date literature seek remained necessarily unchanged from earlier summaries (3,8,11,12). When put next with PCV13, PCV15 met noninferiority standards for all shared PCV13 serotypes, and immune responses for non-PCV13 serotypes 22F and 33F had been statistically considerably upper. PCV20 met noninferiority standards for all PCV13 serotypes when put next with PCV13 and for 6 of 7 non-PCV13 serotypes (now not met for serotype 8) when put next with PPSV23 (24–26). When put next with PCV20, PCV21 met noninferiority standards for 10 of 10 shared serotypes, and immune responses for 10 of eleven distinctive serotypes had been statistically considerably upper (now not met for serotype 15C). No vaccine-related critical opposed occasions (SAEs) had been reported after PCV15 or PCV20 management; two vaccine-related SAEs were in the past reported after PCV21 management (8).
PCV20 Postlicensure Protection Knowledge
Research of stories to VAERS after PCV20 management in adults elderly ≥19 years throughout October 2021–August 2024 confirmed a sign for Guillain-Barré syndrome (GBS); on the other hand, the full reporting charge remained low (0.7 instances according to million doses disbursed) (3). Number one research of CMS information thru Might 2024 confirmed a statistically vital sign for GBS§§ after PCV20 management in Medicare beneficiaries elderly ≥65 years. Then again, the sign used to be now not statistically vital when making use of an alternate GBS definition in sensitivity research or adjusted for the sure predictive price of diagnostic codes when put next with affirmation by way of chart overview (3).
Financial Research
Two financial fashions (Tulane-CDC and Merck) assessed the cost-effectiveness of PCV20 and PCV21 use amongst PCV-naïve adults elderly 50–64 years (10). A 3rd type (Pfizer) assessed the cost-effectiveness of PCV20 use simplest (10). All 3 fashions used quality-adjusted life-year (QALY) as the main well being result. The Tulane-CDC type estimated prices of $131,023–$214,430 according to QALY won for PCV21 and $251,037–$546,811 for PCV20. The Merck type estimated $251,048–$425,455 according to QALY won for PCV21 and $548,114–$879,117 for PCV20. The Pfizer type estimated $56,376–$133,524 according to QALY won for PCV20. Value-effectiveness estimates had been maximum delicate to assumptions about oblique results from pediatric vaccination and period of coverage from vaccination. Obstacles of the fashions integrated uncertainties about period of coverage from vaccination, magnitude of oblique results from pediatric vaccination, and have an effect on of long run supplementary pneumococcal vaccine doses for adults.
Suggestions for Use of PCV
ACIP really useful PCV for all PCV-naïve adults elderly ≥50 years. Suggestions for PCVs for adults elderly 19–49 years with a menace situation and for adults who’ve in the past won PCV13 stay unchanged (Desk) (8). The advice used to be supported by way of a number of components, together with the possible to support vaccination protection and cut back pneumococcal illness prevalence and mortality in adults elderly 50–64 years, specifically amongst demographic teams experiencing upper illness charges. Ease of enforcing constant age-based suggestions for all PCVs used to be additionally regarded as. Uncertainties relating to key assumptions guiding the industrial fashions and better charge according to QALY estimates for PCV20 when put next with PCV21 had been stated.
Number of PCV in Populations with Top Proportions of Serotype 4 Pneumococcal Illness
In lots of U.S. settings, PCV21 is anticipated to hide extra circulating pneumococcal lines than do different really useful PCVs. In positive populations during which ≥30% of pneumococcal illness¶¶ is because of serotype 4, pneumococcal vaccines that come with serotype 4 (PCV20 on my own or PCV15 and PPSV23 in sequence) (Determine) are anticipated to offer broader serotype protection towards in the community circulating lines than does PCV21 (Field).
PPSV23 Use in PCV13-Skilled Adults Who Have Now not Finished the Advisable Vaccination Sequence
Amongst adults elderly ≥19 years who’ve began their pneumococcal vaccination sequence with PCV13 however have now not won all really useful doses, PPSV23 is now not really useful as an strategy to whole the sequence. Both PCV20 or PCV21 is really useful to finish the sequence as in the past really useful. (Desk).
Coadministration with Different Vaccines
In response to CDC’s Common Easiest Observe Pointers for Immunization, regimen management of a pneumococcal vaccine with different age-appropriate doses of vaccines on the identical discuss with is really useful for adults who haven’t any particular contraindications to vaccination on the time of the well being care discuss with (33).
Contraindications and Precautions
Vaccination suppliers must seek the advice of the vaccine package deal insert for precautions, warnings, and contraindications (4–7). Vaccination with PCV or PPSV23 is contraindicated in individuals recognized to have had a critical allergy (e.g., anaphylaxis) to any part of the vaccine. As a result of PCVs are conjugated to CRM197, a unhazardous genetically altered diphtheria toxin, those vaccines also are contraindicated in individuals recognized to have had a critical allergy to any diphtheria toxoid–containing vaccine (4–7).
Reporting of Vaccine Opposed Occasions
Opposed occasions happening after management of any vaccine must be reported to VAERS. Directions for reporting to VAERS are to be had at or by way of calling 800-822-7967.
Long run Analysis and Tracking Priorities
CDC and ACIP will proceed to evaluate protection and public well being have an effect on of pneumococcal vaccines amongst adults. This contains tracking the period of vaccine-conferred immunity from PCV to decide the desire for a booster to make certain that older adults proceed to be safe beneath the up to date vaccine advice and to measure any oblique results on prevalence in adults from regimen formative years vaccination.
Acknowledgments
Alison Albert, Sofia Bletnitsky, Tarayn Fairlie, Marc Fischer, Julianne Gee, Shelby Miller, Noele Nelson, Laurie Orell, John Su, Liz Velazquez, CDC; Doug Campos-Outcalt, College of Arizona; Rebecca L. Morgan, McMaster College.
ACIP Pneumococcal Vaccines Paintings Workforce
Jamie Loehr, Cayuga Circle of relatives Drugs; Mini Kamboj, Memorial Sloan Kettering Most cancers Heart, Joan and Sanford Weill Scientific Faculty of Cornell College; George Kuchel, UConn Well being; Robert Schechter, California Division of Public Well being; Lucia Lee, Tina Mongeau, Meals and Drug Management; Risa Claytor, Well being Assets and Services and products Management; Uzo Chukwuma, Indian Well being Provider; Mamodikoe Makhene, Meenu Upadyay, Nationwide Institutes of Well being; Lynn Fisher, American Academy of Circle of relatives Physicians; Monica Ardura, American Academy of Pediatrics, Committee on Infectious Sicknesses; Jason Goldman, Saba Hasan, American Faculty of Physicians; David A. Nace, American Geriatrics Society, Submit-Acute and Lengthy-Time period Care Scientific Affiliation; Cora Hoover, Affiliation of Immunization Managers; Mary Hayney, American Pharmacists Affiliation; Eva Wong, Canadian Nationwide Advisory Committee on Immunization; James McAuley, Infectious Sicknesses Society of The united states; Robert Hopkins, William Schaffner, Nationwide Basis for Infectious Sicknesses; Virginia Caine, Nationwide Scientific Affiliation; Monica M. Farley, Emory College; Keith Klugman, Gates Basis; Sarah S. Lengthy, Drexel College Faculty of Drugs; Katherine A. Poehling, Wake Wooded area College Faculty of Drugs; Arthur Reingold, College of California, Berkeley; Lorry Rubin, Cohen Kids’s Scientific Heart of New York; Richard Ok. Zimmerman, College of Pittsburgh.
1Division of Bacterial Sicknesses, Nationwide Heart for Immunization and Breathing Sicknesses, CDC; 2Immunization Services and products Department, Nationwide Heart for Immunization and Breathing Sicknesses, CDC; 3Immunization Protection Administrative center, CDC; 4Memorial Sloan Kettering Most cancers Heart, Joan and Sanford Weill Scientific Faculty of Cornell College, New York, New York; 5UConn Well being, Farmington, Connecticut; 6California Division of Public Well being; 7Cayuga Circle of relatives Drugs, Ithaca, New York.
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FIGURE. Serotypes*,† integrated in pneumococcal vaccines recently really useful for adults — United States, 2024
Abbreviations: PCV = pneumococcal conjugate vaccine; PCV15 = 15-valent PCV; PCV20 = 20-valent PCV; PCV21 = 21-valent PCV; PPSV23 = 23-valent pneumococcal polysaccharide vaccine.
* PCV21 is licensed for the prevention of invasive pneumococcal illness brought about by way of serotype 15B founded upon prespecified standards for the percentage of contributors with fourfold or extra upward thrust in opsonophagocytic process responses.
† PCV21 incorporates serotype 20A.
TABLE. Medical steering for enforcing pneumococcal vaccine suggestions for adults elderly ≥19 years — United States, October 2024
Possibility or age crew
Vaccine won in the past
Choices for vaccination
Adults elderly ≥50 years
None or PCV7 simplest at any age
A unmarried dose of PCV21, PCV20, or PCV15. If PCV15 is run, a unmarried dose of PPSV23* must be administered ≥1 yr after the PCV15 dose. A minimal period of 8 weeks may also be regarded as if PCV15 is utilized in adults with an immunocompromising situation,† cochlear implant, or CSF leak.
PPSV23 simplest
A unmarried dose of PCV21, PCV20, or PCV15 ≥1 yr after the remaining PPSV23 dose.
PCV13 simplest
A unmarried dose of PCV21 or PCV20 ≥1 yr after the PCV13 dose.
PCV13 at any age and PPSV23 at age <65 years
A unmarried dose of PCV21 or PCV20 ≥5 years after the remaining pneumococcal vaccine dose.
PCV13 at any age and PPSV23 at age ≥65 years
Shared medical decision-making is really useful relating to management of both a unmarried dose of PCV21 or PCV20 for any grownup elderly ≥65 years who has finished the really useful vaccination sequence with each PCV13 and PPSV23 (i.e., PPSV23 administered at age ≥65 years) however PCV21, PCV20, or PCV15 now not but won. If a choice to manage PCV21 or PCV20 is made, a unmarried dose is really useful ≥5 years after the remaining pneumococcal vaccine dose.
Adults elderly 19–49 years with an immunocompromising situation,† a CSF leak, or a cochlear implant
None or PCV7 simplest at any age
A unmarried dose of PCV21, PCV20, or PCV15. If PCV15 is used, administer a unmarried dose of PPSV23* ≥8 weeks after the PCV15 dose.
PPSV23 simplest
A unmarried dose of PCV21, PCV20, or PCV15 ≥1 yr after the remaining PPSV23 dose.
PCV13 simplest
A unmarried dose of PCV21 or PCV20 administered ≥1 yr after the PCV13 dose.
PCV13 and 1 dose of PPSV23
A unmarried dose of PCV21 or PCV20 ≥5 years after the remaining pneumococcal vaccine dose. The pneumococcal vaccination sequence is whole, and it don’t need to be adopted by way of further pneumococcal vaccine doses.
PCV13 and a couple of doses of PPSV23
The pneumococcal vaccination suggestions must be reviewed once more when the individual turns age 50 years. On the other hand, a unmarried dose of both PCV21 or PCV20 must be administered ≥5 years after the remaining pneumococcal vaccine dose. If PCV21 or PCV20 is used, the sequence is whole, and it don’t need to be adopted by way of further pneumococcal vaccine doses.
Adults elderly 19–49 years with persistent scientific prerequisites§
None or PCV7 simplest at any age
A unmarried dose of PCV21, PCV20, or PCV15. If PCV15 is run, a unmarried dose of PPSV23* must be administered ≥1 yr after the PCV15 dose.
PPSV23 simplest
A unmarried dose of PCV21, PCV20, or PCV15 ≥1 yr after the remaining PPSV23 dose.
PCV13 simplest
A unmarried dose of PCV21 or PCV20 ≥1 yr after the PCV13 dose.
PCV13 and 1 dose of PPSV23
The pneumococcal vaccination suggestions must be reviewed once more when the individual reaches age 50 years.
Abbreviations: CSF = cerebrospinal fluid; PCV = pneumococcal conjugate vaccine; PCV7 = 7-valent PCV; PCV13 = 13-valent PCV; PCV15 = 15-valent PCV; PCV20 = 20-valent PCV; PCV21 = 21-valent PCV; PPSV23 = 23-valent pneumococcal polysaccharide vaccine.
* For adults who’ve won PCV15 however have now not finished their really useful pneumococcal vaccine sequence with PPSV23, 1 dose of PCV21 or PCV20 is also used if PPSV23 isn’t to be had.
† Power renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV an infection, Hodgkin illness, leukemia, lymphoma, a couple of myeloma, cast organ transplant, congenital or obtained asplenia, or sickle mobile illness or different hemoglobinopathies.
§ Alcoholism; persistent center illness, together with congestive center failure and cardiomyopathies; persistent liver illness; persistent lung illness, together with persistent obstructive pulmonary illness, emphysema, and bronchial asthma; cigarette smoking; or diabetes mellitus.
BOX. Medical steering on choice of pneumococcal conjugate vaccine in communities with prime percentages of serotype 4 pneumococcal illness — United States, 2024
PCV21 incorporates 8 pneumococcal serotypes that don’t seem to be integrated in in the past really useful pneumococcal vaccines (i.e., PCV15, PCV20, and PPSV23). Then again, PCV21 does now not comprise positive pneumococcal serotypes which can be contained in in the past really useful pneumococcal vaccines, one among which is pneumococcal serotype 4.
In positive grownup populations within the western United States, prime percentages (i.e., ≥30%) of IPD brought about by way of serotype 4 have passed off. The to be had IPD serotype information from CDC’s Lively Bacterial Core surveillance, in addition to equivalent surveillance from Alaska and Navajo Country, point out that this serotype is especially prevalent in Alaska, Colorado, Navajo Country, New Mexico, and Oregon. Serotype 4 IPD happens throughout age teams; on the other hand, instances are ceaselessly noticed amongst adults elderly <65 years who’ve underlying prerequisites, similar to alcoholism, persistent lung illness, cigarette smoking, homelessness, and injection drug use. In such populations in those geographic spaces, different really useful pneumococcal vaccines (e.g., PCV20 on my own or each PCV15 and PPSV23) are anticipated to offer broader serotype protection towards in the community circulating lines when put next with PCV21.
The odds of serotype 4 IPD instances in different spaces of the western United States with out IPD surveillance are recently unknown. IPD surveillance from different geographic spaces in america (e.g., midwestern, japanese, and southern areas) has now not detected vital percentages of serotype 4.
This medical steering can be reviewed and up to date as pneumococcal illness epidemiology evolves.
Abbreviations: IPD = invasive pneumococcal illness; PCV = pneumococcal conjugate vaccine; PCV13 = 13-valent PCV; PCV15 = 15-valent PCV; PCV20 = 20-valent PCV; PCV21 = 21-valent PCV; PPSV23 = 23-valent pneumococcal polysaccharide vaccine.
Advised quotation for this text: Kobayashi M, Leidner AJ, Gierke R, et al. Expanded Suggestions for Use of Pneumococcal Conjugate Vaccines Amongst Adults Elderly ≥50 Years: Suggestions of the Advisory Committee on Immunization Practices — United States, 2024. MMWR Morb Mortal Wkly Rep 2025;74:1–8. DOI:
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