pneumococcal vaccine (Prevenar 13 / 13vPnC / PCV 13)

21‑Valent Pneumococcal Conjugate Vaccine V116 (CAPVAXIVE®): Pediatric First Approval.

Shirley Matt M

The 21‑valent pneumococcal conjugate vaccine (PCV) V116 (CAPVAXIVE®), developed by Merck & Co., has been approved in the USA since June 2024 for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in adults, with subsequent approvals in adults in the EU and a range of other countries. With the inclusion of eight S. pneumoniae serotypes that are not included in other currently licensed pneumococcal vaccines, V116 was designed to target residual pneumococcal disease in adults. Noting that some of the unique serotypes in V116 are responsible for significant pneumococcal disease in children and adolescents, the potential value of V116 in also complementing existing pediatric pneumococcal vaccination regimens has been explored. Supported by phase III clinical evaluation in children and adolescents with an increased risk of pneumococcal disease, in March 2026, V116 received its first pediatric approval, in the EU, for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae in children and adolescents 2 to < 18 years of age who previously completed a primary pediatric pneumococcal vaccination regimen. Subsequently, in June 2026, the US approval for V116 was extended to include use in individuals 2-17 years of age who are at increased risk for pneumococcal disease. This article summarizes the milestones in the development of V116 leading to these first pediatric approvals for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae.

Protection and Duration of 23-Valent Pneumococcal Polysaccharide Vaccine Against Hospitalization for Community-Acquired Pneumonia in Older Adults with Low Vaccination Coverage: A Multicenter Matched Case-Control Study in China.

Yang Tianchi T, Ying Xingqiu X, Wu Xiaoqing X, Shao Junzhe J et al.

Background/Objectives: 23-valent pneumococcal polysaccharide vaccine (PPV23) effectiveness against community-acquired pneumonia (CAP) remains controversial, with critical gaps in low-coverage settings and beyond 5 years post-vaccination. We estimated real-world PPV23 effectiveness against CAP hospitalization and characterized its duration among elderly adults in a low-coverage region. Methods: A multicenter matched case-control study was conducted across 14 hospitals in Eastern China (2018-2022). Cases were patients aged ≥60 years hospitalized with clinically diagnosed CAP. Up to three controls per case were matched on sex, age (±3 years), admission date (±5 days), hospital, and residential community. Conditional logistic regression estimated vaccine effectiveness (VE), adjusting for chronic comorbidities and healthcare utilization. Results: Among 6645 cases and 15,806 controls, 5-year PPV23 coverage was 2.14% (cases) and 2.76% (controls). PPV23 was associated with a 22.5% reduction in CAP hospitalization (adjusted VE = 22.5%, 95% CI: 4.1% to 37.3%). Protection was concentrated in non-severe CAP (adjusted VE = 25.7%, 95% CI: 7.0% to 40.7%), with no significant effect in severe CAP (adjusted VE = -11.7%, 95% CI: -115.1% to 42.0%). Extending the exposure window to 6 years yielded no significant VE (adjusted VE = 17.3%, 95% CI: -1.8% to 32.8%). Conclusions: PPV23 provides meaningful protection against CAP hospitalization in elderly adults in low-coverage settings, only for non-severe disease. Waning efficacy beyond 5 years supports revaccination at that interval.

Ensuring Maternal and Infant Protection: A Commentary on Pneumococcal Vaccine Safety in Pregnancy and Lactation.

Levin Lane L, Valencia Sara S, Ault Kevin K

Oral HPV Dynamics in MSM Living with HIV in the Nine-Valent HPV Vaccination Era.

Zulian Verdiana V, Sanctis Martina De M, Pauciullo Silvia S, Sciamanna Roberta R et al.

Background/Objectives: Oral human papillomavirus (HPV) infection is emerging as a key driver of HPV-associated oropharyngeal cancer, especially in high-risk groups such as men who have sex with men (MSM) living with HIV (PLWH). However, evidence on oral HPV persistence and the impact of nine-valent HPV vaccination in adults remains limited. We conducted a prospective longitudinal study including 76 MSM PLWH, of whom 64 were nine-valent HPV-vaccinated and 12 unvaccinated. Methods: Oral rinse samples were collected at baseline (T0) and after 6 months (T6). HPV DNA detection and genotyping were performed using the Allplex™ HPV28 assay. Oral HPV dynamics (persistence, clearance, and incidence) were assessed for high-risk (HR) HPV, low-risk (LR) HPV, and vaccine-type HPV genotypes. Results: Baseline oral HPV prevalence was high (59.2%), with HR HPV detected in 43.4% of participants. HPV16 was the most frequent genotype at both T0 and T6. Among participants HPV-positive at baseline, persistence of HPV DNA was high and similar regardless of vaccination status (77.8%). However, incident vaccine-type oral HPV infection was significantly lower among vaccinated individuals than unvaccinated participants (6.3% vs. 33.3%; OR 0.13, 95% CI: 0.03-0.71; p = 0.0441). Finally, reporting ≥10 sexual partners in the previous year was significantly associated with baseline oral HPV positivity (p = 0.0298). Conclusions: In MSM PLWH, oral HPV infection is highly prevalent and persistent, underscoring that it may represent a reservoir for HPV-related oropharyngeal disease. In our small observational cohort, nine-valent HPV vaccination was associated with lower incident detection of vaccine-type oral HPV, supporting targeted vaccination and oral HPV surveillance in high-risk adult populations, while highlighting the need for larger longitudinal studies to confirm these findings and better define the magnitude and durability of vaccine-associated protection at the oral site.