Safety profiles of PCV10 and PCV13 have been reviewed by the WHO GACVS. The GSK and Pfizer products have accrued extensive post-marketing safety surveillance data and are assessed as having excellent safety profiles Go to footnote 1, Go to footnote 2, Go to footnote 3, Go to footnote 4, Go to footnote 5 . In the clinical trials of the newer PCVs, PCV10-SII had a similar safety profile compared to PCV10-GSK and PCV13-PFZ Go to footnote 6, Go to footnote 7 ), and the extended-valency PCVs (i.e., PCV14-BE, PCV15 and PCV20) have a similar safety profile to PCV13-PFZ. Go to footnote 8 Go to footnote 9 Go to footnote 10, Go to footnote 11
Children with impaired immune responsiveness may exhibit reduced antibody response to PCV10-GSK, PCV13-PFZ and PCV15, which were the only PCVs evaluated in this population.
Safety studies suggest that PCV15 and PCV13 have comparable safety profiles in high-risk groups, including among children with HIV infection and sickle cell disease, and among healthy children. Go to footnote 12, Go to footnote 13
- Go back to footnote reference 1
Artama M, Rinta Kokko H, Nohynek H, Jokinen J, Palmu AA et al. (2018). Register based ecologic evaluation of safety signals related to pneumococcal conjugate vaccine in children. Curr Drug Saf. 13(2):107–112. doi: 10.2174/1574886313666180219123253.
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Feikin DR, Kagucia EW, Loo JD, Link Gelles R, Puhan MA et al. (2013). Serotype specific changes in invasive pneumococcal disease after pneumococcal conjugate vaccine introduction: a pooled analysis of multiple surveillance sites. PLoS Med. 10(9):e1001517. doi: 10.1371/journal.pmed.1001517.
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World Health Organization (n.d.). Pneumosil® – prequalification dossier and related information. World Health Organization. Available at: https://extranet.who.int/pqweb/content/pneumosil%C2%AE 0 (accessed 4 August 2025).
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Løchen A, Croucher NJ, Anderson RM et al. (2020). Divergent serotype replacement trends and increasing diversity in pneumococcal disease in high-income settings reduce the benefit of expanding vaccine valency. Sci. Rep. 10, 18977. doi: 10.1038/s41598-020-75691-5.
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World Health Organization (n.d.). Pneumococcal vaccines and vaccine safety reviews. Global Advisory Committee on Vaccine Safety (GACVS). World Health Organization. Available at: https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/pneumococcal (accessed 4 August 2025).
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Clarke E, Bashorun A, Adigweme I, Badjie Hydara M, Umesi A, Futa A et al. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021;21:834-46. doi: 10.1016/S1473-3099(20)30735-0.
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Adigweme I, Futa A, Saidy-Jah E, Edem B, Akpalu E, Dibbasey T et al. Immunogenicity and safety of a 10-valent pneumococcal conjugate vaccine administered as a 2 + 1 schedule to healthy infants in The Gambia: a single-centre, double-blind, active-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2023;23:609-20. doi: 10.1016/S1473-3099(22)00734-4.
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Matur RV, Thuluva S, Gunneri S, Yerroju V, Reddy Mogulla R, Thammireddy K et al. Immunogenicity and safety of a 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX 14) administered to 6-8 weeks old healthy Indian Infants: A single blind, randomized, active-controlled, Phase-III study. Vaccine. 2024;42:3157-65. doi: 10.1016/j.vaccine.2024.03.056.
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Wagner G, Gartlehner G, Thaler K, Ledinger D, Feyertag J, Klerings I et al. Immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine, a systematic review and meta-analysis. NPJ Vaccines. 2024;9:257. doi: 10.1038/s41541-024-01048-y.
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Senders S, Klein NP, Tamimi N, Thompson A, Baugher G, Trammel J et al. A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2024;43:596-603. doi: 10.1097/INF.0000000000004334.
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Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J et al. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024;43:587-95. doi: 10.1097/INF.0000000000004300.
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Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S et al. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023;37:1227-37. doi: 10.1097/QAD.0000000000003551.
- Go back to footnote reference 13
Quinn, C.T., Wiedmann, R.T., Jarovsky, D., Lopez Medina, E., Rodriguez, H.M. et al. (2023) ‘Safety and immunogenicity of V114, a 15 valent pneumococcal conjugate vaccine, in children with SCD: a V114 023 (PNEU SICKLE) study’, Blood Advances, 7(3), pp.414 421. doi:10.1182/bloodadvances.2022008037.
