Safety of a 2-dose primary series of 13-valent pneumococcal conjugate vaccine in Indonesian infants
BACKGROUND In 2017, the Indonesian Technical Advisory Group on Immunization recommended a safety monitoring demonstration program for the 13-valent pneumococcal conjugate vaccine (PCV13) in West Lombok and East Lombok, West Nusa Tenggara to evaluate the 2-dose primary series (2 and 3 months of age) for serious adverse events (SAEs), adverse events, systemic events, and local reactions.
METHODS A total of 1,083 infants from 10 primary healthcare centers were analyzed, with 687 receiving the first dose and 396 receiving the second dose. Based on the national immunization program, they received PCV13 + DTwP-HB-Hib + OPV (n = 544), PCV13 + DTwP-HB-Hib (n = 101), or PCV13 only (n = 403). They were monitored for 30 min after vaccination for any immediate SAEs, and parents were given a diary card to record safety information prospectively for 28 days.
RESULTS No immediate SAEs were observed, and no SAEs were reported during 28 days after vaccination. Reports of local reactions and systemic events predominated on days 1–3 post-vaccination. Severe fever (axillary temperature >39.0°C) was uncommon (<2% of all infants). Most irritability was mild to moderate. Local pain was more frequent after the first dose than after the second dose. It was distributed evenly across mild, moderate, and severe classifications, while redness and swelling were mostly mild to moderate.
CONCLUSIONS The PCV13 primary series demonstration program in Indonesia confirmed tolerable local and systemic reactions.
WHO Publication. Pneumococcal vaccines WHO position paper - 2012 - recommendations. Vaccine. 2012;30(32):4717-8. https://doi.org/10.1016/j.vaccine.2012.04.093
World Health Organization. Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper -February 2019. Wkly Epidemiol Rec. 2019;94(08):85-103.
McAllister DA, Liu L, Shi T, Chu Y, Reed C, Burrows J, et al. Global, regional, and national estimates of pneumonia morbidity and mortality in children younger than 5 years between 2000 and 2015: a systematic analysis. Lancet Glob Health. 2019;7(1):e47-57. https://doi.org/10.1016/S2214-109X(18)30408-X
Thompson A, Gurtman A, Patterson S, Juergens C, Laudat F, Emini EA, et al. Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries. Vaccine. 2013;31(45):5289-95. https://doi.org/10.1016/j.vaccine.2013.08.025
Kartasasmita CB, Hadinegoro SR, Kurniati N, Triasih R, Halim C, Gamil A. Epidemiology, nasopharyngeal carriage, serotype prevalence, and antibiotic resistance of Streptococcus pneumoniae in Indonesia. Infect Dis Ther. 2020;9(4):723-36. https://doi.org/10.1007/s40121-020-00330-5
International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. VIEW-hub [Internet]. [cited 2023 Jan 28]. Available from: www.view-hub.org.
The Indonesian Food and Drug Authority (BPOM). Latest Indonesia BPOM approved Prevenar 13 local product document. The Indonesian Food and Drug Authority (BPOM); 2020.
Directorate of Immunization Management. [Technical guidelines, implementation of pneumococcal conjugated vaccine (PCV) immunization]. Indonesian Ministry of Health; Directorate of Immunization Management: 2022. Indonesian.
Indonesian Ministry of Health. [The Minister of Health rules number 12 year 2016 about administration of immunization]. Jakarta; 2017. Indonesian.
Communication and informatics office of the Bangka Belitung Islands Province. [Deputy governor: protect children of Bangka Belitung from pneumonia with PCV immunization] [Internet]. Communication and informatics office of the Bangka Belitung Islands Province; 2021 [cited 2021 May 1]. Available from: https://babelprov.go.id/content/wagub-lindungi-anak-babel-dari-pneumonia-dengan-imunisasi-pcv. Indonesian.
Indonesian Ministry of Health, Directorate General of Disease Prevention and Control. [Technical guide PCV immunization demonstration program implementation]. Indonesian Ministry of Health, Directorate General of Disease Prevention and Control; 2017. Indonesian.
Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine. 2006;24(22):4727-36. https://doi.org/10.1016/j.vaccine.2006.03.032
Kieninger DM, Kueper K, Steul K, Juergens C, Ahlers N, Baker S, et al. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine. 2010;28(25):4192-203. https://doi.org/10.1016/j.vaccine.2010.04.008
Sundoro J, Rusmil K, Sitaresmi MN, Arhana A, Djelantik IGG, Hadinegoro SR, et al. [Safety profile following Pentabio® primary dose vaccination in Indonesian infants]. Maj Kedokt Bandung. 2017;49(2):86-93. Indonesian. https://doi.org/10.15395/mkb.v49n2.1052
Gidudu JF, Walco GA, Taddio A, Zempsky WT, Halperin SA, Calugar A, et al. Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2012;30(30):4558-77. https://doi.org/10.1016/j.vaccine.2012.03.085
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