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The Journal of Pediatric Infectious Diseases and Immunology > Vol.34 No.3 contents > Abstract

Article in Japanese

Evaluation of the safety of the adsorbed 13-valent pneumococcal conjugate vaccine for use in children in routine practice

Noriko MATSUMOTO1), Masayuki OHKURA1), Bennett LEE2), Tomoyuki HAYAMIZU2),

We conducted a post-marketing surveillance to assess the current status of use and the safety of the 13-valent pneumococcal conjugate vaccine (13vPnC) in children. This was a non-interventional, prospective, observational study focused on safety associated with the first to fourth vaccinations of 13vPnC-naïve infants aged 2‒7 months. From March 2014 to February 2015, 1087 subjects were registered, and all case report forms were collected. Among them, data from 1071 subjects were analyzed. Most subjects received multiple vaccinations; only ~4% received 13vPnC alone. Adverse drug reactions (ADRs) occurred in 432 subjects (40.3%); these were mild to moderate in severity. The most frequently reported local ADR was vaccination site erythema (n=283; 26.4%) followed by swelling (n=249; 23.2%). Systemic ADRs included fever (n=232; 21.7%) and seizure (n=1; 0.1%). 13vPnC is generally administered as per instructions and is frequently administered together with other vaccines. Although the incidences of ADRs were high in concurrent use with some specific vaccines, they were mild to moderate in severity. In conclusion, no specific safety problems were identified for 13vPnC.

1)PMS Affairs, Pfizer R&D Japan G.K.
2)Japan Vaccine Medical Affairs, Pfizer Japan Inc.

Key words 13-valent pneumococcal conjugate vaccine, children, post-marketing surveillance, current status of use, safety
Received May 26, 2022
Accepted August 12, 2022

34 (3):183─197,2022