Pneumococcal Conjugate Vaccine Safety in Elderly Adults

Hung Fu Tseng, Lina S Sy, Lei Qian, In-Lu A Liu, Cheryl Mercado, Bruno Lewin, Sara Y Tartof, Jennifer Nelson, Lisa A Jackson, Matthew F Daley, Eric Weintraub, Nicola P Klein, Edward Belongia, Elizabeth G Liles, Steven J Jacobsen, Hung Fu Tseng, Lina S Sy, Lei Qian, In-Lu A Liu, Cheryl Mercado, Bruno Lewin, Sara Y Tartof, Jennifer Nelson, Lisa A Jackson, Matthew F Daley, Eric Weintraub, Nicola P Klein, Edward Belongia, Elizabeth G Liles, Steven J Jacobsen

Abstract

Background: The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65 years. The study examines adults ≥65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13 as compared with vaccination with PPSV23, a long-standing vaccine with a satisfactory safety profile.

Methods: The cohort study included 6 Vaccine Safety Datalink sites. The exposed person-time included follow-up time of the first PCV13 received by subjects age ≥65 years from January 1 to August 15, 2015. The comparator person-time included follow-up time after the first PPSV23 received by subjects of the same age during Janaury 1 to August 15 of each year of 2011-2015. The prespecified AEs included cardiovascular events, Bell's palsy, Guillain-Barré syndrome, syncope, erythema multiforme, thrombocytopenia, cellulitis and infection, allergic reaction, and anaphylaxis. Inverse probability of treatment weighting-adjusted Poisson regression models was used to estimate the relative risk (RR) of each AE.

Results: A total of 313 136 doses of PCV13 and 232 591 doses of PPSV23 were included. The adjusted RRs comparing the incidence of AEs following PCV13 vs PPSV23 were all <1, except for anaphylaxis, which was insignificant with an RR of 1.32 (95% confidence interval, 0.30-5.79). Only 1 patient who received PCV13 and 4 other vaccines concomitantly was confirmed by medical chart review as having experienced anaphylaxis after vaccination.

Conclusions: These data do not support an increased rate of adverse events following PCV13 administration in elders compared with PPSV23 and should provide reassurance regarding continued use of PCV13.

Keywords: adult vaccination; adverse events; pneumococcal conjugate vaccine.

Figures

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Figure 1.
Abbreviations: ED, emergency department; IPTW, inverse probability of treatment weighting; VSD, Vaccine Safety Datalink.

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Source: PubMed

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