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
Author Information
Hung Fu Tseng: Kaiser Permanente, Pasadena, Southern California.
Lina S Sy: Kaiser Permanente, Pasadena, Southern California.
Lei Qian: Kaiser Permanente, Pasadena, Southern California.
In-Lu A Liu: Kaiser Permanente, Pasadena, Southern California.
Cheryl Mercado: Kaiser Permanente, Pasadena, Southern California.
Bruno Lewin: Kaiser Permanente, Pasadena, Southern California.
Sara Y Tartof: Kaiser Permanente, Pasadena, Southern California.
Jennifer Nelson: Kaiser Permanente, Seattle, Washington.
Lisa A Jackson: Kaiser Permanente, Seattle, Washington.
Matthew F Daley: Kaiser Permanente, Denver, Colorado.
Eric Weintraub: Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
Nicola P Klein: Kaiser Permanente, Oakland, Northern California.
Edward Belongia: Marshfield Clinic Research Institute, Marshfield, Wisconsin.
Elizabeth G Liles: Kaiser Permanente, Northwest, Portland, Oregon.
Steven J Jacobsen: Kaiser Permanente, Pasadena, Southern California.
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.
