Adverse Events Examined Following PCV13 Vaccination in Children

Of 10,007 reports of AEs identified, 17.0% were considered serious
Of 10,007 reports of AEs identified, 17.0% were considered serious

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SAN DIEGO—Adverse events (AEs) following vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) reported to the Vaccine Adverse Event Reporting System (VAERS) post-licensure were found to be consistent with AEs observed in pre-licensure clinical trials, according to results of a surveillance study presented at IDWeek 2017.

The VAERS was utilized to identify AEs reported following PCV13 vaccination in children aged 6 weeks to 59 months. The Medical Dictionary for Regulatory Activities (MedDRA) was used to code the signs and symptoms of AEs identified. “Physicians reviewed the VAERS forms and available medical records of serious reports (death, life-threatening illness, hospitalization, prolongation of hospitalization and permanent disability) and reports of Kawasaki disease and anaphylaxis,” lead author, Jorge Arana, MD, MPH, from the Centers for Disease Control and Prevention (CDC), Atlanta, GA. Additionally, death certificates and/or autopsy reports were examined to determine any causes of death.

Of the 10,007 reports of AEs identified in VAERS following PCV13 vaccination, 1,706 (17.0%) were considered serious. PCV13 was administered alone in 927 cases (9.3%). 

“The most frequently reported symptoms were pyrexia (26.4%), injection site erythema (15.3%) and irritability (14.6%). Injection site erythema (25.4%), injection site swelling (20.6%) and pyrexia (20.1%) were most frequent among children who were given PCV13 alone,” the authors reported. The median time from vaccination to the beginning of symptoms was reported as 1 day and ranged from the day of vaccination to 2,033 days after vaccination.

The study authors also reported that 222 death reports (2.2%) were identified in their search, with the most common cause being sudden infant death syndrome (37.8%). The most common non-death serious reports involved pyrexia (45.1%), irritability (40.4%), and vomiting (39.7%). Kawasaki disease and anaphylaxis were each reported in 20 cases (0.2%).

The authors concluded, “AEs reported to VAERS following PCV13 were consistent with AEs previously observed in pre-licensure clinical trials and other post-licensure studies of PCV13.”

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Reference:

Arana J, Moro P, Lewis P, Cano M. Post-licensure Surveillance of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Children 6 weeks–59 months old, Vaccine Adverse Event Reporting System (VAERS), United States, 2010–2017. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. http://www.idweek.org