Date of Award
Master of Public Health (MPH)
Richard Rothenberg MD, MPH
Pedro Moro MD, MPH
Comparison of Post-licensure safety surveillance of 13-Valent Pneumococcal Conjugate vaccine and 7-Valent Pneumococcal Conjugate vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS).
Background: On February 24, 2010, Food and Drug Administration (FDA) licensed a 13-valent pneumococcal conjugate vaccine (Prevnar 13®, [PCV13]) for use among children aged 6 weeks--71 months. The Advisory Committee on Immunization Practices (ACIP) recommended PCV13 routine vaccination of all children aged 2--59 months, children aged 60--71 months with underlying medical conditions, with PCV13 replacing PCV7 for all doses.
Methods: We searched case reports to the Vaccine Adverse Event Reporting System (VAERS), a US passive surveillance system, for adverse events (AEs) reported after immunization with PCV13 vaccine from February 24, 2010 through February 24, 2011 for persons vaccinated from February 24, 2010 through December 31, 2010 and compared them with AEs reported by persons who were vaccinated with PCV7.
Results: VAERS received 1503 reports of AEs after PCV13; multiple vaccines were given in 79.0% of reports. One hundred eighty (11.9%) were coded as serious, including nineteen reports of death. The most frequently reported symptoms were injection site reactions, fever, irritability and vomiting. Seven hundred fifty-eight (50.4%) reports comprised males. Most reports (37.7%) were from children 1-2 years. Total number of reports received for PCV13 was very similar to those received after vaccination with PCV7.
Conclusions: AEs reported to VAERS following 13-valent pneumococcal conjugate vaccine were consistent with AEs previously observed in pre-licensure trials. We did not identify any major safety concerns or outcomes.
Arana, Jorge E., "Comparison of Post-Licensure Safety Surveillance of 13-Valent Pneumococcal Conjugate Vaccine and 7-Valent Pneumococcal Conjugate Vaccine: Data from the Vaccine Advere Event Reporting System (Vaers)." Thesis, Georgia State University, 2011.