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Study documents adverse events of pneumococcal vaccine in children.
2004 NOV 3 - (NewsRx.com & NewsRx.net) -- Examination of reports from the first 2 years after licensure of a new vaccine against pneumococcal infections indicates that the majority of adverse effects are minor, but that continued surveillance is warranted, according to a new study.
The U.S. Food and Drug Administration (FDA) licensed the 7-valent pneumococcal conjugate vaccine (PCV, trade name Prevnar) on February 17, 2000, according to the Journal of the American Medical Association article. The recommended vaccination series includes doses at ages 2, 4, 6 and 12-15 months, with catch-up doses through 9 years of age. Pneumococcal conjugate vaccine has been rapidly adopted into routine pediatric practice, reflecting concern for the gravity of serious pneumococcal infections (such as meningitis or pneumonia) and confidence in the efficacy and safety of PCV.
Prior to licensure, almost 19,000 infants and children received PCV in randomized clinical trials that demonstrated good efficacy against invasive infections and a favorable safety profile. However, rare vaccine complications may not emerge before licensure for a variety of reasons, particularly the relatively limited sample sizes of trials.
Robert P. Wise, MD, MPH, of the FDA, and colleagues analyzed the summary of data from the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance database, in the first 2 years after PCV licensure. Reports studied were for children younger than 18 years and vaccinated with PCV.
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Source: HighBeam Research, Study documents adverse events of pneumococcal vaccine in children.