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February 22, 2007 Yesterday, the US Centers for Disease Control and Prevention (CDC) convened the Advisory Committee on Immunization Practices (ACIP) to review post-marketing safety surveillance data on RotaTeq®, the rotavirus vaccine by Merck and Co., Inc. Because of a suspected association between intussusception (a blockage of the intestine) and an earlier rotavirus vaccine (RotaShield®) that was withdrawn from the US market in 1999, the CDC is monitoring this new vaccine with particular care. Since the vaccine’s introduction in February 2006 through February 14, 2007, the rate of reports of intussusception following RotaTeq® vaccination recorded through the CDC’s Vaccine Adverse Event Reporting System did not exceed expected background rates in the absence of vaccination. Also, active surveillance being conducted in a population of insured children has not identified any reports of intussusception within 30 days of more than 28,000 administered doses of RotaTeq®. Upon review of this information, the committee expressed no safety concerns regarding use of RotaTeq® and stood by its initial recommendation for routine administration to all US infants at ages 2, 4, and 6 months. The committee also reviewed baseline epidemiological data on rotavirus hospitalizations and noted that the data provides an opportunity to monitor the vaccine’s impact. Click here to learn more about the role of the ACIP. Presentations and minutes from this week’s meeting will be posted to the ACIP website in coming weeks.
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The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance. |