POST 01057E : FDA UPDATE ON ROTAVIRUS VACCINE

POST 01057E : FDA UPDATE ON ROTAVIRUS VACCINE 23 February 2007 _______________________________ FDA issues information update on rotavirus vaccine The US Food and Drug Administration (FDA) posted a public health notification on February 13, 2007, to encourage health care workers to recognize and report possible vaccine adverse events following the introduction of Merck & Co., Inc.’s RotaTeq® vaccine. The notification is intended to provide health care workers with an update on information collected as part of the US Vaccine Adverse Event Reporting System (VAERS), which is routinely used for tracking vaccine safety. In February 2006, the Advisory Committee on Immunization Practices (ACIP) to the CDC unanimously recommended routine use of RotaTeq® in US infants to prevent rotavirus, the leading cause of severe diarrhea, vomiting, fever, and dehydration in infants and young children. Because of a suspected association between intussusception (a rare, life-threatening blockage of the intestine) and an earlier rotavirus vaccine (RotaShield®), the US CDC and FDA are monitoring the new RotaTeq® vaccine with particular care. Prior to last year’s FDA approval of Merck’s vaccine, investigators conducted a rigorous clinical trial with more than 70,000 subjects and found that RotaTeq® was not associated with an increased risk of intussusception, or other serious adverse events, when compared to placebo. In the US, intussusception is estimated to spontaneously occur in approximately 18 to 43 per 100,000 infants annually. While 28 reported cases of intussusception were identified through post-marketing surveillance following administration of RotaTeq®, it is important to note, as the FDA states, "the number of intussusception cases reported to date after RotaTeq administration does not exceed expected background rates among unvaccinated children of the same age." In fact, the number of reported cases is lower than expected based on estimates of naturally-occurring episodes of intussusception in children in this age range (CDC, unpublished data). Media reports of the FDA notice implied a link between the vaccine and intussusception that is not supported by the current data. In a statement posted online February 14, the US CDC affirmed its continued support of ACIP’s recommendation for use of the vaccine: "This notice does not mean there is a problem with the RotaTeq® vaccine. CDC is not changing its policy at this time. CDC continues to support the Advisory Committee on Immunization Practices’ recommendation for routine immunization of all U.S. infants with three doses of RotaTeq® administered orally at ages 2, 4 and 6 months." The ACIP will conduct a regularly-scheduled review of the safety tracking data during its upcoming meeting on February 21, 2007, and the CDC stated that it will continue to monitor reports of possible adverse effects of the vaccine. Visit http://www.fda.gov/cber/safety/phnrota021307.htm to read the FDA notice. Visit http://www.cdc.gov/nip/vaccine/rota/rotateq_2-07.htm for additional information and answers to common questions on the CDC’s website. Visit http://www.merck.com/newsroom/press_releases/product/2007_0213.html to read the vaccine manufacturer’s press release. Deborah Phillips Communications Associate PATH Rotavirus Vaccine Program mailto:[email protected] ______________________________________________________________________________ All members of the TechNet21 e-Forum are invited to send comments on any posting or to use the forum to raise a new discussion or request technical information in relation to immunization services. The comments made in this forum are the sole responsibility of the writers and do not in any way mean that they are endorsed by any of the organizations and agencies to which the authors may belong. ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:[email protected] Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de coopération internationale en santé et développement, Québec, Canada (http://www.ccisd.org) ______________________________________________________________________________