NEW FDA VACCINE ALERT (posted March 23, 2010)
The FDA has released a statement instructing health care providers to suspend the use of Rotarix, the rotavirus vaccine manufactured by GlaxoSmithKline. Below is the link to the press release and other information on the FDA website regarding the recommendation to suspend use of the Rotarix vaccine. I have included some summary information you may find helpful.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm
-- FDA is temporarily suspending the use of Rotarix, the rotavirus vaccine made by GSK
-- components of a virus called porcine circovirus type 1 (PCV 1) were found in the vaccine
-- this virus can be found in other things, such as food, and is not known to cause illness in humans or other animals
-- the virus is harmless, but since it shouldn't be present, FDA is taking precautionary measure
-- this suspension will give FDA time to gather more information
-- providers should suspend use of Rotarix, but continue to keep and store the vaccine properly
-- parents of children who have received the vaccine should be reassured that this virus is harmless and does not impact the effectiveness of the vaccine
-- the virus has not been detected in the Merck product, Rotateq, and CDC is working with Merck to maintain stable supply (they do have Rotateq in the CDC stockpile)
-- more information will posted on FDA website today
-- a HAN alert was sent to clinicians around 2:30pm ET March 22, 2010
Additional materials related to today’s FDA Press Briefing on Rotarix Vaccine can be found online at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm .
Additional information will be sent as it becomes available.
NEW MESSAGE FROM COMMITTEE CHAIR: (posted Jan 25, 2010)
Dear Colleagues:
With the new year come new materials to help providers educate themselves and others about immunization. Here are 3 you might consider looking at:
- The Immunization Action Coalition has just published a new issue of Needle Tips, an online publication that contains updates on vaccines your patients should receive, how they should be administered, precautions for special populations, and much more. Every issue is CDC-reviewed and will bring your knowledge current on this important element of preventive medicine. Needle Tips is available at http://www.immunize.org/nt. You can sign up to be notified when new issues are released, and can also subscribe (for free) to other Immunization Action Coalition publications when you visit http://wwwimmunize.org/subscribe.
- Another new resource from the AAP is specifically designed for residents and young physicians, called ImmuneWise. It’s a campaign designed to help providers educate parents about immunizations. The information has been provided to residents attending the AAP NCE as a CD, but is now available online at http://www.aap.org/sections/ypn/r/advocacy/
The site includes downloadable powerpoint presentations that can be used for morning reports & noon conferences.
- Finally, a new resource is TIDE - Teaching Immunization Delivery and Evaluation. The site is directed at residents and serves as an immunization curriculum. Go to: http://www2.edserv.musc.edu/tide/menu.lasso
James H. Conway, MD FAAP
Associate Professor of Pediatrics
Univ of Wisconsin School of Med & Public Health
(posted Jan 25, 2010)
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