Other safety alerts
|
| |
| The United States: FDA actions on Rotarix and RotaTeq |
| |
On May 7, 2010, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened to discuss the findings of PCV and PCV DNA in rotavirus vaccines. The meeting included a discussion of FDA’s evaluation of laboratory results from the manufacturers of Rotarix and RotaTeq rotavirus vaccines and FDA’s own laboratories.Based on a careful evaluation of information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency revised its recommendation and lifted the temporary suspension of the use of the Rotarix vaccine. FDA determined based on the benefit of the vaccine over the theoretical risk of PCV that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. FDA also recommended that clinicians and public health professionals inform parents of the findings of PCV DNA or PCV in rotavirus vaccines, and that there is no evidence that these findings pose a safety risk in humans.
Please refer to the following website in FDA for details:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205546.htm
In Hong Kong, Rotarix Vaccine Oral Suspension (by GlaxoSmithKline Ltd) and Rotateq Vaccine Oral Suspension (by Merck Sharp & Dohme (Asia) Ltd) had been recalled in March 2010 and May 2010 respectively as a precautionary measure following the discovery of PCV-1. The Department of Health has concluded that the benefits of these vaccines outweigh the risks. The vaccines have resumed for use in Hong Kong since May 2010 following the assessment. The above information had been posted on the website of Pharmaceutical Service on March 23, 2010, May 7, 2010 and May 17, 2010 respectively.
Ends/Wednesday, December 29, 2010
Issued at HKT 14:30
|
| |
|
