Updated FDA recommendations on Rotarix® and RotaTeq® vaccines

On 22 March 2010, the U.S. Food and Drug Administration (FDA) learned that DNA from porcine circovirus type 1 (PCV1), a virus not known to cause disease in humans, was present in the Rotarix® vaccine. At that time, the FDA recommended that clinicians temporarily suspend use of Rotarix® until more was known about the situation.

On 6 May 2010, the FDA indicated that preliminary studies showed the RotaTeq® vaccine contained fragments of DNA from PCV1 and a related porcine circovirus type 2 (PCV2).

Both Rotarix® and RotaTeq® are vaccines used for the prevention of rotavirus disease in infants.

Based on careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of scientific literature, and input from scientific and public health experts, the FDA has updated its recommendations on both vaccines. It has determined that it is now appropriate for clinicians and health care professionals to resume the use of Rotarix® and to continue the use of RotaTeq®.

If you have any further questions or need more information please contact the WHO Regional Office for Europe:

Dr Liudmila Mosina
Technical Officer for New Vaccine Introduction
WHO Regional Office for Europe
Denmark
Tel: +45 3917 1503
E-mail: mol@euro.who.int

or

Dr Rebecca Martin
Targeted Diseases and Immunization Team Leader
WHO, Regional Office for Europe
Denmark
Tel: +45 3917 1216
Email: rma@euro.who.int