Regulatory Roundup: FDA Clears Infant Rotavirus Vaccine

May 20, 2010
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Clears Infant Rotavirus Vaccine

FDA stated on May 14, 2010, that US healthcare practitioners can resume the use of Rotarix (Rotavirus Vaccine, Live, Oral) used to treat the disease in infants, effective immediately. This action supersedes the agency’s March 22 recommendation, which called for healthcare providers to halt its use. FDA has determined that the presence of porcine circovirus type 1 (PCV-1) in the vaccine poses no safety risk.