GSK Unveils Update On Rotarix Filing In Japan

GlaxoSmithKline (GSK) has filed its vaccine for the prevention of rotavirus gastroenteritis (approved as Rotarix in a number of countries outside of Japan). The company claims that the candidate vaccine, which is given orally, is the first to be filed for approval for the prevention of rotavirus gastroenteritis in infants in Japan.

Rotarix is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection.

The company said that the vaccine is immunogenic and can be co-administered with all major infant vaccinations including oral polio vaccine.

Rotarix is available as a vial of lyophilized vaccine to be reconstituted with a liquid diluent in a prefilled oral applicator. Each 1-ml dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution.