The Center for Drug Evaluation (CDE) website has indicated that Wuhan Institute of Biological Products Co., Ltd’s oral hexavalent reconstituted rotavirus live vaccine (Vero cells) is on course for priority review. This priority status is granted for the vaccine’s use in preventing acute gastroenteritis caused by rotavirus in infants and young children, highlighting its potential impact on public health.
Innovative Vaccine for Pediatric Use
The product, the first of its kind in China to be filed for marketing, is indicated for 6-12 week-old infants. The innovative nature of the drug and its pediatric use are key factors in its designation for priority review status. This recognition underscores the importance of advancing vaccines that can protect young populations from rotavirus-related illnesses.
Market Landscape for Rotavirus Vaccines in China
Currently, commercially available rotavirus vaccines in China include Lanzhou Institute of Biological Products Co., Ltd.’s trivalent recombinant live attenuated rotavirus vaccine and oral rotavirus live vaccine, as well as MSD’s RotaTeq (pentavalent reassortant live attenuated rotavirus vaccine). GSK’s Rotarix, which has received global approval, has not yet entered China’s market, making the potential approval of Wuhan Institute’s hexavalent vaccine a significant development in the country’s vaccine landscape.-Fineline Info & Tech
