BioCentury
ARTICLE | Clinical News

Quadrivalent Vaxigrip regulatory update

February 17, 2014 8:00 AM UTC

Sanofi disclosed in its 2013 earnings that it withdrew an MAA for a quadrivalent formulation of its Vaxigrip to prevent influenza caused by influenza virus subtypes A and B contained in the vaccine in children and adults ages >=9 years to update the pharmaceutical section at the request of the regulatory authorities. Sanofi said it will start a Phase III trial this year to provide the necessary data. The pharma said it is using the opportunity to contemplate a wider indication to include children >=3 years. Sanofi said it will resubmit the application "as soon as possible," but declined to disclose details. ...