FDA OKs Protein Sciences Extended Shelf Life for Flublok

FDA has approved a Protein Sciences BLA supplement to extend the shelf life for Flublok, its seasonal influenza vaccine. The shelf life has been extended to nine months from the date of manufacture — increasing the previous shelf life by three months. The longer shelf life is intended to help healthcare providers and pharmacies stock Flublok and vaccinate people throughout the influenza season, which in some years can last as long as April or May, according to the company. Additionally, a separate submission is under review at the agency to extend Flublok’s shelf life to one year.

Flublok was approved in 2013  based on data from a 9,000 patient clinical study. The data showed that Flublok proved to be 43% more effective than a traditional egg-based flu vaccine in protecting people against cell culture confirmed influenza, the company says.