FDA extends shelf life of Flublok influenza vaccine

MERIDEN, Conn. - Protein Sciences announced Thursday that FDA has extended the shelf life for Flublok, its seasonal influenza vaccine, to nine months from the date of manufacture. That increases the previous shelf life by three months.  The longer shelf life will make it easier for healthcare providers and pharmacies to stock Flublok and vaccinate people throughout the influenza season, which in some years can last as long as April or May.

"We are pleased to add an extended shelf life to the list of product improvements we have been able to achieve for Flublok," stated Penny Post, Protein Sciences VP regulatory affairs.  "We were first able to expand the approved age range for Flublok to everyone 18 years and older in October 2014.  In addition to the nine month shelf life we just achieved, Flublok Quadrivalent is under review and FDA approval is anticipated this fall.  We are working towards securing a one year shelf life as well."

In a clinical study of approximately 9,000 adults 50 years and older, Flublok proved to be 43% more effective than a traditional egg-based flu vaccine in protecting people against cell culture confirmed influenza, the company noted.