Flublok 9-Month Shelf Life Approved by FDA
The Food and Drug Administration (FDA) has approved a longer shelf life for the influenza vaccine Flublok (Protein Sciences), extending the previous shelf life of 6 months to 9 months from the date of manufacture.
The extended shelf life will make it more convenient for healthcare providers and pharmacies to stock Flublok and vaccinate patients throughout the influenza season. Increasing the shelf life by 3 months can extend the vaccine supply until April or May in some years.
Protein Sciences has been making various product improvements to the Flublok vaccine. In addition to an extended shelf life, Flublok gained an expanded age range for patients 18 years and older in October 2014. The Company is also working to secure a one year shelf life, and developing Flublok Quadrivalent which is under FDA review and anticipated for approval this fall.
Flublok, the first recombinant protein-based vaccine was approved by FDA back in January 2013. Flublok is made in a 100% egg-free system using modern cell culture technology, without an infectious influenza virus or antibiotics in manufacturing. It is highly purified, containing no preservatives (eg, thimerosal), gelatin or latex, and contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein).