FDA approves Protein Sciences’ 2015/16 formulation of Flublok influenza vaccine

Each year, manufacturers of influenza vaccine must receive approval from the FDA for changes they make to their vaccines so that the vaccines protect against the new strains of flu that are predicted to circulate next flu season.

The company noted that traditional egg-based vaccine manufacturers may experience production delays during years when there are two or more new strains of flu as traditional manufacturing technology is slow.

This year, there are two strain changes and the technology used to make Flublok is fast.

The FDA approval allows the company to deliver Flublok to distributors and retailers in mid-August.

Early availability of Flublok is especially important for those that rely on Flublok’s properties for protection from the flu.

Compared to traditional flu vaccines, Flublok contains three times more active ingredients.

Protein Sciences president and CEO Manon Cox said: "We are extremely pleased with the early approval of the 2015/16 Flublok formulation.

"We expect Flublok to be available in Target pharmacies and other retail chains before most other vaccines this year. Flublok is approved for use in everyone 18 years and older."

Data from a recent clinical study of the quadrivalent version of Flublok in about 9,000 adults 50 years and older showed that Flublok recipients were 31% less likely to develop laboratory confirmed influenza compared to those who received a traditional egg-based quadrivalent vaccine.