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FDA Approves 2015/2016 Formulation of Flublok Influenza Vaccine

First recombinant protein-based vaccine for prevention of seasonal flu

The FDA has approved the composition of Flublok influenza vaccine for the 2015/2016 flu season. Each year, influenza vaccine manufacturers must receive the agency’s approval for changes that they make to their vaccines so that the vaccines will protect against the new strains of flu that are predicted to circulate during the next flu season.

The new Flublok formulation is expected to be available to distributors and retailers in mid-August.

A recent clinical study of the quadrivalent version of Flublok in approximately 9,000 adults (50 years of age and older) showed that Flublok recipients were 31% less likely to develop laboratory-confirmed influenza compared with subjects who received a traditional egg-based quadrivalent vaccine.

Flublok, the first recombinant protein-based vaccine for the prevention of seasonal influenza disease, was approved by the FDA in January 2013. According to the vaccine’s manufacturer (Protein Sciences Corporation), Flublok is the only flu vaccine made in a 100% egg-free system and is not subject to the egg-adapted mutations associated with low vaccine effectiveness. Flublok provides three times more antigen than traditional flu vaccines (3 × 45 mcg hemagglutinin protein versus 3 × 15 mcg hemagglutinin protein) and does not contain preservatives (such as thimerosal, a mercury derivative), egg proteins, gelatin, or latex.

Trivalent Flublok is approved for adults (18 years of age and older) to prevent influenza disease. The vaccine’s most common adverse effect is injection-site pain. Headache, fatigue, or muscle ache may also occur.

Source: PR Newswire; July 8, 2015.


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