Flublok egg-free flu vaccine approved

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Flublok egg-free flu vaccine approved
Flublok egg-free flu vaccine approved

The FDA has approved a new cell-culture seasonal influenza vaccine -- Flublock (Protein Sciences)-- for adults aged 18 to 49 years. Like other currently available seasonal flu vaccines, the vaccine protects against two influenza A strains -- H1N1 and H3N2 -- and a B strain.

The trivalent recombinant hemagglutinin [rHA] influenza vaccine does not contain live influenza virus or chicken eggs, thereby shortening the time needed for production. Flublok is highly purified and it contains three times the amount of active ingredient in traditional influenza vaccines with no preservatives (eg, thimerosal), antibiotics or adjuvants.

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research said in a press release. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”

The vaccine's approval was based on data from two randomized, placebo-controlled trials, one with 4,648 healthy adults and another involving 460 healthy adults. In the larger study, Flublok was 44.6% effective against all circulating influenza strains, not just those that matched the strains included in the vaccine.

The most common adverse events were pain at the injection site (>37%), headache (>15%), fatigue (>15%) and myalgia (>11%). 

Flublok is available as a single 0.5mL dose for intramuscular injection. Flublok will be widely available for the 2013-2014 influenza season and is available in limited supply for the current season. For more information call (888) 855-7871 or visit www.flublok.com
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