Protein Sciences Corporation announced today that the FDA has approved the Company's strain change amendment for its seasonal influenza vaccine, Flublok. Every year influenza vaccine manufacturers must receive approval from the Agency for changes they make to the upcoming season's manufacturing process and product formulation, as the influenza vaccine is adapted annually. Early approval for Flublok will enable delivery on time to healthcare providers in the fall. This is especially important for those that rely on Flublok's unique properties for protection from the flu; namely, that the vaccine is egg-free, highly pure and triple the strength compared to conventional influenza vaccines.
President and CEO of Protein Sciences, Manon Cox said, "We anticipate having the first doses of Flublok available in September and the FDA's approval supports this timeline." She added, "We are still accepting orders for the fall and providers are encouraged to order through our distributors FFF Enterprises and ASD Healthcare."
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