FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas

The US Food and Drug Administration revealed it has approved privately-held US biotech firm Protein Sciences Corp’s Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) - the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body, the FDA noted. The majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases.

“Technological advance” in flu vaccine products, says agency