US FDA approves new flu vaccine made using novel technology
Flublok is manufactured by Protein Sciences
The US Food and Drug Administration has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.
Developed by Protein Sciences, a specialist in vaccine development and protein production based in Meriden, Connecticut, US, Flublok is approved for the prevention of seasonal influenza in the 18–49 age group. The company says approval for all adults is expected later this year.
‘This approval represents a technological advance in the manufacturing of an influenza vaccine,’ said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
‘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.’
We use advanced scientific technology to make just the active ingredient of the vaccine without any other viral components
Most flu vaccines are made using the influenza virus or chicken eggs, Flublok, by contrast, consists only 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 majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new for flu vaccine production, such protein-based vaccines are used to prevent other infectious diseases.
Manon Cox, CEO of Protein Sciences, said: ’Flublok is truly a modern vaccine. We use advanced scientific technology to make just the active ingredient of the vaccine without any other viral components. This is the first influenza vaccine on the market to do so.’
Flublok is a trivalent composition of recombinant influenza hemagglutinin (rHA) proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain. The proteins are manufactured using Protein Sciences’ proprietary baculovirus expression vector system (BEVS) technology and expresSF+ cell line.
In a clinical trial Flublok was found to be about 44.6% effective against all influenza strains, not just the three contained in the vaccine, the FDA said.
