FDA approves Protein Sciences quadrivalent flu vaccine
According to the vaccine maker, Flublok Quadrivalent is the first high antigen content quadrivalent flu to be approved by the US Food and Drug Administration (FDA).
“The US has been trending toward the use of quadrivalent flu vaccines in recent years,” said Manon Cox, CEO of Protein Sciences Corporation. “We are looking forward to launching the vaccine next year and, in the meantime, continuing to make trivalent Flublok available this year.”
The vaccine protects against four strains of influenza: three of the same strains found in trivalent Flublok plus an additional B strain, and like the trivalent product is not reliant on traditional manufacturing processes.
Rather than use production methods that involve growing live influenza virus in hens eggs, Protein Sciences employs an insect virus-based expression system to make large quantities of viral hemagglutinin, the protein that elicits the strongest immune response
Such an approach removes the risk of contamination from the live virus or hens egg and offers significant time advantages, the firm previously told this publication.
“We can manufacture vaccine in significantly less time - 2-3 months vs. 6 months - and that can be shortened even further to a few weeks if we already have recombinant baculoviruses made/stored that express the desired hemagglutinin protein,”spokeswoman Rachael Felberbaum said.
Protein Sciences’ manufacturing plant is the Pearl River facility in New York, refitted in just ten weeks after the firm acquired the site from Pfizer in 2012.