The uniquely futuristic billion-dollar cell culture Seqirus vaccine factory in Holly Springs has hit another milestone, with U.S. Food and Drug Administration marketing approval for the Flucelvax Quadrivalent flu vaccine made there.
Flucelvax Quadrivalent is the first four-strain cell structure-derived inactivated influenza vaccine for adults and children over 4 years of age.
The quadrivalent vaccine covers two strains each of influenza A and influenza B. Significantly, the vaccine is derived from a cell culture rather than the standard process of growing vaccines in chicken eggs.
Cell culture is a faster-turnaround process that allows people with egg allergies to receive protection from flu. It’s the same technology the company used in its first product Flucelvax. The change to using cells in sterile bioreactors rather than viruses in eggs represents the first major development in influenza vaccine manufacturing technology since vaccine production began in the 1930s. And it’s significant in helping North Carolina to become a world leader in vaccine manufacturing.
“Flucelvax Quadrivalent will provide healthcare providers and their patients with an important option to further broaden their influenza coverage,” Seqirus president Gordon Naylor said. “We are pleased to offer Flucelvax Quadrivalent, which is produced at our full-scale cell culture influenza vaccine manufacturing facility in North Carolina, to our valued customers during the 2016-2017 flu season.
A groundbreaking vaccine option
“As the first and only cell culture-derived seasonal influenza vaccine in the U.S. to offer four-strain flu protection for people aged four years and older, Flucelvax Quadrivalent will provide healthcare providers and their patients with an important option to further broaden their influenza coverage.”
The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A viruses and a single strain of influenza B virus. However, since 1985, two distinct lineages of influenza B virus have co-circulated with varying dominance. The use of a four-strain influenza vaccine like Flucelvax Quadrivalent may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.
Each year in the U.S., an average of 200,000 people are hospitalized from flu complications. As a result, the Centers for Disease Control and Prevention (CDC) encourages annual vaccination for everyone aged six months and older.
Seqirus is the company minted in 2015 after its Australian parent, CSL, purchased the former Novartis full-scale cell culture manufacturing site and related technology that enables rapidly increased production of flu shots in response to outbreaks or pandemic. The North Carolina Biotechnology Center was actively involved in recruiting the factory to Holly Springs.
(C) N.C. Biotechnology Center
