First cell-based four-strain flu vaccine gets FDA approval

Seqirus has announced that the US Food and Drug Administration (FDA) has approved their Flucelvax Quadrivalent™ (Influenza Vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. Flucelvax Quadrivalent helps protect against the two influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.

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 US alone, an average of 200,000 people are hospitalized due to flu complications. To reduce morbidity and mortality resulting from influenza, the Centers for Disease Control and Prevention (CDC) encourages annual vaccination for all individuals aged six months and older.

“Despite strong recommendations for everyone in the US six months of age and older to be vaccinated against the flu every year, fewer than half of eligible people did so in the 2014-2015 season. This includes children, the group with the highest incidence during community outbreaks,” said Dr. Gary S. Marshall, Chief of Pediatric Infectious Diseases at the University of Louisville. “Even healthy people are at risk—they should be vaccinated to protect themselves and to prevent transmission to others.”

Flucelvax Quadrivalent is produced using the same full-scale cell culture manufacturing technology as its predecessor Flucelvax™ (Influenza Vaccine), which allows the potential for rapidly increased production of flu shots in response to outbreaks or pandemic. Cell culture technology does not depend on eggs for manufacturing, and the vaccine is produced in sterile bioreactors. The change to using cells rather than eggs represented the first major development in influenza vaccine manufacturing technology since vaccine production began in the 1930s.