Flucelvax Quadrivalent Flu Vaccine Gets FDA Nod for People 4 Years of Age and Older

Cell-based vaccine is successor to trivalent Flucelvax

The FDA has approved Flucelvax Quadrivalent (influenza vaccine, Seqirus), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people ages 4 years and older. The vaccine helps protect against the two influenza A viruses and two influenza B viruses recommended by the World Health Organization (WHO) and the FDA for the 2016–2017 flu 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 cocirculated with varying dominance. The use of a four-strain influenza vaccine such as Flucelvax Quadrivalent may provide protection against both B lineages, which in turn may lead to a decrease in the influenza burden, according to Seqirus.

Each year in the United States, an average of 200,000 people are hospitalized because of flu complications. To reduce the morbidity and mortality resulting from influenza, the Centers for Disease Control and Prevention (CDC) encourages annual vaccination for all individuals ages 6 months and older.

Flucelvax Quadrivalent is produced using the same cell-culture manufacturing technology as its predecessor, Flucelvax, a trivalent influenza vaccine. Because the two vaccines have overlapping compositions, the clinical efficacy and safety data from clinical trials of Flucelvax are relevant to Flucelvax Quadrivalent.

In clinical studies of adults 18 to 49 years of age, Flucelvax was shown to be efficacious against influenza caused by vaccine-like strains (84%) and by all circulating influenza strains (70%). Its quadrivalent formulation was also shown to be immunogenic against the flu in adults 18 years of age and older and in children 4 through 17 years of age. Flucelvax Quadrivalent produced stronger antibody responses to the influenza B virus strain, which was not contained in the trivalent comparator flu vaccine.

In July 2015, the CSL Group and its affiliates acquired the influenza vaccine business of Novartis AG in the United States. The influenza vaccine business previously owned by Novartis has been integrated into CSL’s influenza vaccine business, which now operates as Seqirus.

Source: PR Newswire; May 23, 2016.