Flucelvax Quadrivalent (vaccine) is approved by FDA as a seasonal influenza vaccine for people aged four years and older- Seqirus/CSL

The FDA has approved Flucelvax Quadrivalent (Influenza Vaccine), from Seqirus/CSL, 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.

In clinical studies of adults aged 18 to 49 years, Flucelvax has been shown to be efficacious against influenza caused by vaccine-like strains (83.8%) and by all circulating influenza strains (69.5%). Its quadrivalent formulation was also shown to be immunogenic against the flu in adults aged 18 years and older (Study 1) and children aged 4 through 17 (Study 2).

Flucelvax Quadrivalent produced stronger antibody responses to the influenza B virus strain, which was not contained in the trivalent comparator flu vaccine, and is well-tolerated with a safety profile similar to its comparator vaccines. It also leverages the safety database demonstrated by its predecessor in more than 11,000 people. The most common (more than 10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%) headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%). The most common (more than 10%) local and systemic reactions in adults over 65 years of age were injection site pain (21.6%), and injection site erythema (11.9%).