FDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.
FDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and FDA for the current influenza season.
Each year, an average of 200,000 people are hospitalized because of influenza-related complications in the United States. As a result, the Centers for Disease Control and Prevention (CDC) encourages annual vaccination for all individuals aged six months and older.
Flucelvax Quadrivalent is now indicated for active immunization in persons aged 4 years and older, for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine.
Flucelvax Quadrivalent is an extension of Flucelvax, a cell-based trivalent vaccine that contains two strains of influenza A viruses but only one of influenza B. Since 1985, 2 strains of influenza B have co-circulated with varying dominance. The use of the quadrivalent vaccine may now provide protection against both B lineages, helping to decrease the prevalence of influenza in the US.
"As the first and only cell culture-derived seasonal influenza vaccine in the U.S. to offer 4-strain flu protection for people aged 4 years and older, Flucelvax Quadrivalent will provide healthcare providers and their patients with an important option to further broaden their influenza coverage," said Gordon Naylor, president of Seqirus.
In trials, Flucelvax was shown to be efficacious against influenza caused by virus-like strains in 83.8% of patients and by all circulating influenza strains in 69.5% of patients. Flucelvax Quadrivalent produced stronger antibody responses to the influenza B strain, which was not contained in the trivalent comparator vaccine and has a safety profile similar to its comparator vaccines.
The most common adverse reactions associated with the use of the vaccine include injection site pain and redness, headache, fatigue and myalgia.
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