FDA approves Sanofi Pasteur’s sBLA for Fluzone Intradermal Quadrivalent vaccine for adults

For three years, the vaccine has been available in trivalent formulation and now it is available in a quadrivalent formulation to help protect against four strains of influenza virus.

Traditional trivalent influenza vaccines contain two strains of influenza A and one strain of influenza B.

Influenza B represents 20-25% of circulating influenza strains and is associated with substantial morbidity and mortality.

Sanofi Pasteur US vice-president of Scientific & Medical Affairs and chief medical officer David Greenberg said: "Influenza B is a common cause of influenza-related morbidity and mortality across all age groups.

"Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system."

The quadrivalent vaccine was developed to help address frequent B-strain mismatches and broaden coverage against influenza by incorporating a B strain from each lineage.

This is the first and only four-strain influenza vaccine option administered intradermally through a small, 1.5 mm micro-needle, which is 90% smaller than typical needles used for intramuscular injection of influenza vaccines.

The approval was based on results from a Phase III clinical trial of 3,355 adults that compared this vaccine, which included B strains from both lineages, to two trivalent intradermal controls.

The two trivalent intradermal controls included licensed trivalent Fluzone Intradermal vaccine that contained a B strain of one lineage and an investigational intradermal vaccine that contained a B strain from the opposite lineage.