FDA Okays 4-Strain Seasonal Influenza Vaccine

Megan Brooks


December 17, 2012

The US Food and Drug Administration (FDA) today approved a new 4-strain influenza vaccine for adults and children aged 3 years and older to help prevent disease caused by the seasonal influenza virus subtypes A and B contained in the vaccine.

Fluarix Quadrivalent (GlaxoSmithKline) is the first intramuscular vaccine to offer protection against 4 influenza strains, the company said.

Currently-administered trivalent (3-strain) influenza vaccines help guard against the 2 A virus strains most commonly occurring in humans and the B strain expected to be predominant in a given year, the company noted in a statement.

However, since 2000, 2 B influenza virus strains (Victoria and Yamagata) have cocirculated to varying degrees each influenza season. Various degrees of mismatch have occurred between the B strain included in trivalent vaccines and the B strain that actually circulated, causing an increased risk for influenza-related morbidity across all age groups.

The new 4-strain vaccine continues to help protect against the 2 A strains and also adds coverage against a second B strain.

"Trivalent influenza vaccines have helped protect millions of people against flu, but in 6 of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected," Leonard Friedland, MD, vice president and director of clinical and medical affairs at GlaxoSmithKline North America Vaccine Development, said in a statement.

"Fluarix Quadrivalent will help protect individuals against both B strains and, from a public-health standpoint, can help decrease the burden of disease," he concluded.

The company said the vaccine will be available in time for the 2013-2014 influenza season. The company added it will also fulfill orders for its trivalent vaccines.

Fluarix Quadrivalent is not currently approved or licensed in any country outside of the United States.

The full US prescribing information will be available on the manufacturer's Web site.