US FDA grants GSK OK for 1st quad intramuscular flu vaccine
This article was originally published in Scrip
British pharma giant GlaxoSmithKline won the US FDA's approval to market Fluarix Quadrivalent (influenza virus vaccine), the first intramuscular vaccine to cover against four influenza strains in adults and children as young as 3 years.
The vaccine contains two type A strains and two type B lineages, as opposed to the trivalent vaccines, which contain two strains of type A influenza and one B lineage strain.
Gaithersburg, Maryland-based MedImmune actually beat GSK to the market with the first flu vaccine ever to contain four strains – winning that OK on 29 February, although the former firm's product, FluMist Quadrivalent, is live a attenuated trivalent nasal vaccine (scripintelligence, 1 March 2012).
Since about 2000, the B virus strains Victoria and Yamagata have co-circulated to varying degrees each season in the US. But various degrees of mismatch have occurred between those two strains in the trivalent vaccines and the B strain that actually has circulated, causing an increased risk of influenza-related morbidity across all age groups, GSK noted.
The company said its Fluarix Quadrivalent would help protect against the two A strains, while adding coverage against a second B strain during the flu season.
"Trivalent influenza vaccines have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected," said Dr Leonard Friedland, vice president and head of GSK North America Vaccines Clinical Development. "Fluarix Quadrivalent will help protect individuals against both B strains and from a public-health standpoint, can help decrease the burden of disease."
The GSK product, however, will not be available until the 2013-14 flu season, as is the case for MedImmune's nasal quad vaccine.
Also not yet available is Novartis' Flucelvax, the first cell-culture vaccine in the US intended to protect against seasonal influenza, which gained the FDA's blessing last month (scripintelligence, 21 November 2012).
GSK noted that health care providers traditionally order flu vaccines about a year in advance of each flu season.
This past February, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that the trivalent formulation influenza vaccines for the US 2012-2013 influenza season contain an A/California/7/2009 (H1N1)-like virus; a A/Victoria /361/2011 (H3N2)-like virus; and a B/Wisconsin /1/2010-like virus (B/Yamagata lineage).
The committee also recommended that the B/Brisbane/60/2008-like virus strain (B/Victoria lineage) be included with the three trivalent formulation strains for the quadrivalent formulation influenza vaccine (scripintelligence, 1 March 2012).
Earlier this month, the head of the US Centers for Disease Control and Prevention (CDC) warned that the US flu season had an early start, with the predominant strain, influenza A H3N2, a particularly hard-hitting bug (scripintelligence, 4 December 2012).
"While flu is always unpredictable, the early nature of the cases as well as the specific strains we're seeing suggest that this could be a bad flu year," said CDC Director Dr Thomas Frieden.