FDA panel endorses quadrivalents, setting stage for new flu market
It will be a different influenza vaccine market moving forward. After years of consideration, an FDA panel has given its approval to quadrivalent or four-strain vaccines. It should be a boost to consumers who suffered through a particularly bad flu season this year and to the two companies that already have quadrivalents approved, GlaxoSmithKline ($GSK) and AstraZeneca's ($AZN) MedImmune.
The FDA advisory panel on vaccines gave its endorsement Wednesday to a proposal by the World Health Organization (WHO) that next season's flu vaccines contain two "A" influenza strains and at least one "B" strain, according to The Wall Street Journal. The quadrivalent vaccines will contain two "A" strains and two "B" strains. The panel suggested that the "B" strain from this season's vaccine be altered to better match the influenza strains that wreaked havoc in the U.S. this year.
Three-strain vaccines will continue to be available but should over time be replaced with four-strain versions. With four strains, the vaccines boost the likelihood of health experts and vaccine manufacturers matching circulating strains with the ones in the vaccine. Glaxo in December got its Fluarix Quadrivalent approved following the approval of MedImmune's FluMist Quadrivalent. It puts four strains into a mist for patients who shy away from needles.
With the FDA endorsement, they will be able to start taking orders for the next flu season, the WSJ points out. Sanofi ($SNY) has an FDA approval pending for a quadrivalent but, assuming it is approved, may not get the nod in time to get in on the next season. It would then sell its three-strain version instead.
- read the Wall Street Journal story (sub. req.)
Special Report: Major Vaccine Approvals of 2012