MedImmune files for quadrivalent influenza vaccine approval

MedImmune has filed for approval of a quadrivalent influenza vaccine that contains two influenza B strains.

The idea of a quadrivalent flu vaccine has been examined for several years, but this will be the first time a company has attempted to overcome the difficult problem of predicting what influenza B strain will circulate in a given season by targeting four separate strains, according to CIDRAP News.

MedImmune’s vaccine is a quadrivalent version of its previously licensed nasal flu vaccine FluMist. MedImmune, located in Gaithersburg, Maryland, recently announced that the U.S. Food and Drug Administration has received its licensure application.

Because of the constraints of production timelines, the strains chosen to be used in seasonal flu vaccines must be chosen up to six months ahead of the beginning of flu season. Flu experts have had limited success in predicting each seasons' type B lineage.

Vaccines that target either the Yamagata or the Victoria lineage provide limited protection against the other.

The U.S. Centers for Disease Control and Prevention has reported that both B lineages have been in circulation to some degree during the past decade.

"In the United States, in a recent 10 year interval of influenza seasons, the predominant circulating influenza B lineage was different in five seasons from the one selected for inclusion in the vaccine," Robert Belshe, director of the Center for Vaccine Development at Saint Louis University, said, CIDRAP News reports.

In clinical trials, the quadrivalent live attenuated vaccine has compared well against two versions of the trivalent FluMist.

"We believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate," Filip Dubovsky, MedImmune's vice president of clinical development, said, according to CIDRAP News.