Flu Vaccine Recalled Due to Efficacy Concerns

GlaxoSmithKline (GSK) has voluntarily recalled all remaining FluLaval Quadrivalent Thimerosal-Free prefilled flu vaccine syringes, citing potential decreased protection against influenza.

The drug manufacturer notified the FDA and US Centers for Disease Control (CDC) about the recall after it detected reduced vaccine potency during routine testing. The potency issue only affected doses administered in early January 2015 or later, as those administered through the end of 2014 did not fall below specified potency limits, GSK said.

The recalled vaccine does not pose any safety concerns for those who received it. The company noted the recall does not affect FluLaval Quadrivalent Multi Dose Vials (MDV), FluLaval [trivalent] MDV, or any other GSK vaccines.

Flulaval Quadrivalent prefilled syringes are designed to protect against 4 influenza viruses. GSK spotted reduced potency in the 2 influenza B viruses contained in the vaccine, though the potency of the 2 influenza A viruses was within limits.

Those who received the vaccine in early January 2015 or later should speak with their health care professional about alternative flu prevention options, especially if they intend to travel to the Southern Hemisphere, where the flu season is just beginning. In the United States, the CDC does not recommend revaccination for individuals who received the recalled vaccine, since flu activity is declining.

Between October 1, 2014, and April 11, 2015, there have been more than 17,000 laboratory confirmed cases of hospitalizations related to influenza, according to the CDC. Approximately 93% of adults hospitalized for influenza had at least 1 underlying medical condition prior to contracting the flu.