The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune’s FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017 influenza season because the intranasal vaccine has failed to demonstrate significant effectiveness in children over the past 3 seasons. The recommendation does not affect plans to distribute the vaccine in other countries, according to MedImmune parent company AstraZeneca.
According to the CDC, data from the 2015-16 flu season show that the effectiveness of FluMist Quadrivalent in children aged 2-17 was 3%, meaning that “no protective benefit could be measured.” The vaccine had demonstrated “poor and/or lower than expected vaccine effectiveness” in the previous 2 seasons as well, the agency said. FluMist Quadrivalent was approved by the FDA in February 2012.
AstraZeneca says that its own studies show 46-58% effectiveness of FluMist Quadrivalent against the flu strains that circulated during the 2015-16 season and adds that the company “is working with the CDC to better understand its data to help ensure eligible patients continue to receive the vaccine in future seasons in the US.”
US sales of FluMist Quadrivalent totaled $206 million in FY 2015, the company said, and it will write down ~$80 million in the 2nd quarter of 2016. The CDC noted that as many as 14 million doses of FluMist Quadrivalent had been expected to be available in the US and that approximately one third of children in the US who were vaccinated in the past few years received the nasal spray flu vaccine.
Read the CDC statement.
Read the AstraZeneca press release.
