AstraZeneca announces renewed recommendation and availability of FluMist Quadrivalent vaccine in the U.S.
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted in favor of a renewed recommendation for the use of AstraZeneca’s FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) in the U.S. for the 2018-2019 season.
The recommendation follows the presentation of positive results from a U.S. study in children between the ages of 2 to <4 years evaluating the shedding and antibody responses of the H1N1 strain in the live attenuated influenza vaccine (LAIV)/FluMist Quadrivalent.
Study results demonstrated that the new 2017-2018 H1N1 LAIV post-pandemic strain (A/Slovenia) performed significantly better than the 2015-2016 H1N1 LAIV post-pandemic strain (A/Bolivia), which was previously associated with reduced effectiveness. The antibody response induced with the new H1N1 LAIV strain was comparable to earlier data seen with the highly effective H1N1 LAIV strain included in the vaccine before the 2009 influenza pandemic.
“This study validates the improvements we’ve made to our strain selection process and confirms an improved H1N1 LAIV strain was included in the 2017-2018 formulation,” Gregory Keenan, vice president, U.S. Medical Affairs, AstraZeneca, said. “We are pleased that the ACIP has voted in support of a renewed recommendation for FluMist Quadrivalent in the U.S. and look forward to continuing to work with public health authorities to optimize protection against influenza.”
FluMist Quadrivalent is approved for use in the U.S., Canada, and the European Union. Limited quantities of FluMist Quadrivalent continue to be available the U.S. for the current 2017-2018 season. FluMist Quadrivalent will be available in the U.S. for the 2018-2019 influenza season, pending annual strain approval from the Food and Drug Administration (FDA). The vaccine has remained recommended for use and available in Canada and the EU.
The full results of AstraZeneca’s U.S. pediatric clinical study evaluating the shedding and antibody responses of the H1N1 strain in the LAIV/FluMist Quadrivalent will be presented at a forthcoming medical meeting.