AstraZeneca PLC Takes a $80 Million Hit as the CDC Says Flu Vaccine Flumist Does Not Work
June 23, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – AstraZeneca said it will take an $80 million inventory write-down in the second quarter after the U.S. Centers for Disease Control and Prevention announced they would not use the company’s influenza vaccine due to a lack of effectiveness.
AstraZeneca’s influenza vaccine, FluMist Quadrivalent, a nasal inhalant, has been recommended in previous years by the CDC, but the health organization’s Advisory Committee on Immunization Practices, said the vaccine “should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons in the U.S.,” AstraZeneca said in a statement on its website.
The CDC said preliminary data for FluMist in children ages two to 17 during the 2015 flu season only provided relief in 3 percent of patients, which made it highly ineffective. That’s a reversal of a move only two years ago when the CDC pushed the use of FluMist in children, touting its efficacy data. In its statement dismissing FluMist, the CDC said flu vaccine efficacy “can range widely from season to season and can be affected by a number of factors, including characteristics of the person being vaccinated, the similarity between vaccine viruses and circulating viruses, and even which vaccine is used.”
FluMist, a Live Attenuated Influenza Vaccine (LAIV), contains live, weakened influenza viruses. Vaccines containing live viruses can cause a stronger immune response than vaccines with inactivated virus, the CDC said in a statement. The CDC said that when there is a good match between the strains in the vaccine and those that circulate during the influenza season, vaccines are typically 50 to 60 percent effective.
AstraZeneca said the U.S. CDC effectiveness data for 2015-2016 season “contrast with studies by AstraZeneca as well as preliminary independent findings by public health authorities in other countries.” AstraZeneca said its own findings “demonstrate FluMist Quadrivalent was 46 to 58 percent effective overall against the circulating influenza strains during the 2015-2016 season.”
AstraZeneca said it will work with the CDC to better understand the health organization’s data to help “ensure eligible patients continue to receive the vaccine in future seasons in the U.S.”
FluMist has been a choice for physicians to use on children since it does not require an injection, Reuters noted. FluMist was first approved in 2003 and since then, more than 116 million doses have been distributed worldwide, the Telegraph of London reported.
Sales of FluMist in the United States in 2015 were $206 million, AstraZeneca said.
Vaccine manufacturers had projected that as many as 171 million to 176 million doses of flu vaccine, in all forms, would be available for the United States during the 2016-2017 season. AstraZeneca projected a supply of as many as 14 million doses of the vaccine, or about 8 percent of the total projected supply, the CDC said.
Despite the $80 million inventory write-down, AstraZeneca said it continues to maintain its financial guidance for 2016. However, Richard Parkes, an analyst with Deutsche Bank , told Reuters the CDC ruling would likely “drag down” AstraZeneca’s consensus earnings forecasts by about 2 percent and ripple effects of 1 to 2 percent could be felt for a couple of years.