AstraZeneca Plans $80 Million Charge Due To CDC Finding on Nasal Flu Vaccine
AstraZeneca reports that the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has provided its interim recommendation on the use of the company’s FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) in the US for the 2016-2017 influenza season. The updated guidance states the vaccine should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons in the US, which indicated FluMist Quadrivalent did not demonstrate statistically significant effectiveness in children 2-17 years of age.
The US product sales of FluMist Quadrivalent in FY 2015 amounted to $206 million; global product sales were $290 million. The ACIP's updated recommendation is expected to result in very limited US demand in the second half of 2016, and consequently, the company will take an inventory write-down of approximately $80 million in the second quarter of 2016.
The US 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, said AstraZeneca. “These findings demonstrate FluMist Quadrivalent was 46-58% effective overall against the circulating influenza strains during the 2015-2016 season,” said AstraZeneca in a statement. “As influenza vaccine effectiveness varies from season to season, it is evaluated in annual observational studies. The CDC states that when there is a good match between the strains in the vaccine and those that circulate during the influenza season, vaccines are typically 50-60% effective.”
,AstraZeneca said it 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. The distribution and use of the vaccine in other countries are progressing as planned for the forthcoming influenza season, pending the annual release process from relevant regulatory authorities.