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LONDON (Alliance News) - FTSE 100-listed drugmaker AstraZeneca PLC on Thursday said a negative recommendation for the use of its FluMist vaccine in the upcoming flu season is expected to result in "very limited US demand" in the second half of 2016.
As a result, AstraZeneca said it will take an inventory write-down of around USD80 million in the second quarter of 2016. Despite this, AstraZeneca has maintained its financial guidance for the year as a whole.
US sales of FluMist in 2015 amounted to USD206 million.
AstraZeneca on Thursday said the Advisory Committee on Immunization Practices of the Centers for Disease Control & Prevention in the US has made a negative interim recommendation on the use of the UK group's FluMist treatment for the 2016-17 influenza season.
The updated guidance from the ACIP 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. This indicated AstraZeneca's FluMist Quadrivalent did not demonstrate any statistically significant effectiveness in children aged between two and 17.
AstraZeneca said the data from the CDC contrasts with its own studies and those from health authorities in other countries, which showed a 46% to 58% effectiveness of the vaccine against circulating influenza strains during the previous flu season.
Influenza vaccine effectiveness varies from season to season, which is why the vaccines are evaluated in annual observational studies. AstraZeneca said it is working with the CDC to better understand its data, in order to help ensure eligible patients continue to receive the vaccine in future seasons in the US.
AstraZeneca said distribution and use of the vaccine is progressing as planned in other countries, pending the annual release process from the relevant regulatory bodies.
Shares in AstraZeneca were up 0.6% at 3,909.00 pence Thursday morning.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance, updated by Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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