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US authorities recommended against AstraZeneca’s flu vaccine Quadrivalent

PBR Staff Writer Published 24 June 2016

The Advisory Committee on Immunization Practices (ACIP) of US Centers for Disease Control and Prevention (CDC) has recommended not to use live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine during the 2016-2017 flu season.

The US authorities have recommended against its use saying that the vaccine showed 'poor or relatively lower effectiveness' of LAIV from 2013 through 2016.

CDS said in a statement: "In late May, preliminary data on the effectiveness of LAIV among children 2 years through 17 years during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network.

"That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3 percent (with a 95 percent Confidence Interval (CI) of -49 percent to 37 percent). This 3 percent estimate means no protective benefit could be measured."

LAIV is sold as FluMist Quadrivalent and it is produced by AstraZeneca subsidiary MedImmune and was initially licensed in 2003 as a trivalent (three-component) vaccine.

AstraZeneca said that the recommendation is in contrast to the study conducted by the company and other independent studies done by public health authorities in other countries.

The company said in a statement: "AstraZeneca 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."

Following the recommendation, the company has announced to take $80m write down during the second quarter of 2016 as it would lead to limited demand for the vaccine.

The company however said that it will not impact the financial guidance of during 2016. AstraZeneca had recorded sales of $206m for its FluMist Quadrivalent during 2015 while its global sales was $290m.

FluMist Quadrivalent is administered as a nasal spray and claimed to contain four protective strains for the prevention of influenza.

So far the company has sold more than 116 million doses of the vaccine across the world.