CDC shuns AZ's FluMist, all but nixing U.S. sales this season

cdc

Dealing a blow to AstraZeneca in its largest FluMist Quadrivalent market, a CDC committee has recommended against any use of the nasal vaccine for the upcoming season. It’s a setback that AZ says it’s still working “to better understand” as the pharma navigates a changing flu vaccine landscape.

AstraZeneca will take an $80 million inventory write-down in the second quarter, but is likely to take a larger hit on lost sales. The U.S. accounted for more than two-thirds of FluMist Quadrivalent's revenue last year, with $206 million of its $290 million in global sales. AstraZeneca says it expects “very limited U.S. demand” for the vaccine in the second half, but it maintains its overall 2016 financial guidance.

Despite the company’s own financial expectations, however, Deutsche Bank’s Richard Parkes said the FluMist Quadrivalent hit would likely depress earnings by about 2% this year, Reuters reports. A 1% to 2% risk to future earnings remains if the issue persists, he added.

In issuing its recommendation, the CDC’s Advisory Committee on Immunization Practices weighed "data showing poor or relatively lower effectiveness" from three previous flu seasons. In late May, the body received data showing that FluMist was just 3% effective in children aged 2 to 17 during the 2015-2016 flu season, compared with an estimated 63% effectiveness for flu shots. ACIP said "no protective benefit could be measured" from the nasal vaccine.

AstraZeneca said some of the CDC data doesn't jibe with its own or with findings from studies by independent health authorities in the U.K. and Finland. The company said its vaccine was 46% to 58% effective overall last season.

What's odd, as Reuters reports, is that the CDC back in 2014 recommended FluMist over injectable competitors due to its superior efficacy at the time. Children are often given the nasal vaccine to avoid injections.

AstraZeneca said it’s communicating with the agency to learn more, explaining that it is working to “ensure eligible patients continue to receive the vaccine in future seasons in the US.” Around the globe, the company is “progressing as planned for the forthcoming influenza season, pending the annual release process from relevant regulatory authorities,” its statement said.

Though losing the U.S. market is never what a pharma wants for big sellers, the move comes at an especially competitive time in the flu vaccine market. A new player has joined the quadrivalent fray--Seqirus, formed last year from the joining of bioCSL and Novartis’ flu vaccines--and received FDA approval in May for its Flucelvax Quadrivalent. Seqirus will now contend with Big Pharma players in the race for control in that four-strain vaccine market, and it's gunning for first place in overall flu vax sales within 5 to 10 years. For now, Seqirus is the second-largest provider of flu vaccines worldwide, trailing Sanofi's flu franchise.

- here's the AstraZeneca release
- here's the CDC statement
- more from Reuters

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