AstraZeneca's struggling FluMist loses out on crucial CDC vaccine backing—again

Last June, a key CDC vaccines committee stiff-armed AstraZeneca's nasal influenza vaccine based on worries about its effectiveness. Despite the company's efforts to fix things since then, the committee once again advised doctors to eschew FluMist for the upcoming flu season.

The Advisory Committee on Immunization Practices (ACIP) has extended its recommendation against FluMist into next season, 2017-2018. The decision will stand "until further data becomes available in October 2017," according to an AZ spokesperson.

Last summer, after reviewing FluMist's low efficacy numbers for the previous three years, the committee made the same determination, forcing AZ to take an $80 million inventory write-down and eliminating the prospect of any meaningful sales in the vaccine’s biggest market.

At the time, AstraZeneca said it was working "to better understand" the problem and that it hoped to get the nasal vaccine recommended for future seasons. Those efforts have fallen short, at least for now, but the drugmaker said it is still aiming to win a 2017-18 recommendation.

If new data in October support future use, health officials could reverse the recommendation, AZ’s spokesperson added.

After generating $290 million in global sales back in 2015—$206 million of that haul in the U.S.—FluMist fell to $104 million worldwide last year, demonstrating the type of financial damage an adverse ACIP decision can do. In the wake of that recommendation, health officials worried that the lack of a nasal option might hurt flu vaccine coverage rates, but those concerns didn’t materialize. The CDC reported Friday that coverage rates have hovered around 60% in recent seasons.

Interestingly, a Canadian study last August found FluMist trivalent—a previous version that covered three strains of the virus, rather than the current four—was as effective as flu shots over the previous three seasons. That data suggested a problem could have arisen when the vaccine went from three strains to four.

Competition in flu vaccines has been fierce of late, with CSL’s decision to purchase Novartis’ flu assets and from Seqirus, which is now the second-largest player in the field behind Sanofi. Four companies are now vying for quadrivalent sales, including AstraZeneca with its struggling FluMist, while flu vaccines were strong points for both GlaxoSmithKline and Sanofi in the first quarter of 2017.