Pharma distribution channels crank up for flu season

Pharmaceutical Commerce, Pharmaceutical Commerce - July/August 2010,

Newly commercialized vaccine-production methods could moderate the feast-or-famine uncertainties of vaccine supply

The waning days of summer are vacation times for many people, but those involved in the manufacture and distribution of flu vaccine have been busier than ever, and will continue to be amped up until the start of flu season on Oct. 1. This year, the flu “market” will be complicated by the entry of new types of flu vaccines—quadrivalents (replacing trivalent formulations) and two vaccines based on recombinant-DNA or cell culture manufacture, rather than the traditional growth inside eggs: Protein Science’s Flublok brand was approved in January and Novartis’ Flucelvax was approved last November. Among other benefits, these vaccines hold the promise of being rapidly ramped up in production should the flu season suddenly become severe, since they don’t depend on obtaining suitable eggs, inoculating the eggs and then waiting for the virus to replicate.

According to data from the Centers for Disease Control and Prevention, last year’s flu season was more severe than in recent years, and peaked relatively early. No forecast is made, at least this early, on the severity of the coming season—which of course is one of the unique features of managing flu prevention and neither overstocking nor understocking vaccines. CDC says that 135-139 million doses will be ready by Oct. 1, and has been releasing production lots already. Last February, an FDA vaccines committee met to settle on the virus strains expected to predominate this year: there are two Type A viruses and one Type B (which then comprise the “trivalent” vaccine); one other Type B was included (which defines the “quadrivalent” vaccine.)

CDC and others recommend that all persons over 6 months of age be vaccinated, but especially children under 5 and adults over 65. Vaccines are administered in doctors’ offices and hospitals, at retail pharmacies, and at employer sites and public health clinics. Retailers are cranking up their machinery: Walmart’s Sam’s Club pharmacies are now offering year-round vaccination programs for flu as well as nine other common vaccines; CVS Caremark just announced the results of a consumer survey showing that while a majority (59%) of consumers agree that it is a social responsibility to get vaccinated, only 49% were “more likely” than last year to get one.

CVS and its Minute Clinic chain will provide vaccinations to walk-in customers, along with a discount card for other purchases. CVS, together with Walgreens, Rite-Aid and the Target shopping chain are among the places to obtain the recently introduced Fluzone High-Dose trivalent vaccine, which contains four times the concentration of hemagglutinin antigen as the regular Fluzone vaccine; Sanofi-Pasteur just released a study in Europe concluding that the High-Dose formulation was 24.2% more effective in producing a vaccine response. Sanofi-Pasteur is marketing the vaccine especially for the elderly, and has packaged it with a short intradermal (rather than intramuscular) needle for injection. Meanwhile, MedImmune, makers of the Flumist nasal spray vaccine, are working with Walgreens and Target to broaden the distribution of their formulation, which will be available this year only as a quadrivalent form, and is targeted for ages 2-49.