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Flu Vaccines for Everyone?

By Amy Tsao Springtime is just around the corner, and with any luck, this year's flu will soon be gone. The 2003-04 season probably won't make the record books as the worst influenza outbreak in recent years, but its casualties are still expected to exceed the average of 20,000 deaths and 110,000 hospitalizations that the flu inflicts annually, according to the Center for Disease Control (CDC) in Atlanta. The government's immunization strategy also came in for new scrutiny. Supplies of flu vaccine ran short, and it turned out that the formula didn't target the most virulent strains of the virus making their way through the U.S.

The hot debate now is whether the nation should move toward universal -- or nearly universal -- vaccinations against flu. With the public riled up over the relative ineffectiveness of the government's anti-influenza campaign, experts expect the issue to be on the front burner at this year's meeting of the influential Advisory Committee on Immunization Practices (ACIP) on Feb. 24 and 25 in Atlanta. "Many would advocate [that] we as a society have our eyes on the goal of a recommendation of flu vaccine for every member of society," says William Shaffner, chair of the Preventive Medicine Dept. at Vanderbilt University, who adds: "There's merit to that argument." Also likely to be discussed is whether the government should start stockpiling flu vaccine to assure wider availability.

COSTLY GUESSWORK. Manufacturers and public-health experts agree that the CDC needs to greatly expand the number of people it recommends should get routine, annual flu vaccines -- and not just to minimize deaths and sickness. A higher minimum annual demand for flu shots would give manufacturers an incentive to ramp up production regardless of how accurate the prediction for influenza outbreak will be in any given year. Says Clement Lewin, vice-president for strategic planning and business intelligence at the vaccines division of Chiron (CHIR) in Emeryville, Calif.: "Once you have recommendations in place, physicians start routinely vaccinating people who come in."

A big reason shortages occur is that the few pharmaceutical companies that make flu vaccine for the U.S. -- Chiron, Aventis (AVE), and Medimmune (MEDI) with Wyeth (WYE) -- lose a bundle if they produce too much vaccine. It's costly to manufacture and has to be reformulated each year as flu strains evolve, notes Gerald Keusch, provost and dean for global health at Boston University.

That makes selling flu vaccine less financially attractive than selling pills for chronic conditions such as high cholesterol and depression. Indeed, the number of flu-vaccine makers has been halved in the last several years, and some experts fear that the remaining companies could drop out of the business if the situation doesn't improve.

FAULTY PREDICTIONS. As it is now, the nation is largely failing to achieve its goal of vaccinating everyone in high-risk groups. The CDC says that a record 87 million people were vaccinated in 2003, but that's still less than half of the 180 million people the agency figured were in high-risk groups. And only about two-thirds of the most vulnerable population -- people 65 and older -- got the vaccination.

The potential public-health benefits of improving the system are clear. Wider vaccination would reduce the number of deaths as well as complications leading to pneumonia and hospitalization. Reducing the incidence of flu has clear economic benefits, too, including lowering the rate of work absenteeism and reducing doctors' visits and inappropriate use of antibiotics.

The process of choosing the right strains to target with the next season's vaccine will remain challenging. "The science of predicting strains is no better than predicting the weather beyond a two-day forecast," Keusch says. Next year's flu strains for the U.S. have already been predicted and selected, but "things can change," points out Keusch. "That's just the nature of nature."

"PANDEMIC PREPAREDNESS." Shaffner believe more flexible technologies can be developed that would allow scientists to adapt vaccines more quickly, but they'll be costly. "There's a sense that flu vaccines ought to be cheap," he says. "But there's a hard-nosed realization that those days may be gone forever."

The ability to increase vaccine production in the event of a massive outbreak is another matter of rising concern. "What's going to be in the back of everyone's mind is the issue of pandemic preparedness," notes says Jim Young, president for research and development at Medimmune. He points to unknown quantities like the avian flu, now affecting Asian countries, that could have a more serious impact if the virus mutates. Having recently heard testimony from various parties on flu readiness, a congressional committee now says it will consider whether "financial [incentives] are needed for the private sector."

FluMist is not yet approved for the highest-risk groups

The company that would probably benefit most from an expanded flu vaccination program is Medimmune. Its inhaled flu vaccine, FluMist, which it developed with partner Wyeth, had a weak debut this year. Medimmune has said it's considering strategic options for FluMist, including a possible breakup with Wyeth. That's partly because the vaccine is now approved only for use by people aged 5 to 49. But expanding FluMist's market will require a bundle of cash.

"NO BACKUP." Young says Medimmune, which has already spent $200 million to develop FluMist, will need to pour an additional $400 million into studies to broaden its recommended use. He's hoping that data from ongoing studies will show the product's superiority over injected vaccines. After adding the over-50 crowd in recent years, the ACIP has already advised the CDC to add infants between 6 and 23 months to the recommended list for 2004-05.

Bernstein Research analyst Geoff Porges also predicts that the ACIP will create a task force to investigate the feasibility of mass vaccinations. "Once these ideas get a life of their own, they ultimately prevail," says Porges, who expects to see universal coverage by decade's end. In the meantime, the CDC may begin stockpiling the vaccine. As it is now, "in a tight situation, there's no backup," he notes.

Flu viruses are notoriously wily, having adapted to every attempt humans have made to contain them. But it may be a wise step for public-health officials to better protect the population while keeping the private sector from fleeing the business. Tsao covers biotechnology issues for BusinessWeek Online. Follow her Biotech Beat column only on BusinessWeek Online

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