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Why it's so hard to get the flu vaccine supply right

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Phamacist Prakash Deshpande injects Judith Echevarria with influenza vaccine at a Manhattan pharmacy. Americans are clamoring for influenza vaccine thanks an an unusually early flu season this year.

Drugs stores running out of vaccine. One company’s supply nearly sold out. An unusually early flu season has Americans clamoring for vaccines and all of a sudden they are scarce.

Yet back in September, public health officials were begging people to get vaccinated. Why the disconnect?

There are four main reasons:

  • Flu vaccine is hard to make and it takes months
  • Americans are ambivalent about vaccines in general and only want flu vaccines when they are scared (like now)
  • Doctors are not paid to encourage and remind patients to get a flu shot, and they are afraid to order too much in case they’re stuck with the extra
  • Vaccine makers only want to make as much as they can sell and last year the U.S. threw away 30 million doses

It may be 2013, but the United States still uses technology developed in the 1940s to make flu vaccines. In fact, the process for making next year’s flu vaccine is just starting to gear up right now, even though this year’s flu season is nowhere near to being over.

Experts have to first predict which strains of flu virus will be circulating next year. Influenza mutates all the time and there are different strains, so this is tricky. It’s also the reason people have to get a new flu vaccine every year.

The virus must be isolated from patients’ blood, purified, and injected into chicken eggs to grow. These aren’t just any chicken eggs, either – they have to be fertilized, have a chicken embryo inside and they need to be a certain size. The process is fraught with danger and often breaks down if eggs don’t develop right or if there’s contamination.

Then the virus is purified and made into vaccine. New technology is in the works and Novartis now makes flu vaccine at a factory in Holly Springs, North Carolina, using dog cells instead of eggs—a process that’s slightly faster, easier to control and that can be scaled up more quickly.

The hope is for a universal flu vaccine – one that would work against all strains of flu and protect people for years at a time, but progress is slow.

“A vaccine that would provide protection against all of the known strains of influenza has been a goal since flu vaccine was discovered,” says Dr. John Treanor, a vaccine researcher at the University of Rochester in New York. “It’s not going to be a straightforward, easy shot.”

In the meantime, companies predict how much demand there will be months before flu season even starts, and there’s no way to ramp up production when a season like this one hits and there’s suddenly a surge in demand.

This leads to the next problem: Americans don’t like getting flu shots. It’s the main reason demand is hard to predict. About 128 million people, or about 42 percent of the U.S. population, got immunized against influenza last year. That’s even though the Centers for Disease Control and Prevention says everyone over the age of six months should get a vaccine – every year. More than 30 million doses of flu vaccine never got used and were almost certainly thrown away, according to CDC.

“If people followed the recommendations every year, there would be no shortages,” says Dr. Walter Orenstein of Emory University’s Emory Vaccine Center and a former head of the CDC’s immunization program.

“The first issue is that Americans are pretty deeply divided on whether they think flu vaccination is a good idea,” says Katherine Harris, a RAND Corporation economist who studies flu vaccine issues.

“There are the people that get it and the people that don’t, and the people that don’t get it have pretty bad attitudes about it.”

And people aren’t afraid of the flu, even though it kills as many as 36,000 people in a bad year, including 100 children every year. Flu puts as many as 200,000 people into the hospital every year. But in some years it may be a mild season and kill 4,000 people. This variation lulls people into thinking flu isn’t a problem. “Many people who don’t get flu vaccine don’t get it because they don’t feel they, personally, are at risk,” Treanor says.

The flu vaccine isn’t perfect, either, leading many to think it’s a waste of time to get one. This year’s is only 62 percent effective. On top of that. lots and lots of viruses act like flu – causing coughing, headache, muscle aches and so on – so  many people believe they have flu even if they don’t. But Orenstein says if 80 percent of Americans got vaccinated with this vaccine, it would provide “herd immunity” against flu.

“I have had in the last three weeks two respiratory illnesses,” Orenstein says. “And I was vaccinated. But even if one was the flu, the other one was not. Maybe neither of them was flu.” But such uncertainty can make people doubtful about the value of vaccination.

The belief that flu vaccine causes flu is still rampant, although doctors all agree it’s not true. Many people also fear side-effects from the vaccine. Vaccine regulators and public health experts still remember the 1976 swine flu debacle, when the U.S. government rushed out a mass immunization against a swine flu virus that never spread off one military base.

Several hundred cases of a rare neurological disease called Guillain-Barre syndrome were reported afterward and the incident made many people mistrustful of immunizations.  More recent fears center on a mercury-based preservative called thimerosal, which was taken out of most vaccines after activists claimed it could cause autism. The link is discredited by many scientific studies but suspicion persists among some parents and activists.

Harris says people do trust their personal physicians, but doctors are not usually paid by health insurance companies to talk people into getting flu vaccines, and they aren’t paid much to administer them. Doctors have to compete with pharmacies, big companies that buy up vaccine to give to their employees, and large stores like Wal-Mart and Target to even get vaccine to stock, and they have to eat the cost if they don’t sell all the vaccines they buy to patients.

“It is a cost that comes right off their books,” Harris says. So many don’t even bother.

“We don’t really have a way for compensating health care providers for encouraging us to take preventive steps,” she said. The 2010 Affordable Care Act does have provisions for rewarding preventive medicine, however, which take effect in 2014.

Harris believes that if doctors’ offices worked harder to remind people to get a flu shot, more people would get it, vaccine makers would provide more supply, and flu shot shortages would ease up.

The Trust for America's Health agrees. It recommends that insurers be required to cover flu vaccines under public and private insurance without cost-sharing.  "For instance, currently, 12 states and Washington, D.C. do not require Medicaid to cover flu shots with no co-payment requirements for beneficiaries under the age of 65," the group said in a statement released Tuesday.

The federal government is trying to help in other ways, too. Ten years ago, just four companies made flu vaccines. This year, the U.S. government has licensed vaccines made by seven manufacturers. They include a nasal spray that’s been shown to work especially well in children and a special formulation for older people, whose immune sytems don’t respond as well to vaccines.

The idea is to spread the risk as well as to increase availability. Sanofi Pasteur, which provides about half of the flu vaccine in the U.S., says it has sold out of four of its six formulations of its Fluzone seasonal flu vaccine because of late-season demand.

Companies are wary of making too much vaccine, however, because they can’t re-sell it next year. The flu strains will likely have changed enough to make this year’s vaccine out of date for next year. “It’s not like you can carry it over if you don’t use it,” says Orenstein.

In 2008-2009 the U.S. government shipped 162 million doses of vaccine, but only 90 million were used. And last year 30 million doses or more went unused – most at a loss to the drug makers.

As a result, this year the seven companies made 135 million doses of flu vaccine. So far 128 million have been distributed to pharmacies, doctors’ offices and other providers.

“We have received reports that some consumers have found spot shortages of the vaccine,” Food and Drug Administration commissioner Dr. Margaret Hamburg says in her blog. “We are monitoring this situation and will update you at our Website and at www.flu.gov.” There’s a flu vaccine finder on those websites.

“The flu season usually peaks in January or February, but can extend as late as May,” Hamburg adds – meaning it’s not too late to get a vaccine if you can find one.

“All of us should be encouraging our friends, our neighbors – everyone – to get vaccinated,” Orenstein said.