It should have been health officials’ dream year — Americans flocking to clinics, rolling up their sleeves and demanding flu shots.
After all, federal health officials had just teamed up to try to roll out the biggest influenza vaccination effort ever and had hoped to inoculate 100 million people.
Instead, the reality is a nightmare scenario with frightened senior citizens rolling out of bed at dawn to queue at local grocery stores to get jabs, residents traveling across borders to Mexico and Canada in search of vaccine and politicians demanding answers.
Chiron Corp. will have to destroy 48 million doses of vaccine after British and U.S. regulators found system-wide problems that caused bacterial contamination at the company’s plant in Liverpool, England, earlier this month.
It cost the United States half its vaccine supply, although rival vaccine makers Aventis and MedImmune have squeezed out enough extra doses to bring the expected deliveries up to about 61 million.
“There is nothing like a shortage to spur interest,” Dr. William Shaffner, an infectious disease expert at Vanderbilt University in Tennessee, said dryly after he himself spent hours standing in line at a Florida grocery store to get vaccinated.
“It was extremely orderly and very genial,” Schaffner added in a telephone interview.
“I would wish that we could replicate this 100,000-fold across the United States each autumn. My hats off to these people who were so knowledgeable and desirous of getting vaccinated and understanding of its benefits.”
Schaffner and other experts have been warning this could happen for years.
They had hoped to encourage more Americans to get vaccinated in part to raise demand and, in turn, perhaps get companies interested in making flu vaccine again.
Who wants to make vaccine?
They noted that only three companies now supply influenza vaccine to the country -- and the situation is similarly dire with other vaccines, especially the childhood vaccines against bacterial meningitis and diphtheria.
But the United States places public health firmly in the private arena, allowing market forces to shape what drugs are made and how.
Vaccines are bad business, heavily regulated, unprofitable and subject to uncertain markets. Influenza vaccine is especially fraught with danger.
It has to be reformulated every year to match the circulating strains of flu. It has to be grown in eggs, and not just any old egg but specially grown fertilized eggs that meet standards of size and chick development.
This takes months and because eggs are not especially clean, purification measures are tedious. This is the process that stung Chiron.
Most years, vaccine makers have to throw away flu vaccine.
Even last year after media coverage of an early flu season prompted heavy demand, 4 million doses were destroyed because no one used them.
As Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Diseases, points out, cholesterol drugs are taken daily for a person’s whole life and cost thousands of dollars a year. An annual flu shot costs $15.
Getting what you pay for
Schaffner said higher prices may have to be an eventual reality, however.
“We have to be ready to pay more for influenza vaccine,” he said. “We have to come to the realization that the era of dirt cheap vaccines is over.”
Vaccine makers need a guaranteed market, too, he said. Health and Human Services Secretary Tommy Thompson has proposed a program similar to BioShield, which guarantees the government will buy a specified number of vaccines against potential biological agents such as anthrax and smallpox.
But that would take approval by Congress, which failed to act this year and in years past on influenza and childhood vaccines despite urging from the CDC, HHS and National Institutes of Health.
“We need a combined public-private national adult immunization program,” Schaffner said.
The Food and Drug Administration has pledged to review how it regulates vaccines, to ease requirements on makers, but has to be mindful that a significant minority of the public mistrusts vaccine safety as it is and may not welcome such a move.
And the NIH is helping makers find cleaner, quicker and more efficient ways to make flu vaccines -- without eggs, for instance -- but even so methods would remain cumbersome and final development is years away.
Politicians on both sides are promising action, but Schaffner is worried that they will forget their promises after the Nov. 2 presidential elections.
“Every time we have an influenza or other vaccine crisis, we struggle to solve it and by the time March and April roll around there are other problems. The folks who advocate for public health get lost in an avalanche of other lobbying interests,” he said.