The tiny tubes of FluMist quiver as they speed hour after hour down the assembly line, armed with an invisible blend of virus and targeted in a chaotic flu season at the many Americans cut off from a flu shot.
The line was to have stopped more than a month ago, just after the last of 1.1 million tubes was boxed, labeled and frozen to minus 25 degrees Celsius. Then the government discovered that half the country's expected inventory of vaccine shots would be discarded because of contamination fears, and the Gaithersburg biotech company that makes the nasal spray agreed to ramp back up for 2 million additional doses.
The government has urged the use of FluMist by children, health care workers and other adults within the specified parameters of age and wellness. Yet finding one of those doses may not be easy in coming weeks.
In the Washington area, the product is carried by neither CVS nor Rite Aid stores. Giant and Safeway grocery stores will sell it in their pharmacies, but, because of differing state regulations, only in Virginia and only in certain locations. As for medical offices, availability may be as uneven as that of flu shots. Many doctors have yet to order the spray or have ordered limited quantities.
Even in the public health sector, stock will be scattershot. The District and Fairfax County health departments opted against FluMist, deciding to concentrate just on medically high-risk residents for whom the spray is not authorized. The Anne Arundel County Health Department, however, received 800 doses for its emergency responders and front-line workers in clinics, hospitals and nursing homes. "We knew we at least could reach that group," said Elin Jones, a spokeswoman.
The situation echoes the larger hit-or-miss distribution of this year's influenza vaccine. Since learning in early October that 48 million shots were suspect, federal officials have struggled to match the remaining supply with demand and need. Public confidence in their ability to do so plummeted after repeated scenes of elderly men and women standing long, anxious hours at grocery store immunization clinics. Even last week, some nursing homes had yet to hear whether they would get vaccine for residents this winter.
Under current government guidelines, the shots should be aimed only at those younger than 2 and older than 64, children and adults with chronic conditions, pregnant women and health care workers dealing with certain populations. FluMist is approved for healthy individuals ages 5 to 49, and in their continuing triage, officials hoped eligible health care workers would step forward first.
With all of the initial FluMist distributed some time ago, manufacturer MedImmune Inc. has been waiting for the government's approval to begin releasing the recent batch. Company spokeswoman Jamie Lacey said clearance was received yesterday to ship the first 200,000 or so doses, some earmarked for the military, others for pharmacies and hospitals.
A vaccine with needs
When the remaining FluMist will be sent out is still unknown. Each lot of 100,000 to 200,000 doses carries with it 80 pages of data for scrutiny by the Food and Drug Administration. MedImmune has asked the FDA for ongoing releases as the documentation is reviewed. There is a narrowing window as winter approaches, with peak flu season in January and February.
"The idea is to get [it] out when people are still seeking vaccine," Lacey said.
There will be no mass supermarket clinics for FluMist. In contrast to the injectable vaccine, the spray is shipped frozen into the marketplace and must be kept frozen until just before use. That requirement is one of several differences — among them, higher cost — that have limited public acceptance of FluMist since its debut in 2003. So disastrous were sales last year that MedImmune considered calling it quits with the spray.
Perhaps the most important difference, though, lies in the very nature of the vaccine, the culmination of more than four decades of research begun by a University of Michigan scientist after the pandemic of 1957-58. Seventy thousand Americans died of influenza that year.
FluMist contains a live but weakened flu virus that has been genetically designed to survive temporarily in the cooler passages of the nose, triggering a person's immune system to produce disease-fighting antibodies. In warmer environs of the body, the attenuated virus doesn't stand a chance.
Many parents remain wary, opting for a needle no matter what tears it provokes in their children. The Alexandria-Lakeridge Pediatric Centers ordered 80 doses of FluMist early and used them all but has no plans to get more. "There wasn't really a large demand," said Rachelle Mitchell, a nurse. "A lot of parents got really antsy."
Use of FluMist to increase
Concerns may lessen next year after the spray becomes part of the federal Vaccines for Children program, a decision announced in late October. "It's a further endorsement, no question about it," spokeswoman Lacey said.
Likewise, the results of clinical trials may sway opinion. MedImmune reported this summer that FluMist provided greater protection in children than the traditional flu shot, and a worldwide study under way with more than 8,000 children as young as 6 months will look at how the spray's next generation, requiring mere refrigeration, compares in effectiveness and safety.
The FluMist traveling down the assembly line last week was in the final stage of a complex, months-long manufacture that began in California, jumped clear across the country and an ocean to Speke, England, then returned to a windowless building on Philadelphia's north side.
At this station, concentrate of three exotic-sounding strains of influenza — this year, New Caledonia, Wyoming and Jilin — is thawed in liter containers from minus 60 degrees Celsius, blended with a diluting solution, poured into the tiny sprayers and refrozen. A clock runs on every step of the process. And then it starts over again.
"It's been an interesting couple of weeks," said Charles Katzer, a MedImmune vice president who heads the plant. "We've not heard the end of this story."