Lured partly by this season's shortage, two companies that are trying to enter the market for the first time could produce a total of about 30 million doses. But the companies, GlaxoSmithKline PLC of Britain and ID Biomedical Corp. of Canada, still must clear the Food and Drug Administration's regulatory hurdles.
MedImmune Inc. of Gaithersburg could produce upward of 10 million doses of its nasal flu vaccine FluMist for next season. But the company won't say how many doses it will manufacture until it knows more about the nation's supply and whether the government will ease manufacturing and shipping requirements for FluMist and loosen restrictions so that the vaccine can be offered to people over age 49.
Chiron Corp. had to discard 48 million does of flu vaccine when contamination problems were discovered at a British plant in October.
(Chiron Corp. Photo Via AP)
The Business of Vaccine Production It takes up to 10 months to produce the flu vaccine, and any delay in the complex process can affect the timing of the vaccine's availability for the following season.
That has left the focus on Sanofi Pasteur, formerly Aventis Pasteur and the only other licensed flu vaccine provider in the United States. But the company, which is the vaccines group of Sanofi-Aventis in Paris, says it can stretch to produce only 60 million shots, about 40 million shy of the government's goal.
Then there's the question of demand. After making do without flu shots this season, will millions of Americans decide they can get by without a shot again next season? Or will they flock to doctors and drugstores that give shots to anyone?
"It's an open question as to what the fundamental underlying demand will be," said Alex Hittle, an analyst with A.G. Edwards & Sons Inc. in St. Louis. "Companies want to be reasonably sure of selling this stuff. How can you calculate what to do?"
Unable to calculate next season's market, the major distributors of flu vaccine are putting everything on hold. Henry Schein Inc. of Melville, N.Y., isn't soliciting advance orders, as it normally does by now. FFF Enterprises Inc. in Temecula, Calif., has been telling health care providers attempting to book orders that it will get back to them once the situation becomes clearer.
"It's really a cat and mouse game right now," said Neil Herson, executive vice president and general manager of ASD Healthcare, an Addison, Tex.-based subsidiary of AmerisourceBergen Corp. "It would be ridiculous to go out and pre-book not knowing what the supply will be, not knowing what the price will be. That's a high-risk game. You could really get egg on your face. So we'll have to wait."
Herson said he doesn't expect his company to begin taking advance orders for flu shots until the end of March, which is usually when orders trail off.
If demand again falls short of expectations, vaccine manufacturers could have to throw out unused doses, costing them millions of dollars. Federal officials have floated the idea that the government might buy leftover doses to reduce risk and encourage more manufacturers to enter the vaccine market, but no action has been taken.
"I know there has been discussion about finance methods, but as far as I know nothing has been decided," said Bruce Gellen, director of the National Vaccine Program Office at the Department of Health and Human Services.
With all the uncertainty, Frank's organization of family physicians has recommended that its more than 93,000 members stock only enough flu shots for their patients in high-risk groups -- children under 2, the elderly and those with chronic health problems -- once vaccine makers and distributors start taking orders.
Such cautious strategies could hurt the government's effort to expand the number of people being vaccinated -- ultimately to nearly 185 million people -- partly to help create a more stable market for vaccine manufacturers. Some experts say they worry that doctors may stop offering flu shots to avoid the uncertainties and logistical hassles.
"We are hearing the frustrations of the medical community," said Greg Reed, program manager for the Maryland Center for Immunization, part of the state's Department of Health and Mental Hygiene. "I'm fearful they're just going to get out of the flu vaccine business, and when it comes flu season, they'll just tell their patients, 'Go to the health department.' "
He said public health departments cannot handle that much demand.
Gellen of the National Vaccine Program Office said he hopes some of the uncertainty will be sorted out in coming weeks, when Chiron is expected to update its situation and manufacturers meet with federal health officials to select the strains of flu they will use to make next season's vaccines.