Now, of course, there’s no escaping it – for all through the month of October, headlines were chock full of articles concerning the impending flu vaccine shortage in the U.S., and the devastating effect of the loss of Chiron’s vaccine for this season. With only two main companies responsible for supplying all the vaccine for the U.S., the failure of one to come through turned into a major disaster-in-the-making.

The flu vaccine shortage made it painfully clear how fragile our vaccine supply chain really is. Very importantly, the situation has also thrown into high relief the disturbing fact that the country’s healthcare system is ill-prepared to respond quickly to an epidemic – whether it’s the flu or a bioterror attack.


It all started in late August, when Chiron announced that it had run across sterility problems with a “small number” of lots of its Fluvirin vaccine manufactured at a plant in the U.K., thereby pushing back the shipping date for 46-48 million doses until early October.

In and of itself, the delay worried health care officials and the government (not to mention Wall Street) – for those 50 million doses represented half the U.S.’ flu vaccine supply for this year, with the other half coming from French firm Aventis Pasteur (part of the Sanofi-Aventis Group).

They were right to worry. As it turned out, the sterility problem was wide-spread, and by early October the U.K.’s Medicines and Healthcare Products Regulatory Agency had suspended Chiron’s license to manufacture the vaccine at its Liverpool facility. In the weeks that followed, FDA inspectors visited the plant and reached the same conclusion.

This unsettling bit of news meant that Chiron would be unable to supply any flu vaccine for the 2004-2005 season. With Chiron out of the picture, the government started hunting down alternate sources that could make up at least some of the shortfall. Some of that will come from MedImmune Inc., which will supply about 3 million doses of its intranasal vaccine FluMist, priced at least 50 percent lower this year to more closely match the cost of the injectable vaccines.

And British giant GlaxoSmithKline plc said it was in discussions with the FDA regarding the potential for gaining rapid approval of its own flu vaccine, Fluarix, which is sold in 70 other countries but was never submitted for review in the U.S. Moreover, Canadian firm ID Biomedical Corp. has also developed a vaccine, Fluviral S/F, which it markets in Canada. The FDA is inspecting both companies’ manufacturing facilities; if they pass muster, they could free up another 5 million doses, which will be distributed in the U.S. as investigational new drugs.


But even if there had been enough flu vaccine available this year to dose every person who wanted a shot, the underlying problem remains: There is not enough financial incentive in vaccine development to satisfy most biotech and pharmaceutical companies. The costs are high – $800 million or more, at least as much as it takes to develop a drug – but the rewards are low, since vaccines sell for far less than prescription drugs. As well, traditional flu vaccines are grown in fertilized chicken eggs, a laborious process that begins long before each flu season and must be repeated anew each and every year in response to the flu virus’ proclivity to mutate. Deciding in advance how much vaccine to make, and which three flu strains to target, is risky business, making it even less attractive to drug companies.

The flu vaccine crisis, though, has prompted the powers that be to reconsider the basic strategy. The issue has been debated by Congress, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). And they’ve already swung into action. MedImmune stepped up FluMist production by 1 million doses at the request of the CDC. Most recently, the HHS awarded Aventis a $41 million contract to establish and maintain flocks of egg-laying hens so that the company is able to make vaccine for pandemic flu (a global epidemic-to-be that could arise at any time) or future vaccine shortages at full capacity on a year-round basis.

The Aventis contract is part of the HHS’ National Pandemic Influenza Preparedness and Response Plan, unveiled in August. This plan provides for a coordinated national strategy to prepare for and respond to a flu pandemic and includes activities to boost vaccine development and stockpile antiviral drugs.

The plan also provides guidance to state and local health departments and the healthcare system and can be viewed as part of a larger effort to put in place an emergency response plan that covers other scenarios, including a bioterrorist attack.

Under Project BioShield and earlier programs, the U.S. government has already initiated efforts to stockpile anthrax and smallpox vaccines. But it’s still in the earliest stages of this program – as it is with the flu pandemic plan – meaning that the U.S. remains extremely vulnerable to infectious epidemics of all sorts.