Can vaccine makers deliver on flu shot deals?

This week has been big on H1N1 vaccine contracts. U.K. [1], France [2] and Germany [1] all announced that they'd secured millions of doses for their people. But that's not the full story. It's true that they've inked deals with drugmakers. But those deals come with a couple of assumptions: One, the vaccines will be available on schedule. Two, that they can be delivered.

And there are problems with both. Already the WHO has announced that vaccine makers are having trouble cultivating antigen from the available H1N1 strains, getting only about one-quarter the usual yield with seasonal flu. Now, two vaccine makers are warning of possible shortfalls because of that yield problem. Novartis says its yield is 30 percent to 50 percent of normal; Baxter didn't put a number to it, but said optimizing yields "is proving a challenge."

As you know, vaccine manufacturing depends on the antigen. And that means millions of vaccine doses could arrive later than those government customers expect. Already Baxter has warned the U.K. that it's sending over smaller quantities than expected at the end of next month, and it's saying that it can't accept any more orders. WHO is fiddling with the virus in hopes of getting a better-yielding version to vaccine makers, and the manufacturers are tweaking their processes in an attempt to boost yield.

Meanwhile, some experts are raising questions about getting the shots to customers once they're made. This won't be a problem for at least one of France's contracts; Sanofi-Aventis will be making its 28 million doses (plus an optional 28 million more) right there in the country. But it could be a major snag for countries whose orders have to be shipped across national borders.

Just think: A manufacturing plant is churning out millions of doses for foreign customers, but its home country doesn't have enough shots--or has none at all. That country might seize the vaccine shipments. That country could cut off shipments till it gets what it considers its share. Obviously the risk is greatest if the virus evolves to greater virulence.

Now the inevitable question is, which countries are most at risk of seeing their vaccine contracts go unfulfilled? Which leads us to follow-up question No. 2: Where is flu vaccine made? Eleven countries account for 90 percent of it, and they include the U.S., Australia, Japan, and other "high-income" countries.

- read the Canadian Press story [3]
- see the article [4] in the Financial Times
- see the Wall Street Journal story [5]
- get more [6] from Reuters
- check out the post [7] at Avian Flu Diary

ALSO: The U.K. plans to launch a phone hotline to allow flu patients to be diagnosed over the phone and get prescriptions for antiviral meds. Report [8]

Related Articles:
France orders $1.4B worth of flu shots [2]
Germany, U.K. load up on flu vaccine [1]
NIH summit hopes to heighten pandemic preparedness [9]
Glaxo expects vax orders to spike as WHO outlines deadlines [10]