Monday, May 30, 2005

The vaccine business

With the antiviral Tamiflu in short supply and a threatened pandemic from avian flu, attention has once again turned to vaccines. If there is a pandemic in the next few months with H5N1 flu there is insufficient time to manufacture a vaccine against it. But let's be optimistic and say the pandemic doesn't materialize. Even in a "normal" flu year, almost 40,000 Americans die of influenza, and in the absence of a policy of universal vaccination, this will happen again next year.

In the 1960s there were as many as 26 companies in the US flu vaccine business and even in 1992 there were 10 (Motley Fool). Last year the list was down to two, Chiron and Sanofi-Pasteur, so the contamination in the Chiron UK plant was a serious blow. Other big drug manufacturers had switched their investments to more profitable pharmaceuticals like impotence or cholesterol lowering drugs, items with extremely high profit margins and a requirement for constant use. Vaccines, where the demand is inconstant or unpredictable and use perhaps once in the patient's lifetime, were of less interest, not because they weren't profitable, but because they aren't obscenely profitable.

But contrary to what manufacturers claim, there is still plenty of reasonable profit in vaccine manufacture. Their arguments to the contrary are directed at wringing regulatory and legal concessions to make them even more profitable. Senator Joe Lieberman's (R. D.-CT) new "Bioshield II" Bill is an egregious example of buying Big Pharma's argument and giving away the store.

Evidence for the "reasonable" profitability of influenza vaccines comes from the new interest of drug comopanies in the area, even without the incredible concessions they are demanding. Taking advantage of the Chiron debacle, which cost the US half its flu vaccine supply last year, the UK's GlaxoSmithKline (GSK) has applied for FDA approval for its Fluavirix vaccine, already available in 75 countries, and ID Biomedical is conducting clinical trials for its Fluviral product for the 2006 - 2007 season (Motley Fool). Sanofi-Pasteur and MedImmune are already approved providers in the US, so the new additions would double the vaccine sources.

It is expected that Sanofi-Pasteur will be able to provide about 60 million doses this year, with Chiron another 30 million and MedImmune 3 million. MedImmune's FluMist is a nasal-spray vaccine, not an injectable. MedImmune expects to slash its price this year and will put on a full court press of "physician eduction" in the hopes of boosting its popularity. However it needs to be stored frozen and is so far not approved for the very young and the very old, the two biggest high risk groups. It is also a live virus vaccine, raising questions about side effects in immunocompromised people or immunocompromised contacts of those vaccinated (Motley Fool).

Even with GSK's entry into the market, it is unlikely we will have enough supply for a policy of universal vaccination in the US. But what is really needed is global universal vaccination. If the market doesn't work, we should be looking at non-market solutions, such as state or national vaccine institutes. A dozen vaccine institutes scattered around the world would be a major step forward in 21st Century public health.

Unfortunately this solution has the drawback of being too simple.