The Grand Challenge of Incremental Vaccine Development

June 27, 2005

In reading this article about a $14.8 million grant awarded by the Gates Foundation to an Arizona researcher trying to create an oral vaccine for bacterial pneumonia, I learned something I didn’t know about vaccine development– namely that the process for approving a vaccine for infant can take quite a long time “because the vaccine first is tested on adults, and if those are successful, then it is tested on a younger group each time until it reaches the infant category.”

It’s certainly reassuring to hear that the process is that thorough– but it also gives me a greater appreciation of the investment required to bring a new vaccine to market. The article also underscores the lack of sufficient incentives in the free market to develop many essential medicines:

“Large for-profit pharmaceutical companies are reluctant to get into the vaccine business because they can’t make as much money on a vaccine that only gets used by a person twice in their lifetime.”

The project is among 43 winners chosen by the Gates Foundation to receive five year grants of up to $20 million (a sum, it is worth pointing out, that is significantly larger than most NIH grants):

“…the 14 goals that the foundation wanted scientists to pursue included: vaccines that need no refrigeration and can be given without needles; vaccines that create immunity with one dose and are safe for newborns; new ways to kill or cripple mosquitoes; more nutritious staple crops; better animal models for human diseases; blood tests that can be done in villages without electricity; and new ways to attack diseases like tuberculosis and hepatitis when they are dormant.”

And the intellectual property angle?

“As part of receiving a grant, the researchers are allowed to patent anything they invent, but they must guarantee that it will be made available to poor countries at low cost or free.”

These terms are identical to what the WHO generally stipulates in contracts with its collaborators– and in contrast, the Times article notes, to patent rights resulting from work associated with NIH grants– which “normally go to the university involved” without requirements to offer preferential access to developing countries.

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