Lessens learned from H1N1 pandemic revealed

Pharmaceutical companies have begun the process of finding out where things went wrong in their experiences during the less damaging than expected H1N1 pandemic.

During the outbreak, the senior management of the pharmaceuticals had to contend with a skeptical public, government policies constantly shifting, a limited manufacturing capability and scientific uncertainty, the Financial Times reports.

“Luckily the pandemic was mild – we had reached the limits of what we could do,” Andrin Oswald, head of vaccines at Novartis, a Swiss pharmaceutical, told the Financial Times.

The Council of Europe appears to believe they did a little too much, accusing the industry of distorting public health priorities across Europe, wasting public money and causing near panic among the public at large.

Last year, however, things were not so clear. Data on the virus was scant, test batches were still in development and governments were bracing for large demand and relatively little supply of the vaccine. Pharmaceutical companies were challenged to manufacture a vaccine of dubious efficacy, make it safe and distribute it as widely as possible.

Vaccine manufactures were left struggling, in the absence of clear policy guidelines, to predict future demand, allocate scarce resources and face the risk that the governments of the countries where production occurred would seize their stockpiles without purchase. As a result, each manufacturer had to develop its own strategy, the Financial Times reports.

Furthermore, complex regulatory requirements meant that companies were forced to use only existing and approved factories, lowering their capacity to provide more of the vaccine. Production could not be expanded until the World Health Organization declared that the H1N1 threat was higher than for the seasonal flu. They also needed authorities to provide them with a vaccine seed of the virus and reagents for its testing.

In autumn 2009, the situation shifted and the pharmaceuticals struggled to adapt. The virus was less virulent than expected - only one dose, instead of two, was need for a vaccine to be effective and governments began to renegotiate their contracts. Manufacturers found themselves with diminished orders and fewer and fewer alternative purchasers as time passed.

“One lesson was that a contract is not always a contract,” Oswald told the Financial Times. “You just have to factor that in as one of the business risks.