Thursday, February 16, 2006

New Rotavirus Vaccine an Expensive Ethical Fix

Recently, Merck secured FDA approval for its new rotavirus vaccine, Rotateq. The new vaccine has been viewed as an alternative to Rotashield, Wyeth's ill-fated rotavirus vaccine that was found to lead to an increased rate of intussusception, a potentially fatal intestinal complication.

In 1999, Rotashield was pulled from the US market. However, continued vaccine studies were considered in the developing world, where pediatric rotavirus mortality rates are greater than morality rates from Rotashield-induced intussusception. Many argued that support for these studies would presuppose that lower standards for pediatric vaccine safety in the developing world were ethically permissible. In the end, developing countries refused to use a vaccine that had been deemed too dangerous for US children.

Now, eight years after Wyeth's development of Rotashield, Merck has developed Rotateq, a vaccine that solves the intussusception problem. For some, this new vaccine marks the end of a bitter debate regarding the use of Rotashield in the developing world.

However, this shiny solution comes with a shiny price tag. Merck will charge $187.50 for the three required doses of Rotateq, making Rotateq one of the most expensive vaccines on the market. Merck predicts that, by 2009, the vaccine will bring in as much as $500 million in annual revenue. Rotashield, meanwhile, had a significantly cheaper $114 price tag.

It is good to know that Merck’s $500 million dollar profit will come largely from the developed world, where rotavirus is more of a nuisance than a killer. Indeed, the vast majority of rotavirus deaths– 82% of them – occur in the poorest countries.

Rotateq’s price tag brings it far out of reach of the countries that most desperately need a rotavirus vaccine. Thus, although we may have succeeded in developing a rotavirus vaccine that addresses an important side-effect issue, we have not succeeded in producing a vaccine for the developing world. For the poorest nations, where rotavirus mortality is the highest, the choice may still be between a cheaper, more dangerous vaccine or no vaccine at all.

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