Why isn’t there an ‘accelerated pathway’ for approving treatments during a pandemic?

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Credit: New York Times

Commercial biopharmaceutical discovery is a less than ideal vehicle for responding to an outbreak of a new viral pathogen spreading like wildfire through an immunologically naive population. Drug manufacturers are accustomed to navigating a regulatory and clinical development process that typically takes years, sometimes a decade or more; similarly, regulators have little experience for drug development in the context of a pandemic. There is no accelerated pathway for COVID-19 or any other emerging infectious disease.

A second problem is that for antiviral R&D, funding needs to be not only available when the pathogenic threat is clear and present but also sustained in between outbreaks. “In pharma, everything takes time, and it takes longer if you have to start from zero,” says John Rex, an infectious diseases physician and operating partner with Advent Life Sciences in London. Thus, novel antiviral discovery and development against COVID-19, or any other emerging pathogen for that matter, faces a problem of basic economics: there are no market mechanisms for unpredictable outbreaks.

Related article:  5 percent of COVID-19 survivors have super strength ‘neutralizing antibodies’ crucial for developing a vaccine

Rex believes that governments should regard effective antivirals and vaccines not as a burdensome drain on limited resources, but rather much as householders regard insurance policies and fire extinguishers: as products we buy hoping never to have to use.

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