Tecovirimat, a little-known antiviral, shows promise against monkeypox. But human data and supplies of the drug are limited.
In the United States, the FDA hasn’t authorized tecovirimat’s use against monkeypox because, the agency says, the disease hasn’t been eradicated and therefore it is still possible to test the drug in humans. This means that US physicians can access the drug, deemed experimental for monkeypox, only by requesting special permission through the US Centers for Disease Control and Prevention .
The FDA finds itself in a “tricky position”, McQuillen says. The agency was criticized during the COVID-19 pandemic when it authorized the emergency use of drugs such as hydroxychloroquine and they turned out not to be effective. Making tecovirimat completely accessible could hinder clinical trials to determine the drug’s efficacy, because people might not want to enrol if there’s a chance they will receive a placebo, he says.