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Malaria drug Trump touted as coronavirus treatment has been given FDA emergency authorization

March 30, 2020, 10:00 AM UTC

A drug President Donald Trump backed as a possible “game changer” in the fight against the coronavirus pandemic received an emergency-use designation from U.S. regulators.

The Health and Human Services Department accepted 30 million doses of the drug, hydroxychloroquine, from Novartis AG’s Sandoz unit, Secretary Alex Azar said in a statement late Sunday.

Normally used to treat malaria, hydroxychloroquine yielded promising yet inconclusive results in a small coronavirus trial. While Trump has said the drug is safe, it does carry significant side effects. Some people have been sickened, with one reported death, after taking various versions to try to ward off the new illness.

Trump said 1,100 patients in New York City are getting treatment using hydroxychloroquine. As global cases surged past 700,000, the city has emerged as one of the pandemic’s hot spots.

“Let’s see how it works,” Trump said in his daily briefing Sunday. “It may, it may not.”

WHO Director-General Tedros Adhanom Ghebreyesus has cautioned against the use of unproven treatments against coronavirus.

“The history of medicine is strewn with examples of drugs that worked on paper or in a test tube but didn’t work in humans or were actually harmful,” he said in a briefing. “We must follow the evidence. There are no shortcuts.”

A rush to use medicines against coronavirus could also cause shortages for patients with illnesses that the drugs are normally used to treat. India banned exports of hydroxychloroquine to maintain supplies needed to combat malaria.

The Food and Drug Administration gave emergency use authorization to hydroxychloroquine and a related malaria drug, chloroquine, according to the statement. The agency can authorize emergency use when there are no available alternatives and the “known and potential” benefits of the product outweigh known and potential risks.

Efforts to find solutions to the virus’s advance are mounting as the number of worldwide cases soars, and health systems in Italy and Spain threaten to crack under the burden of desperately ill and contagious patients. A variety of treatments, including Gilead Sciences Inc.’s remdesivir, are currently in randomized, controlled clinical trials.

Scientists are also investigating the utility of a vaccine against tuberculosis that’s been used for about a century to see whether it will bolster the body’s immune system against coronavirus. The shot, called BCG or bacillus Calmette-Guerin, is being given to health-care workers in Melbourne to see whether it will protect them.

More coronavirus coverage from Fortune:

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—Everything you need to know about the coronavirus stimulus checks
—Glow sticks to surgical masks: Businesses pivot to tackle coronavirus shortages
—The world’s largest coronavirus lockdown is off to a rocky start
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—The $2 trillion coronavirus stimulus package isn’t green, but it helps
—Listen to Leadership Next, a Fortune podcast examining the evolving role of CEO
—WATCH: World leaders and health experts on how to stop the spread of COVID-19

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