Covid-19: US approves emergency use of convalescent plasma despite warnings over lack of evidence

The US Food and Drug Administration (FDA) has approved convalescent plasma for emergency use in hospital patients with COVID-19.

The announcement on 23 August said that the FDA had concluded that plasma from recovered patients “may be effective” in treating the virus and that the “potential benefits of the product outweigh the known and potential risks.” The move came despite the absence of results from randomised controlled trials, with only a preprint paper on the effects on hospitalised COVID-19 patients being published to date.

Experts have warned that although these early findings show promise there is not enough evidence to show that it works.

Plasma from recovered patients was approved on a case by case basis by the FDA for people critically ill with COVID-19 in March. Since then more than 70 000 patients have been treated with plasma. Emergency use approval allows clinicians to use unapproved medical products to diagnose, treat, or prevent serious or life threatening diseases or conditions when there are no adequate, approved, and available alternatives.

The FDA’s commissioner, Stephen Hahn, said, “I am committed to releasing safe and potentially helpful treatments for covid-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from covid-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”

But Martin Landray, professor of medicine and epidemiology at the University of Oxford and lead researcher for the RECOVERY trial, which is comparing treatments for COVID-19, including convalescent plasma for hospital patients, urged caution. He said, “There is a huge gap between theory and proven benefit. That is why randomised clinical trials are so important. At present, we simply don’t know if it works."

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Source: BMJ, 25 August 2020