Covid-19: FDA gives emergency use authorisation to plasma therapy

The United States Food and Drug Administration (USFDA) has issued an emergency use authorisation (EUA) for investigational convalescent plasma for the treatment of Covid-19 in hospitalised patients as part of the agency’s ongoing efforts to fight the novel coronavirus.

Based on scientific evidence available, the FDA concluded that “this product may be effective in treating Covid-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.”

The development comes against the political backdrop of the November elections in the US, and the race to have medical treatment options for Covid-19 ahead of D-day. In fact, the last few weeks have seen ambivalent reports in the US on whether plasma therapy did in fact benefit patients.

India too, is testing this therapy at hospitals in different parts of the country.

Meanwhile, the FDA said that its action followed extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorises the distribution of Covid-19 convalescent plasma in the US and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed Covid-19 in hospitalised patients.

In a statement, Stephen M Hahn, FDA Commissioner, said, “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.”

“At the same time, we will continue to work with researchers to continue randomised clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus,” he added.

Scientific evidence

The FDA said it was reasonable to believe that Covid-19 convalescent plasma may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalised patients. Possible side-effects of Covid-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion-associated lung injury, as well as the potential for transfusion-transmitted infections, it said.

The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of Covid-19, the agency said, adding that it be revised or revoked if it is determined that the EUA no longer meets the statutory criteria for issuance.