A National Institutes of Health panel released a statement on Tuesday saying that convalescent plasma should “ not be considered standard of care for the treatment of patients with COVID-19.”
The guidance comes after the FDA issued an emergency use authorization for the use of convalescent plasma as a treatment for COVID-19.
While the NIH’s guidance is an initial setback for proponents of the treatment, the NIH is encouraging further study of plasma in clinical trials.
The emergency use authorization came after prodding from the White House. Trump held a news conference last Sunday applauding the FDA for issuing an emergency use authorization for convalescent plasma as a coronavirus treatment. The news conference came a day after Trump accused the FDA for holding back a COVID-19 treatment.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump said on Twitter. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Trump tagged FDA Commission Stephen Hahn in the tweet, who then issued the EUA the following day.
Despite the EUA, the NIH panel said that there is not enough evidence for or against plasma to be used as a treatment.
“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” the NIH panel said.
An emergency use authorization stipulates that “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by (an infectious disease) when there are no adequate, approved, and available alternatives.”
The Red Cross, among other organizations, have been encouraging recovered COVID-19 patients to donate plasma to provide coronavirus patients with possible antibodies against the virus.
