On Thursday, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that doctors have treated so many Covid-19 patients with convalescent plasma, it has been difficult to figure out if the treatment works.
"The problem with convalescent plasma is the great enthusiasm about it," Woodcock said in an online conversation about the latest science behind monoclonal antibody treatments and convalescent plasma. "It exceeded anyone's expectation as far as the demand."
Woodcock, who has shifted to lead therapeutic efforts under the Trump administration's Operation Warp Speed, said plasma has shown some promise in early studies, but said Thursday there is still not yet enough evidence that it works.
Her team counted 162 prospective studies and several more observational studies, but she said only six met the standard that could produce actionable results. There is no randomized clinical trial data yet, she said, but some of those trials are ongoing.
"We continue to have hints that this is an effective treatment in this particular virus," Woodcock said, adding that the NIH will initiate or boost additional trials to find out for sure, she said.
https://www.cnn.com/2020/08/23/health/covid-19-convalescent-plasma-eua-white-house/index.html