72 COVID-19 therapeutics trial underway, 211 in planning stages: FDA
A top Trump administration health official has said that as many as 19 therapeutics trial are underway and 211 in planning stages in a bid to find the cure for coronavirus.
“We are leaving no stone unturned to find the treatment for COVID-19... We don't have any approved therapeutics for COVID-19 but we are actively involved with the academic, commercial and private sector to find it,” FDA Commissioner Stephen M Hahn told reporters at a White House news conference.
“Seventy-two trials of therapeutics are underway in the United States under FDA oversight and 211 are in the planning stages, so we expect to see more. This includes convalescent plasma as well as antiviral therapies,” Hahn added. According to Hahn, work is continuing on finding a vaccine. FDA has authorised two firms on vaccine trials.
Hahn said that the FDA has told manufacturers that in order to market anti-body tests in the US, they have to validate their tests.
“They have to tell us that they validated their tests, and in the package insert they have to let people know, end users, labs etc., that those tests were not authorised by FDA,” he said. So far, the US has authorised four and more are in the pipeline, he added. Antibody tests that are used to detect natural immunity and the FDA's approach to help make these tests available, he noted.
These are just one part of FDA’s larger response effort. They can play a role in helping move the economy forward by helping healthcare professionals identify those who have immunity to the COVID-19, he asserted. During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorisations (EUA) requests to FDA for tests that detect the virus.
To date, the FDA has issued 44 individual emergency use authorisations for test kit manufacturers and laboratories. In addition, 19 authorised tests have been added to the EUA letter of authorisation for high complexity molecular-based laboratory developed tests (LDTs).
