72 COVID-19 therapeutics trials underway, 211 in planning stages: FDA
Washington, Apr 25 () A top Trump administration health official has said that as many as 72 trials of therapeutics are underway and 211 in the planning stages to find a cure for the deadly coronavirus.
Commissioner of Food and Drug Administration (FDA) Stephen M Hahn told reporters at a White House news conference on Friday that the work was under way on finding a vaccine for the coronavirus and the FDA had authorised two firms on vaccine trials.
"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," Hahn said.
"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," he added.
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). LKJ RHL MRJ MRJ