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The Food and Drug Administration (FDA) approved on Friday the request of the Chinese company Clover Biopharmaceuticals to carry out clinical trials of its vaccine against the coronavirus disease 2019 (Covid-19) in the country.
In a statement issued Friday night, FDA CEO Eric Domingo said the company was the second to obtain approval for its clinical trial application after US company Janssen Pharmaceuticals Company of Johnson and Johnson, which was approved on December 28, 2020.
To date, the FDA has received three clinical trial requests that have been evaluated by the Vaccine Expert Panel of the Department of Science and Technology.
The FDA is currently awaiting clarification on the third applicant, Sinovac Life Sciences, before giving the green light to its trial request.
“The FDA is currently awaiting a response to the clarifications for the proposed Sinovac Life Sciences vaccine study before issuing a decision on the application,” said Domingo.
Domingo also said they were now processing the approval of new coronavirus vaccines developed by Pfizer-BioNtech and AstraZeneca for emergency use authorization (USA).
He said the approval decision is “expected to be published within 21 calendar days after the application is submitted.”
Domingo added that US approval of the Russian-developed Sputnik V was received on Thursday, but its manufacturers were “instructed to comply with the missing documents.”
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