FDA approved clinical trials for Clover COVID-19 vaccine in the Philippines.
The Food and Drug Administration (FDA) announced that the agency had approved the application of Clover Biopharmaceuticals to conduct Phase III COVID-19 vaccine clinical trials in the Philippines.
In a statement, the Food and Drug Administration said that the agency approved the clinical trial for the COVID-19 vaccine developed by Clover Biopharmaceuticals AUS Pty Ltd. yesterday, January 8, 2021.
Clover Biopharmaceuticals was the second vaccine developer that had secured approval from the Philippine regulators in order to conduct clinical trials in the Philippines.
The first vaccine developer that was approved to conduct clinical trials in the Philippines was Janssen Pharmaceuticals and it was expected to start the clinical trials this month.
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Meanwhile, the Food and Drug Administration was still awaiting necessary documents from Sinovac Biotech in China before it can issue a decision on its application.
“The FDA is currently awaiting response to clarifications for the proposed study on the Sinovac Life Sciences vaccine before issuing a decision on the application,” the agency said.
In a related development, the Food and Drug Administration confirmed that Gamaleya Research Institute in Russia had already submitted its application for emergency use authorization (EUA) in the Philippines for its COVID-19 vaccine.
With this, Gamaleya was the third vaccine developer that had applied for an emergency use authorization in the Philippines.
The Food and Drug Administration said that the EUA applications of Pfizer-BioNTech and AstraZeneca-Oxford were currently being evaluated.
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