The Food and Drug Administration approved on Friday Clover Biopharmaceuticals’ application for its COVID-19 vaccine trial in the Philippines.

This makes the Chinese company the second vaccine developer to receive approval for clinical trials in the country, FDA Director General Eric Domingo said.

The FDA had approved the application of Johnson & Johnson’s Janssen last December 28.

Clinical trials are meant to check the safety and efficacy of vaccines on a larger group of people.

To date, the FDA has received three clinical trial applications as assessed by the Department of Science and Technology’s Vaccines Expert Panel.

FDA is currently awaiting clarification on the third applicant, Sinovac Life Sciences, before green lighting its trial 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,” Domingo said.

Domingo also said they were now processing the approval of new coronavirus vaccines developed by Pfizer-BioNtech and AstraZeneca for Emergency Use Authorization (EUA).

He said that the decision of approval is “expected to be released within 21 calendar days upon filing of application.”

Domingo added that the EUA approval of Russian-developed Sputnik V was received on Thursday, but its manufacturers were “instructed to comply with lacking documents.” 

Topics: Food and Drug Administration , Clover Biopharmaceuticals , COVID-19 , vaccine trial

Source:
https://manilastandard.net/news/national/343975/fda-okays-clover-covid-19-vaccine-clinical-trial.html

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