FDA approves Clover Biopharmaceutical’s clinical trial application for COVID-19 vaccine

Kristine Sabillo, ABS-CBN News

Posted at Jan 08 2021 07:01 PM | Updated as of Jan 08 2021 09:08 PM

A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. Dado Ruvic, Reuters/file

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

“The FDA also approved the clinical trial for the vaccine developed by Clover Biopharmaceuticals AUS Pty Ltd. today, 08 January 2021,” it said in a statement.

Clover Biopharmaceuticals AUS Pty Ltd. or Clover Australia is the Australian subsidiary of Sichuan Clover Biopharmaceuticals, Inc. Clover Biopharmaceuticals is a global biotechnology company “founded by a team of world-class scientists returning to China.” (Reference: https://www.cloverbiopharma.com/index.php?m=content&c=index&a=lists&catid=34)

The FDA approval makes Clover the second vaccine developer to get the green light for clinical trials in the country.

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

“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,” FDA Director General Eric Domingo said in the statement, referring to the third company that applied for clinical trials in the country.

The FDA said it continues to accept clinical trial applications.

Clinical trials are meant to check the safety and efficacy of vaccines on a larger group of people. Many of those interested in running clinical trials in other countries, such as the Philippines, are already on their Phase 3 trials, involving a large number of participants.

Currently, the World Health Organization lists Clover Biopharmaceuticals as undergoing Phase 2 or 3 clinical trials.

According to the WHO’s draft vaccine landscape document, Clover is working on a protein sub-unit vaccine, which only use one part — such as the spike protein — of the virus to induce an immune response.

A December news release from the company alleged “positive” results for its Phase 1 study.

Besides the 3 mentioned companies seeking independent clinical trials, the WHO is also set to test vaccines in the Philippines.