FDA: 2 COVID-19 vaccines, Janssen and Clover Biopharma, approved for PHL clinical trial

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The Food and Drug Administration (FDA) announced the approval of the vaccine against COVID-19 developed by China’s Clover Biopharmaceuticals, after it had approved the vaccine developed by Janssen Pharmaceuticals of Johnson and Johnson. (Courtesy FDA)

 

(Eagle News) — Two COVID-19 vaccines have now been cleared for clinical trials in the Philippines, according to the Food and Drug and Drug Administration (FDA).

This was after it had approved on Friday, Jan. 8, 2021 the vaccine developed by Clover Biopharmaceuticals AUS Pty Ltd of China, days after it had approved the vaccine made by Janssen Pharmaceutical Companies of Johnson & Johnson.

With this development, two vaccines against COVID-19 are now given the green light for clinical trials in the Philippines.

The first to be approved was Janssen vaccine on December 28, and the second was the vaccine by China’s Clover Biopharmaceuticals.

The building of Clover Biopharmaceuticals in China. (Screenshot of Clover Biopharmaceuticals website/Courtesy http://www.cloverbiopharma.com/)
(File photo) A health worker sorts blood samples for Covid-19 vaccination study at the Center for Pediatrics Infectology Studies (CEIP) where the pharmaceutical company Janssen, of Johnson & Johnson, is developing the phase 3 study of the vaccine in Cali, Colombia on November 26, 2020. (Photo by Luis ROBAYO / AFP)

The FDA said that it “continues to accept applications for the conduct of COVID-19 Vaccine clinical trial (CT) in the Philippines.”

-Sinovac application for clinical trial still being reviewed-

“To date, FDA has received three (3) applications which underwent review and assessment of the Department of Science and Technology – Vaccine Expert Panel (DOST-VEP) and the Single Joint Ethics Review Board (SJREB),” it said.

FDA Director General said that the third and remaining vaccine candidate being reviewed is the COVID-19 vaccine developed by Sinovac Biotech Ltd, another pharmaceutical firm from China.

“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”, Director General Domingo said.

-Emergency use applications-

Meanwhile, the FDA said that the “acceptance and review of applications for Emergency Use Authorization (EUA) of COVID-19 vaccines is also underway.”

“Evaluation of Pfizer-BioNTech COVID-19 Vaccine and AztraZeneca Pharmaceuticals-ChAdOx1-S (recombinant) COVID-19 Vaccine is ongoing,” it said.

Domingo said that the decision whether their application for EUA will be approved is expected to be released within 21 calendar days upon filing of application.

the FDA said that it had also received on Thursday, Jan. 7, the EUA application of Sputnik V vaccine developed by Gamaleya National Center of Epidemiology and Microbiology- Ministry of Health Russia.

“The submission was pre-assessed and the applicant was instructed to comply with the lacking documents,” Domingo said.

(Eagle News Service)