China's Sinovac may start COVID-19 vaccine clinical trials in PH anytime — FDA

Kristine Sabillo, ABS-CBN News

Posted at Jan 19 2021 02:29 PM

A nurse prepares a dose of the Sinovac's CoronaVac COVID-19 vaccine at the Sancaktepe Sehit Dr. Ilhan Varank Training and Research Hospital in Istanbul, Turkey Jan. 14, 2021. Murad Sezer, Reuters

MANILA — The Food and Drug Administration said Tuesday that while Chinese firm Sinovac has yet to finish its emergency use authorization (EUA) application in the Philippines, it may start its COVID-19 vaccine clinical trials in the country anytime.

FDA Director General Eric Domingo told ABS-CBN News that Sinovac’s clinical trial application was approved on January 15.

“They can start the trial anytime,” he said in a text message.

This makes Sinovac the third company to be allowed to run clinical trials in the Philippines — following the approval of clinical trials. by Johnson & Johnson’s Janssen and Clover Biopharmaceuticals.

A clinical trial would allow the said companies to test their COVID-19 vaccines in the country to see if they are effective and safe for Filipinos. This is usually part of the Phase III trials of the vaccine development process. 

The FDA approved Janssen’s application on December 28 and Clover Biopharmaceuticals’ on January 8.

“Lahat ng nag-apply ng clinical trials sa FDA na-approve na po 'yan. I would presume nagsisimula na po 'yan,” Domingo said during a Laging Handa briefing on Tuesday.

(All the clinical trial applications have been approved by the FDA. I would presume that they are already starting.)

Besides the 3 companies, which will be holding their clinical trials independently and with a local research partner, the World Health Organization is also expected to run its Solidarity Trial in the Philippines. There is still no update on what vaccines the WHO trial will use or when it will start.

Meanwhile, Sinovac is still working on its EUA application to allow is vaccine to be used by priority sectors in the Philippines through a national vaccination program. 

The government aims to begin immunization next month, hoping to inoculate 70 million people, or two-thirds of its population, this year.
It hopes to secure supply deals for 148 million doses this January. The Philippines has firmed up supply deals with Sinovac, US-based Pfizer, Novavax, Moderna, AstraZeneca, Johnson & Johnson, and Russia's Gamaleya Institute, vaccine czar Carlito Galvez earlier said.


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