China's Sinovac Biotech has submitted its application to the Food and Drug Administration (FDA) to conduct Phase III clinical trials for its COVID-19 candidate vaccine in the Philippines.

The Chinese firm recently passed the evaluation of the Department of Science and Technology 's vaccine experts panel, which was first of the three stages of evaluation required before a clinical trial can be conducted. 

"Ang nakalusot sa pre-screening ng vaccine experts panel ay yung Sinovac galing China na today ay nag apply na rin po sa FDA ng permission to conduct a clinical trial here ," said FDA Director-General Rolando Enrique Domingo during a televised public briefing. 

“Yun pong Phase I and Phase II na kanyang mga resulta na tiningnan ng vaccine experts panel ay nakita naman po na very mild lamang ang mga side effects, nothing serious kaya rin naman po ito nakapasa sa kanila ,” said Domingo. 

Domingo said that the evaluation of the Single Joint Research Ethics Board for the Sinovac candidate vaccine is also ongoing. 

“Nandyan din yung ethics review to make sure na protektado ang safety ng mga magiging clinical trial participants ,” he said. 

It will take two to three weeks for the FDA to review Sinovac’s application for clinical trials, said Domingo. 

“Meron pa tayong mga datos na hinihingi sa kanila, mga information sa produkto, labelling halimbawa, of course dahil gawa sya sa ibang bansa  may ibang translation kami na hinihingi sa certificates, so dadaan po ito sa regulatory review at technical review dito sa FDA at sa mga grupo ng ating eksperto ,” he said. 

Avigan

In a related development, the Department of Health (DOH) said that the recruitment of COVID-19 patients to participate in clinical trials for Japanese anti-flu drug Avigan is still ongoing.  This trial was supposed to start last month. 

“When it comes to Avigan, atin na pong nag uumpisa ng pagre-recruit ng mga pasyente for the clinical trial ,” said Health Undersecretary Maria Rosario Vergeire in a separate briefing. 

“Ang ating target na pasyente sa Avigan trial is just 100--- spread across four hospitals dito sa Metro Manila ,” she added. 

The hospitals that were identified to take part in the Avigan trials are the Philippine General Hospital, Santa Ana Hospital, Dr. Jose N. Rodriguez Memorial Hospital, and Quirino Memorial Medical Center.