MANILA — The Food and Drug Administration on Friday said the country’s vaccine expert panel recently received and is now studying the application of United Kingdom-based drug maker AstraZeneca to hold COVID-19 vaccine clinical trials in the Philippines.
“The vaccine expert panel is now evaluating several applications or several that signified interest (in running clinical trials in the country),” FDA Director General Eric Domingo said during a virtual briefing.
“Recently we accepted an application from AstraZeneca,” he added, after mentioning the other vaccine developers also interested in clinical trials in the Philippines such as Russia’s Gamaleya Institute, China’s Clover Biopharmaceuticals and European firm Janssen Pharmaceutical.
AstraZeneca is a British pharmaceutical company that partnered with Oxford University in developing a COVID-19 vaccine.
Recent reports said the vaccine showed encouraging immune response among the elderly. It is one of the several vaccines that have already reached the Phase 3 process for vaccine development.
Health Undersecretary Maria Rosario Vergeire during the same briefing told media that she and Secretary Carlito Galvez Jr., the Philippines’ designated vaccine czar and chief implementer of the country's national policy against COVID-19, met with AstraZeneca recently.
“They have that intention,” she said. “Sa ganyan magandang indikasyon 'yan kasi gusto ng Philippine government na talagang mai-try out muna sa ating mga Pilipino bago natin umpisahan ang pagbabakuna sa ating kababayan,” she said.
(That is a good indication because the Philippine government wants to have vaccines tested first among Filipinos before it is distributed to many.)
Domingo said only Chinese company Sinovac has finished the pre-evaluation process of the vaccine expert panel and is now officially lodged with the FDA.
“Mukhang konting documentation na lang 'yung kulang (ng Sinovac) para ma-complete ang requirements ng ating regulatory reviewers and of course the ethics boards and the FDA,” he said. “Hopefully this will all be resolved soon.”
(It seems there are only a few documents remaining to complete the requirements of our regulatory reviewers and of course the ethics boards and the FDA. Hopefully this will all be resolved soon.)
If Sinovac is able to pass the FDA process, it may be the first company to hold COVID-19 vaccine clinical trials in the Philippines. There is still no definite date for the World Health Organization’s multi-country clinical trials, which will test several vaccines against COVID-19.
Vergeire previously explained that it is better to have clinical trials in the country to check if a vaccine is safe and effective for Filipinos. She said vaccines may have different effects on different races.