A COVID-19 vaccine candidate from China’s Sinovac firm has passed a preliminary review by local experts and filed Thursday its application to hold clinical trials in the Philippines, the Food and Drug Administration said.
The expert panel “endorsed positively” the Sinovac vaccine after reviewing its safety profile, effect, and study design, said FDA Director General Eric Domingo.
Sinovac needs to submit additional information on the vaccine, its labeling details, and translation of related certificates. The FDA will then take two to three weeks to study these documents, he said.
“Dadaan po ito ngayon sa regulatory review, at saka technical review dito po sa FDA at saka sa mga grupo rin po ng ating eksperto. Titingnan po iyong design ng study at iyong produkto po mismo, kung wala pong problema,” Domingo said in a Laging Handa public briefing.
“And’yan din po iyong research ethics board na review to make sure na protektado po ang safety ng magiging clinical trial participants at lahat po ng sasali dito,” he added.
Phase 3 clinical trial requires “a few thousand” participants. Earlier phases found “nothing serious” in terms of side effects, said Domingo.
The Philippine experts panel is also reviewing vaccine candidates Janssen, Russia’s Sputnik V, and those under the solidarity trial of the World Health Organization, he said.
The Sinovac vaccine was tested by Sao Paulo state’s research center Butantan Institute. It recently said the two-dose vaccine called CoronaVac, proved to be safe in a trial so far involving 9,000 volunteers.
It is the first set of results of Sinovac’s Phase 3 global trials, which are also being conducted in Turkey and Indonesia.
Vaccines are considered essential to curb the rampaging virus, which has killed over one million people globally.
Experts have warned that the safety of inactivated coronavirus vaccine candidates should be observed over longer periods, as some other inactivated vaccines had led to disease enhancement effect, where vaccine-triggered antibodies, instead of offering protection, could worsen infections when people became exposed to a virus after inoculation.(with Reuters/ABS-CBN News)
