After passing PH vaccine panel evaluation, Sinovac seeks FDA OK
MANILA, Philippines — China’s Sinovac Biotech has submitted to the Food and Drug Administration (FDA) of the Philippines its application to conduct Phase 3 of clinical trials of its coronavirus disease (COVID-19) vaccine in the country.
FDA Director-General Eric Domingo said Sinovac submitted its application on Thursday, days after it hurdled the evaluation of a panel composed of the country’s vaccine experts.
“Nakapasa na po sa pre-screening ng vaccine experts panel ‘yung Sinovac na nag-apply na rin po today sa FDA. So that is undergoing regulatory evaluation. Ganun din po ‘yung ethics board evaluation niya tuluy-tuloy din po ‘yun,” Domingo said over state-run PTV’s Laging Handa Public Briefing.
(Sinovac, which already passed the pre-screening of the vaccine experts panel, has also applied today to the FDA. So it is undergoing regulatory evaluation. Its ethics board evaluation is ongoing as well.)
Sinovac is the first drugmaker to get the panel’s green light. The panel is also evaluating the COVID-19 vaccines of Russia’s Gamaleya Research Institute and Johnson & Johnson’s Janssen subsidiary for late-stage trials.
After evaluating data from Phase 1 and 2 of the clinical trials, Domingo said the panel approved Sinovac’s vaccine after only seeing “very mild” side effects.
“Meron pa po tayong mga datos na hinihingi sa kanila. Mga impormasyon tungkol sa produkto. ‘Yun pong kanyang labelling halimbawa dahil gawa siya sa ibang bansa, may mga translation kaming hinihingi sa certificates,” Domingo said.
(We are requiring more data from them such as the product information. The labeling for example since it came from another country, we required translations from them for the certificates.)
“Dadaan po ito ngayon sa regulatory review at technical review dito sa FDA at sa ibang mga eksperto. Titignan po ‘yung design ng mismong study at iyong bakuna, iyong produkto mismo kung wala tayong problema,” he added.
(It will now go through regulatory review and technical review with the FDA and other experts. We will look at the design of the study and the vaccine itself, the product itself to check if we do not have a problem.)
He went on: “Nandiyan din po ‘yung research ethics na review para masiguro na protektado ang safety ng clinical trial participants.”
(There is also a research ethics review to ensure the safety of clinical trial participants.)
The Philippines so far has 362,243 confirmed COVID-19 cases, including 311,506 recoveries and 6,747 deaths.
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