In this picture taken on April 29, 2020, a package of the experimental vaccine test for the COVID-19 coronavirus is pictured at the Quality Control Laboratory at the Sinovac Biotech facilities in Beijing. 鈥� Sinovac Biotech, which is conducting one of the four clinical trials that have been authorised in China, has claimed great progress in its research and promising results among monkeys. (Photo by NICOLAS ASFOURI / AFP) / TO GO WITH Health-virus-China-vaccine,FOCUS by Patrick Baert
MANILA, Philippines 鈥� China鈥檚 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鈥檚 vaccine experts.
鈥淣akapasa na po sa pre-screening ng vaccine experts panel 鈥榶ung Sinovac na nag-apply na rin po today sa FDA. So that is undergoing regulatory evaluation. Ganun din po 鈥榶ung ethics board evaluation niya tuluy-tuloy din po 鈥榶un,鈥� Domingo said over state-run PTV鈥檚 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.)
READ: Sinovac needs ethics review, FDA approval before COVID vaccine trials 鈥� DOST
Sinovac is the first drugmaker to get the panel鈥檚 green light. The panel is also evaluating the COVID-19 vaccines of Russia鈥檚 Gamaleya Research Institute and Johnson & Johnson鈥檚 Janssen subsidiary for late-stage trials.
After evaluating data from Phase 1 and 2 of the clinical trials, Domingo said the panel approved Sinovac鈥檚 vaccine after only seeing 鈥渧ery mild鈥� side effects.
鈥淢eron pa po tayong mga datos na hinihingi sa kanila. Mga impormasyon tungkol sa produkto. 鈥榊un pong kanyang labelling halimbawa dahil gawa siya sa ibang bansa, may mga translation kaming hinihingi sa certificates,鈥� 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.)
鈥淒adaan po ito ngayon sa regulatory review at technical review dito sa FDA at sa ibang mga eksperto. Titignan po 鈥榶ung design ng mismong study at iyong bakuna, iyong produkto mismo kung wala tayong problema,鈥� 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: 鈥淣andiyan din po 鈥榶ung research ethics na review para masiguro na protektado ang safety ng clinical trial participants.鈥�
(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.
READ: Philippines eyes Sinovac trial as early as November 鈥� FDA