The FDA “does not have any authority” to release clinical trial data of China’s Sinovac COVID-19 vaccine, according to DOH.
The Food and Drug Administration (FDA) didn’t have any authority to release clinical trial data of China’s Sinovac COVID-19 vaccine, according to the Department of Health (DOH).
In a report on Manila Bulletin, the Department of Health on Tuesday said that the Food and Drug Administration wasn’t authorized to release the clinical trial data of China’s Sinovac vaccine.
Health Undersecretary Maria Rosario Vergeire said in a press briefing that only China’s Sinovac Biotech can release their own clinical trial data with regards to their COVID-19 vaccine.
In addition, Vergeire said that regulatory authorities were bound not to share the documents submitted to them, adding that vaccine manufacturers — including Sinovac — have the right to publish their data or not.
“The Food and Drug Administration does not have any authority at all to publish data that are not theirs. These data that has been submitted to them was a requirement submitted by the manufacturers. The FDA does not own these data. Ang ating regulatory authorities bounded sila na kailangan ang mga dokumentong sina-submit sa kanila ay hindi nila naishe-share kahit kailan. Manufacturers have that right. The Sinovac manufacturers ang may karapatan pong mag-publish o hindi mag-publish, nasa kanila po yung ball na iyan,” Vergeire said.
Before recommending the use of China’s Sinovac COVID-19 vaccine to medical frontliners, Vergeire said that the local health experts were able to study the unpublished clinical data of the said vaccine.
Meanwhile, Health Secretary Francisco Duque III said in an interview on ABS-CBN News Channel that the Health Technology Assessment Council (HTAC) was already reviewing China’s Sinovac COVID-19 vaccine.
Duque also said that the HTAC evaluation was being conducted for the procurement of Sinovac COVID-19 vaccines. Also, Duque said that the HTAC review wasn’t a prerequisite on the use of the initial Sinovac COVID-19 vaccine doses since these were donations from China.
“As we speak, the HTAC is now doing an evaluation of Sinovac already. We belatedly received the trial data of Sinovac just last week and the FDA immediately submitted it to HTAC. We expect that by about mid to third week of March, we will be able to see the procured one million doses of Sinovac,” Duque said.