The Food and Drug Administration (FDA) is not authorized to release the clinical trial data of Sinovac vaccine, the Department of Health (DOH) said on Tuesday, March 2.
DOH Undersecretary Maria Rosario Vergeire said that only Sinovac Biotech can release their own data with regards to their coronavirus disease (COVID-19) vaccine.
“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,” said Vergeire in a press briefing.
“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 (Our regulatory authorities are bound not to share the documents submitted to them. Manufacturers have that right. The Sinovac manufacturers have the right to publish or not (their data). They have that ball),” she added.
Before recommending the use of the Sinovac vaccine to medical front liners, Vergeire said that the local health experts were able to study the unpublished clinical data of the China-made vaccine.
Meanwhile, DOH Secretary Francisco Duque III said that the Health Technology Assessment Council (HTAC) is already reviewing the Sinovac vaccine.
“As we speak, the HTAC is now doing an evaluation of Sinovac already,” said the Health chief in an interview on ABS-CBN News Channel.
“We belatedly received the trial data of Sinovac just last week and the FDA immediately submitted it to HTAC,” he added.
Duque said that the HTAC evaluation is being conducted for the procurement of Sinovac vaccines. “We expect that by about mid to third week of March, we will be able to see the procured one million doses of Sinovac,” he said.
The Health chief said that the HTAC review is not a prerequisite on the use of the initial doses of Sinovac vaccines since these are donations from China.
“Ideally you would want that but this is needed when the vaccines are to be procured by the government. But for donated vaccines, nothing in the law or provisions of the Universal Health Care law dictates that this should undergo HTAC because in the first place, the safety and efficacy evaluation is the mandate of the Food and Drug Administration,” said Duque.
“HTAC is really an economic tool to evaluate the cost-effectiveness of the vaccines but because this is not to be procured, the FDA evaluation of risk benefit analysis sufficed,” he added.
The HTAC is an independent body, in accordance to the UHC law, that will guide the DOH and PhilHealth “for the development of policies and programs, regulation, and the determination of a range of entitlements such as drugs, medicines, pharmaceutical products, other devices, procedures and services.”