Duque says Sinovac vaccine already undergoing HTAC review but expert says no need for it

The coronavirus vaccine developed by Chinese firm Sinovac Biotech is already undergoing review by the Health Technology Assessment Council (HTAC), Health Secretary Francisco Duque III said Tuesday.

Duque said the Food and Drug Administration (FDA) submitted the needed documents to the HTAC last week.

The HTAC is an independent advisory body tasked to guide the Department of Health and the Philippine Health Insurance Corporation.

“As we speak, they’re already doing it. Ang problema lang, nahuli kasi naming natanggap ‘yung mga trial data from Sinovac,” he said in an interview on ANC.

“The HTAC is also doing an evaluation already of the Sinovac because we will also procure. In fact, what we expect is about mid- to third week of March we would be able to see the procured one million doses of Sinovac,” he added.

The government plans to purchase one million Sinovac doses this month to augment the 600,000 doses donated by the Chinese government.

Doctors from the Philippine General Hospital as well as Vice President Leni Robredo earlier called for an HTAC review of the Sinovac jab to ensure “informed decision-making.”

Duque maintained that the law does not mandate an HTAC evaluation for donated vaccines.

“In the first place, the safety efficacy evaluation is the mandate of the FDA. So the 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 suffices,” he said.

The HTAC has already cleared the Pfizer-BioNTech and AstraZeneca vaccines, millions of doses of which will be donated to the Philippines by the COVID-19 Vaccines Global Access Facility.

“The difference is AstraZeneca and Pfizer had submitted their trial data much earlier and these trial data were published in journals so there was time for HTAC to do it,” Duque said.

Dr. Ernesto Domingo, a Ramon Magsaysay Awardee and a professor at the University of the Philippines College of Medicine, for his part, said that the Sinovac vaccine does not need an HTAC appraisal before it could be given to healthcare workers in accordance with the Universal Healthcare Law.

"No, my answer is you don't need the HTAC to go over this for the vaccine to be given. So I agree, the rollout, it should continue," said  at a Palace briefing.

"It's all there. We know what it is supposed to do, what it can do, what we have to be aware of," Domingo added, saying other international bodies, including the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC) in Atlanta and the National Institutes of Health (NIH), have given their approval for Sinovac.

"When it comes to our place, our own FDA (Food and Drug Administration) said 'Yes you can use it.' I don't see any reason why it should be subjected to HTAC discussion," Domingo said.

Domingo was awarded the Ramon Magsaysay Award for his work on vaccinating babies against Hepatitis B and almost eliminating the chance of their getting infected.

The Philippines began its COVID-19 vaccination program with the rollout of 600,000 Sinovac doses on Monday.

The delivery of Pfizer-BioNTech and AstraZeneca vaccines, meanwhile, has been delayed by logistical bottlenecks. -Julia Mari Ornedo and Jamil Santos/MDM, GMA News