Chinese vaccine maker seeks clinical trials in Phl

China’s candidate vaccine for COVID-19 has officially sought the approval of the Food Drug Administration ( FDA) for phase 3 clinical trials in the country.

FDA director general Eric Domingo said Sinovac Biotech Ltd. submitted yesterday its application to conduct clinical trials after the vaccine expert panel (VEP) of the Department of Science and Technology (DOST) gave its approval a week ago.

“Sinovac passed the screening of the vaccine experts panel and it applied today with the FDA. It will undergo regulatory evaluation while undergoing review of the Ethics Board,” Domingo disclosed during the Laging Handa public briefing yesterday.

During the Phase 1 and Phase 2 clinical trials, she said Sinovac showed only “mild side effects” and, thus, got the nod of the VEP.

Over a thousand Filipinos are expected to participate in the Phase 3 clinical trial upon getting the necessary approval of Philippine government agencies.

Domingo noted that the safety profile and the effects of the vaccine as well as the design for the study to be conducted prior to endorsement to the FDA have been assessed by the VEP.

The FDA would then require the Sinovac manufacturer to submit documents and certificates concerning the product for regulatory and technical review, he said.

Upon submission, the FDA will evaluate and, if there are no other problems, give the approval for the clinical trial within two to three weeks.

“We will make sure of the protection and safety of participants in the clinical trial,” Domingo said.

Also yesterday, Health Undersecretary Maria Rosario Vergeire said the Department of Health (DOH) is still awaiting the list of vaccines to be used in the World Health Organization (WHO) solidarity trial.

“Last I heard, they are considering three to four vaccines,” she said during a virtual briefing.

She also revealed that the recruitment of 100 patients for the Avigan clinical trial is still ongoing.

“Our target is just 100 patients spread across four selected hospitals here in Metro Manila. But even with the challenges, we are not going to reduce the number of patients,” she said, adding that the DOH has sought the assistance of medical directors to speed up recruitment of the required number of patients and hasten the start of clinical trial.

Although there was a proposal to expand the number of participating hospitals, Vergeire said this could only lead to a further delay in the start of the clinical trial.

She also noted that vaccine storage is not expected to be an issue since only limited vaccines will be brought in for clinical trial.

But Philippine Ambassador to China Jose Sta. Romana said that while China has not set conditions for providing the Philippines access to COVID-19 vaccines, it cited the need for storage facilities to address the challenges related to vaccine distribution.

“Distribution will be a challenge, even if we are in the priority list. One, because the Chinese companies we have been in contact with would have said that we need or the recipient countries should make sure that they have the capability for receiving the vaccine. Cold chain storage is needed,” he said at a press briefing.

“These vaccines have to be stored in the freezing conditions. Otherwise if exposed to tropical weather or to normal weather conditions, the vaccine could lose its effectiveness... From our discussions with the Chinese pharmaceutical companies, they have pointed out that the next challenge really is the distribution and deployment of the vaccine,” he added.

Sta. Romana, however, clarified that the recommendation to come up with storage facilities is not a precondition for access. “No, not at all. Actually, we’re the ones, our condition is that it should pass our local requirements.”

“It’s not a condition. It’s just a reminder that if you get the vaccine and you don’t have cold chain storage, then it’s useless. So you have to prepare. Basically it calls our attention to the need for the preparatory work to receive the vaccine on a priority basis and the requirement for it to be effective, storage is a major issue,” he said.

He expressed hope that the mass production and distribution of the vaccines would happen as early as November or December, noting the possibility that one or two vaccines would be approved in China soon.

Once approved, the vaccines have to secure clearance from the Philippine Food and Drug Administration, and the science and health departments.

“So, the prospects are bright in terms of a breakthrough in vaccine,” Sta. Romana said. “(China) will make an announcement in the near future and then they’ll start their mass production. And once there is the mass production, then I think there will be distribution. Hopefully, before the end of the year; but surely by the first quarter of next year.”

Sta. Romana said three to four vaccines are now undergoing clinical trials in China, with one about to complete Phase 3 with “fairly good” results.