Sinopharm calls off COVID-19 vaccine clinical trials in PH, Sinovac awaits ethics review

Kristine Sabillo, ABS-CBN News

Posted at Oct 16 2020 04:29 PM | Updated as of Oct 16 2020 05:23 PM

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MANILA — A Chinese pharmaceutical firm has backed out of initial plans to hold clinical trials for its COVID-19 vaccine in the Philippines, the Department of Science and Technology said Friday.

“Sinopharm, which is also in Phase 3, they updated us that they are now only interested in supplying vaccines not in the clinical trial anymore,” Science Secretary Fortunato de la Peña said during a virtual briefing.

De la Peña did not say why the state-owned Chinese firm changed its decision.

Sinopharm is among the 10 vaccine frontrunners that are already on Phase 3 clinical trials where testing is done to check the safety and efficacy of the vaccines on a larger population. Sinopharm has two vaccines in development.

De la Peña counted Sinopharm as among the 7 vaccine developers who already signed a confidential disclosure agreement (CDA) with the Philippines.

“Of the 17 biotech and pharmaceutical companies we have been in talks with, I said there are 6 who have signed their CDAs,” he said, referring to countries with existing science bilateral agreements with the Philippines.

Sinovac, another Chinese vaccine developer, is ahead of other research groups in its application for a clinical trial in the Philippines.

“Sinovac is the first one to submit all data that was required by the vaccine expert panel,” De la Peña said.

“Our vaccine expert panel has already reviewed and had a go-signal so that the only thing that they await is the ethics research board clearance before endorsing it to FDA (Food and Drug Administration) who will then make the final approval for the clinical trial,” he added.

He said that once Sinovac is approved by the FDA, the clinical trial will be undertaken by their partner local contract research organization (CRO). The government explained in the past that foreign vaccine developers would need to partner up with a local research organization that would help facilitate in the clinical trial.

“So we hope that they will be able or they have already selected a contract research organization,” De la Peña said of Sinovac.

Meanwhile, Russia’s Gamaleya Research Institute is still looking for a local contract research organization to assist them in the planned clinical trials.

The Science Secretary said they are also still waiting for additional data requested by the expert panel.

The other four companies that signed a CDA with the Philippines are companies from China, Australia and Taiwan.

“The other 4 are still in earlier phases of clinical trial and we are closely monitoring their progress,” De la Peña said.

The Belgium-based pharmaceutical company Janssen, owned by Johnson & Johnson, is also applying for clinical trials although its country does not have a bilateral agreement with the Philippines.

“They must complete the lacking data needed in order for the application to proceed for review by the vaccine expert panel and the ethics review board,” De la Peña said.

All of these companies are working on independent trials, which are not part of the World Health Organization’s multi-country Solidarity Trial.

De la Peña said the Philippine government won’t spend for these independent clinical trials.

The WHO, whose Solidarity Trial is estimated to start by the end of the month, still hasn’t released the list of vaccines that will be included in the study.