Sinovac vaccine 'a few more documents' away from PH clinical trials – FDA

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Metro Manila (CNN Philippines, December 8) — The Chinese company Sinovac is close to holding COVID-19 vaccine clinical trials in the country after weeks of delay, the Food and Drug Administration said.

“We’re just waiting for a few more documents just to assure the quality of the vaccine under investigation that will be used,” FDA Director General Eric Domingo told CNN Philippines’ Front and Center on Tuesday.

He did not specify which documents were lacking but said the shortcoming was also the reason why the review period has dragged on.

It should only take from two to three weeks, Domingo said, but it has been nearly seven weeks since the FDA received Sinovac's application. It was the first to reach the FDA after passing the Department of Science and Technology's vaccine experts panel, which scrutinizes the results of a candidate vaccine's Phase 1 and 2 clinical trials.

Aside from Sinovac, the regulatory agency is currently evaluating the applications of Belgium’s Janssen, China’s Clover, and United Kingdom’s AstraZeneca. All are hoping to conduct Phase 3 clinical trials in the Philippines –- the critical stage where thousands of patients have to be inoculated with the potential vaccine ahead of mass rollout.

The government expects at least three Phase 3 trials to begin in January 2021, along with the World Health Organization’s Solidarity Trial.

“Hopefully it will be done fast over a period of two to three months and we have immediately information on which of these vaccines are truly safe and effective,” Jaime Montoya, executive director of DOST’s Council for Health Research and Development, said of the WHO-led vaccine trials.

A Social Weather Stations survey in November showed that only 66% of Filipinos are willing to be vaccinated amid safety concerns. Domingo is urging the public to look at the advantages of being immunized.

“So far, none of the vaccine candidates have shown severe adverse events,” Domingo said.

“The advantages far outweigh the risks and you’re going to get full information and we will need to secure your full informed consent before you allow yourself to be vaccinated,” the FDA chief assured.

Emergency use authorization

The FDA does not only give the go signal for the clinical trials, it has also been given the power by President Rodrigo Duterte to authorize the emergency use of COVID-19 drugs and vaccines.

“Things are going much faster than we anticipated,” Domingo said, referring to UK’s emergency use approval of the vaccine being developed by US drugmaker Pfizer and its German partner BioNTech. The US is expected to give the same authorization to Pfizer and Moderna, which may then apply for emergency use in the Philippines.

Domingo said COVID-19 vaccines may be available in the country by March 2021 should an emergency use authorization be granted in January. Montoya agrees with this timeline, adding that another “safe estimate” would be by the early part of the second quarter.

READ: COVID-19 vaccine emergency approval likely in January, arrival in PH possible by March 2021

The government is looking at vaccinating at least 60 million Filipinos in the next three to five years. It has so far secured only 2.6 million doses of AstraZeneca’s COVID-19 vaccines through a private sector donation, but said it is willing to spend more than ₱73 billion for the immunization program.

At least 20 million people may be inoculated next year, with healthcare workers, frontliners from government agencies, poor families, and vulnerable sectors to be given priority, officials said.

Catch the full interviews on CNN Philippines’ “Front and Center” on Wednesday, December 9, 7 p.m.