China’s pharmaceutical company Sinovac Biotech has applied for an emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, the Food and Drug Administration (FDA) said.
“Yesterday afternoon, Sinovac from China submitted an application. They are undergoing pre-assessment now,” said FDA Director General Rolando Enrique Domingo.
Domingo said that the Chinese company still needs to submit more data about their vaccine. He said that Sinovac has so far submitted the results of their Phase 1 and Phase 2 clinical trials.
“We will have to ask for their Clinical Trial Phase 3 report, which I believe they are collating and consolidating. Until we see them, we cannot assess it fully as the EUA is anchored on the Phase 3 results,” said Domingo.
“We will have to wait for the Phase 3 clinical trial results because that would be the main part that we will be evaluating before actual evaluation starts,” he added.
Sinovac Biotech is the fourth vaccine developer that submitted an application for an EUA in the Philippines for COVID-19 vaccines.
Domingo said it is unsure if Sinovac can secure an approval by February as projected by vaccine czar Secretary Carlito Galvez. “It really depends on how quickly they submit the data that we want, and how convincing the data is,” Domingo said.
Meanwhile, Domingo said that they are still evaluating the applications of United Kingdom-based firm AstraZeneca and Russia’s Gamaleya Research Institute.
So far, American drug-maker Pfizer was the first to secure an EUA approval from the FDA.
“We have pending applications. AstraZeneca is in the middle of evaluation and the experts are waiting for some clarifications and we hope to finish that evaluation and make a decision within the 21 days (of processing) that was set,” he said.
“The early evaluation has started for Gamaleya, for the Sputnik V vaccine…There are still some pending documents and some requirements (needed),” he added.