China's Sinovac applies in PH for COVID-19 vaccine's emergency use

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Metro Manila (CNN Philippines, January 14) — Chinese company Sinovac Biotech has applied for emergency use authorization in the Philippines for its COVID-19 vaccine, Food and Drug Administration Director General Eric Domingo said on Thursday.

He said the firm applied on Wednesday, but submitted incomplete documents. Only the data from phases 1 and 2 of its clinical trial were sent to the FDA. Domingo said they need to dissect the data from phase 3 trials, which studies the vaccine's safety and efficacy on a large number of people.

"On quick glance, medyo kulang pa ang clinical data na pindala nila. We will have to ask them for the phase 3 which they may be collating now because several countries yata ginawa ito," he said in a media briefing.

[Translation: On quick glance, they sent incomplete clinical trial data. We will ask for the phase 3 data, which they may still be collating now since it was held in different countries.]

It normally takes the regulatory agency 21 days to review an application for vaccines that have received EUA from stringent regulatory authorities, but Domingo stressed that Sinovac does not have this yet.

"So far, I think Sinovac has EUA in their country (in China), in Argentina, and Indonesia, and these are not classified as stringent regulatory authorities, which means that we're going to just have to be a little more meticulous when we evaluate the actual submission when they are complete," Domingo told CNN Philippines’ The Final Word.

"Vaccines like Gamaleya and Sinovac do not have EUAs yet from stringent regulatory authorities. They have EUAs from their home country. So kapag ganito, we cannot promise 21 days," he said. 

The official said the FDA can only start the review once it receives the phase 3 findings since this data will show if the benefit of taking Sinovac's vaccine CoronaVac outweighs possible health risks.

"Kung hindi kumpleto, wala kaming ire-review lalo na kung substantial ang kailangan. In this case, phase 3 clinical trial results ang hinihintay natin and that would be the main meat of what will be evaluated," he said.

[Translation: If it's incomplete, there is nothing for us to review since phase 3 is the substantial part.]

Domingo on Thursday also said Sinovac’s clinical trials in the country "might start quite soon." Last month, the director general said they are just waiting for a few more documents from the company to ensure the quality of the vaccine under investigation before they begin the phase 3 trials.

Researchers in Brazil found CoronaVac to only be 50.38% effective in late-stage trials, significantly lower than earlier results showed. While the number exceeds the threshold required for regulatory approval, it falls far below the 78% previously announced, raising questions as to the veracity of the data, and fueling skepticism over the apparent lack of transparency regarding Chinese vaccines.

The Philippines has secured 25 million doses of CoronaVac. Vaccine czar Carlito Galvez Jr. is confident the EUA for the government's vaccine of choice will be ready before its first shipment of 50,000 doses arrives in the country on February 20.

The Duterte administration is being criticized by lawmakers for its seeming preference for Sinovac despite its cost and low efficacy rate in clinical trials compared to other vaccines.