China's Sinovac seeks FDA permit to test coronavirus vaccine in Philippines

MANILA— A COVID-19 vaccine candidate from China's Sinovac firm has passed a preliminary review by local experts and filed Thursday its application to hold clinical trials in the Philippines, the Food and Drug Administration said. 

The expert panel "endorsed positively" the Sinovac vaccine after reviewing its safety profile, effect, and study design, said FDA Director General Eric Domingo. 

Sinovac needs to submit additional information on the vaccine, its labeling details, and translation of related certificates. The FDA will then take 2 to 3 weeks to study these documents, he said. 

"Dadaan po ito ngayon sa regulatory review, at saka technical review dito po sa FDA at saka sa mga grupo rin po ng ating eksperto. Titingnan po iyong design ng study at iyong produkto po mismo, kung wala pong problema," Domingo said in a Laging Handa public briefing.

(It will now go through regulatory review and technical review here at the FDA and our groups of experts. We will look at the design study and the product itself, whether or not there is a problem.)

"And'yan din po iyong research ethics board na review to make sure na protektado po ang safety ng magiging clinical trial participants at lahat po ng sasali dito," he added.

(There is also a research ethics board review to make sure that the safety of clinical trial participants is protected.)

Phase 3 clinical trial requires "a few thousand" participants. Earlier phases found "nothing serious" in terms of side effects, said Domingo. 

The Philippines is one of China's "priority countries" for its vaccine distribution, said Manila's Ambassador to Beijing Chito Sta. Romana. Asked if China had any condition for this, he said: "Not at all." 

"Actually, we’re the ones, our condition is that it should pass our local requirements," he told reporters. 

Manila and Beijing are locked in a maritime dispute. 

China urges the Philippines to prepare cold storage facilities for the vaccine, said Sta. Romana. 

"These vaccines have to be stored in the conditions na freezing conditions. Otherwise if exposed to tropical weather or to normal weather conditions, the vaccine could lose its effectiveness," he said. 

The Philippine experts panel is also reviewing vaccine candidates Janssen, Russia’s Sputnik V, and those under the solidarity trial of the World Health Organization, he said. 

The Sinovac vaccine was tested by Sao Paulo state's research center Butantan Institute. It recently said the 2-dose vaccine called CoronaVac, proved to be safe in a trial so far involving 9,000 volunteers.

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It is the first set of results of Sinovac's Phase 3 global trials, which are also being conducted in Turkey and Indonesia.

Vaccines are considered essential to curb the rampaging virus, which has killed over 1 million people globally. 

Experts have warned that the safety of inactivated coronavirus vaccine candidates should be observed over longer periods, as some other inactivated vaccines had led to disease enhancement effect, where vaccine-triggered antibodies, instead of offering protection, could worsen infections when people became exposed to a virus after inoculation.

Sinovac, a Beijing-based company, said more than 10,000 people in Beijing had been injected with its vaccine. Separately, it said nearly all its employees — around 3,000 in total — and their families had taken it.

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— With a report from Reuters; The New York Times