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| Russia's Gamaleya's vaccine. (Photo from Malay Mail) |
[Asia News Communication = Reporter Reakkana] Russia’s Gamaleya Research Institute has applied to the Philippine health regulator for emergency use authorization of its COVID-19 vaccine but needs to file further documentation, the regulator said late Friday. Gamaleya’s emergency use application is the third the Food and Drug Administration (FDA) has received after Pfizer and AstraZeneca both made similar applications.
“The submission was reassessed and the applicant was instructed to comply with the lacking documents,” FDA Director-General Rolando Enrique Domingo said in a statement. The agency also approved on Friday the application of China’s Clover Biopharmaceuticals to conduct late-stage clinical trials, he added.
Clover is the second Chinese developer to apply for Phase III clinical trials in the Philippines following Sinovac Biotech. In December, the FDA allowed a clinical trial for the COVID-19 vaccine of Johnson & Johnson’s unit Janssen. The Philippines has the second-highest number of coronavirus cases and deaths in Southeast Asia, after Indonesia.
