Russia’s Gamaleya Research Institute of Epidemiology has applied for emergency use authorization for its coronavirus vaccine in the Philippines, according to the local Food and Drug Administration (FDA).
The regulator, which got the application on Jan. 7, had ordered the drugmaker to submit missing documents, FDA Director-General Eric Domingo said on Friday.
Gamaleya withdrew its application for clinical trials of its vaccine on Jan. 6, the Department of Science and Technology (DoST) said.
“Their reason was simple — they would apply for emergency use authorization so they don’t need the clinical trials here,” Science and Technology Undersecretary Rowena Guevarra told an online news briefing.
US drugmaker Pfizer, Inc. and Britain’s AstraZeneca Plc have also filed for emergency use with the FDA.
The three already have existing emergency use approvals in other countries.
Meanwhile, the DoST said China National Pharmaceutical Group Co., Ltd. (Sinopharm) had yet to decide whether to pursue clinical trials for its coronavirus vaccine in the Philippines.
“Sinopharm has yet to decide if it will conduct a clinical trial here or just apply for an emergency use authorization,” DoST Assistant Secretary Leah J. Buenda told a televised public briefing in mixed English and Filipino.
Ms. Buendia said the agency had signed a confidentiality disclosure agreement with Sinopharm even if it had not yet received any data from the Chinese drugmaker. — Vann Marlo M. Villegas and Kyle Aristophere T. Atienza
