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The Philippines has approved Russia’s Sputnik V COVID-19 vaccine for emergency use, the country’s Food and Drug Administration (FDA) said on March 19.

Sputnik V, developed by Russia’s Gamaleya Institute, is the fourth vaccine to get emergency use authorization in the Philippines, which aims to use it to battle a renewed surge in infections.

“The known and potential benefits of the Gamaleya Sputnik V vaccine…outweigh the known and potential risks of said vaccine,” FDA chief Rolando Enrique Domingo told a news conference.

The Philippines, which has the second-highest number of COVID-19 cases and deaths in Southeast Asia, plans to roll out 140.5 million vaccines by December.

He said interim data showed the two-dose Sputnik V vaccine had an efficacy of 91.6 percent in age groups 18 and older.

Last week, a senior official with the European Medicines Agency (EMA) warned European Union members to hold off from giving national authorization for Sputnik V until the agency finishes its safety review.

The official said Sputnik V could be on the market in the EU when the appropriate data have been reviewed.