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Manila Bulletin devider Philippines devider National devider Moderna may apply for COVID-19 vaccine EUA in the coming weeks -- FDA

Moderna may apply for COVID-19 vaccine EUA in the coming weeks -- FDA

Published Feb 9, 2021 02:50 pm

Food and Drug Administration (FDA) Director General Eric Domingo said the American pharmaceutical Moderna will likely apply for an emergency use authorization (EUA) of its coronavirus disease (COVID-19) vaccine in the Philippines in the "next few weeks."

(Photo by Owen Humphreys / POOL / AFP / FILE PHOTO / MANILA BULLETIN)

"They already asked us questions and we've given them information on the process," Domingo said during the Laging Handa public briefing on Tuesday, Feb. 9.

"Maybe Novavax from the Serum Institute of India will follow," he added.

Domingo said the FDA is still waiting for Chinese Sinovac Biotech and Russian Gamaleya Research Institute to submit more documentary requirements before they could decide on their EUA applications.

"We are still requesting the applicant's copy of their official conditional approval in China for us to be able to review it. As of now they have yet to submit a document answering the questions of the experts," he said on Sinovac's application.

Domingo also explained that Gamaleya's Sputnik V vaccine's application status is quite the same as the Sinovac.

"Our regulators still have documents required just to prove good manufacturing practice to assure us of the quality of the product and its stability. This way we can make sure that the product will be in good condition when it arrives in the country. Hopefully they will be able to complete the requirements soon," he added.

Meanwhile, India's Barat Biotech until now has not submitted its clinical trial phase 3 result so we have not started evaluating that, he pointed out.

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