The FDA was eyeing to issue a decision on EUA application of the AstraZeneca vaccine this week.
Food and Drug Administration (FDA) Director-General Eric Domingo on Monday said that the FDA was eyeing to issue a decision on the emergency use authorization (EUA) application of AstraZeneca for its COVID-19 vaccine by this week.
In an interview on ABS-CBN News Channel, Domingo said that the FDA had some questions for Astrazeneca and the vaccine manufacturer finally sent their replies on the evening of Friday.
“Our evaluators are gonna start looking through that again and hopefully come up with a decision soon,” Domingo said.
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The majority of local government units (LGUs) that already secured COVID-19 vaccines for their constituents signed a tripartite agreement with AstraZeneca and the national government.
According to Domingo, the FDA was still asking for additional information on the COVID-19 vaccine developed by Russia’s Gamaleya Institute, while China’s Sinovac only submitted its human clinical trials data last week.
Domingo also said that India’s Bharat Biotechnology has not given their phase 3 human clinical trial results so they can’t start evaluating until they received the information.
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“So that’s at least another two weeks before we even finish evaluating that or even asking them (Sinovac) more questions. Yung Bharat Biotechnology from India has not given their clinical trial phase 3 results so we cannot start evaluating until we get that information,” Domingo said.
As of this writing, only Pfizer had secured the FDA clearance for its COVID-19 vaccine’s emergency use in the Philippines so far.
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