MANILA, Philippines, January 25 ------ The Food and Drug Administration is eyeing to issue a decision on the emergency use authorization (EUA) application of British drugmaker AstraZeneca for its Covid-19 vaccine by this week, FDA director general Eric Domingo said Monday.
“For AstraZeneca, I hope we can come up with the decision this week,” Domingo said in an interview on ABS-CBN News Channel. “We had some questions for them and they finally sent their replies on the evening of Friday. So our evaluators are gonna start looking through that again and hopefully come up with a decision soon,” he added.
Most local government units that already secured vaccines for their constituents signed a tripartite deal with AstraZeneca and the national government. Domingo said the FDA is still asking for additional information on the vaccine developed by the Gamaleya Institute of Russia while China’s Sinovac only submitted its clinical trials data last week.
“So that’s at least another two weeks before we even finish evaluating that or even asking them (Sinovac) more questions,” Domingo said. “Yung Bharat Biotechnology from India has not given their clinical trial phase 3 results so we cannot start evaluating until we get that information,” he added. Only US pharmaceutical giant Pfizer has so far secured the FDA clearance for its vaccine’s emergency use in the Philippines.
Source: newsinfo.inquirer.net