Decision on AstraZeneca’s EUA application for Covid-19 vaccine expected this week
Vials with a sticker reading, “COVID-19 / Coronavirus vaccine / Injection only” and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo
MANILA, Philippines — 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.
Food and Drug Administration Director General Eric Domingo (Consuelo Marquez, INQUIRER.net FILE PHOTO)
Most local government units that already secured vaccines for their constituents signed a tripartite deal with AstraZeneca and the national government.
LIST: More LGUs, private firms ink deals for supply of AstraZeneca vaccine
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.
