FDA to still review documents on new Sinovac data

Documents regarding new studies on the efficacy of Sinovac-developed vaccine against COVID-19 will still undergo evaluation of the Food and Drug Administration.

This followed the release of trial data by Sinovac showing that the vaccine is more effective if the second dose is administered not shorter than 21 days from the injection of the first dose.

Experts are also studying the adjustment in the number of doses to increase the level of protection the vaccine can provide against the virus.

“In any recommendations being given, it has to be forwarded to the Food and Drug Administration because the FDA is our National Regulatory Agency,” Health Undersecretary Maria Rosario Vergeire said.

“Sila ‘yung naglabas ng EUA kung saan doon po natin inanchor ‘yung ating mga guidelines for specific vaccines that are being used right now [The FDA issues EUA (emergency use authorization) where we anchor our guidelines for specific vaccines that are being used right now],” Vergeire added. 

FDA is still waiting for official documents from Sinovac before the conduct of evaluation. – Report from Mark Fetalco/AG-jlo#

 

 

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