EU Drug Regulator Believes Sputnik V Vaccine Can Be Evaluated In 'Less Time Than Normal'
Sumaira FH Published March 04, 2021 | 02:40 PM
BRUSSELS (UrduPoint News / Sputnik - 04th March, 2021) The European Medicines Agency (EMA), which announced starting the rolling review procedure for Russia's Sputnik V coronavirus vaccine, said on Thursday it would likely be able to evaluate the application quicker than usual, but noted that the exact date of vaccine authorization could not be predicted.
"EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application. EMA will assess Sputnik V's compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review," the EU drug regulator said in a press release.
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