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EU begins real-time review of Sanofi-GSK Covid-19 vaccine – Times of India


Europe’s drug regulator stated on Tuesday it had began a real-time review of the Covid-19 vaccine developed by French drugmaker Sanofi and Britain’s GlaxoSmithKline, the fifth shot presently beneath such a review.
The resolution to begin the “rolling review” of the vaccine, Vidprevtyn, was primarily based on preliminary outcomes from lab research and early-stage medical trials in adults, the European Medicines Agency (EMA).
Late-stage international trials for the protein-primarily based coronavirus vaccine candidate started in May.
Sanofi and GSK hope to get approvals by the tip of 2021 after early-stage outcomes confirmed the vaccine produces a sturdy immune response.
“EMA will assess the compliance of Vidprevtyn with the standard EU requirements for effectiveness, security and high quality,” the regulator stated, with out giving particulars on information it had obtained to this point and an anticipated timeline for approval.
EMA’s rolling critiques are aimed toward dashing up the approval course of by permitting researchers to submit findings in real-time earlier than closing trial information is on the market.
Sanofi stated different rolling critiques of its vaccine have been additionally about to begin in Britain, Canada and Singapore, in addition to with the World Health Organization.
Vidprevtyn makes use of the identical know-how as one of Sanofi’s seasonal influenza vaccines. It will likely be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.
Other Covid-19 vaccine candidates within the EU’s rolling review are these from CureVac, Novavax, Sinovac and Russia’s Sputnik V.



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