• Sun. Oct 17th, 2021

Sputnik vaccine and Ema authorization, “decision soon”


May 12, 2021

“Four Covid vaccines are currently being evaluated in Europe: CureVac, Novavax, Sinovac and Sputnik” and “we hope to reach a decision soon”. For the Russian vaccine Sputnik “site inspections for good manufacturing practices have been held and are ongoing even now and we are also gathering more information to fill some gaps in the dossier. We should be able in the coming weeks to define a timetable for any approval “. The point was made by Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency EMA, during a meeting with the press to update on the activities of the EU body in the context of the pandemic. CureVac’s path is proceeding rapidly even if, Cavaleri specified, “a roadmap” for a possible go-ahead “has not yet been established and the main guide will be the results of the pivotal studies that are still in progress. we will have, it will be possible for us to define with the producer what the deadlines for a potential authorization could be. All this could be imminent and we hope to see good results “soon. “So – the expert summarized – it is a bit premature to define an exact timetable but we believe, if the results arrive quickly, we can be very fast”. As for Novavax, “as announced by the company itself we will discuss what can be done in terms of production” and this node “will be re-discussed around July to see exactly when this vaccine can be approved”, continued Cavaleri. Finally, for Sinovac “we have already started the rolling review and we are defining when some key elements of the dossier could be sent to us in order to know more precisely when this vaccine could be approved”.