Europe’s drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi and the UK’s GlaxoSmithKline, the fifth shot currently under such a review.
The decision to start the “rolling review” of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said.
Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.
Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.
“EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality,” the regulator said in a statement, without giving details on data it had received so far and an expected timeline for approval.
“EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.”
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