Sanofi and GSK start Covid vaccine 'rolling review'

French and British drugmakers hope to gain approval for Vidprevtyn by end of year

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Europe's drug regulator said on Tuesday it had started a real-time review of Vidprevtyn, the Covid-19 vaccine developed by French drugmaker Sanofi and Britain's GlaxoSmithKline, which showed promising results in trials in May.

The decision to start the "rolling review" of the vaccine was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said. It is the fifth shot under such a review currently.

Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.

Sanofi and GSK hope to gain 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. It did not give details of data it had received so far or an expected timeline for approval.

EMA's rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real time before final trial data is available.

Vidprevtyn uses the same technology as one of Sanofi's seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

The Covid-19 vaccine candidates in EU's rolling review

  • Vidprevtyn
  • CureVac
  • Novavax
  • Sinovac
  • Sputnik V
Updated: July 20th 2021, 5:10 PM
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