EU starts real-time review of Sanofi-GSK coronavirus jab

Sanofi-GSK hopes to get approvals by the end of this year after early-stage results showed the vaccine produces a robust immune response.

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.”

The agency’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.

Sanofi said other rolling reviews of its vaccine were also about to start in the UK, Canada, and Singapore, as well as with the World Health Organization.

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 four vaccines with EMA authorisation in the EU are Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson.

Unlike the mRNA vaccines like Pfizer and Moderna, which need to be stored at ultra-cold temperatures, the Sanofi jab can be kept closer to room temperature, potentially helping the rollout.

The jab would require two doses, like most other vaccines on the market.

Other COVID-19 vaccine candidates in the EU’s rolling review are those from CureVac, Novavax, Sinovac, and Russia’s Sputnik V.