EU Begins Real-Time Review of Sanofi-GSK COVID-19 Vaccine

By Reuters Staff

July 22, 2021

(Reuters) - 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 Britain's GlaxoSmithKline, the fifth shot under such a review currently.

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 https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn.

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, without giving details on data it had received so far and 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, a recombinant protein manufactured in insect cells, as one of Sanofi's seasonal influenza vaccines. It will be coupled with an adjuvant made by GSK that has also been used in previous licensed flu vaccines.

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

Click https://tmsnrt.rs/3zarDeI for a Reuters graphic https://tmsnrt.rs/3c7R3Bl on vaccines in development.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....