EU Launches Real-Time Review of Sanofi-GSK Coronavirus Vaccine

EU Launches Real-Time Review of Sanofi-GSK Coronavirus Vaccine

The European medicines regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drug maker Sanofi and Britain’s GlaxoSmithKline, the fifth shot currently under such scrutiny.
The decision to launch the ‘continuous review’ of the vaccine, Vidprevtyn, was based on preliminary results from early-stage laboratory studies and clinical trials in adults, said the European Medicines Agency (EMA) .

Global advanced trials for the protein-based coronavirus vaccine candidate began in May.

Sanofi and GSK hope to get the approvals by the end of 2021 after initial results show the vaccine produces a robust immune response.

“The EMA will assess Vidprevtyn’s compliance with usual EU standards for efficacy, safety and quality,” the regulator said in a statement, without giving details of the data it had received. so far nor on the schedule for approval.

“The EMA will communicate further when the marketing authorization application for the vaccine has been submitted. “

The agency’s ongoing reviews aim to speed up the approval process by allowing researchers to submit their results in real time before final trial data becomes available.

Sanofi said further ongoing reviews of its vaccine were also about to begin 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 shot booster, manufactured by GSK.

The four vaccines authorized by the EMA in the EU are Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.

Unlike mRNA vaccines such as Pfizer and Moderna, which must be stored at ultra-cold temperatures, the Sanofi jab can be stored closer to room temperature, which can potentially aid deployment.

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

The other COVID-19 vaccine candidates in the EU’s continuing review are those from CureVac, Novavax, Sinovac and Russian Sputnik V.


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