The European Medicines Agency announced on Tuesday that it had started a “continuous review” of the French vaccine against the Sanofi coronavirus, which could lead to an authorization for use in the European Union.
“The EMA will assess Vidprevtyn’s compliance with usual EU standards for efficacy, safety and quality,” the agency said.
Sanofi’s drug, developed with British company GSK, joins four others on the EMA’s review list, including Russian Sputnik V and Chinese Sinovac.
Unlike mRNA vaccines, which must be stored at ultra-cold temperatures, Sanofi vaccine can be stored closer to room temperature, which can potentially facilitate deployment.
The jab would require two doses, like most other vaccines on the market.
It combines an antigen developed by Sanofi, which stimulates the production of germ-killing antibodies, with adjuvant technology from GSK, a substance that enhances the immune response triggered by a vaccine.
Sanofi and GSK announced in May that they would launch the latest trials after finding that their drug “achieved high rates of neutralizing antibody responses” in phase 2 clinical trials.
The EMA said its decision to start the review was based on preliminary results that “suggest the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against disease ”.
“The EMA will assess the data as it becomes available to decide whether the benefits outweigh the risks,” the agency said, adding that it could not give a timeline for the review. .
The four vaccines authorized by the EMA in the EU are Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.
© 2021 AFP
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