EMA Starts Rolling Review Of Glaxo - Sanofi COVID-19 Vaccine

EMA's human medicines committee has kicked off a rolling review of a COVID-19 vaccine from Sanofi SA SNY and GlaxoSmithKline plc GSK, which started a 35,000-patient Phase 3 trial in May.

• The vaccine dubbed Vidprevtyn is based on a recombinant protein antigen developed by Sanofi and includes an immune-boosting adjuvant developed by GSK to boost its efficacy.
• Although it is a late entrant into the EU's vaccination program, the shot is being studied in the original virus and beta variant, a critical addition to the current vaccine armamentarium. 
• 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, EMA said.
• Early-stage results showed that 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.
• Sanofi and GSK hope to get approvals by the end of 2021.
• Four more are under rolling review, including another adjuvanted recombinant protein vaccine from Novavax Inc NVAX, CureVac NV CVAC, Sinovac Biotech Ltd SVA, and Russia's adenoviral Sputnik V.
• Price Action: GSK shares are down 0.75% at $39.00, while SNY stock is up 0.36% at $51.35 during the market session on the last check Tuesday.
• Photo by hakan german from Pixabay