- Sanofi SA SNY and GlaxoSmithKline plc GSK have launched a Phase 3 trial for its recombinant COVID-19 vaccine candidate, which they hope to get approved by the end of 2021.
- The study is one of the first late-stage trials that combine tests for boosters and variants as the companies adapt their strategies to deal with an evolving coronavirus.
- Earlier this month, the companies reported positive interim results from the Phase 2 study showing "strong immune responses" in early tests of their COVID-19 vaccine.
- "In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus, while a second stage will evaluate a second formulation targeting the B.1.351 virus," Sanofi said.
- The virus lineage known as B.1.351 was first detected in South Africa.
- "Recent scientific evidence shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants," Sanofi said.
- Sanofi also confirmed it would begin clinical studies in the coming weeks to assess the vaccine's efficacy as a booster, regardless of what vaccine a subject may have received first.
- Pending a positive Phase 3 outcome, the vaccine could be approved in the fourth quarter of 2021.
- Sanofi and GSK were forced to restart their trial in December when the vaccine showed a low immune response in older adults due to a weak antigen formulation.
- Price Action: SNY shares are down 0.37% at $53.71, and GSK stock is down 0.57% at $38.49 during the premarket session on the last check Thursday.
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