Sanofi-GSK's COVID-19 Vaccine Candidate Reports Success In Mid-Stage Study
Sanofi SA (NASDAQ: SNY) and its collaborating partner GlaxoSmithKline plc (NYSE: GSK) have reported "strong immune responses" in early tests of their COVID-19 vaccine, raising hopes it could join the fight against the pandemic.
The firms are combining a Sanofi-developed antigen, which stimulates the production of germ-killing antibodies, with GSK's adjuvant technology, a substance that bolsters the immune response triggered by a vaccine.
The experimental vaccine "achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers," it said in a statement.
"A global pivotal Phase 3 study is expected to start in the coming weeks."
The Phase 2 interim results showed 95% to 100% seroconversion following the second injection in all age groups (18 to 95 years old) across all doses, with acceptable tolerability and no safety concerns.
A single dose generated high neutralizing antibody levels in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
The company plans to initiate a global Phase 3 study with the 10µg dose in more than 35,000 adult participants.
It will assess the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South African) variants.
In parallel, the companies intend to conduct booster studies with various variant formulations to assess if a lower vaccine dose generates a strong booster response regardless of the initial vaccine platform received.
The vaccine's approval is expected in the fourth quarter of 2021, subject to regulations and Phase 3 outcome.
Price Action: GSK shares are down 0.15% at $39.02, and SNY shares are up 0.42% are at $52.96 during the premarket session on the last check Monday.
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