French pharmaceutical company Sanofi reported positive results from a clinical trial of its main coronavirus vaccine candidate, developed with the UK’S healthcare company GSK, on Monday.
The announcement that the vaccine demonstrated strong immune responses across all adult age groups in Phase 2 trial follows several months of delay caused by a setback in the immune responses observed in older adults participating in the clinical trials.
“Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed,” Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said in a press release.
The Phase 2 study, in which 722 volunteers were given the vaccine candidate, showed a 95% to 100% efficacy rate following a second injection with “acceptable tolerability and with no safety concerns.”
After a single injection, high neutralising antibody levels were generated in participants with evidence of prior infection, which suggests the vaccine could have a strong potential for development as a booster vaccine, the companies said.
A global Phase 3, randomised, double-blind study will be initiated in the coming weeks, and is expected to enroll more than 35,000 adult participants from a broad range of countries.
The companies will also conduct booster studies with various variant formulations to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine people have received.
The GSK-Sanofi coronavirus vaccine is not expected to be ready before late 2021, depending on whether the Phase 3 outcomes are positive.