Observer Report London
Sanofi and GSK started enrollment in their Phase 3 clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate.
The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America.
The Phase 3 studyfollowsthe interim Phase 2 results which showed that the adjuvanted recombinant Covid-19 vaccine candidateachieved high rates of neutralizing antibodyresponses in all adult age groups, with 95 to100% seroconversion rates.
After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
Pending positive Phase 3 outcomes and regulatory reviews, the vaccine could be approved / authorized inQ4 2021.