French drug maker Sanofi (SNY) and GlaxoSmithKline PLC (GSK.L,GSK) announced Monday that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in Phase 2 trial.
The COVID-19 vaccine candidate 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. A global Phase 3 study is expected to start in the coming weeks.
The companies noted that the Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups, from 18 to 95 years old, and across all doses, with acceptable tolerability and with no safety concerns.
After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said, “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, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases. With these favorable results, we are set to progress to a global Phase 3 efficacy study.”
Based on these positive Phase 2 interim results, the companies plan to initiate a global Phase 3, randomized, double-blind study with the 10µg dose, in combination with GSK’s pandemic adjuvant, in the coming weeks.
The Phase 3 trial is expected to enroll more than 35,000 adult participants from a broad range of countries and will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 (South African) variants.
The companies also intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine platform received.
The companies noted that the vaccine is expected to be approved in the fourth quarter of 2021 pending positive Phase 3 outcomes and regulatory reviews.
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