Sanofi and GSK’s COVID-19 vaccine may be available this year

Sanofi and GlaxoSmithKline said today that their joint COVID-19 vaccine candidate may be available by the end of this year after positive mid-stage results.

The adjuvanted recombinant candidate achieved strong rates of neutralizing antibody responses — 95% to 100% seroconversion — in all adult age groups in a Phase 2 study, the two pharma compnanies said in a joint press release.

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The high antibody responses occurred across all doses, with acceptable tolerability and with no safety concerns. “Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old),” Sanofi and GSK said.

In addition, 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,” the companies said.

A global pivotal Phase 3 study is expected to start in the coming weeks.

Thomas Triomphe

“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,” said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur. “We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible.”

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Roger Connor, president of GSK Vaccines, said the pharma makers’ goal is to have the vaccine available before the end of the year. Sanofi has vaccine purchasing agreements in place with the U.S., the EU, Britain and Canada, and the World Health Organization-backed COVAX facility, Reuters reported.

The Phase 3 trial for the vaccine candidate is expected to enroll more than 35,000 adults 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.

In parallel, the companies 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.

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