GlaxoSmithKline (GSK) - Get GSK plc American Depositary Shares (Each representing two) Report and France's Sanofi SA (SNY) - Get Sanofi Report said Monday that they will start a new trial of their protein-based coronavirus vaccine this month and hope to have it ready for distribution by the end of the year.
The re-start follows a failed trial in December and would involve around 720 adults in the U.S. and central America. The vaccine candidate, a combination of the technology used in Sanofi's annual flu shot and a booster developed by GlaxoSmithKline, could be ready by the fourth quarter if phase 2 and phase 3 trials are successful, the companies said.
If approved, GlaxoSmithKline and Sanofi would add to a global vaccine market currently dominated by Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Report Moderna (MRNA) - Get Moderna Inc. Report and AstraZeneca (AZN) - Get AstraZeneca PLC Report, the three internationally-approved candidates currently being distributed in Europe. In the United States, only Pfizer and Moderna have received Emergency Use Authorization from the Food & Drug Administration, with a public hearing for Johnson & Johnson's (JNJ) - Get Johnson & Johnson Report single-dose treatment set for February 26.
"Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study." said Thomas Triomphe, executive vice president at Sanofi Pasteur. "We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data."
"This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages," he added. "We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile."
GlaxoSmithKline shares were marked 0.6% higher in late-morning trading in London, while Sanofi's U.S.-listed shares slipped 0.45% lower in pre-market trading on the Nasdaq.
U.S. coronavirus cases have fallen 14% from a week ago, according to data from John's Hopkins University, to around 56,000. That compares to a daily vaccination rate of around 1 million, based on data from the Centers for Disease Control, with around 44 million Americans having received at least one dose of either the Pfizer or Moderna shot.