Sanofi eyes vaccine approval by first half of 2021

French drugmaker Sanofi SA said it expects to get approval for the potential Covid-19 vaccine it is developing with Britain’s GlaxoSmithKline Plc (GSK) by the first half of next year, faster than previously anticipated.

Sanofi, which is hosting a virtual research and development event, and GSK had said in April that the vaccine, if successful, would be available in the second half of 2021.

“We are being guided by our dialogue with regulatory authorities,” Sanofi research chief John Reed told reporters yesterday when asked about the accelerated timeframe.

There are currently no vaccines to prevent the coronavirus that has infected more than nine million people and killed over 469,000 globally, and only a couple of medicines that have demonstrated benefit in hospitalised Covid-19 patients in clinical trials.

Many drugmakers are racing to come up with a safe and effective vaccine that can be large-scale produced. Moderna Inc, the University of Oxford in collaboration with AstraZeneca Plc, and an alliance of BioNTech and Pfizer Inc grabbed headlines by moving to human trials as early as March.

Sanofi chief executive Paul Hudson said the firsts in the race now were not assured of victory.

“There are companies moving faster, but let us be brutally clear, speed has three downsides,” he said.

“They are using existing work, in many cases done for SARS; it is likely not to be as efficacious; and there is no guarantee on supply in large volumes.”

The probability of success for Sanofi was “higher than anybody else”, Hudson said.

The comments echoed those of GSK, whose chief medical officer for vaccines said on Friday that the company was aiming for quality before speed.

Sanofi, whose Pasteur vaccines division has a long-established reputation, notably in flu, is currently working on two vaccine projects.

One uses an adjuvant made by GSK to potentially boost its efficacy. It has received financial support from the US Biomedical Advanced Research and Development Authority.

The other, being developed with US company Translate Bio Inc, relies on a different technology known as mRNA, similar to the Moderna approach.

Clinical trials of the vaccine developed with GSK, described as a recombinant vaccine because of the use of GSK’s boosting adjuvant, are to start in September. Trials of the mRNA vaccine candidate should begin around the end of the year, the company said.