Sanofi eyes approval of COVID-19 vaccine by first half of 2021

Sanofi eyes approval of COVID-19 vaccine by first half of 2021

A researcher works in Sanofi's industrial development laboratory
A researcher works in an industrial development laboratory at the French drugmaker's vaccine unit Sanofi Pasteur plant in Marcy-l'Etoile, near Lyon, on Jun 16, 2020 (Photo: GONZALO FUENTES / POOL / AFP)

PARIS: French drugmaker Sanofi said on Tuesday (Jun 23) it expects to get approval for the potential COVID-19 vaccine it is developing with Britain's GlaxoSmithKline 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 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, when asked about the accelerated time frame.

There are currently no vaccines to prevent the coronavirus that has infected more than 9 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.

READ: First results of COVID-19 vaccine trial in Germany expected in two months

READ: WHO eyes hundreds of millions of COVID-19 vaccine doses before 2021

Many drugmakers have embarked in a race to come up with a safe and effective vaccine that can be produced at large scale.

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 securing victory.

"There are companies moving faster, but let us be brutally clear, speed has three downsides," he said of the competition.

"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," Hudson said.

The probability of success for Sanofi is "higher than anybody else," the CEO said.

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

READ: GSK in quest to be best, not first, in race for COVID-19 vaccine

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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 (BARDA).

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.

Sanofi said it had the capacity to produce up to 1 billion doses a year of its recombinant vaccine, and that it would be able to supply up to 360 million doses of its mRNA vaccine annually.

In April, Sanofi said it had manufacturing capacity for 600 million doses for its recombinant vaccine, with the ambition to double production by mid-2021.

Source: Reuters/ga

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