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

By Matthias Blamont
PARIS (Reuters) - French drug maker Sanofi SA announced on Tuesday that approval for the potential COVID-19 vaccine it is developing with GlaxoSmithKline Plc in the UK will be received faster than expected in the first half of next year.
Sanofi, which is hosting a virtual research and development event, and GSK announced in April that if successful, the vaccine would be available in the second half of 2021.
"We are guided by our dialogue with regulators," Sanofi research chief John Reed told reporters when asked about the accelerated time frame.
There are currently no vaccines against the coronavirus that infected more than 9 million people and killed over 469,000 people worldwide, and only a few drugs that have shown benefits in clinical trials in COVID-19 patients in hospital.
Many drug manufacturers are striving for a safe and effective vaccine that can be manufactured on a large scale.
Moderna Inc, Oxford University in partnership with AstraZeneca Plc, and an alliance between BioNTech and Pfizer Inc made headlines in March when they switched to human studies.
Paul Hudson, Sanofi's chief executive, said the first few races were unsure whether they could win.
"There are companies that move faster, but let's be brutally clear, speed has three disadvantages," he said of the competition.
"They take advantage of existing work, which in many cases is done for SARS. They are probably not as effective. There is no guarantee that they will be delivered in large quantities," said Hudson.
The probability of success for Sanofi is "higher than for everyone else," said the CEO.
The comments were in line with those of GSK, whose chief vaccine doctor told Reuters on Friday that the company was striving for quality over speed.
Sanofi, whose Pasteur vaccine department has long had a good reputation, especially for flu, is currently working on two vaccine projects.
An adjuvant manufactured by GSK is used to potentially increase its effectiveness. It has received financial support from the U.S. Biomedical Advanced Research and Development Authority (BARDA).
The other, developed with the U.S. company Translate Bio Inc, is based on another technology known as mRNA, which is similar to the Moderna approach.
Clinical trials with the GSK-developed vaccine, which is known as a recombinant vaccine due to the use of GSK's boosting adjuvant, are scheduled to begin in September. Trials with the mRNA vaccine candidate should begin late in the year, the company said.
Sanofi said it has the capacity to produce up to 1 billion doses of its recombinant vaccine per year and can deliver up to 360 million doses of its mRNA vaccine annually.
In April, Sanofi announced that it had production capacity for 600 million doses of its recombinant vaccine, with the goal of doubling production by mid-2021.
The company also announced plans to expand Translate Bio's vaccine development efforts to provide the U.S. group with upfront payments of $ 425 million.

(Reporting by Matthias Blamont; editing by Bill Berkrot and Kim Coghill)

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