Volunteers in clinical trials were mistakenly given lower doses than they were supposed to get in initial clinical trials due to a miscalculation in the manufacturing process, Thomas Triomphe, Sanofi’s executive vice president for vaccines, told the Journal.
To fix the problem, scientists have to reformulate the vaccine. Sanofi and GlaxoSmithKline said they hope to restart clinical trials in February, which would set back its potential authorization time to the fourth quarter of 2021. The drugmakers were aiming for approval in the first half of the year.
“It’s a sad setback. But we prefer to take a step back, let the science work and come back with a product that is very efficacious in addition to being safe. You don’t want to do compromises there,” Mr. Triomphe told the Journal.
Sanofi and GlaxoSmithKline’s vaccine candidate will make up 10 percent of total global COVID-19 vaccine doses expected from Western drugmakers next year, the Journal reported. The drugmakers received a $2.1 billion contract from Operation Warp Speed, the White House’s initiative to speed COVID-19 vaccine and drug development, the largest contract handed out under the program.
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