06.24.20

Sanofi Sees Potential Approval of COVID-19 Vaccine in First Half of 2021

Source: FirstWord

Sanofi said Tuesday that it expects potential approval of a COVID-19 vaccine being jointly developed with GlaxoSmithKline in the first half of next year, brought forward from an earlier estimate of the second half of 2021. A phase 1/2 study of the recombinant protein-based​ vaccine approach, which uses GlaxoSmithKline’s adjuvant AS03, is scheduled to start in September, with Sanofi noting that it has capacity to manufacture up to 1 billion doses a year.

“We are being guided by our dialogue with regulatory authorities,” commented Sanofi research chief John Reed. Meanwhile, CEO Paul Hudson suggested that the probability of success for Sanofi’s vaccine is “higher than anybody else.” Hudson said “there are companies moving faster, but let us be brutally clear, speed has three downsides…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 accelerated timeline for the vaccine was detailed as part of Sanofi’s virtual R&D day, at which the company is detailing its latest research efforts following an overhaul late last year. “Since last December, we have been making tremendous progress on our ability to grow a pipeline of potentially transformative treatments,” remarked Hudson.

Along with the vaccine partnered with GlaxoSmithKline, Sanofi is also collaborating with Translate Bio on an mRNA vaccine for COVID-19, with the companies further expanding their agreement on Tuesday. The French drugmaker said that it expects to start a Phase I study of an mRNA vaccine candidate by the end of the year, with a possible approval at the earliest in the second half of 2021. In addition, Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 million to 360 million doses.

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