Sanofi will provide manufacturing support for Pfizer/BioNTech’s COVID-19 vaccine

Sanofi has signed an agreement with BioNTech to support manufacturing of that company’s Pfizer-partnered COVID-19 vaccine.

As part of the deal, Sanofi will provide BioNTech with access to its established manufacturing infrastructure, as well as its expertise, with the aim of producing over 125 million doses of the vaccine in Europe.

Sanofi will begin to perform late-stage manufacturing from summer 2021 to support the scale-up of Pfizer/BioNTech’s mRNA-based vaccine.

Earlier this month, Pfizer/BioNTech temporarily slowed down shipments of its COVID-19 vaccine to the EU.

Pfizer said in a statement that shipments of the vaccine doses were being impacted by changes made to its manufacturing processes as part of its new production capacity goal.

BioNTech recently increased the production capacity for the vaccine, announcing that it is now aiming to deliver up to two billion doses of the jab this year.

“We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so,” said Paul Hudson, chief executive officer of Sanofi.

“As always, our top priority is to focus our efforts and capabilities on fighting this global pandemic. First and foremost, we will do this by continuing to develop our own COVID-19 vaccines candidates, in parallel with this industrial cooperation,” he added.

In an interview with French newspaper Le Figaro on Tuesday, Hudson said that Sanofi is aiming to provide 100 million doses of the COVID-19 vaccine by the end of the year, with these being “destined for the EU”.

One of Sanofi’s COVID-19 vaccine candidates, which it is developing with British drugmaker GlaxoSmithKline (GSK), yielded some disappointing results last month.

In an interim analysis of results from a phase 1/2 study of Sanofi/GSK’s adjuvanted recombinant protein-based COVID-19 vaccine, the observed immune response in elderly participants was found to be low.

The companies attributed this underwhelming response to an ‘insufficient concentration’ of the antigen component of the vaccine.

Sanofi/GSK have now rescheduled their previous timeline for the vaccine, with a new plan to launch a phase 2b study next month.

The phase 2b study will test an improved antigen formulation, after a recent challenge study in non-human primates showed that this new formulation could protect against lung pathology.

With Sanofi’s own vaccine efforts thrown off schedule, it is aiming to lend its expertise to bolster the availability of Pfizer/BioNTech’s approved jab.

“Since our main vaccine is a few months late, we asked ourselves how we could be of assistance now,” said Hudson.

Meanwhile, a phase 1 trial of Sanofi’s other investigational vaccine candidate, currently being developed with Translate Bio, is expected to launch in Q1.