Sanofi, whose own COVID-19 vaccine isn't ready yet, gets green light to start making BioNTech/Pfizer doses

The French biopharma giant Sanofi still doesn’t have a COVID-19 vaccine to offer the world, so it’s making other companies’ vaccines instead.

Late Thursday, the European Medicines Agency (EMA) approved the use of Sanofi’s manufacturing site in Frankfurt for the production of BioNTech/Pfizer’s Comirnaty vaccine. This, and another newly approved German site, operated by Siegfried Hameln, will together pump out an extra 50 million Comirnaty doses over the remainder of this year.

Sanofi’s deal with Germany’s BioNTech was announced back in January, a month after Sanofi and its development partner GSK announced the failure of their vaccine candidate to generate a sufficient immune response in older people. At the time, Sanofi CEO Paul Hudson insisted his company’s own development efforts would continue, but he said the pharma industry had a “collective goal of putting all the effort in to curb this pandemic.”

“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved,” Hudson said in January. The following month, Sanofi revealed a similar production arrangement for J&J’s vaccine in France, and in April Sanofi struck another deal to make Moderna’s vaccine in the U.S.

Sanofi’s BioNTech deal should cover the production of over 125 million doses in total. The Moderna deal—production is scheduled to start this month—covers up to 200 million doses, and Sanofi should be making 12 million J&J doses a month once the EMA clears that arrangement (the agency said Friday that it had nothing to share on that front).

Of course, Europe’s vaccine landscape is very different now from how it was earlier this year, when the BioNTech and J&J deals were announced. Back then, supply was a problem. Now Europe has more doses than it needs, and debate is raging over rich countries’ failure to share enough of their surplus with poorer countries that have managed to vaccinate far fewer of their citizens.

Still trying

Sanofi and GSK still hope to gain regulatory approval for their two-dose COVID-19 vaccine candidate toward the end of this year. They kicked off a fresh Phase III trial in May, soon after Hudson suggested their potential jab could be used to address new coronavirus variants or deployed as booster shots.

The Sanofi/GSK candidate is an adjuvanted recombinant protein-based vaccine that is based on Sanofi’s existing flu vaccine. Sanofi has also been working with Translate Bio on a COVID-19 vaccine candidate (and a separate jab for seasonal flu) that uses mRNA technology, of the sort that underpins BioNTech/Pfizer’s and Moderna’s vaccines. Initial results are expected later this month for the COVID-19 vaccine candidate.

Last month, Sanofi said it would buy Translate Bio for $3.2 billion. “Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines,” said Hudson when the purchase was announced.

Sanofi and BioNTech have quite a long-standing relationship that began with a cancer immunotherapy-focused research collaboration deal in 2015. At the start of 2019, Sanofi invested €80 million ($94.5 million) in BioNTech as their joint work moved into clinical testing.