Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster

After months of review at European regulators’ desks, GSK and Sanofi have scored a world-first nod to enter the COVID-19 vaccine market in Europe with their pandemic booster VidPrevtyn Beta.

Thursday, the European Commission signed off on the Sanofi-GSK booster to augment protection against COVID-19 in adults ages 18 and up, making VidPrevtyn the first next-gen, protein-based adjuvanted COVID-19 vaccine approved in Europe.

Wedding a beta antigen with GSK’s pandemic adjuvant, VidPrevtyn is designed to offer “broad protection against multiple variants” of the coronavirus, the partners said in a release. The shot can be used as an adjunct in adults who’ve already received primary vaccination with mRNA or adenoviral COVID shots.

“Shipments of VidPrevtyn Beta are ready to be distributed to European countries as per Advance Purchase Agreements,” Sanofi and GSK added.

Sanofi and GSK did not comment on the exact number of dose orders they’ve received, but a Sanofi spokesperson confirmed via email that the partners have advance purchase agreements locked in with the European Commission to supply more than 20 EU member states. Sanofi and GSK also have purchase agreements in place with the U.K. and Canada, she added.

Still, in an era where even established mRNA shots from Pfizer-BioNTech and Moderna are experiencing dwindling demand, it remains unclear how much use the shot will see in the real world.

The partners have been working with European regulators on their shot for more than a year. The European Medicines Agency last July initiated a rolling review on VidPrevtyn, with the bloc’s drug regulator formally kicking off its appraisal of the partners’ approval application in March.

VidPrevtyn won a European green light based on a primary phase 3 trial plus two separate immunogenicity studies, which GSK and Sanofi ran at the height of the omicron variant’s reign. In those trials, the partners’ shot triggered a “strong immune response against multiple variants," the companies said.

While GSK and Sanofi are no doubt pleased with their win—which comes in the wake a high-profile strikeout earlier on in the COVID-19 vaccine race—it’s a tumultuous time for pandemic prophylactic manufacturers.

Look no further than AstraZeneca, which elected to withdraw its U.S. FDA application for its COVID shot Vaxzevria on the very same day VidPrevtyn clinched approval. As for the company’s rationale, the U.S. market is already flush with coronavirus vaccines, and demand for the shots is waning, AZ CEO Pascal Soriot said Thursday.

In the third quarter, AZ's global Vaxzevria sales plummeted by 83% to just $173 million.

AstraZeneca isn’t an outlier, either.

Over the same third-quarter stretch, Pfizer and BioNTech’s Comirnaty logged sales of $4.4 billion, a 66% decline year over year. Pfizer recently dialed up its 2022 Comirnaty revenue projection by $2 billion to $34 billion, but analysts have argued the shot’s solid performance won’t last long as interest in boosters languishes.