Sanofi to Apply For Approval of Coronavirus Vaccine

The Sanofi and Glaxo SmithKline corporations will seek approval for their coronavirus vaccine candidate, officials announced on Wednesday, stating they hoped their inoculation could be used as either a standalone vaccine or a booster shot with other existing vaccines.

The French-owned Sanofi Pasteur Labs, along with its British partner GlaxoSmithKline are ready to go forward with the cumbersome approval process despite suffering several setbacks on the road to its development.

The companies announced to the press on Wednesday that they intended to submit data to regulators from a late-stage trial of the vaccine as well as another study which looked at its safety and efficacy as a booster only.

Sanofi vaccine paired with adjuvant from Glaxo SmithKline

They added that the full results for both studies should be published sometime “later this year.”

Sanofi, despite being a giant among world pharmaceutical firms, didn’t fare as well as the others that won approval — or at least emergency authorization –– for their coronavirus inoculations in the last year.

The British form GSK, which is the world’s largest vaccine maker as far as gross sales are concerned, did not opt to develop its own vaccine candidate, instead supplying its adjuvant technology to developers who would be responsible for creating vaccines.

Unlike the revolutionary vaccines developed by Pfizer/BioNTech and Moderna, which depend on mRNA as a base, Sanofi-GSK’s inoculation uses a conventional protein base that is similar to one of Sanofi’s seasonal influenza vaccines.

However, it is coupled with GSK’s adjuvant, which boosts the effectiveness of the vaccine. Another plus is that it is also easier to store and transport than other shots that are already on the market.

Officials from Sanofi and GSk told the press that the final analysis of the booster trial, which included subjects who had previously been given mRNA-based shots or adenovirus viral vectors, demonstrated that it could increase neutralzsing antibodies by a multiple of between 18 to 30.

“We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period,” said Roger Connor, the President of GSK Vaccines.

Preliminary data from the late-stage trial of the inoculation as a standalone, two-dose series demonstrated that it was 100% effective against severe coronavirus and hospitalization, showing 75% efficacy against moderate and severe disease.

Thomas Triomphe, executive vice president for Sanofi Vaccines, stated “No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines.”

The two companies told Reuters that they were in discussions for the authorization and approval for their shot with medicines regulators, including the U.S. Food and Drug Administration and the European Medicines Agency.

Richard Hatchett, the head of the Coalition for Epidemic Preparedness Innovations, said that the new protein-based vaccines that are paired with adjuvants such as GSK’s could “potentially become the workforce for vaccinations in the future.”

Sanofi and GSK delayed their release of data from the booster trial to this year, while Sanofi dropped plans for its own mRNA-based shot after the meteoric rise of the Pfizer-BioNTech and Moderna inoculations, showing almost 100% efficacy in trials.