European drugmakers seek approval for promising new Covid vaccine

(CN) — French drug manufacturer Sanofi and its British partner GlaxoSmithKline announced Wednesday they are submitting data from their Covid-19 vaccine trials to seek regulatory approval for the drug to be used as a two-dose shot as well as a booster.

Late-stage trials of the vaccine as a standalone two-dose shot showed it was 100% effective against severe Covid-19 hospitalization, with 75% efficacy against moderate or severe infections.

Sanofi and GSK said that data from the booster trial, which included participants who had previously been given shots using mRNA technology or adenovirus viral vectors, showed the new vaccine could increase neutralizing antibodies by 18 to 30 times.

The shot also showed 58% efficacy against symptomatic disease in its Phase 3 clinical trial. Although that number is lower than what was observed for the messenger RNA, or mRNA, vaccines made by Pfizer-BioNTech and Moderna in their initial trials, it is “in line with expected vaccine effectiveness in today’s environment dominated by variants of concern,” Sanofi and GSK said in a statement.

The companies are seeking regulatory approval from the U.S. Food and Drug Administration and European Medicines Agency.

Unlike the newer mRNA technology used in approved Covid-19 vaccines, the Sanofi and GSK shot relies on a conventional protein-based approach.

Protein vaccines have been used for decades to protect people from hepatitis, shingles and other viral infections. These shots deliver fragments of proteins from the pathogen, along with immunity-stimulating adjuvants, directly to a person’s cells, which elicits an immune response.

Although safe for most of the population, vaccines based on mRNA and viral-vector technologies have been linked to rare but potentially severe side effects, including heart inflammation and blood clots.

Another benefit of protein-based vaccines is that they are relatively inexpensive to manufacture and have more temperature stability versus the ultralow freezing storage required for the mRNA vaccines.

These advantages could potentially help to increase global access to vaccines and narrow the immunization gap between rich and poor countries.

Sanofi and GSK had hoped to win authorization for their vaccine last year, but the companies were set back when clinical trials showed they needed to develop and test a stronger version.

"The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all age," Thomas Triomphe, executive vice president of Sanofi Vaccines, said in a statement. "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."

Sanofi and GSK are one of four pharmaceutical candidates that received billions of dollars for development from Operation Warp Speed, a Trump administration program created to accelerate Covid-19 vaccine production.

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