Sanofi, GSK to seek authorization for COVID-19 vaccine following ‘strong’ results

Sanofi and GSK said Wednesday that they plan to submit their COVID-19 vaccine for authorization following “strong” results in a Phase 3 trial.

The latest COVID-19 vaccine entrant could play an important role in helping vaccinate the world, given that it is easier to store than the mRNA vaccines from Pfizer and Moderna.

The vaccine had 100 percent efficacy against severe disease and hospitalization. Efficacy against any infection at all was 57.9 percent. While that is lower than was reported originally for Pfizer and Moderna, Sanofi and GSK said the results reflect the latest variants, and are “in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.” 

The companies also said the vaccine had a “favorable safety profile.” 

They plan to submit for authorization to the Food and Drug Administration and the European Medicines Agency.  

“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” said Thomas Triomphe, executive vice president at Sanofi Vaccines.  

“We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment,” he said. “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 vaccine can also be used as a booster, including in people who originally received an mRNA vaccine. 

The Sanofi-GSK uses a more traditional vaccine technology, as opposed to the newer mRNA used by Pfizer and Moderna. Therefore it could both convince some people skeptical of mRNA vaccines to get the shots, and, importantly, help reach lower-income countries due to easier storage requirements.  

Novavax, another vaccine maker, also applied for authorization last month, further adding to the arsenal.