Sanofi has new coronavirus vaccine candidate that’s 100% effective against severe disease, hospitalizations

Another coronavirus vaccine option could soon be available as Sanofi announced that its more traditional vax is 100% effective against severe COVID-19 disease and hospitalizations.

Sanofi and GSK said they will be seeking regulatory authorization for their protein-based vax candidate, which produced robust immune responses in their trials.

In the primary series trial, two doses of the Sanofi-GSK vaccine was: 100% effective against severe COVID-19 disease and hospitalizations; 75% effective against moderate or severe COVID-19 disease; and 57.9% effective against any symptomatic COVID-19 disease.

When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.

The vax can also be used as a booster for other vaccines, including the Pfizer and Moderna mRNA vaccines. In participants who had received a primary series of an mRNA or adenovirus vaccine, the Sanofi-GSK booster vax produced a significant increase in neutralizing antibodies of 18- to 30-fold.

“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” Roger Connor, president of GSK Vaccines, said Wednesday. “Our adjuvanted protein-based vaccine candidate uses a well-established approach that has been applied widely to prevent infection with other viruses including pandemic flu.

“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,” Connor added.

No other global Phase 3 efficacy study has happened during this period with so many variants of concern, including the extraordinarily contagious omicron variant, according to the pharmaceutical companies. The vax effectiveness data is similar to the recent clinical data from authorized vaccines, they added.

“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” said Thomas Triomphe, executive VP of Sanofi Vaccines. “The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment.”

Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concerns.

The companies plan to submit their trial data to the U.S. Food and Drug Administration for authorization.