Sanofi, GSK Seeking Approval for COVID-19 Vaccine

Sanofi and GSK today announced they will try to get approval from the FDA and the European Medicines Agency (EMA) for their COVID-19 vaccine, entering a crowded market.

The two pharma makers said in a press release that they will submit data from both booster and Phase 3 efficacy trials as the basis for regulatory applications their vaccine, a refrigerator temperature-stable adjuvanted protein-based vaccine.

Pfizer/BioNTech, Moderna and Johnson & Johnson are marketing their COVID-19 vaccines in the U.S. and other countries, while Novavax just began shipping its vaccine to European Union states.

The Sanofi-GSK vaccine is “strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings,” the two companies said.

In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a “significant increase” in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups.

When the vaccine was used as a 2-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.

The pharma makers’ efficacy study showed that two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% against any symptomatic COVID-19 disease in the seronegative population.

Notably, the vaccine provided 100% protection against severe disease and hospitalizations and 75% efficacy against moderate-to-severe disease in seronegative populations.

“While sequencing is still in progress, early data indicate 77% efficacy against any Delta variant-associated symptomatic COVID-19 disease, in line with expected vaccine effectiveness,” Sanofi and GSK said.

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

“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 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.”

Triomphe said that no other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and the data are similar to the recent clinical data from authorized vaccines.

“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines. 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,” said Roger Connor, president of GSK Vaccines.

“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.