With test data showing their COVID-19 vaccine’s capabilities to fight COVI-19 in regular or booster form, Sanofi and GSK announced this week that they intend to submit data as the foundation of regulatory authorization requests.
The Sanofi-GSK offering is a refrigerator temperature-stable, adjuvanted protein-based vaccine. In a primary, two-dose series, the vaccine offers 100 percent efficacy against severe COVID-19 cases and hospitalizations, 75 percent efficacy against moderate or severe cases, and 57.9 percent efficacy against general, symptomatic cases. Boosting increased neutralizing antibodies by another 18 to 30-fold, and its safety profiles have been favorable. If approved, this would grant the world one more tool for use against COVID-19 amid a still-raging pandemic.
“The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages,” Thomas Triomphe, executive vice president of Sanofi Vaccines, said. “We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment. 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.”
Combined, the primary dose and booster doses of the vaccine candidate brought with it an 84-153 fold increase in neutralizing antibodies against COVID-19 across age groups. No safety concerns emerged among either young or old recipients. Full study results for the vaccine will be published later this year.
“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” Roger Connor, president of GSK Vaccines, said. “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.”
Along its research and development path, the Sanofi-GSK vaccine has been supported with funds from U.S. federal funds. The companies hope to apply for authorization from the U.S. Food and Drug Administration and the European Medicines Agency.