Sanofi and GlaxoSmithKline’s Covid-19 vaccine lags behind peers in clinical development, but partners stress that their vaccine’s special features make it valuable as a vaccination option .and Analysis of key clinical data Now, the companies said Wednesday they plan to seek authorization from regulators.
The Sanofi-GSK vaccine is protein-based and consists of Sanofi-designed antigens and GSK adjuvant, a component that boosts the immune response. These vaccine components have been used successfully in influenza vaccines, so regulators and clinicians are familiar with them. Another key feature is that the Sanofi-GSK vaccine can be stored at standard refrigerator temperatures, an advantage over the ultra-cold storage and distribution requirements of messenger RNA vaccines.
The Phase 3 study enrolled more than 10,000 volunteers 18 and older who were randomly assigned to receive the Sanofi-GSK vaccine or a placebo. Filmed at 21-day intervals at locations in the US, Asia, Africa and Latin America. In testing the vaccine as a primary vaccination, the companies reported 100 percent efficacy in two shots for severe Covid-19 disease and hospitalization, and 75 percent efficacy in moderate or severe disease.
Efficacy decreased to 57.9% as measured against omicron and other relevant variants. Reduced efficacy is expected as other vaccines have also shown reduced efficacy against the new variant. However, comparisons with clinical trial efficacy markers released for previously licensed vaccines are tricky, as these studies were primarily conducted before delta and omicron variants emerged.
Sanofi and GSK had to overcome clinical trial setbacks. In late 2020, the partners announced a Delay In a mid-term testing program to tweak the vaccine to boost immune responses in older adults.when partners can Preliminary data for Phase 2 reported last MayPfizer/BioNTech, Moderna, and Johnson & Johnson’s Covid vaccines have been licensed and widely distributed across the U.S.
according to Covid Data Tracker Maintained by the Centers for Disease Control and Prevention, approximately 215 million people in the United States are fully vaccinated (either two doses of mRNA vaccine or one dose of J&J vaccine), or 64.8% of the population. According to the CDC, 93.2 million people received booster shots, or 43.4% of those who were fully vaccinated.
Given that the components of the Sanofi-GSK vaccine are known and have a good safety record, the vaccine may win over some who are hesitant to make a vaccine with a new technology. The Sanofi-GSK vaccine could also find a place as a booster. The data reported Wednesday included results from another trial testing the vaccine as a booster for those who had already received the primary vaccination series of an already licensed mRNA or adenovirus vaccine. The companies reported that their vaccines resulted in an 18- to 30-fold increase in neutralizing antibodies across vaccine platforms and age groups.
“The Sanofi-GSK vaccine demonstrates a universal ability to advance across all platforms and across all age groups,” Thomas Triomphe, executive vice president of Sanofi Vaccines, said in a prepared statement. The robust efficacy of the vaccine as a lead series vaccine in today’s challenging epidemiological environment has also been observed. No other global Phase 3 efficacy study has involved so many variants of interest, including omicron, during this period, and these efficacy data are comparable to recent Clinical data from licensed vaccines are similar.”
Data from both clinical trials were reported in press releases. Sanofi and GSK said full data from those studies will be released later this year. In both studies, both companies reported that the vaccine was well tolerated in both young and old with no safety concerns. Sanofi and GSK said they were already in discussions with regulators including the FDA and the European Medicines Agency about applying for authorization.
Credit: Maxim Tkachenko, Getty Images
