French pharmaceutical giant Sanofi announced this Wednesday large-scale positive results of its vaccine against Covid-19, developed jointly with the British laboratory GSKafter a year of rehearsals and postponements.
“Sanofi and GSK will seek regulatory approval of their Covid-19 vaccine” in the United States and the European Union, both groups announced in a statement, after trials with thousands of people.
Although the full studies have not yet been published, their results show that the drug helps prevent hospitalization due to coronavirus.
In addition, the vaccine would be slightly more than 50% effective for symptomatic Covid-19. That is “comparable with the efficacy of vaccines already available,” he stressed. Sanofiin a context of strong spread of the pandemic due to the Omicron variant.
At phase 3 trial from the VAT08 primary series, two doses of the Sanofi-GSK vaccine in people who do not have antibodies demonstrated 100% efficacy against severe Covid-19 disease and hospitalizations.
The final analysis of the global VAT02 booster dose trial confirms the universal ability to increase neutralizing antibodies by 18- to 30-fold across all vaccine platforms (mRNA, adenovirus).
Likewise, a 75% efficacy against moderate or severe Covid-19 disease was observed; and 57.9% efficacy against any symptomatic Covid-19 disease, in line with the expected effectiveness of the vaccine in the current environment dominated by worrying variants.
The companies highlight that, in addition, it has a favorable safety profile after the primary series and vaccination as a booster dose, and was well tolerated in young adults and older people without safety problems.
In participants who had received a licensed adenovirus or mRNA vaccine, the Sanofi-GSK booster vaccine induced a significant 18- to 30-fold increase in neutralizing antibodies across all vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased between 84- and 153-fold compared to pre-booster levels.
The Executive Vice President of Sanofi Vaccines, Thomas Triomphehas shown his satisfaction with these data “The Sanofi-GSK vaccine demonstrates a universal capacity as a booster for all platforms and at all ages. We have also observed a solid efficacy of the vaccine as a primary series in the current difficult epidemiological environment”.
“No other global phase 3 efficacy study has been conducted during this period with as many variants of interest, including Omicron, and these efficacy data are similar to recent clinical data for licensed vaccines,” he added.
For his part, the President of GSK Vaccines, Roger Connor, has highlighted that “the evolution of the epidemiology of Covid-19 demonstrates the need for a variety of vaccines. Our protein-based adjuvanted vaccine uses a well-established approach that has been widely applied to prevent infection with other viruses, including influenza pandemic”. “We are confident that this vaccine can play an important role as we continue to deal with this pandemic and prepare for the post-pandemic period,” she concluded.
If the vaccine is authorized, that will mean the end of a long journey for both pharmaceutical companies, who hoped to be able to market the drug in mid-2021.
The first difficulties arose with the correct dosage of the vaccine, and then with the difficulties of finding people who had never been infected, so that the tests were reliable.
Sanofi had to abandon its attempts to create a vaccine based on mRNA technology, which has been the basis of its rivals Pfizer/BioNTech and modern.