New Crown Recombinant Protein Vaccine Phase 3 Clinical Results Announcement Plan to Seek Regulatory Authorization

On February 24, Sanofi and GlaxoSmithKline (GSK) announced that the two sides plan to simultaneously submit phase 3 efficacy trial data of their jointly developed recombinant protein new crown vaccine and clinical data as a booster needle to seek regulatory approved
.

The vaccine candidate contains a recombinant protein from the new coronavirus and an adjuvant that boosts the immune response
.

As a booster vaccine, it significantly increased neutralizing antibody levels by 18- to 30-fold in adult and elderly vaccinated individuals, regardless of whether they had received mRNA or adenovirus vaccines
.

▲ The Sanofi-GSK vaccine was used as a booster to significantly increase the level of neutralizing antibodies in the 18-55-year-old group (the previous column of icons) and the >56-year-old group (the next column of icons) (Image source: Reference [1])

Meanwhile, phase 3 clinical trial data showed that two doses of Sanofi-GSK vaccination was 57.
9% (95% CI, 26.
5, 76.
7) effective in preventing symptomatic COVID-19 in a seronegative population
.

Mr.
Roger Connor, President of GSK Vaccines, said: "The evolving epidemiology of COVID-19 indicates the need for multiple vaccines
.

The companies are in discussions with regulators, including the U.

References:

[1] Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine.