Sanofi and GSK seek COVID-19 vaccine approval - European Medical Journal

Sanofi and GSK seek COVID-19 vaccine approval

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Words by GOLD newsdesk

Following positive clinical trial results, Sanofi and GSK are seeking regulatory approval for their adjuvanted protein-based COVID-19 vaccine.

The Phase 3 trial revealed two doses of the vaccine to be 100% effective in preventing severe cases of COVID-19 and hospitalisations. Final analysis of the booster trial also showed the vaccine induced a significant increase in neutralising antibodies across vaccine platforms and age groups.

The vaccine was tested against a significant number of COVID-19 variants, including Omicron. “No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern,” said Thomas Triomphe, Executive Vice President, Sanofi Vaccines. “And these efficacy data are similar to the recent clinical data from authorised vaccines.”

While protein-based vaccines take longer to develop than mRNA vaccines, they have a strong reputation for safety and effectiveness. Roger Connor, President of GSK Vaccines, said: “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.”

Sanofi and GSK will be seeking approval for the vaccine as a primary two-dose series and a booster dose.

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