Sanofi and GSK Launch Phase 2b Study for Adjuvanted Recombinant Protein-based COVID-19 Vaccine
Paris-based Sanofi and GSK announced the initiation of a new Phase 2b study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
Sanofi provides its recombinant antigen in a partnership between the two companies, and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. The recombinant technology combined with GSK’s adjuvant offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission, stated Sanofi.
“Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study,” said Thomas Triomphe, EVP, and Head of Sanofi Pasteur, in a related press statement.
“We are confident that our vaccine candidate has strong potential, and we are very encouraged by the latest preclinical data. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages. We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile.”
On July 31, 2020, the U.S. government stated it would provide up to $2.1 billion for the vaccine's development, including clinical trials and manufacturing scale-up and delivery of an initial 100 million doses. The vaccines intended for the USA would be produced in Sanofi's Swiftwater, Pennsylvania facility.
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