Gritstone gets BARDA contract up to $433M to evaluate Covid-19 candidates

Gritstone awarded a contract by the Biomedical Advanced Research and Development Authority BARDA to conduct a Phase 2b comparative study evaluating Gritstone’s self-amplifying mRNA, samRNA, vaccine candidate containing Spike plus otherviral targets to protect against COVID-19. The agreement, which is valued at up to $433M, was awarded as part of ‘Project NextGen,’ an initiativeby the U.S. Department of Health and Human Services or HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19.Under the contract, Gritstone bio will conduct a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of the Gritstone next-generation COVID-19 vaccine candidate with an approved COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA. Gritstone will run the study in the United States in collaboration with the COVID-19 Prevention Network , a NIAID-supported network of clinical trial sites based at Fred Hutchinson Cancer Center with experience conducting large COVID-19 vaccine trials. “We are honored to receive this award from BARDA to advance our next-generation samRNA vaccine against COVID-19 (the CORAL program), which provides strong validation of our innovative vaccine platform in infectious diseases. Not only does this contract supply the necessary resources to advance the development of CORAL, but it also signifies the trust and confidence the U.S. government has placed in our novel vaccine approach,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio.