Gritstone bio has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) to conduct a comparative study evaluating the company's self-amplifying mRNA (samRNA) vaccine candidate as part of a larger push to develop better COVID-19 vaccines.
The agreement, which is valued at up to $433 million, was awarded as part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19.
Under the contract, Gritstone — a California-based biotech with a mission to "develop the world’s most potent vaccines" — 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.
Gritstone's innovative vaccine platform relies on self-amplifying mRNA, which the company says is rapidly emerging as a well-tolerated, scalable and widely-applicable platform technology. The technology can be used to develop multiple vaccines simply by changing the sequence of the antigen (the target) that is encoded in the vector RNA and delivered in a lipid nanoparticle. Unlike traditional mRNA, samRNA creates multiple copies of the antigen RNA once in the cell, which Gritstone says can lead to extended duration and magnitude of antigen expression.