According to Codagenix, the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) will provide up to $389 million to support a Phase 2b trial of CoviLiv live attenduated intranasal vaccine as a booster. Under the contract, the first tranche provided by BARDA will be $10 million. Codagenix is developing CoviLiv in partnership with the Serum Institute of India.
The Phase 2b study is expected to enroll 10,000 subjects who have completed a primary series of vaccines and will evaluate CoviLiv in comparison with “an authorized mRNA XBB.1.5 comparator vaccine.” In September 2021, Codagenix announced that it would advance the vaccine (formerly Covi-Vac) into Phase 2/3 development based on positive results from a Phase 1 trial. A Phase 3 trial of CoviLiv as a primary vaccine is currently underway
Codagenix Executive Chairman and CEO Paul Grint commented, “We are thrilled to partner with BARDA as part of Project NextGen to investigate how CoviLiv’s unique clinical profile could potentially position it as a critical next-generation booster for people who have received mRNA COVID-19 vaccines and are looking to increase protection against variants using an intranasally administered vaccine. This agreement, along with our ongoing Phase 3 study conducted as part of the WHO’s Solidarity Trial Vaccines, allows us to advance CoviLiv and our live-attenuated, vaccine platform to tackle the greatest unmet needs in viral respiratory illnesses including RSV and influenza.”
Serum Institute of India Executive Director Rajeev Dhere said, “Codagenix’s collaboration with the BARDA signifies a significant milestone in the development of the CoviLiv vaccine, designed to prevent symptomatic COVID-19 in individuals. Together, we are working on the development of this intranasal vaccine, which is currently undergoing safety and efficacy evaluations in a global Phase 3 trial. Codagenix’s CoviLiv vaccine expresses all proteins of the SARS-CoV-2 virus, and this partnership represents a significant advancement in our collective fight against COVID-19.”
Read the Codagenix press release.
