With a new disease variant come further questions of vaccine viability and new tests, and this week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced an expansion of a vaccine agreement with Gritstone bio Inc. to test its mRNA COVID-19 vaccine against the Omicron variant.
The expansion will provide up to $5 million additional funds for Gritstone to pursue a Phase 1 clinical trial of its vaccine candidate in South Africa. South Africa is both where Omicron first emerged at the end of November and where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is scheduled to begin.
“While key questions are yet to be answered about Omicron, its transmissibility, and its potential ability to evade our current vaccines, the stakes are too high to delay developing Omicron-specific vaccine candidates,” Dr. Richard Hatchett, CEO of CEPI, said. “Given the uncertainties, we must accelerate crucial R&D, so vaccines are available to tackle Omicron as soon as possible – just in case we need them.”
Its partner, Gritstone, is a clinical-stage biotechnology company. The COVID-19 vaccine it is currently testing utilized SARS-CoV-2 T cell epitopes, and these are seemingly minimally affected by the mutations of the Omicron variant. This development spurs CEPI’s hopes that it will continue to be effective against this and future variants of COVID-19.
CEPI’s additional funding will expand the Phase 1 trial of Gritstone’s Beta variant vaccine to include segments focused on an Omicron-specific version. The latter is already being manufactured and, if it meets with regulatory approval, could allow for testing in Q2 2022. South Africa’s University of Witwatersrand will conduct both trials.
“Omicron is an example of a novel SARS-CoV-2 variant that may escape clinical protection conferred by vaccines that only afford narrow, Spike-specific immunity,” Dr. Andrew Allen, co-founder, president and CEO of Gritstone, said. “Our SAM technology provides an innovative platform likely capable of delivering on the attractive concept of broad, durable immunity. We are thrilled to be quickly expanding our relationship with CEPI in our shared goal of finding new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.”
If authorized, Gritstone will be made available to the COVAX facility — which CEPI co-runs — for equitable procurement and distribution worldwide.
While the final word on Omicron’s capabilities is still out, early research indicates it may host an increased risk of re-infection. Some of its mutations may also reduce the clinical efficacy of existing vaccines and therapeutic antibodies.