US-based biotech Novavax, announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.
The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunise up to 10,000 individuals between 18-84 years of age, with and without relevant comorbidities, over the next four to six weeks.
“With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373’s efficacy,” said Gregory M. Glenn, President, Research and Development at Novavax.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries,” Glenn said.
NVX-CoV2373 is a protein sub-unit vaccine made using company's recombinant protein nanoparticle technology that includes Novavax’ proprietary MatrixM adjuvant.
The vaccine will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.
Earlier this month Novavax reached an agreement with the Serum Institute of India to produce as many as 2 billion doses a year. The vaccine is expected to be brought online by mid -2021.
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