Novavax has initiated its first phase 3 clinical trial to assess the efficacy, safety, and immunogenicity of its NVX-CoV2373 COVID-19 vaccine candidate.
The US vaccine development company is carrying out the late-stage trial in the UK in partnership with the UK government’s Vaccines Taskforce.
The phase 3 trial of NVX-CoV2373 will aim to enroll and immunize up to 10,000 individuals between 18-84 years of age, irrespective of relevant comorbidities, over the next four to six weeks.
Gregory M. Glenn – President of Novavax Research and Development said: “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.
“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research.”
According to the US vaccine development company, NVX-CoV2373 is a stable, prefusion protein made using its recombinant protein nanoparticle technology that includes its MatrixM adjuvant.
The COVID-19 vaccine candidate has a favorable product profile that will enable handling in an unfrozen, liquid formulation which can be stored at 2°-8°C, thereby allowing for distribution using standard vaccine channels, said Novavax.
The US vaccine developer said that it has continued to scale-up its manufacturing capacity, which at present is at up to two billion annualized doses, once all capacity has been brought online by mid-next year.