Novavax announced that it has started a late-stage trial of its experimental COVID-19 vaccine in partnership with the UK government’s Vaccines Taskforce.
The Phase 3 trial is expected to enroll and test the drugmaker's vaccine candidate, NVX-CoV2373, in up to 10,000 participants aged between 18 and 84 years over the next four to six weeks.
If successful, this will be the Maryland, U.S.-based company's first vaccine brought to market. The drugmaker has plans to begin a late stage trial in the U.S. in October, which would mark the fifth late stage trial from a company supported by Operation Warp Speed. The other four candidates currently in late stage testing in the U.S. were developed by Moderna, Pfizer/BioNTech, AstraZeneca/University of Oxford and most recently, J&J.
According to Novavax, "consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic" the drugmaker will be publishing its UK study protocol shortly.
The company also announced a COVID-19 vaccine manufacturing deal with Endo International whereby its subsidiary, Par Sterile Products, will provide fill-finish manufacturing services at a factory in Rochester, Mich. The product being produced is expected to be used in the company's Phase 3 trials for NVX-CoV2373 in the U.S. as well as for potential general distribution to the public if the vaccine candidate receives any type of regulatory approval or authorization.