Novavax starts first phase 3 COVID-19 vaccine trial in the UK

Almost a month after initiating the phase 2 portion of its COVID-19 vaccine trial in the US and Australia, Novavax has launched its first phase 3 trial in the UK.

The planned phase 3 study, which is being conducted in partnership with the UK government’s Vaccine Taskforce, will evaluate the efficacy, safety and immunogencity of Novavax’s COVID-19 vaccine, NVX-CoV2373.

The company is expecting to enrol and immunise up to 10,000 individuals aged between 18-84, with and without relevant comorbidities, over the next four to six weeks. Participants will either receive two intramuscular injections of Novavax’s vaccine and Matrix-M adjuvat, or a placebo shot.

The trial will aim to enrol at least 25% of participants over the age of 65, as well as give priority to groups that have been the most affected by COVID-19, including certain racial and ethnic minorities.

“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries,” said Gregory Glenn, president, research and development at Novavax.

“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,” he added,

In a phase 1 study of Novavax’s vaccine candidate, the shot produced high levels of antibodies against the SARS-CoV-2 virus, which causes COVID-19, after a single dose of the vaccine.

Participants treated with NVX-CoV2373 also demonstrated higher levels of antibodies after two doses compared the levels seen in recovered COVID-19 patients. The addition of its Matrix-M adjuvant also boosted the effect of the vaccine in the early stage study, Novavax reported.

Novavax has been awarded $1.6bn by the US government under the Operation Warp Speed scheme to accelerate the research and development of its vaccine candidates. Under the terms of the deal, Novavax will produce 100 million doses of its vaccine by the beginning of 2021, if it continues to prove effective in further clinical studies.

The UK government also signed a deal with Novavax in August, which led to the phase 3 clinical trial, and has also partnered with FUJIFILM Diosynth Biotechnologies to manufacture certain components of the vaccine in the UK.