COVID-19 Vaccine Candidate Goes into Phase 3 Trial in UK

Novavax, a biotech company based in Gaithersburg, MD., announced late yesterday it had initiated a phase 3 trial for its COVID-19 vaccine, NVX-CoV2373, in the United Kingdom (UK).

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

The study will look at the efficacy, safety, and immunogenicity of NVX-CoV2373.

The trial is being conducted in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M—the company’s proprietary adjuvant—administered 21 days apart, while half of the trial participants will receive placebo.

The trial is designed to enroll at least 25 percent of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

NVX-CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology that MatrixM. The vaccine has a favorable product profile that 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.

Previous studies have shown the vaccine was observed to be safe and elicited an immune response. The results were published in The New England Journal of Medicine.

The vaccine is currently in ongoing phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

Back on September 15, the company announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373. With this agreement, Novavax increases its manufacturing capacity of its vaccine to over 2 billion doses annually, when all planned capacity has been brought online by mid-2021.