Clinical trial to enroll up to 10,000 volunteers across the UK to assess whether NVX-CoV2373 is effective in the prevention of COVID-19
GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today 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 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.
"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, M.D., 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. 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."
NVX-CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology that includes Novavax' proprietary MatrixM™ adjuvant. 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.
Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.
About the Phase 3 Study
Consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic, Novavax will be publishing its UK study protocol in the coming days.
The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M 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.
The trial has two primary endpoints. The first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease. An interim analysis will be performed when 67% of the desired number of these cases has been reached.