Novavax Inc. (Nasdaq: NVAX) has progressed their investigational vaccine product for COVID-19 called NVX-CoV2373 to Phase 3 to evaluate the efficacy, safety and immunogenicity of this candidate. Much of Novavax research occurs outside of the United States. For example, their Phase 1 trial occurred only in Australia. However, they expanded that study (NCT04368988) to include locations in the United States as well. Their other Phase 2 study (NCT04533399) is managed in South Africa. Now a Phase 3 study is being conducted in the United Kingdom (UK) in partnership with the UK Government Vaccines Taskforce and is expected to enroll up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.
Big U.S. Federal Grant with Ties to Vaccine Release in 2020
Novavax made it from small biotech to big time in early July when the company announced that the U.S. federal government via Operation Warp Speed awarded it $1.6 billion award to support completion of late-stage clinical development, including this Phase 3 clinical trial. The funds also go toward the establishment of major manufacturing capability and include the delivery of 100 million doses of their experimental vaccine candidate early as late 2020.
The UK Study
Gregory M. Glenn, MD, President, Research and Development for the company suggests that the UK is a good place for rapid completion because of the “…[H]igh 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.” Dr. Glen further elaborated that data generated from this specific trial will be used to support a regulatory filing for ultimate approval and license in the UK, EU and other countries.
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 the 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 the 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.
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
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