By
Godfrey Benjamin
October 4th, 2023
Following the news about the progress with COVID-19 vaccine trials, Novavax shares which closed 0.86% higher on Thursday gained more than 7.33% in the pre-market.
American vaccine development company Novavax Inc (NASDAQ: NVAX) has revealed that it has commenced its late-large COVID-19 vaccine trials in the United Kingdom stirring a rise in the company’s shares in the pre-market. Per the official announcement, the trial involving Novavax (NVAX) COVID-19 vaccine candidate NVX-CoV2373, will enroll as much as 10,000 participants between the ages of 18 – 84 years.
According to NVAX, the COVID-19 vaccine trial is in partnership with the UK Government’s Vaccines Taskforce and would seek to evaluate the vaccine candidate’s efficacy, safety, and immunogenicity. The company also noted that the results from the stage 3 trial will be used in securing regulatory approval in the UK, EU, and other countries.
“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. “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,” added he.
Following this update, Novavax shares which closed 0.86% higher on Thursday gained more than 7.33% in the pre-market. The shares of Novavax have been seeing significant gains in 2020 recording a 71.7% jump in July alone.
Novavax Stage 3 COVID-19 Vaccine Trials
As detailed by the company, the stage 3 trial will span a period of about 4 to 6 weeks, during which it will adhere to transparent information sharing as the process progresses.
The UK-staged “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 a 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 have two primary endpoints which include 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, and 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.
While the company noted that an interim analysis will be performed when about 67% of these infections have been achieved, “the primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease,” Novavax affirmed.