Novavax shared the latest data from its ongoing late-stage COVID-19 vaccine trial, which shows that its yet-to-be authorized shot provides 100 percent protection against moderate and severe disease and has an overall efficacy of 90.4 percent, including against variants of concern.
The company’s candidate recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373, is being evaluated in the PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19) Phase III trial, which has close to 30,000 participants across 119 states in the US and Mexico. In the late-stage study, the company has committed to enrolling a representative population of communities and demographic groups most impacted by the disease.
With promising efficacy results and preliminary data showing that the vaccine is safe, Novavax’s shot will be a welcome addition to the global COVID-19 vaccine efforts. However, there are still a few months until it can join the club as Novavax says it will likely be the end of September when the company will be ready to submit applications for regulatory approvals. Novavax says it still has to complete the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.
Upon regulatory approvals, Novavax is on track to reach a manufacturing capacity of 100 million doses per month by the end of September and 150 million doses per month by the end of the year.
PREVENT-19 is a randomized, placebo-controlled, observer-blinded study that is evaluating the safety, efficacy and immunogenicity of NVX-CoV2373, which contains Novavax’s patented saponin-based Matrix-M adjuvant.
The trial achieved its primary endpoint of prevention of PCR-confirmed symptomatic COVID-19. In the analysis, a total of 77 cases of COVID-19 were observed of which 63 were in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild. There were ten moderate cases and four severe cases, all in the placebo group, giving rise to a vaccine efficacy of 100 percent against moderate or severe disease.
The candidate vaccine also demonstrated an efficacy of 93.2 percent against variants of concern (VoC) and variants of interest (VoI), which represented 82 percent of the cases. Thirty-eight of the VoC/VoI cases were in the placebo group and six in the vaccine group.
The Centers of Disease Control and Prevention (CDC) define a VoC as a variant for which there is evidence of increased transmissibility, more severe disease, significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures. VoIs are variants with specific genetic markers associated with receptor binding changes, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact, or predicted increase in transmissibility or disease severity.
Novavax’s COVID-19 vaccine also showed positive results among high-risk populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure). Among these groups, vaccine efficacy was 91 percent, based on 62 COVID-19 cases observed in the placebo group and 13 in the vaccine group.
In May, Gavi, the vaccine alliance, announced it had signed an advanced purchase agreement (APA) to buy 350 million doses of Novavax’s vaccine, secured on behalf of the global COVAX facility global vaccine distribution initiative. Deliveries of the doses are expected to begin in the third quarter upon regulatory approvals. COVAX has been facing critical shortages of vaccines after its biggest supplier, the Serum Institute of India, suspended exports until the end of the year as India’s COVID-19 cases have been soaring, creating an urgent demand for vaccines.