Novavax’s NVX-CoV2373: Still a Top Contender Despite Delays

GlobalData forecasts that Novavax’s investigational Covid-19 vaccine NVX-CoV2373 will still be the second-leading vaccine candidate after BioNTech/Pfizer’s Comirnaty based on peak forecast sales despite facing delays.

NVX-CoV2373 is forecast to have $33.3bn total sales for 2021–2027, according to a Q1 2021 drug sales analyst consensus forecast from GlobalData’s Pharma Intelligence Center Drug Sales and Consensus Forecast Database. NVX-CoV2373 is a protein-based subunit vaccine derived from the coronavirus spike (S) protein and developed using Novavax’s proprietary recombinant nanoparticle vaccine technology. The vaccine candidate has demonstrated a potent efficacy of 96.4%, which is on a par with the leading vaccine candidates from Pfizer/BioNTech and Moderna, making it a strong contender among the second wave of vaccines to enter the market.

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Novavax expects to receive UK and US Food and Drug Administration (FDA) approval in Q2 2021 after recently reporting promising results from the final analysis of its phase III UK trial. Although Novavax’s phase III trial in the US is still ongoing, the company expects that the FDA will allow it to use UK trial data for emergency use authorisation. Novavax started the rolling review process of its vaccine candidate with several regulatory agencies in February, including the European Medicines Agency (EMA), FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), and Health Canada.

NVX-CoV2373 is expected to generate $1.8bn in sales in 2021 and have a steady sales growth through 2027, with a peak of $7.2B expected in 2027 (Figure 1). Novavax’s vaccine has many advantages to help its uptake. In addition to showing high efficacy against the original strain of the virus, it has also been shown to be 86.3% effective against the newer UK variant, which will help boost the vaccine roll-out in the UK once approved. As the vaccine is stable and can be stored at refrigerator temperatures, this may allow for wider distribution.

The results from NVX-CoV2373’s phase IIb trial conducted in South Africa have been less promising. The vaccine demonstrated an overall efficacy of 48.6% against predominantly variant strains circulating in the trial region and 55.4% efficacy among human immunodeficiency virus-negative participants. Nevertheless, across both the UK and South Africa trials, NVX-CoV2373 has demonstrated 100% protection against severe disease, including all hospitalisation and death.

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If NVX-CoV2373 receives approval, it will boost the vaccine roll-out across multiple geographies in H2, which will help bring the pandemic under control.