This week kicked off with a bang, as Novavax (NVAX) took another step forward in the COVID-19 vaccine race. On Monday August 17, the biotech announced the start of the Phase 2b trial of NVX-CoV2373, its adjuvanted recombinant protein COVID-19 vaccine candidate, in South Africa.
The trial is part of a randomized, observer-blinded, placebo-controlled efficacy study and is comprised of two cohorts. Cohort 1 will assess the candidate’s efficacy, safety and immunogenicity in approximately 2,665 healthy volunteers, while the second will evaluate the vaccine in 240 medically stable, HIV-positive adult patients.
5-star analyst Mayank Mamtani, of B.Riley FBR, points out that the Bill & Melinda Gates Foundation awarded NVAX a $15 million grant to fund the trial, and the Coalition for Epidemic Preparedness Innovations (CEPI) is set to fund the manufacturing of all doses used in this study, “as part of its coordinating global vaccine scale-up and distribution efforts to enable global equitable access.” It should also be noted that if this study is successful, the Serum Institute of India will likely supply vaccines, as part of a recently announced agreement to supply 1 billion doses for low- and mid-income countries.
What are the implications of the trial? Mamtani explained: “We believe this Phase 2b clinical trial has the potential to provide an early readout on vaccine efficacy, along with additional safety and immunogenicity data, which ultimately could further de-risk late-stage development of '2373. In our view, this also offers optionality for an earlier Emergency Use Authorization (EUA) granted by U.S. FDA in case of an overwhelmingly positive outcome, including prior to the completion of Phase 3 study planned to commence next month in U.S. and Australia assuming safety criteria is met in terms of number of subjects exposed to '2373.”
Additionally, the trial could be highly informative as it is taking place in South Africa amid a winter surge. According to Mamtani, the “infection/attack rate represents one of the most critical variables impacting timelines for data generation from major vaccine candidates who have progressed to late-stage clinical development,” with South Africa boasting the fifth largest number of confirmed cases globally.
It should come as no surprise, then, that Mamtani stands squarely with the bulls. To this end, the top analyst rates NVAX a Buy and gives it a $257 price target, implying 76% upside potential. (To watch Mamtani’s track record, click here)
Based on 4 Buys and a lone Sell, the word on the Street is that NVAX is a Moderate Buy. At $227.60, the average price target indicates 56% upside potential. (See Novavax stock-price forecast on TipRanks)
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