The trial is part of a randomized, observer-blinded, placebo-controlled efficacy study and consists 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 NVAX has awarded a $ 15 million grant to fund the trial, and the Coalition for Epidemic Preparedness Innovations (CEPI) has been set up to production of all doses used in this study, “as part of their coordinating global fax scaling-up and distribution efforts to enable worldwide equivalent access.” It should also be noted that if this study is successful, the Serum Institute of India is likely to provide vaccines, as part of a recently announced agreement to provide 1 billion doses for low- and middle-income countries.
What are the implications of the trial? Mamtani explained: “We believe that this Phase 2b clinical trial has the potential to provide an early reading on the effectiveness of vaccines, along with additional data on safety and immunogenicity, which ultimately led to the development of the late 2373 stage. In our view, this also provides options for an earlier Emergency Use Authorization (EUA) granted by the US FDA in the event of an overwhelmingly positive outcome, including prior to the completion of the Phase 3 study planned to next month in the US and Australia to begin adopting safety criteria will be met in terms of the number of subjects exposed to ‘2373.’
In addition, the trial can be very informative, as it takes place in South Africa amid a winter surge. According to Mamtani, the ‘infection / attack rate’ represents one of the most critical variables affecting timelines for data generation of major vaccine candidates who have progressed to late-stage clinical development, ‘with South Africa in fifth place. largest number of confirmed cases worldwide.
Based on 4 purchases and a lone sale, word on the street that NVAX is a moderate purchase. At $ 227.60, the average price target shows 56% upside potential. (See Novavax share price forecast on TipRanks)
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