By Pavel Ryzhov, Ph.D.
With COVID-19 cases escalating around the world, there is an urgent need for a safe and efficacious vaccine. However, the complexity of the R&D process and required rigorous clinical testing is extending the timeline of approval.
Cambridge, MA-based Moderna, Inc. has been at the forefront in conducting human trials for its messenger RNA (mRNA) based vaccine candidate (mRNA-1273). The vaccine is a prefusion stabilized form of the Spike (S) protein found on the surface of the virus that is responsible for binding to cells via its interaction with angiotensin-converting enzyme 2. On July 27th, Moderna announced the commencement of the randomized, placebo-controlled Phase 3 study (NCT04470427) against COVID-19, testing mRNA-1273 dosage of 100 μg.
The primary endpoint is the prevention of symptomatic COVID-19 disease, and secondary endpoints are prevention of severe COVID-19 (requiring hospitalization), and prevention of infection by SARS-CoV-2 regardless of symptoms. Furthermore, the primary efficacy analysis will constitute an event-driven analysis based on the number of symptomatic COVID-19 disease participants.
The Coronavirus Efficacy (COVE) study is done in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), Biomedical Advanced Research and Development Authority (BARDA) and a leading global contract research organization PPD. Just a day earlier, the company announced a modification to its contract with BARDA for an additional $472 million funding to support the study. These partners have already been involved in the prior stages of the vaccine development, with PPD providing clinical and laboratory services, study design, and patient enrollment.
The trial aims to enroll 30,000 participants in the US across nearly 100 clinical research sites. Moderna wants to prioritize the diversity of the population, citing it as the key to accurate and fair representation of the highest COVID-19 risk communities.
The announcement follows the streak of preceding milestones going back to the beginning of the pandemic. The first participant of Phase 1 clinical trial was enrolled on March 16th, a mere 63 days after the sequencing of the complete coronavirus genome, with interim analysis of the study recently published in The New England Journal of Medicine. The Phase 2 trial began in May and has since fully completed its patient enrollment in both age cohorts (18-55 and 55+, n=300 each).
An important consideration in vaccine development is the downstream scaling of manufacturing capabilities. To address that, Moderna’s other strategic partners, Lonza and Catalent, are involved in the preparations, aiming to deliver approximately 500 million to 1 billion vaccine doses per year, starting in 2021.
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