Prama Ghosh, Amity University Kolkata
An interim review shared by an independent data and safety monitoring board (DSMB) about mRNA-1273 – a COVID-19 vaccine overseeing its Phase 3 trial suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults after its interim analysis with the trial oversight group on Nov. 15, 2020.
The data from the interim analysis which comprised 95 cases of symptomatic COVID-19 among volunteers reported that the candidates were safe and the efficacy rate of the vaccine was 94.5%. The vaccine was well tolerated by the volunteers.
The mRNA-1273 vaccine candidate co-developed by Moderna, Inc., a Cambridge, Massachusetts-based biotechnology company and the National Institute of Allergy and Infectious Diseases (NIAID) as a part of the National Institutes of Health combines mRNA (messenger RNA) from Moderna as a delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists.
Results from earlier stage clinical testing which included more than 30,000 participants at 100 clinical research sites in the United States indicated that the vaccine candidate is well-tolerated and immunogenic.
The Phase 3 vaccine efficacy trial of the vaccine which is known as COVE was sponsored by Moderna and begun under a multi-agency collaboration led by HHS and the Department of Defense known as Operation Warp Speed (OWS). The trial was funded by Biomedical Advanced Research and Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases (NIAID).
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