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Abstract
Governments, bilateral and multilateral organizations, nongovernmental organizations (NGOs), and the private sector rapidly recognized the need for the funding of extensive vaccine research, development, manufacturing, and clinical trials to rapidly advance several vaccines to meet global demand. Funding for vaccines studied in the US was provided by several organizations/governments, including but not limited to the Coalition for Epidemic Preparedness Innovations (CEPI), the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services, the German government, the Wellcome Trust, and the UK Department for International Development [13–17]. To put the size of these studies in perspective, safety and efficacy for other vaccines that have been licensed was demonstrated in clinical trials ranging from ~1000 subjects for varicella and hepatitis A vaccines, ~70,000 for rotavirus vaccines, ~5000 for H. influenzae vaccine, and ~15,000 for the more recently approved zoster vaccine [21–27].5.3 Safety follow-up “A high degree of safety is a primary goal for any widely used vaccine” [10]. An independent Data Safety Monitoring Board (DSMB) was convened; the sole responsibility of this board was to conduct multiple reviews of safety data in each trial to ensure that no harm was done to study participants and to stop any study in which the results were futile.5.4 Parallel conduct of trials While standard processes were followed for the design and conduct of clinical trials, innovation played an important role in expediting study conduct.