Abstract
Description The world is in the midst of a pandemic from COVID-19, a disease caused by the virus SARS-CoV-2. Despite broad mitigation efforts, new cases continue with 74 million cases and 1.6 million deaths worldwide. Regardless of previous research efforts, there is no commercially available vaccine for any coronavirus. Novel vaccine development has historically taken at least 10 years from discovery to availability with only a 6% market entry probability. With the global impact, there is an urgency to expedite a vaccine to protect the population. The U.S. government launched Operation Warp Speed with the goal to produce and deliver 300 million doses of safe and effective vaccines by January 2021. Efforts toward this goal have included coordinated government agency support, parallel clinical trial deployment, de-risking manufacturing earlier in the development process and real-time U.S. Food & Drug Administration evaluation of the safety and efficacy data. Safety is a priority and key analysis has not been eliminated during the compressed timeframe. The two frontrunner candidates show promising efficacy rates for preventing COVID-19 with Moderna reporting 94.1% efficacy and Pfizer reporting 95.0% efficacy. Despite the herculean efforts by scientists to develop an effective vaccine in such a short timeframe, several national surveys suggest that public confidence in these vaccines is low with less than 50% of the survey respondents willing to be vaccinated. According to experts, the U.S. needs the vaccine to be at least 70-80% effective and a 70-80% vaccination rate in order to return to normal. Significant education and promotion is planned in coordination with the Centers for Disease Control.