An urgent request has come from the CDC to evaluate an investigational vaccine designed to protect against COVID-19 (Corona Virus) given the high number of people that have become infected in the United States. The open-label, phase 1 trial will enroll 45 healthy adult volunteers, ages 18-45 for 6 weeks. The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. The vaccine is called mRNA-1273 and was developed by a biotechnology company called Moderna. At the end of this 6-week trial, positive results were found for a specific dose of the vaccine. The vaccine is ready for a phase 2 trial, but the lead scientist of the project comes to your team at the FDA with a request to skip phase 2 and 3 trials and bring the vaccine to market now.
Would you be willing to approve this request? Explain your response.
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