Operation Warp Speed (OWS) is a partnership formed in May 2020 between the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector, with the goal of developing and distributing a COVID-19 vaccine by end of 2020. Unfortunately, the name can be misleading. Operational Warp speed helped expedite the vaccine process, but all steps were still appropriately taken. The NEJM and MDH resource below provides a summary of Operation Warp Speed and the process of vaccine development.
COVID-19 vaccines were tested in large clinical trials to make sure they met safety standards. Many people participated in the trials from different ages, races, ethnicities, as well as those with different medical conditions. There are two advisory groups that review data from the trials. The Vaccine and Related Biological Products Advisory Committee (VRBPAC) advises the FDA and the Advisory Committee on Immunization Practices (ACIP) advises the CDC. The COVID-19 vaccines will be continually monitored for safety after authorization.
The genetic sequence of the virus was published very early which provided the underlying code for the spike protein on the virus. It also closely resembled other coronaviruses that researchers and vaccine makers have studied which gave a base of knowledge for the development of these vaccines. mRNA vaccines in particular are faster to make as you don’t have to wait for the virus to grow in large quantities and then chemically activate it. Recruitment for subjects for clinical trials was also easier and we had a large burden of disease in this country to get the necessary data to obtain results.