The Centers for Disease Control and Prevention (CDC) has been organizing the logistics for an eventual distribution of a successful vaccine. For example, agencies such as UPS, which would be involved in distributing the vaccines rapidly, have been going through in-house drills, with a deadline of Nov. 1 to be ready. Moderna and Pfizer have been undergoing Phase 3 clinical trials for several weeks now, and may have enough statistical clarity to be recommended for distribution as early as October. In fact, a vaccine may be ready and waiting to go, prior to the nation’s logistical readiness to distribute and deploy the vaccine. The CDC has been involved in organizing the states, e.g., to prepare distribution sites, also with a deadline of Nov. 1.
The Data and Safety Monitoring Board (DSMB) oversees the progress of the double-blind trials. NIH Dr. Anthony Fauci explained, “If things are done according to tradition, the DSMB looks at the data intermittently, and makes one of four determinations.” They can simply approve of the procedures, with the trial continuing. They can make recommendations to be implemented. If adverse effects occur, they can stop the trial and flunk the vaccine. However, if the vaccine is shown clearly effective before exhausting the 30,000 cases, the trial can be judged proven and the vaccine judged to work. Specifically, if the total cases of COVID-19 are significantly less than expected for the population in the study, the vaccine would be assumed to be significantly effective. The DSMB would then recommend the vaccine to the FDA, which could grant an Emergency Use Authorization. The latter is designed to balance public health needs with scientific standards. This is all standard operating procedure, not something invented for COVID-19.
