Dr. Fauci’s comments came during a virtual press conference with National Institutes of Health Director Francis Collins, MDm PhD, “We’re beginning a Phase 3 trial that is very quick—it certainly is the world’s record—when one thinks from the time of the sequence to a Phase 3 trial,” Fauci said.ae0fcc31ae342fd3a1346ebb1f342fcb However, he was sure to emphasize that the remarkably fast approval process included “no compromise at all in safety or scientific integrity.” When asked specifically if the vaccine would potentially be approved as early as October—a development that could result in an “October surprise” before the general election in November—Fauci said it’s “conceivable,” and noted that the speed of the vaccine development may depend on another surge in cases. “If we have a real blast of a rash of infection in those sites in which we do have active enrollment [in trials], that you might get an answer earlier than November,” he said. “I doubt that, but we’re leaving an open mind that that might be possible.” Fauci repeated these points in a later interview with Fox News White House reporter John Roberts. “If you look at the accrual and the rate of accrual … you could project that you’ll get an answer [on FDA approval for the Moderna vaccine] sometime in the mid-to-late fall—that would be November, that could be October,” said Fauci. The immunologist’s take on the approval timeline for a vaccine is a not to be understated, as he has developed a reputation for telling hard-truths, while some detractors have labeled him an “alarmist.” Of course, FDA approval is the next critical step in the march toward having a publicly available vaccine. The subsequent production and distribution of such a vaccine will likely take several more months. And to learn more about potential COVID-19 vaccines, make sure you’re The Biggest Myth About the COVID Vaccine You Need to Stop Believing
