Stephen Hahn, commissioner of the Food and Drug Administration penned an editorial in the August 5 issue of The Washington Post, stating: ” But let’s be clear: The development effort must adhere to standards that will ensure any COVID-19 vaccine’s safety and effectiveness.” The FDA stated that any authorized or approved COVID-19 vaccine must demonstrate that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated, suggesting that this 50% threshold is appropriate for the current pandemic.
FDA has also stated a testing requirement that assures vaccine clinical development include diverse populations most affected by COVID-19, including racial and ethnic minorities, elderly, and people with medical conditions. Many of these populations are often excluded from typical drug development.
The FDA has stated that they will closely monitor the safety of any vaccine after authorization or approval.
The editorial makes no mention of trial design or the use of real-world evidence trials.
(Source: Hahn SM, Washington Post, August 5, 2020)