To follow this plan, it’s important to make sure the FDA’s process is undisturbed. First, clinical trials must continue until they establish whether the vaccines cause a substantial reduction in the likelihood and severity of Covid infections without significant safety problems. These outcomes are monitored by independent experts who make up the data safety monitoring board for each trial. They, not politicians, should determine when there is sufficient evidence from the trial, and report on the trial’s findings.
Second, companies will need to present their evidence to the FDA in an application for emergency use. The FDA scientific staff will review it and report an assessment of the evidence, which will be shared publicly at a meeting of the FDA’s independent expert advisory committee. They’ll determine whether the standards for an emergency authorization have been met. The FDA has committed to a public advisory committee for each individual vaccine.
Next, the FDA will take what it has learned from this public airing of evidence to make a decision about emergency authorization. The decision will be reflected in a detailed written report.