October 09, 2020

FDA Issues New Guidance on COVID-19 Vaccine Approval

On Tuesday afternoon, the FDA issued new guidance regarding the criteria it would be using when granting Emergency Use Authorization (EUA) for COVID-19 vaccines. The guidance largely consists of expected requirements for safety and effectiveness. FDA is now also recommending that COVID-19 clinical trials should include at least two months of follow-up after the trial participants complete the full vaccination regimen. This period of follow-up is expedited from the normal vaccine approval process, but makes the possibility of a vaccine being authorized prior to the election very slim