USA – Exclusion not necessary for EUA vaccine, therapeutic recipients

In an update to its guidance on conducting clinical trials amid the COVID-19 pandemic, the US Food and Drug Administration (FDA) on Wednesday explained COVID-19 treatments and vaccines used under an emergency use authorization (EUA) are not considered investigational products for the purposes of clinical trial exclusion criteria.

The guidance, first issued in March 2020, has been updated several times throughout the pandemic to address questions raised by industry about the conduct of clinical trials during the pandemic.

Many clinical trial protocols feature exclusion criteria that screens out participants who have received another investigational medical product. Under normal circumstances, unapproved vaccines and therapeutics are not in widespread use outside clinical trials or through expanded access. However, FDA has now issued EUAs for several therapeutics, including monoclonal antibodies developed by Eli Lilly and Regeneron and Gilead’s antiviral drugs Veklury (remdesivir), and vaccines developed by Pfizer and BioNTech and Moderna, to treat or prevent COVID-19 that have been administered to millions of individuals in the US…