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Regulatory Focus™ > News Articles > 2021 > 1 > FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients

FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients

Posted 28 January 2021 | By Michael Mezher 

FDA: 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.
This has led to some confusion among clinical trial sponsors as to whether the use of unapproved therapeutics or vaccines under an EUA would bar recipients from participating in clinical trials with such exclusion criteria.
“When a medical product is being used under an EUA, it is an authorized (though not an approved or cleared) medical product for use in clinical care that has met statutory criteria under section 564 of the [Federal Food, Drug, and Cosmetic Act] FD&C Act,” FDA writes.
The agency further clarifies that because a vaccine or therapeutic used under an EUA is not being studied under an investigational new drug application (IND) or investigational device exemption (IDE), it does not consider the clinical use of EUA products to be investigational.
“In contrast, when the same product is used in a clinical investigation under an IND or IDE, the product’s safety and/or effectiveness is being studies for investigational uses, and FDA would consider receipt in this situation to be receipt of an investigational product,” FDA writes.
FDA further explains that this interpretation does not prevent sponsors from having such exclusion criteria. “As always in the design of a clinical investigation, there may be valid scientific reasons to have an exclusion (and even a discontinuation) criterion for a medical product … whether that product was used under an EUA or not.” For example, use of an excluded product may pose a risk to participants in a trial or could potentially impact the trial by confounding its results.


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