REGULATORY UPDATE for Biotherapies: New FDA Guidance for Cellular and Gene Therapy Products During the COVID-19 Pandemic Addresses Eligibility After COVID-19 Vaccine

January 20, 2021

The Food and Drug Administration issued the guidance, Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, to provide manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products with risk-based recommendations to minimize potential transmission of SARS-CoV-2. This guidance is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s June 2020 guidance, Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry

The scope of this guidance applies to CGT products regulated by FDA’s Center for Biologics Evaluation and Research as biological products under section 351(i) of the PHS Act and as drugs under section 505 of the FD&C Act. This guidance does not apply to those human cells, tissues and cellular- or tissue-based products (HCT/Ps) regulated solely under section 361 of the PHS Act (42 U.S.C. 264), as described in 21 CFR 1271, or regulated as medical devices under the FD&C Act. 

The recommendations in this guidance address donor assessment, cellular or tissue source material, manufacturing and material testing. The recommendations will remain in effect only for the duration of the public health emergency and are being implemented immediately, without prior public comment. 

The recommendations issued in this guidance are consistent with information posted by FDA in the Jan. 4 safety and availability communication, Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic, including the recommendation that establishments not screen for or defer HCT/P donors who have been vaccinated against COVID-19 with non-replicating, inactivated or RNA-based COVID-19 vaccines.

The recommendations do not address donor eligibility following receipt of a live-attenuated vaccine. For FDA’s recent update on blood donor deferral following receipt of alive-attenuated vaccine, refer to Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation.