The new guidance provides recommendations for developers of SARS-CoV-2-targeting monoclonal antibodies during the COVID-19 public health emergency. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged. This guidance provides recommendations on efficient approaches to the generation of non-clinical, clinical, and chemistry, manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.

The revised guidance covering drugs and biological products more broadly, originally published in May 2020, describes the FDA’s current recommendations regarding phase 2 and phase 3 clinical trials for drugs and biological products under development to treat or prevent COVID-19, including the patient population, trial design, efficacy endpoints, safety considerations and the statistical considerations for such trials and more. Today, this guidance was updated to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of authorized COVID-19 vaccines. 

With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.