How do EUAs for COVID-19 vaccines affect IBC oversight requirements for ongoing clinical trials?
—Research Project Manager, Gene Therapy Sponsor
There are at least a dozen mRNA, DNA, or virally vectored COVID-19 vaccines currently being tested in clinical trials. Given their composition, administration of such vaccines to research subjects constitutes human gene transfer under the NIH Guidelines, meaning IBC oversight is likely required at each individual trial site. Of note, the NIH Guidelines apply to research, irrespective of a product’s FDA emergency use authorization (EUA) or approval status; if a subject is enrolled in a human gene transfer research trial, the fact that the gene transfer product has an EUA or is approved for use does not exempt that research from IBC oversight.
As EUAs for the aforementioned COVID-19 vaccines are issued, many sponsors are amending existing clinical trial protocols to allow previously-blinded placebo recipients to receive active vaccine. Importantly, subjects in these amended protocols are being vaccinated and followed as part of the clinical trial itself, rather than under the umbrella of an EUA outside of a clinical trial. Because of this, continued IBC oversight of such research is required. Sites should work with their IBCs to ensure compliance obligations are met, particularly as EUA issuance may lead to two groups of people receiving the same vaccine at the same site, but with differing oversight, biocontainment, and safety requirements.