Article | April 15, 2020

How Sites Can Prepare For COVID-19 Genetically Engineered Vaccine Studies

Source: Advarra

By Daniel Eisenman, Ph.D., RBP, SM(NRCM), CBSP, Director of Biosafety Services

cell and gene therapy

The global pandemic caused by the coronavirus (SARS-CoV-2) and the disease it causes (COVID-19) has brought vaccine research to the forefront. Currently available genetic engineering techniques and the available SARS-CoV-2 genome sequence provide a wealth of opportunities for research and development of new vaccines. In fact, the most prominent vaccine candidates contain engineered genetic material.

In particular, these candidates work with the gene encoding the virus’ spike protein. This approach is comparable to a subunit vaccine in the sense that the vaccine only delivers the key target antigen for the immune system to attack without the added risk associated of utilizing an attenuated or killed coronavirus.

Clinical researchers are likely familiar with the regulatory requirements pertaining to the Food and Drug Administration (FDA) phases of research, as well as with institutional review board (IRB) review. But they may not be aware that research involving investigational products containing engineered genetic material may also require review by an institutional biosafety committee (IBC).

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