A couple highlights from SG’s letter to CDC
- DNA integration could theoretically impact a human's oncogenes - the genes which can transform a healthy cell into a cancerous cell.
- DNA integration may result in chromosomal instability.
- The Guidance for Industry discusses biodistribution of DNA vaccines and how such integration could affect unintended parts of the body including blood, heart, brain, liver. kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, the site of administration and subcutis at injection site.