A review of fetal cell lines used during drug development: Focus on COVID-19 vaccines, transplant medications, and biologics.

Abstract

The recent coronavirus disease 2019 (COVID-19) pandemic and vaccine mandates have increased the number of patient questions related to how fetal cell lines are used during drug development and final manufacturing. This article describes our literature search and review of COVID-19 vaccines, transplant medications, and biologics whose development included use of fetal cell lines. A detailed literature search was conducted to identify the common fetal cell lines used in COVID-19 vaccine development; the two most prevalent fetal cell lines identified were HEK-293 and PER.C6. Subsequent literatures searches were conducted to identify transplant medications and biologics whose development included use of the HEK-293 or PER.C6 cell lines. For the COVID-19 vaccines, only the viral vector vaccine by Janssen was found to contain proteins produced by PER.C6 in the final preparation administered to patients, and Novavax is the only vaccine for which fetal cell lines were not directly involved in any portion of drug development. For transplant medications, many medications were studied in fetal cell lines in postmarketing studies after Food and Drug Administration approval; however, none of these medications contained fetal cells or would expose a patient to a fetal cell line. Many new biologics and cellular therapies for genetic diseases and malignancies have been directly developed from HEK-293 fetal cells or contain proteins produced directly from fetal cell lines. There were very few drugs reviewed that were found to contain HEK-293 or PER.C6 fetal cells or proteins derived directly from fetal cell lines; however, use of fetal cell lines in biologics and gene therapies will continue to increase. Healthcare providers should be mindful of patients' beliefs while also correcting common misconceptions about how these fetal cell lines are used throughout drug development and manufacturing.