In my previous article, I reviewed Pfizer’s BNT162 non-clinical summary obtained via a successful freedom of information lawsuit by Judicial Watch[1]. Recently, an analogous set of materials became available for Moderna’s SPIKEVAX. Non-clinical testing is part of the drug or vaccine development process during which the product is tested in cell lines and animals.
The FDA Guidance documents for gene therapy platforms available prior to 2020 are 2013 (nonclinical Guidance[3]) and 2015 (clinical Guidance[4]), however, the FDA has been publishing guidance documents for cellular and gene therapies starting in 1998[5]. Therefore, an extensive body of regulatory knowledge regarding non-clinical and clinical testing requirements for this product class has been available for the past 20+ years.
These materials documented many serious risks, including death, potential to promote cancer, uncontrollable expression of proteins, genotoxicity, reproductive harm, and potential for transmission through “shedding,” among many others. The manufacturers and regulators both were expected to anticipate these risks and design testing programs to exclude or fully characterize them.