https://www.sec.gov/Archives/edgar/data/0001776985/000156459020014536/bntx-20f_20191231.htm#ITEM_3_D

https://archive.md/gH3HE

BioNTech report 2019 to the SEC (Form 20-F)

and I quote:

"No mRNA immunotherapy has been approved, and none may ever be approved. mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new category of therapeutics."

"Currently,mRNA is considered a gene therapy product by the FDA."

"In addition, even if we successfully advance one of our product candidates into and through clinical trials, such trials will likely only include a limited number of subjects and limited duration of exposure to our product candidates.As a result, we cannot be assured that adverse effects of our product candidates will not be uncovered when a significantly larger number of patients are exposed to the product candidate. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of taking our product candidates over a multi-year period."