Biontech annual report – Nasdaq

… Risk Factors: our future revenues from our COVID-19 vaccine are uncertain

… We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine

… and/or variant-specific formulations

… to obtain permanent regulatory approval in the United States, the United Kingdom, the European Union

… Risks Related to our COVID-19 vaccine: 

— the extent to which a COVID-19 vaccine continues to be necessary beyond the current pandemic, including when it becomes an endemic virus

— the durability of immune response generated by our COVID-19 vaccine, which has not yet been demonstrated in clinical trials

— the safety profile of our COVID-19 vaccine

— including if previously unknown side effects

— or increased incidence or severity of known side effects

… the burden of the disease may wane or dissipate such that our and other COVID-19 vaccines may be less essential from an individual and public health perspectives

… It is possible that subsequent data from these clinical trials may not be as favorable as data we submitted to regulatory authorities to support our applications for emergency use authorization

… or that concerns with the safety of our COVID-19 vaccine will arise from the widespread use

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

… mRNA-based medicines are designed not to irreversibly change cell DNA

… Currently, our COVID-19 vaccine is not classified as a gene therapy

             Pfizer