German biotechnology company BioNTech SE admitted in a SEC filing that its product candidates “may not work” and their use “could result in patient injury or death”.
The following are just some of the alarming disclosures Germany’s biotechnology company BioNTech SE made in a SEC FORM F-1 REGISTRATION STATEMENT:
“use of our product candidates (Pfizer-BioNTech COVID-19 vaccine) could be associated with side effects or adverse events which can vary in severity from minor reactions to death & in frequency from infrequent to prevalent” BioNTech’s SEC filing
“Our product candidates may not work as intended, may cause undesirable side effects or may have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences ” BioNTech SE
“Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. … hospitals may have difficulty treating toxicities, … lead to more severe or prolonged toxicities or even patient deaths … hospitals may have difficulty observing patients and treating toxicities, which may be more challenging due to personnel changes, inexperience, shift changes, house staff coverage or related issues. This could lead to more severe or prolonged toxicities or even patient deaths, which could result in us or the FDA, EMA or other comparable regulatory authority delaying, suspending or terminating one or more of our clinical trials, and which could jeopardize regulatory approval. We also expect the centers using our product candidates, if approved, on a commercial basis could have similar difficulty in managing adverse events. Medicines used at centers to help manage adverse side effects of our product candidates may not adequately control the side effects and may have a detrimental impact on the efficacy of the treatment. Use of these medicines may increase with new physicians and centers administering our product candidates.” BioNTech SE
“We have incurred significant losses since our inception and we anticipate that we will continue to incur significant losses for the foreseeable future.”
Source: BioNTech SEC Filing