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mRNA "Vaccines" May cause Undesirable Side Effects That Could Prevent Their Regulatory Approval BioNTech SEC Filing
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mRNA "Vaccines" Are Gene Therapy. May cause Undesirable Side Effects That Could Delay Or Prevent Their Regulatory Approval According To BioNTech SEC Filing
The Truth About "Safe and Effective" mRNA "Vaccines" Hidden In Plain Sight
Excerpts:
Page 28
Currently, mRNA is considered a gene therapy product by the FDA.
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 following marketing approval, if any.
As with most biological products, use of our product candidates could be associated with side effects or adverse events which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. The potential for adverse events is especially acute in the oncology setting, where patients may have advanced disease, have compromised immune and other systems and be receiving numerous other therapies. Undesirable side effects or unacceptable toxicities caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or comparable regulatory authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects.
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