@Patent_SUNon X · 2026-09-11
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I had overlooked one critical point. Example 11 of BioNTech patent, WO2021213924A1, directly connects the starting plasmid vector used for BNT162b2 to the Mainz/BioNTech vector platform that traces back to pCMV-Script, which contains SV40-derived elements.[1–3] Moreover, the authors of these papers overlap with the inventors named in the BNT162b2 patent. Accordingly, the proposition that BioNTech was unaware of the vector lineage of BNT162b2 is no longer consistent with the disclosures in its own literatures. Then, with respect to this plasmid, which inherited a vector backbone derived from an Research Use Only vector,[4] under what legal and regulatory framework did they perform its characterization, qualification, and risk assessment? Furthermore, although the complete sequence had been submitted to the regulatory authorities from the outset,[5] why were the SV40-derived legacy elements contained in that known lineage not specifically highlighted or annotated as individual elements? And why were the origin, source, location, and function of these elements, as well as an element-specific assessment, explicitly added only later, in 2023–2024?[6] In light of the development history disclosed by BioNTech itself, all of this should have been submitted from the outset.
Lineage of “For Research Use Only” Vectors The Rapporteur Rolling Review Critical Assessment Report, which assessed the application materials submitted by BioNTech to the EMA, contains a plasmid map of pST4-1525 (7,824 bp), the plasmid used for the manufacture of BNT162b2. https://t.co/TbxctVggxx https://t.co/vqcOXG8izN
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