EUROPEAN MEDICINES AGENCY (EMA): Plasmid used for the manufacture of BNT162b2 (VACUNA PFIZER-BioNTECH COVID-19)

 

Patent SUN

@Patent_SUN

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. However, this plasmid map does not display the SV40-derived sequence present in the plasmid backbone.[1] 

 

An important fact is that what is omitted from this map is not simply a generic SV40 sequence, but an SV40-derived sequence originating from pCMV-Script, a vector designated “For Research Use Only.” In other words, what is omitted from the Report is an SV40-derived sequence originating from the pCMV-Script, which Stratagene (now Agilent) commercialized as a research-use product rather than as a product for pharmaceutical or clinical use. 

 

Tracing the backbone containing the SV40-derived sequence found in BioNTech's mRNA vaccine manufacturing plasmids leads back to the Stratagene's pCMV-Script. The pCMV-Script is a mammalian expression vector commercialized by Stratagene in 1997. The designation of this vector for research use can be traced not merely to Agilent's current labeling, but to Stratagene's own trademark record dating from the time the product was first commercialized in 1997. 

 

On July 29, 1997, Stratagene filed a U.S. trademark application for “PCMV-SCRIPT” (Serial No. 75332337; Registration No. 2178551).[2] The trademark record identifies Stratagene as both the Original Applicant and Original Registrant and describes the goods as: “kits for gene cloning containing laboratory reagents for research use; laboratory reagents for use in molecular biology” 

 

The record further identifies August 1997 as both the First Use Anywhere and the First Use in Commerce. Thus, the “research use” designation can be traced back to the original commercialization of PCMV-SCRIPT by Stratagene in 1997, when it was registered as a research-use product for gene cloning and molecular biology. 

 

This designation was maintained in subsequent manufacturer documentation. Agilent's official Instruction Manual for the pCMV-Script Vector itself (Catalog #212220) states on its cover: 

 “For Research Use Only. Not for use in diagnostic procedures.”[3] 

 

An even more important fact is that the relationship between the pCMV-Script and the Mainz/BioNTech pST plasmid lineage was expressly documented by the Mainz research group, the group from which BioNTech emerged. 

 

In a 2006 paper, Holtkamp, Kreiter, Türeci, Şahin and colleagues at Johannes Gutenberg University Mainz reported that pST1-2β-globin UTR-A(120) was constructed by introducing a T7 promoter, two tandem human 3′ β-globin UTRs, a poly(A) tail, and a neomycin-resistance gene into the pCMV-Script Vector (Stratagene, La Jolla, CA), and described this construct as the “ancestor” of a subsequent series of vectors.[4] 

 

Another paper from the same Mainz group describes this relationship even more directly: 

 

“All vectors used were variants of the pST1-A120 plasmid, which we engineered from the pCMV-Script vector…”[5] 

 

Accordingly, the vector ancestry from the Stratagene pCMV-Script (research use) to the Mainz pST1 (research use) is not an inference based solely on sequence similarity; it is directly documented in publications by the developers themselves. The pST vector platform subsequently developed in Mainz evolved into a DNA-template platform for the production of mRNA by in vitro transcription (IVT). 

 

The Rolling Review Critical Assessment Report, which assessed the BNT162b2 quality documentation submitted by BioNTech to the EMA, states that the drug substance is manufactured using a linear DNA template and that this template is produced from plasmid DNA amplified in DH10B Escherichia coli. 

 

That plasmid is pST4-1525, which is described as follows: 

 

 “The plasmid, pST4-1525, is a 7,824 base pair plasmid designed for the production of BNT162b2.”[1]

 

Figure S.2.3-1, “pST4-1525 Plasmid Map,” in the same document displays the T7 promoter, 5′ UTR, Kozak sequence, S protein, FI element, poly(A), KanR, ori, and other features, whereas the SV40-derived sequence present in the backbone is not identified as a feature on the map.[1] 

 

Independently of this documentary genealogy, publicly available nucleotide sequences are also consistent with this lineage. The complete sequence of pCMV-Script is deposited in NCBI GenBank as AF028239.1, a 4,278-bp “Mammalian expression vector pCMV-Script.”[6] The Pfizer bivalent BNT162b2 expression vector is deposited in GenBank as OR134577.1, with a length of 7,810 bp.[7] 

 

Direct comparison of the two sequences identifies a continuous 3,469-bp corresponding region between: AF028239.1 nt 810–4278, and OR134577.1 nt 118–3586 

 

Of these 3,469 nucleotides, 3,468/3,469 (99.97%) are identical. There is only a single nucleotide difference, which is explicable by the inheritance of a known pUC-lineage backbone mutation, and there is no insertion or deletion in the alignment. The conserved region also contains the SV40-derived sequence at issue.[6,7] Thus, the SV40-derived sequence found in OR134577.1 does not exist as an isolated SV40 fragment; rather, it occurs within an approximately 3.47-kb conserved pCMV-Script backbone region. 

 

Thus, on the basis of the developmental continuity can be traced as follows: 

 

Stratagene pCMV-Script (Research Use Only) → Mainz pST1 → pST family → pST4-1525 → BNT162b2 manufacturing, with the pCMV-Script-derived research-use backbone retained through the lineage. 

 

Taken together, the evidence establishes the following facts concerning pCMV-Script: 

 

 (1) The pCMV-Script is a mammalian expression vector commercialized by Stratagene in 1997 as a research-use product. This designation can be traced back to Stratagene's PCMV-SCRIPT trademark record from the time of the product's original commercialization.[2] 

 

(2) The official Instruction Manual for the pCMV-Script itself states “For In Vitro Use Only,” and Agilent currently designates the product “For Research Use Only.”[3] 

 

(3) Şahin, Türeci, Holtkamp, Kreiter and colleagues in Mainz themselves reported that pST1 was engineered from this pCMV-Script vector.[4,5] 

 

(4) The publicly available Pfizer bivalent expression vector OR134577.1 contains an approximately 3.47-kb continuous region that is 99.97% identical to the pCMV-Script, and this conserved region includes the SV40-derived sequence.[6,7] 

 

(5) The Rolling Review Critical Assessment Report assessing the BNT162b2 quality documentation submitted by BioNTech to the EMA identifies pST4-1525, a member of the pST lineage, as the plasmid used for BNT162b2 production and reproduces its plasmid map.[1]

 

(6) However, the Rolling Review Critical Assessment Report does not identify on the pST4-1525 plasmid map the SV40-derived sequence carried forward through the vector lineage from pCMV-Script, a vector designated “For Research Use Only” and “For In Vitro Use Only.”[1,3,6,7]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LA CONTESTACIÓN DE LA DELEGACIÓN DEL GOBIERNO EN MADRID A LA COMUNICACIÓN DEL ALCALDE DE MADRID (III)

 

 

 Principales consideraciones de la contestación de la Delegación del Gobierno:

1)  Sobre la  atribución del derecho de reunión principalmente a las personas físicas. Ni los alcaldes ni los ayuntamientos pueden ser titulares del derecho de reunión

El derecho de reunión como cualquier otro es atribuido a las personas, pero su finalidad es la de amparar el resultado de su ejercicio: la reunión o asamblea de una pluralidad de individuos con cualesquiera fines legítimos, incluidos los de la defensa de la autonomía municipal. 

Los alcaldes y los ayuntamientos pueden convocar a sus vecinos para el ejercicio del derecho de reunión en cualquiera de sus sedes y éstos pueden ejercitarlo también sin necesidad de dicha convocatoria. Esto último sería suficiente para considerar legítima y fundada cualquier convocatoria realizada por un municipio o una federación de municipios.

La autonomía local es un derecho constitucional que corresponde a los municipios y estos pueden ejercitar la misma en defensa de sus derechos por cualquier medio lícito incluido el derecho de reunión de sus vecinos ante las sedes municipales.

El TEDH ha declarado expresamente que el derecho de reunión protege las asambleas municipales y a sus miembros y, por tanto, también cualquier reunión de vecinos dirigida a defender su autonomía:

 "Official meetings, notably parliamentary sessions, also fall within the scope of Article 11 (Forcadell i lluis v. Spain (dec.), 2019, § 24)."

2) A las Administraciones Publicas solo se les reconocen derechos fundamentales  cuando su contenido coincide con la función que cumplen en la estructura constitucional

Esta y cualquier otra interpretación restrictiva del derecho de reunión en el caso considerado está claramente excluida por el TEDH y es además incompatible con la autonomía local, en la medida en que la actuación considerada está vinculada a la defensa constitucional de la autonomía local de un municipio:

 "In view of its importance the right to freedom of assembly should not be interpreted restrictively(Kudrevičius and Others v. Lithuania [GC], 2015, § 91; Tsaava and Others v. Georgia [GC], 2025, § 414).
To avert the risk of a restrictive interpretation, the Court has refrained from formulating the notion of an assembly or exhaustively listing the criteria which would define it (Navalnyy v. Russia [GC], 2018, § 98)."

3)  No cabe que la organización municipal, o la federación de municipios, sea titular de un derecho que consiste en concitar una asociación transitoria de personas

La organización municipal no "concita" nada, simplemente  actúa para posibilitar el ejercicio del derecho de reunión previsto en el espacio público de su sede y lo hace con arreglo a lo establecido en el artículo 4º de la Carta Europea de la Autonomía local.

Puede concluirse, por ello, que la Delegación de Gobierno podía y debía haberse ahorrado sus consideraciones claramente erróneas y restrictivas del derecho en cuestión.

No más afortunadas fueron sus conclusiones:

 

Debió tramitarse la comunicación recibida por ser la misma totalmente legítima y fundada con arreglo a todo lo anterior y a la Ley Orgánica 9/1983:

Artículo octavo.

La celebración de reuniones en lugares de tránsito público y de manifestaciones deberán ser comunicadas por escrito a la autoridad gubernativa correspondiente por los organizadores o promotores de aquéllas, con una antelación de diez días naturales, como mínimo y treinta como máximo. Si se tratare de personas jurídicas la comunicación deberá hacerse por su representante.

Cuando existan causas extraordinarias y graves que justifiquen la urgencia de convocatoria y celebración de reuniones en lugares de tránsito público o manifestaciones, la comunicación, a que hace referencia el párrafo anterior, podrá hacerse con una antelación mínima de veinticuatro horas.

Artículo noveno.

1. En el escrito de comunicación se hará constar:

a) Nombre, apellidos, domicilio y documento oficial de identificación del organizador u organizadores o de su representante, caso de personas jurídicas, consignando también la denominación, naturaleza y domicilio de éstas.

b) Lugar, fecha, hora y duración prevista.

c) Objeto de la misma.

d) Itinerario proyectado, cuando se prevea la circulación por las vías públicas.

e) Medidas de seguridad previstas por los organizadores o que se soliciten de la autoridad gubernativa.

2. La autoridad gubernativa notificará al Ayuntamiento afectado los datos contenidos en el escrito de comunicación, excepto cuando se trate de una convocatoria urgente de las previstas en el párrafo segundo del artículo anterior, a fin de que éste informe en un plazo de veinticuatro horas sobre las circunstancias del recorrido propuesto. En caso de no recibirse el informe en dicho plazo, el mismo se entenderá favorable. El informe se referirá a causas objetivas tales como el estado de los lugares donde pretenda realizarse, la concurrencia con otros actos, las condiciones de seguridad de los lugares con arreglo a la normativa vigente y otras análogas de índole técnico. En todo caso, el informe no tendrá carácter vinculante y deberá ser motivado.

Considerar, como hace la Delegación del Gobierno en Madrid en un asunto de notoria importancia constitucional, que las personas jurídicas privadas pueden convocar y promover reuniones -y comunicarlas-, pero que no pueden hacerlo los Ayuntamientos y su Federación es un resultado " (in) constitucional" notable, teniendo en cuenta lo que dispone el artículo 9.2 de la Constitución:

"Corresponde a los poderes públicos promover las condiciones para que la libertad y la igualdad del individuo y de los grupos en que se integra sean reales y efectivas; remover los obstáculos que impidan o dificulten su plenitud y facilitar la participación de todos los ciudadanos en la vida política, económica, cultural y social"

También a los Ayuntamientos y a su Federación.Lo que lícitamente en este caso hicieron.

Y no menos a la Delegación del Gobierno en Madrid y a su Delegado (Francisco Martín Aguirre), que ignoró cualquier consideración -que resultaba obligada- del mismo. Invocando, supuestamente, los principios constitucionales. 

LA CONVOCATORIA DE CONCENTRACIONES DE LA FEDERACIÓN ESPAÑOLA DE MUNICIPIOS Y PROVINCIAS PARA EL DÍA 2-09-2026(II)

 

 

Carta Europea de Autonomía Local. Hecha en Estrasburgo el 15 de octubre de 1985

 «El Reino de España declara que la Carta Europea de la Autonomía Local se aplicará en todo el territorio del Estado en relación con las colectividades contempladas en la legislación española de régimen local y previstas en los artículos 140 y 141 de la Constitución. No obstante, el Reino de España únicamente no se considera vinculado por el apartado 2 del artículo 3 de la Carta en la medida en que el sistema de elección directa en ella previsto haya de ser puesto en práctica en la totalidad de las colectividades locales incluidas en el ámbito de aplicación de la misma.»

Artículo 2.º Fundamento constitucional y legal de la autonomía local.

El principio de la autonomía local debe estar reconocido en la legislación interna y, en lo posible, en la Constitución.

Artículo 3.º Concepto de la autonomía local.

1. Por autonomía local se entiende el derecho y la capacidad efectiva de las Entidades locales de ordenar y gestionar una parte importante de los asuntos públicos, en el marco de la Ley, bajo su propia responsabilidad y en beneficio de sus habitantes.

2. Este derecho se ejerce por Asambleas o Consejos integrados por miembros elegidos por sufragio libre, secreto, igual, directo y universal y que pueden disponer de órganos ejecutivos responsables ante ellos mismos. Esta disposición no causará perjuicio al recurso a las asambleas de vecinos, al referéndum o a cualquier otra forma de participación directa de los ciudadanos, allí donde esté permitido por la Ley.

Artículo 4.º Alcance de la autonomía local.

1. Las competencias básicas de las Entidades locales vienen fijadas por la Constitución o por la Ley. Sin embargo, esta disposición no impide la atribución a las Entidades locales de competencias para fines específicos, de conformidad con la Ley.

2. Las Entidades locales tienen, dentro del ámbito de la Ley, libertad plena para ejercer su iniciativa en toda materia que no esté excluida de su competencia o atribuida a otra autoridad.

Artículo 10. El derecho de asociación de las Entidades locales.

1. Las Entidades locales tienen el derecho, en el ejercicio de sus competencias, de cooperar y, en el ámbito de la Ley, asociarse con otras Entidades locales para la realización de tareas de interés común.

2. El derecho de las Entidades locales de integrarse en una asociación para la protección y promoción de sus intereses comunes y el de integrarse en una asociación internacional de Entidades locales deben ser reconocidos por cada Estado.

3. Las Entidades locales pueden, en las condiciones eventualmente previstas por la ley, cooperar con las Entidades de otros Estados.

Artículo 11. Protección legal de la autonomía local.

Las Entidades locales deben disponer de una vía de recurso jurisdiccional a fin de asegurar el libre ejercicio de sus competencias y el respeto a los principios de autonomía local consagrados en la Constitución o en la legislación interna.

EL DERECHO DE REUNIÓN Y LOS EDIFICIOS PÚBLICOS MUNICIPALES SEGÚN LA DOCTRINA DEL TEDH

Article 11 of the Convention

“1. Everyone has the right to freedom of peaceful assembly and to freedom of association with others, including the right to form and to join trade unions for the protection of his interests.

2. No restrictions shall be placed on the exercise of these rights other than such as are prescribed by law and are necessary in a democratic society in the interests of national security or public safety, for the prevention of disorder or crime, for the protection of health or morals or for the protection of the rights and freedoms of others. This Article shall not prevent the imposition of lawful restrictions on the exercise of these rights by members of the armed forces, of the police or of the administration of the State.”

C. Scope of the right to freedom of assembly

14. In view of its importance the right to freedom of assembly should not be interpreted restrictively(Kudrevičius and Others v. Lithuania [GC], 2015, § 91; Tsaava and Others v. Georgia [GC], 2025, § 414).
To avert the risk of a restrictive interpretation, the Court has refrained from formulating the notion of an assembly or exhaustively listing the criteria which would define it (Navalnyy v. Russia [GC], 2018, § 98).

15. The concept of “assembly” is an autonomous one; it covers, in particular, gatherings which are not subject to domestic legal regulation, irrespective of whether they require notification or authorisation or whether they are exempt from such procedures. Thus, the Court found Article 11 applicable to a peaceful “walkabout” gathering whereby groups of persons acted in a coordinated and purposeful way, to express a political message; the applicant did not consider them “marches” or “meetings” subject to notification under the applicable national law (Navalnyy v. Russia [GC], 2018, § 108). Likewise, the Court found that the gathering described by the applicant as a “flash mob” could be considered an assembly irrespective of whether it fell under the notions of “public event” or “static demonstration” set out in domestic law (Obote v. Russia, 2019, § 35), with reference to the autonomous concept of “assembly” under the Convention.

16. Assembly is defined, in particular, by a common purpose of its participants and is to be distinguished from a random agglomeration of individuals each pursuing their own cause, such as a queue to enter a public building. Thus a group of activists present outside a courthouse for the purpose of attending a court hearing in a criminal case of a political nature fell within the notion of “assembly” on the basis that by their attendance they meant to express personal involvement in a matter of public importance. The Court distinguished this unintended gathering from a situation where a passer-by becomes accidentally mixed up in a demonstration and is mistaken for someone taking part in it(Navalnyy v. Russia [GC], 2018, § 110).

17. Lengthy occupation of premises that is peaceful, even though it is clearly in breach of domestic law, may be regarded as a “peaceful assembly” (Cisse v. France, 2002, §§ 39-40; Tuskia and Others v. Georgia, 2018, § 73; Annenkov and Others v. Russia, 2017, § 123).

18. Even if the existence of an assembly is beyond doubt, the admissibility of an Article 11 complaint may be called into question in relation to a particular applicant if he or she denies before the Court having taken part in that assembly. There must be a clear and acknowledged link between the exercise of the freedom of peaceful assembly by the applicants and the measures taken against them (Navalnyy and Yashin v. Russia, 2014, § 52). In establishing such link the Court takes into account the applicant’s initial intention, the extent of actual involvement in the assembly and the content of the pleading before the national instances and the Court (Agit Demir v. Turkey, 2018, § 68; Navalnyy v. Russia [GC], 2018, §§ 109-111; Zulkuf Murat Kahraman v. Turkey, 2019, § 45, Obote v. Russia, 2019, § 35; Kazan v. Türkiye, 2023, § 56). The fact that the applicant was sanctioned for participating in the assembly is not in itself sufficient to bring the complaint within the ambit of Article 11 if the applicant had consistently claimed that he was mistaken for a participant (Kasparov and Others v. Russia, 2013,§ 72). Article 11 of the Convention can be found to be applicable to persons merely observing a demonstration (see, for example, Galstyan v. Armenia, 2007, § 100), although they would need to make a persuasive argument that the mere presence at the rally for the purpose of observing eventscould be considered an exercise of their right to peaceful assembly (Shmorgunov and Others v. Ukraine, 2021, § 487).

19. Although there has been no case to-date concerning a negative right to freedom of assembly, the right not to be compelled to participate in an assembly may be inferred from its case-law (Sørensen and Rasmussen v. Denmark [GC], 2006, § 54; Novikova and Others v. Russia, 2016, § 91).

1. Form and type of assembly

20. This right covers both private meetings and meetings in public places, whether static or in the form of a procession; in addition, it can be exercised by individual participants and by the persons organising the gathering (Kudrevičius and Others v. Lithuania [GC], 2015, § 91; Djavit An v. Turkey, 2003, § 56).

21. Although the primary purpose of Article 11 is to protect the right of political peaceful demonstration and participation in the democratic process, it would be an unacceptably narrow interpretation of that Article to confine it only to that kind of assembly, just as it would be too narrow an interpretation of Article 10 to restrict it to expressions of opinion of a political character (Friend, the Countryside Alliance and others v. the United Kingdom (dec.), 2009, § 50). Article 11 has thus been found to apply to assemblies of an essentially social character (Emin Huseynov v. Azerbaijan, 2015, § 91, concerning police intervention in a gathering at a private café; Djavit An v. Turkey, 2003, § 60, concerning the refusal of the authorities to allow the applicant to cross the “green line” into southern Cyprus in order to participate in bi-communal meetings), as well as to cultural gatherings (The Gypsy Council and Others v. the United Kingdom (dec.), 2002); and religious and spiritual meetings (Barankevich v. Russia, 2007, § 15). Official meetings, notably parliamentary sessions, also fall within the scope of Article 11 (Forcadell i lluis v. Spain (dec.), 2019, § 24).

2. Freedom of forum

22. The right to freedom of assembly includes the right to choose the time, place and manner of conduct of the assembly, within the limits established in paragraph 2 of Article 11 (Sáska v. Hungary, 2012, § 21). Therefore, where the location of the assembly is crucial to the participants, an order to change it may constitute an interference with their freedom of assembly under Article 11 of the Convention (The United Macedonian Organisation Ilinden and Ivanov v. Bulgaria, 2005, § 103; Lashmankin and Others v. Russia, 2017, § 405; Mustafa Hajili and Others v. Azerbaijan, 2022, § 65).

 

 

COVID-19: PATENT US-9884895-B2 (COMPOSICIÓN DE PROTEINAS DE LA ESPÍCULA DE CORONAVIRUS QUIMÉRICOS)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A genetic chimerism or chimera (en-US), also chimaerism or chimaera (en-UK), (/kaɪˈmɪərə, kɪ-/ ky-MEER-ə, kih-) is a single organism composed of cells of different genotypes.

COVID-19: DECLARACIÓN DE CULPABILIDAD DE DAVID M. MORENS (I)

 

District Court, D. Maryland

Docket Number: 8:26-cr-00138

Citation: United States v. Morens, 8:26-cr-00138, (D. Maryland Aug 18, 2026) ECF No. 36

Date Filed: August 18th, 2026

Uploaded: August 18th, 2026, 2:11 p.m. EDT  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Because the plea agreement incorporates a sealed supplement and a separate factual stipulation, the currently public record is incomplete. That gap matters especially to speculation that Morens is cooperating against others. Such cooperation is possible in the abstract but cannot responsibly be asserted from the sealed filing’s existence alone.

 Under the Federal Records Act, an executive-branch employee who conducts official business through a nonofficial electronic messaging account must either copy an official account when creating or sending the record or forward a complete copy to an official account within 20 days. NARA explicitly states that official business conducted through personal accounts can create federal records regardless of the platform.

 The apparent identification of Co-Conspirator 1 as Daszak and Co-Conspirator 2 as Keusch therefore creates legitimate investigative questions.

 

MORENS GUILTY

James Lyons-Weiler, PhD

Aug 19, 2026