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WHO Drug Information, Vol. 36, No. 3, 2022 Proposed INN: List 128 – COVID-19 (special edition) Proposed International Nonproprietary Names: List 128 – COVID-19 (special edition) Comments on, or formal objections to, the proposed names may be forwarded by any person to the INN Programme of the World Health Organization within two weeks of the date of their publication on WHO INN Programme website, i.e., for List 128 – COVID-19 (special edition) of Proposed INN not later than 22 August 2022, exceptionally for this special edition. Publication date: 08/08/2022 Dénominations communes internationales proposées: Liste 128 - COVID-19 (édition spéciale) Des observations ou des objections formelles à l'égard des dénominations proposées peuvent être adressées par toute personne au Programme des Dénominations communes internationales de l'Organisation mondiale de la Santé dans un délai de deux semaines à compter de la date de leur publication sur le site Internet du Programme des DCI de l’OMS, c'est à dire pour la Liste 128 - COVID-19 (édition spéciale) de DCI Proposées le 22 août 2022 au plus tard, exceptionnellement pour cette édition spéciale. Date de publication : 08/08/2022 Denominaciones Comunes Internacionales Propuestas: Lista 128 - COVID-19 (edición especial) Cualquier persona puede dirigir observaciones u objeciones respecto de las denominaciones propuestas, al Programa de Comunes Internacionales de la Organización Mundial de la Salud, en un plazo de dos semanas, contados desde la fecha de su publicación en el sitio web del Programa de las DCI de la OMS, es decir, para la Lista 128 - COVID-19 (edición especial) de DCI Propuestas el 22 de agosto de 2022 a más tardar, excepcionalmente para esta edición especial. Fecha de publicación: 08/08/2022 Proposed INN Chemical name or description: Action and use: Molecular (Latin, English, French, Spanish) formula, Chemical Abstracts Service (CAS) registry number: Graphic formula DCI Proposée Nom chimique ou description: Propriétés et indications: Formule brute, Numéro dans le registre du CAS: Formule développée DCI Propuesta Nombre químico o descripción: Acción y uso: Fórmula molecular, Número de registro del CAS: Fórmula desarrollada 1  Proposed INN: List 128 – COVID-19 WHO Drug Information, Vol. 36, No. 3, 2022 (special edition) secelasomeranum # secelasomeran messenger RNA (mRNA), 5'-capped, encoding a full-length, codon-optimised pre-fusion stabilised conformation variant (K983P and V984P) of the SARS- CoV-2 (severe acute respiratory syndrome coronavirus 2) spike (S) glycoprotein (Beta variant, B.1.351; based upon GISAID No. EPI_ISL_2689878), further optimized by two additional stop codons, flanked by an artificial 5' untranslated region (UTR) and a 3' UTR derived from the human alpha globin gene (HBA1) and terminated by a 3' poly(A) tail; contains N1-methylpseudouridine instead of uridine (all-U>m1Ψ). immunological agent for active immunization (anti-SARS-CoV-2) sécélasoméran ARN messager (ARNm), protégé d’une coiffe en 5', codant la séquence entière d’un variant de la glycoprotéine de spicule (S) du SARS-CoV-2 (coronavirus 2 du syndrome respiratoire aigu sévère; Beta variant, B.1.351; basé sur GISAID No. EPI_ISL_2689878) à la conformation stabilisée par pré- fusion (K983P et V984P) et aux codons optimisés, optimisation renforcée par l’ajout de deux codons stop, flanqué d'une région non traduite (UTR) en 5' artificielle et d' une UTR en 3' dérivée du gène de l'alpha-globine humaine (HBA1) et terminé par une queue poly(A) en 3'; contient de la N1- méthylpseudouridine au lieu de l'uridine (tout-U>m1Ψ). agent immunologique pour immunisation active (anti-SARS-CoV-2) secelasomerán ARN mensajero (ARNm), protegido en 5', que codifica para una variante estabilizada en conformación pre-fusión (K983P and V984P) de la glicoproteína de la espícula (S) del SARS-Cov-2 (coronavirus 2 del síndrome respiratorio agudo severo; Beta variant, B.1.351; basada en GISAID No. EPI_ISL_2689878) completa, con codones optimizados y dos codones de terminación adicionales, flanqueado por una región 5' no traducida (UTR) artificial y una UTR en 3' derivada del gen de la globina alfa humana (HBA1) y terminado por una cola poly(A) en 3'; contiene N1-metilpseudouridina en lugar de uridina (todo-U>m1Ψ). agente inmunológico para inmunización activa (anti-SARS-CoV-2) 2642373-67-7 # Electronic structure available on Mednet: http://mednet.who.int/ # Structure électronique disponible sur Mednet: http://mednet.who.int/ # Estructura electrónica disponible en Mednet: http://mednet.who.int/ Please note that due to exceptional pandemic circumstances, this Proposed INN is open for public consultation for a period of two weeks only (instead of four months) and the publication date to be retained is the date of web publication on the WHO INN website. The procedure “INN for Variant COVID-19 Vaccine Active Substances” can be found at https://www.who.int/publications/i/item/inn- 21-520. Veuillez noter qu'en raison de circonstances pandémiques exceptionnelles, cette DCI Proposée est ouverte à la consultation publique pour une période de deux semaines seulement (au lieu de quatre mois) et la date de publication à retenir est la date de publication sur le site Internet du Programme des DCI de l'OMS. La procédure “INN for Variant COVID-19 Vaccine Active Substances” peut être trouvée à https://www.who.int/publications/i/item/inn-21-520. Tenga en cuenta que debido a circunstancias excepcionales de la pandemia, esta DCI Propuesta está abierta a la consulta pública durante un período de sólo dos semanas (en lugar de cuatro meses) y la fecha de publicación que debe conservarse es la fecha de publicación en el sitio web del Programa de las DCI de la OMS. Se puede encontrar la procedura “INN for Variant COVID-19 Vaccine Active Substances” en nuestro sitio web https://www.who.int/publications/i/item/inn-21- 520. 2 20, AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND – TEL CENTRAL +41 22 791 2111 – FAX CENTRAL +41 22 791 3111 – WWW.WHO.INT Ref.: C.L.35.2022 The World Health Organization has the honour to transmit, in accordance with the “International Nonproprietary Names for Variant COVID-19 Vaccine Active Substances” document available on WHO website: https://www.who.int/publications/i/item/inn-21-520 (INN Working Document 21.520 April 2021), the following list of proposed international nonproprietary names (prop. INN) which has been published by the World Health Organization on the WHO website at https://www.who.int/teams/health-product-and-policy-standards/inn/inn- lists. – p.INN list 128 – COVID-19 (special edition) It would be appreciated if this communication could be forwarded to the appropriate patent and trade-mark office and to any other organization dealing with the introduction of nonproprietary names for pharmaceutical substances. Any comments that may be made, or notifications of a conflict between proposed names and existing proprietary rights, should be addressed to the INN Programme, World Health Organization, 1211 Geneva 27, within two weeks following the publication of the above-mentioned list on the WHO website, i.e. no later than 22 August 2022. The selection of international nonproprietary names by the World Health Organization for use in all Member States presents many difficulties. It would therefore be appreciated if this were borne in mind when it is contemplated to exercise the right to raise objections. Furthermore, the World Health Organization would be grateful if, in the interest of public health and pursuant to the procedure referred to in the first paragraph of this communication, the ... enclosed list of names* could be granted protection in Member States during the period they are under consideration by the World Health Organization as international nonproprietary names. GENEVA, 11 August 2022 ... ENCL: (1)* Prop. INN: List 128 – COVID-19 (special edition) has been published by the World Health Organization on the WHO website at https://www.who.int/teams/health-product-and-policy- standards/inn/inn-lists and will be published in WHO Drug Information, Vol. 36, No. 3 2022. Saatja: <[email protected]> Saadetud: 11.08.2022 12:27 Teema: [HOIATUS - KIRJA SISU EI SAADUD VIIRUSTE SUHTES KONTROLLIDA] WHO: C.L.35.2022 (INN proposed list 128 COVID-19 special edition) Dear Member States of the World Health Organization,Please find attached, in the six official languages, C.L.35.2022 regarding the proposed list 128 - COVID-19 (special edition) - of proposed international nonproprietary names.The annex is the same in all languages and is attached to the English version.Best regards,Department of Governing BodiesWorld Health Organization***DO NOT RESPOND TO THIS E-MAIL. YOU WILL NOT RECEIVE A REPLY***