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Article

Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability

1
Department of Pharmaceutical Sciences, Università degli Studi di Milano, Via G. Colombo, 71-Milan, 20133 Milano, Italy
2
Institute of Molecular Genetics (INGM) Romeo and Enrica Invernizzi, Via F. Sforza, 35-Milan, 20100 Milano, Italy
3
Department of Biomedical Sciences for Health, Università degli Studi di Milano, Via G. Colombo, 71-Milan, 20133 Milano, Italy
*
Author to whom correspondence should be addressed.
Academic Editors: Donatella Paolino and Cinzia Anna Ventura
Pharmaceutics 2021, 13(7), 1029; https://doi.org/10.3390/pharmaceutics13071029
Received: 25 May 2021 / Revised: 29 June 2021 / Accepted: 2 July 2021 / Published: 7 July 2021
(This article belongs to the Collection Women in Pharmaceutics)
Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (<0.2). Samples were stable independently of syringe materials and storage conditions. Only strong mechanical stress (e.g., shaking) caused massive aggregation of lipid nanoparticles and mRNA degradation. These proof-of-concept experiments support the hypothesis that vaccine doses can be safely prepared in a dedicated area using an aseptic technique and transferred without affecting their stability. View Full-Text
Keywords: aggregates; compatibility; COVID-19; DLS; gel electrophoresis; in-use stability; mass vaccination; NTA; TEM aggregates; compatibility; COVID-19; DLS; gel electrophoresis; in-use stability; mass vaccination; NTA; TEM
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MDPI and ACS Style

Selmin, F.; Musazzi, U.M.; Franzè, S.; Scarpa, E.; Rizzello, L.; Procacci, P.; Minghetti, P. Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability. Pharmaceutics 2021, 13, 1029. https://doi.org/10.3390/pharmaceutics13071029

AMA Style

Selmin F, Musazzi UM, Franzè S, Scarpa E, Rizzello L, Procacci P, Minghetti P. Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability. Pharmaceutics. 2021; 13(7):1029. https://doi.org/10.3390/pharmaceutics13071029

Chicago/Turabian Style

Selmin, Francesca, Umberto M. Musazzi, Silvia Franzè, Edoardo Scarpa, Loris Rizzello, Patrizia Procacci, and Paola Minghetti. 2021. "Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination: Demonstration of Stability" Pharmaceutics 13, no. 7: 1029. https://doi.org/10.3390/pharmaceutics13071029

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