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.

Pre-Drawn Syringes of Comirnaty for an Efficient COVID-19 Mass Vaccination : Demonstration of Stability / F. Selmin, U.M. Musazzi, S. Franzè, E. Scarpa, L. Rizzello, P. Procacci, P. Minghetti. - In: PHARMACEUTICS. - ISSN 1999-4923. - 13:7(2021 Jul 07), pp. 1029.1-1029.10. [10.3390/pharmaceutics13071029]

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

Selmin, Francesca;Musazzi, Umberto M.;Franzè, Silvia;Scarpa, Edoardo;Rizzello, Loris;Procacci, Patrizia;Minghetti, Paola
2021-07-07

Abstract

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.
aggregates; compatibility; COVID-19; DLS; gel electrophoresis; in-use stability; mass vaccination; NTA; TEM
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
Pandemics Outbreaks Rationalized: towards a universal therapy to eliminate intracellular pathogens and drug resistance (PANDORA)
PHARMACEUTICS
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/855394
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