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Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate

Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is...

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Autores principales: Hermosilla, Jesús, Alonso-García, Airan, Salmerón-García, Antonio, Cabeza-Barrera, José, Medina-Castillo, Antonio L., Pérez-Robles, Raquel, Navas, Natalia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10675537/
https://www.ncbi.nlm.nih.gov/pubmed/38005967
http://dx.doi.org/10.3390/vaccines11111635
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author Hermosilla, Jesús
Alonso-García, Airan
Salmerón-García, Antonio
Cabeza-Barrera, José
Medina-Castillo, Antonio L.
Pérez-Robles, Raquel
Navas, Natalia
author_facet Hermosilla, Jesús
Alonso-García, Airan
Salmerón-García, Antonio
Cabeza-Barrera, José
Medina-Castillo, Antonio L.
Pérez-Robles, Raquel
Navas, Natalia
author_sort Hermosilla, Jesús
collection PubMed
description Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is related to pharmaceutical stability issues. Proper transportation, storage, and in-use handling before administration to patients are critical steps since failures can potentially reduce potency. In this research, the in-use stability of Comirnaty™ and Spikevax™ clinical samples was analysed and the results were compared. As changes in the size of the mRNA-LNPs are related to potency, these modifications were analysed by qualitative Dynamic Light Scattering (DLS) as a stability-indicating method for control and stressed vaccine samples. Strong stress factors (accelerated light irradiation, manual shaking, and vortex vibration) and conditions that mimic in-use handling (exposure to natural light and room temperature, repeated cycles of injections, and 24 h storage in syringes) were checked. The morphology of the mRNA-LNPs was analysed by Transmission Electron Microscopy (TEM) to better interpret and support the DLS results. Although the two vaccines are based on the same mRNA-LNP technology, the results demonstrate that they are characterised by very different particle size profiles and behaviours against different handling/stress conditions.
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spelling pubmed-106755372023-10-25 Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate Hermosilla, Jesús Alonso-García, Airan Salmerón-García, Antonio Cabeza-Barrera, José Medina-Castillo, Antonio L. Pérez-Robles, Raquel Navas, Natalia Vaccines (Basel) Article Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is related to pharmaceutical stability issues. Proper transportation, storage, and in-use handling before administration to patients are critical steps since failures can potentially reduce potency. In this research, the in-use stability of Comirnaty™ and Spikevax™ clinical samples was analysed and the results were compared. As changes in the size of the mRNA-LNPs are related to potency, these modifications were analysed by qualitative Dynamic Light Scattering (DLS) as a stability-indicating method for control and stressed vaccine samples. Strong stress factors (accelerated light irradiation, manual shaking, and vortex vibration) and conditions that mimic in-use handling (exposure to natural light and room temperature, repeated cycles of injections, and 24 h storage in syringes) were checked. The morphology of the mRNA-LNPs was analysed by Transmission Electron Microscopy (TEM) to better interpret and support the DLS results. Although the two vaccines are based on the same mRNA-LNP technology, the results demonstrate that they are characterised by very different particle size profiles and behaviours against different handling/stress conditions. MDPI 2023-10-25 /pmc/articles/PMC10675537/ /pubmed/38005967 http://dx.doi.org/10.3390/vaccines11111635 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hermosilla, Jesús
Alonso-García, Airan
Salmerón-García, Antonio
Cabeza-Barrera, José
Medina-Castillo, Antonio L.
Pérez-Robles, Raquel
Navas, Natalia
Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title_full Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title_fullStr Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title_full_unstemmed Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title_short Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate
title_sort analysing the in-use stability of mrna-lnp covid-19 vaccines comirnaty™ (pfizer) and spikevax™ (moderna): a comparative study of the particulate
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10675537/
https://www.ncbi.nlm.nih.gov/pubmed/38005967
http://dx.doi.org/10.3390/vaccines11111635
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