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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| Format: | Article |
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MDPI AG
2023-10-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/11/1635 |
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| author | Jesús Hermosilla Airan Alonso-García Antonio Salmerón-García José Cabeza-Barrera Antonio L. Medina-Castillo Raquel Pérez-Robles Natalia Navas |
| author_facet | Jesús Hermosilla Airan Alonso-García Antonio Salmerón-García José Cabeza-Barrera Antonio L. Medina-Castillo Raquel Pérez-Robles Natalia Navas |
| author_sort | Jesús Hermosilla |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T16:23:44Z |
| format | Article |
| id | doaj.art-8930106c7dd740f692882eb2a4ac8ada |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T16:23:44Z |
| publishDate | 2023-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-8930106c7dd740f692882eb2a4ac8ada2023-11-24T15:09:53ZengMDPI AGVaccines2076-393X2023-10-011111163510.3390/vaccines11111635Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the ParticulateJesús Hermosilla0Airan Alonso-García1Antonio Salmerón-García2José Cabeza-Barrera3Antonio L. Medina-Castillo4Raquel Pérez-Robles5Natalia Navas6Department of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, SpainDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, SpainInstituto de Investigación Biosanitaria de Granada (ibs.GRANADA), 18012 Granada, SpainInstituto de Investigación Biosanitaria de Granada (ibs.GRANADA), 18012 Granada, SpainDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, SpainDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, SpainDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, SpainComirnaty™ 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.https://www.mdpi.com/2076-393X/11/11/1635COVID-19 vaccinesComirnaty™Spikevax™DLSin-use stability testingTEM |
| spellingShingle | Jesús Hermosilla Airan Alonso-García Antonio Salmerón-García José Cabeza-Barrera Antonio L. Medina-Castillo Raquel Pérez-Robles Natalia Navas Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate Vaccines COVID-19 vaccines Comirnaty™ Spikevax™ DLS in-use stability testing TEM |
| 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 | COVID-19 vaccines Comirnaty™ Spikevax™ DLS in-use stability testing TEM |
| url | https://www.mdpi.com/2076-393X/11/11/1635 |
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