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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Bibliographic Details
Published in:Vaccines (Basel) 2023-11, Vol.11 (11), p.1635
Main Authors: Hermosilla, Jesús, Alonso-García, Airan, Salmerón-García, Antonio, Cabeza-Barrera, José, Medina-Castillo, Antonio L., Pérez-Robles, Raquel, Navas, Natalia
Format: Article
Language:English
Subjects:
Comirnaty
Comparative studies
COVID-19 vaccines
Disease transmission
DLS
Dynamic stability
Handling
Hospitals
in-use stability testing
Irradiation
Light
Light irradiation
Light scattering
Lipophilic
mRNA stability
Nanoparticles
Nanotechnology
Natural lighting
Pandemics
Pharmaceuticals
Photon correlation spectroscopy
Qualitative analysis
Room temperature
Shaking
Spikevax
Stability analysis
Syringes
Technology
TEM
Transmission electron microscopy
Vaccines
Vibration
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Summary: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.
ISSN:2076-393X
2076-393X
DOI:10.3390/vaccines11111635