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

• Published in: Vaccines (Basel) Vol. 11; no. 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: Journal Article
• Language: English
• Published: Basel MDPI AG 01.11.2023
• 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; Belgium; Madrid Spain; Germany; Spain
• ISSN: 2076-393X; 2076-393X
• DOI: 10.3390/vaccines11111635

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.