Evidence map›Paper›PMID 38005967›Full record

ArticleVaccines2023

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

Jesús Hermosilla, Airan Alonso-García, Antonio Salmerón-García, José Cabeza-Barrera, Antonio L Medina-Castillo, Raquel Pérez-Robles, Natalia Navas

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Article
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  5. Article
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  7. Review
  8. Review
  9. Article
  10. Visualizing lipid nanoparticle trafficking for mRNA vaccine delivery in non-human primates.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  11. Review
  12. Article
  13. Article
  14. Recent Advances in Gene Therapy for Hemophilia.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Jesús HermosillaDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, Spain.
Airan Alonso-GarcíaDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, Spain.
Antonio Salmerón-GarcíaInstituto de Investigación Biosanitaria de Granada (ibs.GRANADA), 18012 Granada, Spain.
José Cabeza-BarreraInstituto de Investigación Biosanitaria de Granada (ibs.GRANADA), 18012 Granada, Spain.ORCID 0000-0002-2161-930X
Antonio L Medina-CastilloDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, Spain.ORCID 0000-0002-0308-9878
Raquel Pérez-RoblesDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, Spain.
Natalia NavasDepartment of Analytical Chemistry, Science Faculty, University of Granada, Fuentenueva Avenue, 18071 Granada, Spain.ORCID 0000-0002-2536-1430
Universidad de Granada · ESInstituto de Investigación Biosanitaria de Granada · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Comirnaty™COVID-19 vaccinesDLSin-use stability testingSpikevax™TEM

Identifiers

PMID38005967
PMCPMC10675537
OpenAlexW4387940357

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.