ArticleBMJ open science2021
Stability testing of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine: a translational study in UK vaccination centres.
Article in BMJ open science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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.
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Who cites it
17 citing papers in PubMed, 33 citations in OpenAlex.
- mRNA lipid nanoparticle vaccines: current status, challenges and future prospects.Molecular biomedicine · 2026Review
- Elucidating the underlying mechanism of mechanical stress-induced impact on mRNA-LNP structure.Scientific reports · 2025Article
- Proof of Concept Application of Hydrophilic Interaction Chromatography for Direct Online Disruption of Lipid Nanoparticles, Intact mRNA Analysis, and Measure of Encapsulation Efficiency.Analytical chemistry · 2025Article
- Prime Editing: A Revolutionary Technology for Precise Treatment of Genetic Disorders.Cell proliferation · 2025Review
- Visualizing lipid nanoparticle trafficking for mRNA vaccine delivery in non-human primates.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Diffusive micromixing combined with dynamic in situ laser scattering allows shedding light on lipid nanoparticle precipitation.Scientific reports · 2024Article
- Impact of mixing and shaking on mRNA-LNP drug product quality characteristics.Scientific reports · 2024Article
- Nanocapsules Comprised of Purified Protein: Construction and Applications in Vaccine Research.Vaccines · 2024Article
- Article
- The Effect of Cryoprotectants and Storage Conditions on the Transfection Efficiency, Stability, and Safety of Lipid-Based Nanoparticles for mRNA and DNA Delivery.Advanced healthcare materials · 2023Article
- Use of Microfluidics to Prepare Lipid-Based Nanocarriers.Pharmaceutics · 2023Review
- Research Advances on the Stability of mRNA Vaccines.Viruses · 2023Review
- The Storage and In-Use Stability of mRNA Vaccines and Therapeutics: Not A Cold Case.Journal of pharmaceutical sciences · 2023Review
- Article
- Vaccination process evaluation at COVID-19 vaccination centers in Lebanon: a national study.Journal of pharmaceutical policy and practice · 2022Article
- Understanding the Pharmacology of COVID-19 mRNA Vaccines: Playing Dice with the Spike?International journal of molecular sciences · 2022Article
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe roll-out of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine has brought many logistical challenges, such as the absence of comprehensive stability data leading to strict handling instructions during dilution and administration. Accidental mishandling therefore presents challenging clinical dilemmas, which often led vaccine providers to err on the side of caution and discard mishandled vials rather than risk administering ineffective vaccine. This study aims to answer key questions about the vaccine's stability to allow for a more informed decision-making process should a non-conformity occur.
methodsResidual vaccine in freshly used, but appropriately stored vials collected from vaccination centres in Brighton, UK, were tested after exposure to various handling conditions and analysed by dynamic light scattering to determine the size of the lipid-mRNA nanoparticles, and gel electrophoresis to visualise the mRNA integrity and separation from the lipid formulation.
resultsKnocking or dropping vaccine samples from small heights resulted in lowest levels of instability, indicating low risk of compromising clinical efficacy. However, repeated drawing and injecting through 23 G needles at high speed and, more significantly, shaking and vortexing led to progressive increase in the size and polydispersity index of the lipid-mRNA nanoparticles, coupled with or caused by up to ~50% release of mRNA from the lipid formulation. This is thought to impact the vaccine's efficacy due to lack of free mRNA protection and cellular internalisation.
conclusionsThese results reiterate the importance of adhering to the manufacturer's instructions on handling, especially with regard to shaking and exposing the vaccine to excessive vibration.
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Registered trials
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.