Definition and research guide
This page combines a MeSH definition, publication statistics and selected research abstracts. It is a starting point for reading the literature, not a medical textbook or a systematic evidence review.
Content available: 4 complete abstracts (739 words), 10 references. Full article text is not stored or reproduced here; follow the PMID, DOI or PMC links to read the original sources and their access terms.
Definition
The relationship between an elicited adaptive immune response and the dose of the vaccine administered. It is typically measured in an assay to ensure proper dosing and storage of vaccines whereas vaccine efficacy determines disease risk reduction attributable to vaccination under ideal conditions such as a clinical trial and vaccine immunogenicity measures vaccine's ability to induce an immune response in a vaccinated individual in observational studies setting.
Definition: NLM Medical Subject Headings (MeSH) scope note (Public domain (U.S. National Library of Medicine); attribution requested). View the MeSH record.
Also known as: Potency, Vaccine; Vaccine Potencies; Potency of Vaccine; Vaccine Stability; Stability, Vaccine; Vaccine Stabilities.
Where it fits in the MeSH classification
- Broader topics
- Vaccine Development; Dose-Response Relationship, Immunologic
Related concepts
- Adaptive Immunity
- Vaccine Efficacy
Research landscape
PubMed indexes 588 records tagged with the MeSH heading “Vaccine Potency” (counts retrieved 2026-10-29). 133 of them (22.6%) were published from 2020 onward, and the busiest period so far is 2010-2019 with 456 records.
Reviews account for 62 records (10.5%) and meta-analyses for 8. Randomized controlled trials number 26 (4.4%) as a share of all records on the topic.
Show the data
| Period | Records |
|---|---|
| through 1999 | 0 |
| 2000-2009 | 0 |
| 2010-2019 | 456 |
| 2020 onward | 133 |
Publication-type chart data
| Type | Records | Share |
|---|---|---|
| Reviews | 62 | 10.5% |
| Meta-analyses | 8 | 1.4% |
| Randomized controlled trials | 26 | 4.4% |
Method: PubMed query "Vaccine Potency"[MeSH Terms] with publication-type and date filters, retrieved 2026-10-29.
Reading the evidence in immunology
Immune responses are studied in model organisms, in cells from donors and in patients, and the same pathway can behave differently across these settings. Mouse immune systems differ from human ones in important ways, and blood measurements may not reflect what happens in tissues. Clinical conclusions about immune-mediated disease or immunotherapy come mainly from controlled trials and long-term cohorts. Check the species and tissue studied, whether markers were linked to outcomes patients notice, and the follow-up time.
Evidence from open-access studies
These open-access studies come from PubMed’s best-match results for this heading (papers whose main topic it is), ranked here by citation count, with one recent addition. Each abstract is reproduced in full under its recorded open licence so that you can read the authors’ own words. They illustrate the literature; they are not a systematic summary of it. Citation counts measure attention, not reliability or clinical benefit.
| Study / authors | Year | Source label / design | Europe PMC citations | Licence / source |
|---|---|---|---|---|
| Addressing the Cold Reality of mRNA Vaccine Stability | 2021 | Research article Design not recorded in structured metadata | 384 | cc by PMID 33321139 · DOI · PMC7834447 |
| A novel mechanism for the loss of mRNA activity in lipid nanoparticle delivery systems | 2021 | Research article Design not recorded in structured metadata | 207 | cc by PMID 34811367 · DOI · PMC8608879 |
| A thermostable messenger RNA based vaccine against rabies | 2017 | Research article Design not recorded in structured metadata | 92 | cc by PMID 29216187 · DOI · PMC5737050 |
| A novel double-mAb sandwich ELISA utilizing broad-spectrum neutralizing antibodies as an in vitro alternative to the rabies vaccine NIH potency assay | 2026 | Research article Design not recorded in structured metadata | 0 | cc by PMID 42908949 · DOI · PMC13683624 |
Addressing the Cold Reality of mRNA Vaccine Stability [1]
Abstract reading summary — source excerpts
- Opening excerpt
- As mRNA vaccines became the frontrunners in late-stage clinical trials to fight the COVID-19 pandemic, challenges surrounding their formulation and stability became readily apparent.
- Closing excerpt
- Consequently, we should not wait for the next pandemic to address and solve the challenges associated with the stability and storage of formulated mRNA vaccines.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (199 words)
As mRNA vaccines became the frontrunners in late-stage clinical trials to fight the COVID-19 pandemic, challenges surrounding their formulation and stability became readily apparent. In this commentary, we first describe company proposals, based on available public information, for the (frozen) storage of mRNA vaccine drug products across the vaccine supply chain. We then review the literature on the pharmaceutical stability of mRNA vaccine candidates, including attempts to improve their stability, analytical techniques to monitor their stability, and regulatory guidelines covering product characterization and storage stability. We conclude that systematic approaches to identify the key physicochemical degradation mechanism(s) of formulated mRNA vaccine candidates are currently lacking. Rational design of optimally stabilized mRNA vaccine formulations during storage, transport, and administration at refrigerated or ambient temperatures should thus have top priority in the pharmaceutical development community. In addition to evidence of human immunogenicity against multiple viral pathogens, including compelling efficacy results against COVID-19, another key strength of the mRNA vaccine approach is that it is readily adaptable to rapidly address future outbreaks of new emerging infectious diseases. Consequently, we should not wait for the next pandemic to address and solve the challenges associated with the stability and storage of formulated mRNA vaccines.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 33321139 · DOI · PMC7834447
A novel mechanism for the loss of mRNA activity in lipid nanoparticle delivery systems [2]
Abstract reading summary — source excerpts
- Opening excerpt
- Lipid nanoparticle (LNP)-formulated mRNA vaccines were rapidly developed and deployed in response to the SARS-CoV-2 pandemic.
- Closing excerpt
- It thus remains critical to ensure robust analytical methods and stringent manufacturing control to ensure mRNA stability and high activity in LNP delivery systems.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (144 words)
Lipid nanoparticle (LNP)-formulated mRNA vaccines were rapidly developed and deployed in response to the SARS-CoV-2 pandemic. Due to the labile nature of mRNA, identifying impurities that could affect product stability and efficacy is crucial to the long-term use of nucleic-acid based medicines. Herein, reversed-phase ion pair high performance liquid chromatography (RP-IP HPLC) was used to identify a class of impurity formed through lipid:mRNA reactions; such reactions are typically undetectable by traditional mRNA purity analytical techniques. The identified modifications render the mRNA untranslatable, leading to loss of protein expression. Specifically, electrophilic impurities derived from the ionizable cationic lipid component are shown to be responsible. Mechanisms implicated in the formation of reactive species include oxidation and subsequent hydrolysis of the tertiary amine. It thus remains critical to ensure robust analytical methods and stringent manufacturing control to ensure mRNA stability and high activity in LNP delivery systems.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 34811367 · DOI · PMC8608879
A thermostable messenger RNA based vaccine against rabies [3]
Abstract reading summary — source excerpts
- Opening excerpt
- Although effective rabies virus vaccines have been existing for decades, each year, rabies virus infections still cause around 50.
- Closing excerpt
- Moreover, storing the vaccine at oscillating temperatures between +4° and +56°C for 20 cycles in order to simulate interruptions of the cold chain during vaccine transport, did not affect the vaccine's immunogenicity and protective characteristics, indicating that maintenance of a cold chain is not essential for this vaccine.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (185 words)
Although effective rabies virus vaccines have been existing for decades, each year, rabies virus infections still cause around 50.000 fatalities worldwide. Most of these cases occur in developing countries, where these vaccines are not available. The reasons for this are the prohibitive high costs of cell culture or egg grown rabies virus vaccines and the lack of a functional cold chain in many regions in which rabies virus is endemic. Here, we describe the excellent temperature resistance of a non-replicating mRNA based rabies virus vaccine encoding the rabies virus glycoprotein (RABV-G). Prolonged storage of the vaccine from -80°C to up to +70°C for several months did not impact the protective capacity of the mRNA vaccine. Efficacy after storage was demonstrated by the induction of rabies specific virus neutralizing antibodies and protection in mice against lethal rabies infection. Moreover, storing the vaccine at oscillating temperatures between +4° and +56°C for 20 cycles in order to simulate interruptions of the cold chain during vaccine transport, did not affect the vaccine's immunogenicity and protective characteristics, indicating that maintenance of a cold chain is not essential for this vaccine.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 29216187 · DOI · PMC5737050
A novel double-mAb sandwich ELISA utilizing broad-spectrum neutralizing antibodies as an in vitro alternative to the rabies vaccine NIH potency assay [4]
Abstract reading summary — source excerpts
- Opening excerpt
- BackgroundRabies remains a devastating zoonotic disease, with prevention measures relying heavily on post-exposure prophylaxis (PEP).
- Closing excerpt
- ConclusionCollectively, these findings provide a robust technical framework for replacing the traditional NIH potency assay with a reliable in vitro method, fully aligning with the 3Rs principles of animal welfare.
- Interpretation limits
- Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (211 words)
BackgroundRabies remains a devastating zoonotic disease, with prevention measures relying heavily on post-exposure prophylaxis (PEP). Evaluating rabies vaccine potency traditionally relies on the in vivo National Institutes of Health (NIH) mouse challenge assay, which is limited by long testing cycles, low reproducibility, and high animal consumption. Developing broad-spectrum monoclonal antibodies (mAbs) and alternative in vitro assays is essential to advance rabies prevention and improve vaccine quality control.MethodsIn this study, we characterized three human-mouse chimeric mAbs (05-2F10, 06-2A12, and 07-4D8-1C1) with broad-spectrum neutralizing activity. Leveraging in vitro pseudovirus neutralization assays, we evaluated candidate mAbs for high neutralizing capacity and low sensitivity to variation to select optimal pairs for assay development. Using these selected mAbs, a double-antibody sandwich ELISA was established to quantify glycoprotein (G) antigen content in human rabies vaccines.ResultsThe three chimeric mAbs exhibited exceptional in vitro neutralization potency and breadth. The established double-antibody sandwich ELISA successfully quantified G antigen content in human rabies vaccines. Importantly, a high correlation was demonstrated between the antigen content quantified by this ELISA and the potency data generated via the traditional in vivo NIH mouse challenge test.ConclusionCollectively, these findings provide a robust technical framework for replacing the traditional NIH potency assay with a reliable in vitro method, fully aligning with the 3Rs principles of animal welfare.
Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 42908949 · DOI · PMC13683624
Key reviews and meta-analyses
The most cited review-type papers among PubMed’s best-match results for this heading, listed with bibliographic details only. Follow the links for the full text and access terms.
- Research article Variable influenza vaccine effectiveness by subtype: a systematic review and meta-analysis of test-negative design studies [5]
- Research article Virus-like particle-based human vaccines: quality assessment based on structural and functional properties [6]
- Research article Correlates of immune and clinical activity of novel cancer vaccines [7]
- Research article Safety and potency of BIV1-CovIran inactivated vaccine candidate for SARS-CoV-2: A preclinical study [8]
- Research article Rotavirus vaccine efficacy: current status and areas for improvement [9]
- Research article Principles of vaccine potency assays [10]
References
- Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E. Addressing the Cold Reality of mRNA Vaccine Stability. . 2021. PMID 33321139 · DOI · PMC7834447
- Packer M, Gyawali D, Yerabolu R, Schariter J, White P. A novel mechanism for the loss of mRNA activity in lipid nanoparticle delivery systems. . 2021. PMID 34811367 · DOI · PMC8608879
- Stitz L, Vogel A, Schnee M, Voss D, Rauch S, Mutzke T, et al.. A thermostable messenger RNA based vaccine against rabies. . 2017. PMID 29216187 · DOI · PMC5737050
- Cai M, Wu X, Shi L, Tong J, He C, Nie J, et al.. A novel double-mAb sandwich ELISA utilizing broad-spectrum neutralizing antibodies as an in vitro alternative to the rabies vaccine NIH potency assay. . 2026. PMID 42908949 · DOI · PMC13683624
- Belongia EA, Simpson MD, King JP, Sundaram ME, Kelley NS, Osterholm MT, et al.. Variable influenza vaccine effectiveness by subtype: a systematic review and meta-analysis of test-negative design studies. Lancet Infect Dis. 2016. PMID 27061888 · DOI
- Zhao Q, Li S, Yu H, Xia N, Modis Y. Virus-like particle-based human vaccines: quality assessment based on structural and functional properties. Trends Biotechnol. 2013. PMID 24125746 · DOI
- van der Burg SH. Correlates of immune and clinical activity of novel cancer vaccines. Semin Immunol. 2018. PMID 29709421 · DOI
- Abdoli A, Aalizadeh R, Aminianfar H, Kianmehr Z, Teimoori A, Azimi E, et al.. Safety and potency of BIV1-CovIran inactivated vaccine candidate for SARS-CoV-2: A preclinical study. Rev Med Virol. 2022. PMID 34699647 · DOI · PMC8646699
- Carvalho MF, Gill D. Rotavirus vaccine efficacy: current status and areas for improvement. Hum Vaccin Immunother. 2019. PMID 30215578 · DOI · PMC6663136
- Verch T, Trausch JJ, Shank-Retzlaff M. Principles of vaccine potency assays. Bioanalysis. 2018. PMID 29333863 · DOI
About this article
- Sources
- NLM Medical Subject Headings (definition, synonyms); NCBI PubMed (counts, identifiers); Europe PMC (open-access abstracts and citation counts).
- Verification
- Every reference was resolved against PubMed on 2026-10-31; title, year and DOI matched.
- Review state
- automated source verified; no human expert review has been recorded yet.
- Version
- 1, last updated 2026-10-29.
See how EvidenceLib is built. Spotted an error? Email support@evidencehelix.com.
Evidence strength
EvidenceHelix's computed view of the study designs behind this topic: how common meta-analyses, randomized trials and reviews are, how recent the literature is, and a plain-language reading. It describes the design mix of the literature. It is not a quality appraisal of any study, and it is not medical advice.