To aspirate or not to aspirate? Considerations for the COVID-19 vaccines

Rzymski, Piotr; Wandalsen, Gustavo Falbo

doi:10.1007/s43440-022-00361-4

Cited by 6 publications

(9 citation statements)

References 49 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The difference in the transmission of the SARS-CoV-2 genetic material into humans (by infection via the nose and mouth, or by vaccination via injection into the muscle) can also make a difference in the pathophysiological processes triggered by it. It should also be noted here that an accidental direct injection into the bloodstream can in principle also occur in the case of vaccination into the muscle, which is probably associated with an increased complication rate [422] , [423] . Rzymski and Fal pointed out that “in vivo evidence suggests that intravenous injection of [the] mRNA vaccine can potentially lead to myocarditis, while introducing adenoviral vector to bloodstream can possibly result in thrombocytopenia and coagulopathy” [422] (a reference to two studies in this regard [424] , [425] ).…”

Section: Sars-cov-2 Infection- and Covid-19 Vaccination-induced Syndr...mentioning

confidence: 90%

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

Scholkmann

May

2023

Pathology - Research and Practice

View full text Add to dashboard Cite

Section: Sars-cov-2 Infection- and Covid-19 Vaccination-induced Syndr...mentioning

confidence: 90%

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

Scholkmann

May

2023

Pathology - Research and Practice

View full text Add to dashboard Cite

“…Although the deltoid muscle (the recommended site for administering COVID‐19 vaccines) is not near major blood vessels, its middle and posterior parts are supplied by several branches of the posterior circumflex humeral artery 136 . At the same time, young males have substantially higher muscle mass and more substantial muscle thickness with more blood vessels 135 . Given that over 2.5 billion mRNA COVID‐19 vaccine doses were administered in 2021 alone, their inappropriate administration may rarely occur, leading to additional risks, which could be potentially higher in males due to anatomical differences.…”

Section: Challenges For Mrna Vaccinesmentioning

confidence: 99%

“…However, it has not been recommended by the WHO primarily as it may increase pain in vaccinated individuals. However, some researchers argue that aspiration during mRNA vaccination should be practiced as a precautionary approach 134,135,137–139 …”

Section: Challenges For Mrna Vaccinesmentioning

confidence: 99%

mRNA vaccines: The future of prevention of viral infections?

Rzymski

Szuster‐Ciesielska

Dzieciątkowski

et al. 2023

Journal of Medical Virology

Self Cite

View full text Add to dashboard Cite

Messenger RNA (mRNA) vaccines against COVID-19 are the first authorized biological preparations developed using this platform. During the pandemic, their administration has been proven to be a life-saving intervention. Here, we review the main advantages of using mRNA vaccines, identify further technological challenges to be met during the development of the mRNA platform, and provide an update on the clinical progress on leading mRNA vaccine candidates against different viruses that include influenza viruses, human immunodeficiency virus 1, respiratory syncytial virus, Nipah virus, Zika virus, human cytomegalovirus, and Epstein-Barr virus. The prospects and challenges of manufacturing mRNA vaccines in low-income countries are also discussed. The ongoing interest and research in mRNA technology are likely to overcome some existing challenges for this technology (e.g., related to storage conditions and immunogenicity of some components of lipid nanoparticles) and enhance the portfolio of vaccines against diseases for which classical formulations are already authorized. It may also open novel pathways of protection against infections and their consequences for which no safe and efficient immunization methods are currently available.

show abstract

“…Hence, it is advisable to ensure that the intramuscularly injected vaccine material does not accidently hit a blood vessel to avoid immediate access to blood circulation. This can be circumvented by first applying an aspiration step to make sure that no blood can be withdrawn from the injection site [28]. It is worth noting that as the number of Fig.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Establishing the Pharmacokinetics of Genetic Vaccines is Essential for Maximising their Safety and Efficacy

Naasani¹

2022

Clin Pharmacokinet

View full text Add to dashboard Cite

In a typical course of drug development, thorough pharmacokinetic (PK) studies are essential for the determination of drug biodistribution, dosage and efficacy without toxicity. For vaccines, however, unless a new formulation component is used, most regulatory agencies rule out the need for studying the biodistribution of the vaccine antigenic material per se, and only dose-immunogenicity studies are performed. This is because traditional vaccines are meant to directly induce immunogenicity by locally recruiting immunocytes that will carry on with the pursuing immunogenic processes. Thus, the clinical outcome from traditional vaccines is determined mainly by an immunological response phase. Yet, the case is significantly different for the emergent genetic vaccines (vectorised DNA or mRNA vaccines), where the clinical outcome is dependent on a combination of two major response phases: a pharmacological phase that involves biodistribution, assimilation, gene translation and epitope(s) presentation, followed by an immunological phase, which is similar to that of traditional vaccines. From a mathematical perspective, processes involved in drug administration are typically subject to inter-and intra-patient statistical distributions like most physiological processes. Therefore, the clinical outcome after administering genetic vaccines obeys a statistical probability distribution combined of the sum of two major response probability distributions, pharmacological and immunological. This implies that the variance coefficient of the summed response probability distributions has a larger value than the variance of each underlying distribution. In other words, due to the multi-phased mode of action of genetic vaccines, their clinical outcome has more variability than that of traditional vaccines. This observation points toward the necessity for regulating genetic vaccines in a similar manner to bio-therapeutics to ensure better efficacy and safety. A structural PK model is provided to predict the sources of variability, biodistribution and dose optimisation.

show abstract

To aspirate or not to aspirate? Considerations for the COVID-19 vaccines

Cited by 6 publications

References 49 publications

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

mRNA vaccines: The future of prevention of viral infections?

Establishing the Pharmacokinetics of Genetic Vaccines is Essential for Maximising their Safety and Efficacy

Contact Info

Product

Resources

About