Abstract
The vaccine distribution chains in several low- and middle-income countries are not adequate to facilitate the rapid delivery of high volumes of thermosensitive COVID-19 mRNA vaccines at the required low and ultra-low temperatures. COVID-19 mRNA vaccines are currently distributed along with temperature monitoring devices to track and identify deviations from predefined conditions throughout the distribution chain. These temperature readings can feed into computational models to quantify mRNA vaccine critical quality attributes (CQAs) and the remaining vaccine shelf life more accurately. Here, a kinetic modelling approach is proposed to quantify the stability-related CQAs and the remaining shelf life of mRNA vaccines. The CQA and shelf-life values can be computed based on the conditions under which the vaccines have been distributed from the manufacturing facilities via the distribution network to the vaccination centres. This approach helps to quantify the degree to which temperature excursions impact vaccine quality and can also reduce vaccine wastage. In addition, vaccine stock management can be improved due to the information obtained on the remaining shelf life of mRNA vaccines. This model-based quantification of mRNA vaccine quality and remaining shelf life can improve the deployment of COVID-19 mRNA vaccines to low- and middle-income countries.
Highlights
The detrimental impact of pandemics, such as the COVID-19 pandemic, can be reduced by rapidly mass-vaccinating the population against the pandemic pathogen
To prevent mRNA degradation and alterations in the mRNA critical quality attributes (CQAs) and mRNA-lipid nanoparticles (LNPs) CQAs, these vaccines are handled and distributed under well-controlled conditions. This is meant to reduce the impact of factors such as temperature, time, light and shear stress on the stability-related mRNA CQAs and mRNA-LNP CQAs
Incidents, faults and failures can still occur. Taken together these efforts could help with enabling the delivery and usage of vaccines in low- and middle-income countries (LMICs), once these COVID-19 mRNA vaccines are made more affordable to LMICs
Summary
The detrimental impact of pandemics, such as the COVID-19 pandemic, can be reduced by rapidly mass-vaccinating the population against the pandemic pathogen. In order to facilitate distribution of its COVID-19 mRNA vaccine, Pfizer has designed special thermal shipping containers that utilise dry ice [18,20,37] This original PBS formulation of this vaccine requires ultra-cold temperatures of between −90 ◦ C and −60 ◦ C, commonly −80 ◦ C for shipment and longer term storage for up to 6 months, cf Table 2 [18,20,37,38]. The PBS formulated BioNTech/Pfizer COVID-19 mRNA vaccine can be transported between −25 ◦ C and −15 ◦ C, commonly −20 ◦ C, and the unpunctured vials can be stored at this temperature for up to 2 weeks [18,20,37,38]. The updated Tris formulation of the BioNTech/Pfizer COVID-19 mRNA vaccine has an enhanced stability profile and can be stored for 9 months at −90 ◦ C to −60 ◦ C, commonly at −80 ◦ C This updated formulation can be stored for up to 10 weeks at temperatures between. Such a detailed mechanistic understanding of LNP instability or the availability of abundant data can support the development of mechanistic or data-driven models, respectively
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