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Abstract
Rapid global COVID-19 pandemic response by mass vaccination is currently limited by the rate of vaccine manufacturing. This study presents a techno-economic feasibility assessment and comparison of three vaccine production platform technologies deployed during the COVID-19 pandemic: (1) adenovirus-vectored (AVV) vaccines, (2) messenger RNA (mRNA) vaccines, and (3) the newer self-amplifying RNA (saRNA) vaccines. Besides assessing the baseline performance of the production process, impact of key design and operational uncertainties on the productivity and cost performance of these vaccine platforms is quantified using variance-based global sensitivity analysis. Cost and resource requirement projections are computed for manufacturing multi-billion vaccine doses for covering the current global demand shortage and for providing annual booster immunisations. The model-based assessment provides key insights to policymakers and vaccine manufacturers for risk analysis, asset utilisation, directions for future technology improvements and future epidemic/pandemic preparedness, given the disease-agnostic nature of these vaccine production platforms.
Highlights
The COVID-19 pandemic, caused by the SARS-CoV-2 virus, created an unprecedented demand for rapid, large-scale vaccine deployment that the world is struggling to meet. This urgency and scale of immunisation against a new disease poses enormous challenges on the entire vaccine deployment pipeline[1–4]. This pipeline has the following main parts: (1) pre-clinical development and testing, (2) clinical development and testing, (3) production process development, scale-up and technology transfer for the manufacturing of the vaccine active ingredient, (4) sourcing of raw materials and consumables for manufacturing both the DS and the final packaged vaccine product filled into glass vials or other containers, (5) DS production under current Good Manufacturing Practices, (6) fill-to-finish processes under cGMP, (7) vaccine distribution and (8) vaccine administration to the population[1–4]
Global COVID-19 vaccination programmes have been constrained by vaccine manufacturing capacity, in lowand middle- income countries[5,6]
The AVV, messenger Range mRNA and saRNA (RNA) (mRNA) and self-amplifying RNA (saRNA) DS production processes and fill-finish processes are described in Supplementary Section 1.1–1.4 of the Supplementary Information document—see Section “Methods”
Summary
The COVID-19 pandemic, caused by the SARS-CoV-2 virus, created an unprecedented demand for rapid, large-scale vaccine deployment that the world is struggling to meet. This urgency and scale of immunisation against a new disease poses enormous challenges on the entire vaccine deployment pipeline[1–4]. Key uncertainties and their impact on COVID-19 vaccine production are analysed and the production process scales, timescale and manufacturing resources required for producing 1 billion COVID-19 vaccines per year are estimated. These estimates can serve as a basis for calculating the requirements to produce vaccines for global demand. The results of this study can inform policy makers and vaccine manufacturers on how to improve manufacturing and asset utilisation against COVID-19 and its variants, and against future outbreaks due to the disease-agnostic nature of these vaccine production platforms[1,26]
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