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Pfizer-BioNTech, Oxford-AstraZeneca, Moderna, Johnson & Johnson - the vaccines that have been approved through 'Emergency Use Authorisation' in many jurisdictions across the world are rolling out. It's a mammoth effort involving a staggering number of individuals and inherent risks, some of which have already become apparent.
Global management consulting firm, McKinsey & Company, has assessed the process for vaccine roll-outs and identified six critical emerging risks, a number of which already exist in some form -
- raw material constraints in production scaling: while there are early indications of sufficient global capacity for syringes and fill-finish materials, niche chemical and biological vaccine components are scattered. This creates the risk of competition between countries becoming reality and the challenges of supply which is created.
- quality-assurance challenges in manufacturing: A new class of vaccines (such as those based on mRNA or viral vectors) at an unprecedented scale of 1.8 billion to 2.3 billion does by mid 2021 requires " massive volumes of inputs, a larger technical workforce, and much expanded ecosystem of production facilities".
- cold-chain logistics and storage-management challenges: maintaining cold chain control for distribution and storage of mRNA-based vaccines will place strain on the production of dry-ice manufacturing. Fast distribution and usage of vaccines due to demand may alleviate some of this potential risk.
- increased labour requirements: estimates show that the need for a trained workforce remains acute given the vaccination protocols which are complex in the handling and preparation of vaccines and the added care requirements for patients. Estimates suggest that COVID-19 vaccination is 3.5 times slower than the annual flu vaccination programs even with streamlined site management.
- wastage at points of care: storing, preparing, scheduling administration of doses at points of care all have error risks. Perhaps the most significant is if there is product wastage when doses are not allocated sufficiently. Vaccine doses come in multidose vials and must be used in a short space of time.
- IT challenges: Vaccine tracking system systems (VTrckS) or immunization information systems (IIS) designed to manage double doses in populations present software challenges. Given there has already been cyber attacks against COVID-19 vaccine developers and regulators, security has a whole new meaning.
The level of vaccination required is also vast with "..twice as many doses of COVID-19 vaccines being administered in one month than were administered for the whole of the 2009 H1N1 flu vaccine'' (McKinsey and Company 2021).
McKinsey's propose a range of responses to the six critical emerging risks -
- scale manufacturing in new and existing facilities
- establishment of predictable supplier plans
- built-in redundancy into distribution
- leverage feedback loops
- use of several types of point-of-care facilities
- track and monitor spoilage at points of care
- pace first-dose allocation
- balance IT upgrades and resilience
A link to the research article is below:
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