Leaders in Pharmaceutical Business Intelligence (LPBI) Group

COVID-19-vaccine rollout risks and challenges

Reporter : Irina Robu, PhD

BioNTech and Pfizer and Moderna COVID-19 vaccines received Emergency Use Authorization in January 2021 in Canada, European Union, United Kingdom and United States. However, in certain places COVID-19 has hit a few hindrances such as stockpiles have accumulated, deployment to vulnerable countries and at-risk groups has been slower than expected.  Yet, experts can see the light at the end of the tunnel of the pandemic. In United States, hundred of organization take a vital role in vaccine deployment, adapting their operations to meet the demands for volume, speed and better technology. Tens of thousands of transporters, vaccine handlers, medical and pharmacy staff, and frontline workers have mandatory training on the specific characteristics of each manufacturer’s distinct vaccines.

The common operating model provides the details of end-to-end vaccine deployment. Possible areas of risk to the rapid delivery of COVID-19 vaccines in the United States include:

Raw-materials constraints in production scaling

Scaling access to material and boosting production levels can cause logistical, contractual and even diplomatic challenges, requiring new forms of collaboration. The top two US manufacturers, for example, can produce 280 million vials per year, capable of holding up to 2.8 billion doses.

Quality-assurance challenges in manufacturing

Generating yields to produce a new class of vaccines—such as those based on mRNA or viral vectors—at an unprecedented scale (1.8 billion to 2.3 billion doses by mid-2021), manufacturers have required massive volumes of inputs, a larger technical workforce.

Cold-chain logistics and storage-management challenges

Manufacturers and distributors are preparing to maintain cold-chain requirements for distribution and long-term storage of mRNA-based vaccines. Large amounts of dry ice may be needed at various locations before administration.

Increased labor requirements

Complex protocols for handling and preparing COVID-19 vaccines have the potential to strain labor capacities or divert workers from other critical roles.

Wastage at points of care

Errors in storing, preparing, or scheduling administration of doses at points of care will have significant consequences and proper on-site storage conditions are also of critical importance.

IT challenges

IT systems, including vaccine-tracking systems and immunization information systems will be vital for allocating, distributing, recording, and monitoring the deployment of vaccines.

There are several possible approaches to help mitigate each of the six risks discussed, each with practical steps for organization to take across the common operating model.

Building resilient raw-materials supplies

• Resilience planning.Producers can partner with global suppliers of raw materials and ancillary-product manufacturers to create redundancies.
• Collaboration between industry and government.Ongoing industry engagement with government is essential for ramping-up production and maintaining high levels of production.

 Scaling manufacturing within quality guidelines

• Scale manufacturing in new and existing facilities.  Various digital and analytics tools can help expand capacity and scale more quickly.
• Assure quality and yield in current facilities. By continuing to coordinate with regulators, manufacturers and authorities can certify that procedures and dosage quality meet both long-established and newly issued guidelines.
• Establish predictable supplier plans. Each manufacturing stakeholder can follow a clearly defined plan and they can also conduct regular cross-functional risk reviews to ensure that quality.

Optimizing the cold chain

• Build redundancy into distribution.Manufacturers, distributers should quickly identify points of failure and creating redundancies at each stage.
• Leverage feedback loops.Reporting systems could be set up to capture supply-chain disruption events as soon as they happen, with data used to refine best practices and procedures and avoid further losses.
• Use point-of-care stock management.Vaccine inventories can be redistributed to locations with greater demand. Strategies to avoid over stockpiling must confirm maintenance of the cold chain to prevent risks to the receiving administration site.

Addressing labor shortages

• Use several types of point-of-care facilities.Rely on hospitals and primary-care locations for vaccine administration, in addition to retail pharmacies.
• Streamline administration across sites.Deploying vaccines at larger, streamlined vaccination sites can be more efficient and improve patient safety, labor utilization, and speed of vaccination.

 Reducing spoilage at points of care

• Track and monitor spoilage at points of care.Manufacturers and distributors can collaborate to establish the means to identify and trace instances of spoilage. They can learn from experience and refine guidance, training, certification, and allocation to optimize utilization of doses.
• Pace first-dose allocation.Allocation of first doses to populations and locations where the need is greatest and the confidence in the availability of second doses is high (such as healthcare professionals and vulnerable populations in nursing homes).
• Prioritize second doses.Authorities can help ensure that the recommended two-dose course schedule for such vaccines as the Pfizer-BioNTech, Moderna, and AstraZeneca vaccines are duly completed.
• Establish recipient commitment.Vaccine recipients could be asked to commit to second-dose appointments at their point of care before first-dose administration.
• Manage certification.National and local government institutions can collaborate to ensure that vaccination certifications are withheld until recipients receive their second dose.

Meeting IT challenges

• Balance IT upgrades and resilience.Stakeholders should identify IT systems that can be relied upon in the deployment of COVID-19 vaccines and assess their ability to perform at scale.
• Share cyberthreat intelligence.COVID-19-vaccine stakeholders should agree upon common requirements and processes for generating and sharing threat intelligence.
• Establish means of demonstrating immunity.Manufacturers and distributers can commission systems to track and verify that vaccine recipients have demonstrated immunity. if it will release them from travel limits and other pandemic-related restrictions.

Although not one organization is involved for managing vaccine deployment, but the risks can be fully address if organizations align on lead organization to build scenarios to test responses to emerging crises. The groups could align on lead organizations to manage issues while building scenarios to test responses to emerging crises. The benefits in managing each of these risks could be demonstrated with compelling metrics and communications.  As COVID-19-vaccine rollouts commence, the steps mentioned above can be undertaken by manufactures, distributors and governments.

SOURCE

https://www.mckinsey.com/business-functions/risk/our-insights/the-risks-and-challenges-of-the-global-covid-19-vaccine-rollout?cid=other-eml-nsl-mip-mck&hlkid=19a51f848bee4d00806d2da81315f70d&hctky=2071733&hdpid=062f1841-f911-48f3-ab14-a9f92e30721f#