National Cancer Institute
National Cancer Institute Fi3z H Lx Wr Yw Unsplash

Looking Beyond Vaccine Approval

Oct. 26, 2020
Developing a safe vaccine is a significant challenge. However, addressing such mass distribution could present equally painful challenges.

Developing a safe COVID-19 vaccine has necessarily become a priority for pharmaceutical companies worldwide. So much so that it is sure to be the quickest vaccine development to date. Naturally, there have been a number of hiccups with major players pausing along the way to ensure overall safety. After all, even though the process is on the fast track, no one wants to the end product to be anything less than safe and effective.

Unfortunately, there are still some notable obstacles ahead. Specifically, current pharmaceutical supply chains lack preparation to meet the scale of demand for global vaccine deployment. This is resulting in new players entering the market including developers, producers, logistics providers and companies in other areas ensure the otherwise mature supply chain functions properly. 

Read on as Daniel Hartnett, former Pentagon advisor and an associate managing director with the Compliance Risk and Diligence practice of Kroll, a division of Duff & Phelps, shares his insights.

IW: Once there is an approved vaccine, what do you see as the biggest supply chain concerns/challenges?

Hartnett: Once a vaccine is approved, it will be necessary to ensure that the global supply chains distributing the vaccine have minimal exposure to third-party risks. Supply chains depend on many disparate outside parties to provide products or services to ensure successful operations. Manufacturers, distributors, logistics and warehousing companies, agents, and even advisors all play a role. Creating new global supply chains for the vaccine will require potentially hundreds of participants, each of whom could potentially open the door to risks that could disrupt the flow of the vaccine to those who need it.

Several third-party risks are of immediate concern for any future COVID-19 vaccine supply chain. The extreme sensitivity of the vaccine, requiring specialized storage and handling, raises the concern of tampering or adulteration during transportation and storage. Preventing theft will also be a challenge, especially considering the vaccine’s extreme demand and phased rollout, creating immediate haves and have-nots on a global scale.

Cyber security threats are also of concern. Adverse actors may seek to steal sensitive manufacturing information about the vaccine, especially in the early stages of distribution. The likely presence of sensitive personally identifiable information (PII) used to track vaccination makes data privacy protection another critical cyber security concern.

Setting up a new global supply chain also raises concerns of bad actors entering the supply chain. Participating third parties may come with a host of regulatory challenges, such as legal violations, bribery and money laundering offenses, fraud and even sanctions violations. They could even introduce unethical business practices, such as labor and human rights violations.

Finally, the global nature of the vaccine’s supply chain will require understanding shifting geopolitical risks. Protectionism and nativism may present sudden supply and demand-side challenges when seeking to distribute the vaccine globally. Consumer sentiment could also shift rapidly, potentially exposing a company to brand risks. This will cause vaccine supply chains to exist in a constant state of flux, exacerbating the third-party risks as new outside partners are constantly introduced.

IW:  What are the keys to overcoming these potential issues?

Hartnett: While eliminating third-party risk is unlikely, conducting comprehensive due diligence on the vaccine’s supply chain will help minimize exposure and subsequent disruption. 

Assessing the adequacy of security protocols and capabilities of all third parties involved in handling the vaccine at any stage is critical. Conduct site visits to inspect the security of manufacturing, storage and distribution facilities. Ensure there is a layered security approach in case one layer of defense is circumvented. Check to make sure that adequate business continuity plans are in place to respond to sudden, unexpected events.

Investigating the cyber security maturity of key third parties is also an important step. Ensure they have policies and control frameworks in line with best practices, such as limiting access control to networks and email platforms. Evaluate their cyber incident response plan, making sure they can respond quickly to any data breach. 

Screening third parties to identify any potential regulatory or reputational “red flags” is also necessary to weed out potential bad actors. Given the likely size of the supply chain, implementing a risk-based approach will help focus efforts and resources on the riskiest third parties in the supply chain. Ensure adequate pre-screening of backup third parties in case primary ones are sidelined for any reason.

Ensuring awareness and understanding of shifting geopolitical developments will help keep supply chains flexible. Be aware of regulatory changes that could challenge the use of certain third parties or jurisdictions in a supply chain. Monitor consumer acceptance of the vaccine product to rapidly respond to any possible anti-brand sentiment.

IW:  You mentioned cybersecurity. Can you expand on the importance of security? 

Hartnett: Ensuring the security and integrity of the end-to-end supply chain will be critical to the successful distribution of any COVID-19 vaccine. Extreme demand worldwide for a vaccine combined with a likely slow, phased global rollout could increase a sense of desperation and need to acquire the product through any means necessary. 

As with any high demand product, theft will be a major concern anywhere along the supply chain. Preventing the rise and spread of a vaccine black market will start with keeping the vaccine out of the hands of criminals. 

Having strong security protocols in place will also minimize the risk of vaccine spoilage. By most accounts, any likely vaccine will require specialized extreme cold storage capabilities to remain viable. Unauthorized opening of the storage container, even if by accident, could ruin the vaccine. 

Strong security protocols will also minimize the risk of intellectual property (IP) theft. This applies not only to attempts to steal vaccine IP by other companies, but also potentially by nation states. Recent reporting highlights how spy agencies around the globe have been targeting companies researching and developing potential vaccines. 

IW: What role do you see technology playing?

Hartnett: Technology can serve as a force enabler for securing any COVID-19 vaccine supply chain, functioning as loss prevention deterrence, detection and investigations tools. 

Closed-circuit television (CCTV) systems, for example, will be integral to monitoring vaccine production and logistics processes, as well as helping track shipments and safeguard storage facilities. Robust access control systems can improve security by limiting access to both sites and computer files or systems, as well as improving visibility by monitoring employee movements. Transportation monitoring capabilities will also improve transparency on a vaccine shipment’s whereabouts, potentially alerting companies to any deviation from the planned itinerary. Smart packaging technology, including radio frequency identification (RFID), anti-tamper/anti-counterfeit, and data logging technologies, can help improve tracking, deter theft and tampering, and ensure the integrity of the vaccine.

Technology can also be leveraged to help assess the cyber security capabilities of your critical third parties. For example, vulnerability scans and penetration tests of your third party’s systems can provide insights into how these systems will perform against cyberattacks. Continuous monitoring of the dark web can help identify breaches of vaccine-related IP or other sensitive data.   

Popular Sponsored Recommendations

Voice your opinion!

To join the conversation, and become an exclusive member of IndustryWeek, create an account today!