Creating a Fit-for-purpose Supply Chain for the COVID-19 Vaccine

The race is on amongst the international scientific research community to develop a vaccine that will prevent infection by SARS-CoV-2, the virus that causes COVID-19.

While many nations who were the early epicentres have successfully flattened the curve, both in terms of new confirmed cases and the number of people who are losing their lives to this novel Coronavirus, the virus is continuing to spread at an accelerated rate elsewhere, particularly in the Americas and Southeast Asia.

There is also the very real risk of a second wave of Coronavirus infection in countries that have already been badly hit earlier in 2020, as autumn looms.

By the end of 2021, the World Health Organisation (WHO) plans to deliver over 2 billion doses of a Coronavirus vaccine internationally to accelerate herd immunity and wipe out the highly infectious virus. But this ambitious timeline presents a huge challenge for pharmaceutical supply chains and healthcare systems.

Decades of underinvestment and growing pressure from numerous stress factors like new medicine types, increasing demand from emerging economies, the rise in counterfeiting and falsification, and stricter regulation has left the pharmaceutical supply chain in substandard condition.

For too long, the pharmaceutical industry has relied on supply chain networks that are neither flexible nor cost-effective. Faced with the task of delivering a safe and effective COVID-19 vaccine to billions of people worldwide, the time for the pharma industry and its partners to act is now.

The benefits of a modern pharma supply chain that’s fit for today’s challenges and tomorrow’s will long outlive the COVID-19 pandemic. It will provide cost-saving and efficiency gains for years to come, while simultaneously helping the industry to fulfil its social responsibilities, including the need to both pioneer more sustainable manufacturing processes and produce more effective and safer medicines the entire world can afford.

Where are we with COVID-19 vaccine development? Developing a new vaccine is a long and complex process, often taking between 10 and 15 years to complete. It also requires huge sums of public and private investment.

The record for the fastest new vaccine developed is currently held for the Zika virus (seven months) but the epidemic naturally came to a halt before the vaccine became available.

There’s also the uncomfortable fact that up to 94 per cent of new vaccines fail to pass the clinical trial stage because generally, vaccines are even more thoroughly tested than non-vaccine drugs due to the number of human subjects in vaccine clinical trials usually being greater.

In vaccine development, there are usually three different phases of clinical trials (Phase I involving a small batch of people, Phase II with a few hundred, then finally Phase III with thousands) and researchers usually leave months in between each phase to review the findings and secure approval for subsequent phases.

According to WHO, as of 6th July, there are 21 candidate vaccines in clinical evaluation with the developers from the University of Oxford and Astra Zeneca, and Sinovac leading the way with their vaccines currently in Phase III clinical trials.

Many are expecting (and very much hoping) a vaccine is available within the next 12–18 months, and that it’s good enough to accelerate a population’s progression towards herd immunity before it’s reached naturally. And the international pharma supply chain needs to be ready to go in anticipation of this date.

What’s needed to deliver a safe and effective vaccine? Delivering a new vaccine for COVID-19 to billions of people worldwide will be one of the greatest challenges faced by modern pharma and its supply chains. The difficulties are intensified by the shortcomings of the current pharma supply chain model, which has been short of investment and innovation for decades.

Linking the laboratory to the marketplace, the supply chain deserves the same

focus and investment given to the discovery, development and marketing of pharma products. Yet inefficiencies and bottlenecks remain, largely hidden behind the closed doors of warehouses.

But faced with the responsibility of delivering the COVID-19 vaccine within such a short timescale, this could be the tipping point we’ve all been eagerly awaiting to kick start the next generation pharma supply chain.

Upscaling Manufacturing Capacity As part of international initiatives to increase pandemic preparedness, upscaling manufacturing capacities for vaccines has been a priority for many years. There have also recently been additional emergency funding packages from governments worldwide in support of bolstering pharma manufacturing capacity even further, in anticipation of an approved COVID-19 vaccine.

However, where to channel this investment is a difficult decision to make before a vaccine has been approved. The manufacturing facilities needed will be dependent on the kind of vaccine which is found to work best, and that won’t be known until the Eureka! moment. Currently, there are clear frontrunners in the race, but this could all change at the final hurdle.

For a vaccine to be made quickly and distributed to populations worldwide by 2021, we need to plan ahead. National governments need to start signalling the quantities of a vaccine they would be prepared to purchase and who they would prioritise immunising first. A further step could be committing to a pre-agreed purchase price ahead of the vaccine being approved to give greater certainty to manufacturers.

The Cold Chain One of the major challenges in distributing a vaccine is always temperature. Vaccines need to be kept at an optimum temperature, usually between 2 and 8 degrees Celsius, to be effective. This critical temperature must be maintained throughout the whole manufacturing and distribution process, up until the point when the vaccine is administered to a patient.

Cold chain logistics will, therefore, be a key focus in preparation for the point at which a COVID-19 vaccine is approved. A cold chain refers to a supply chain with cargo that undergoes end-to-end temperature control through transit and it’s a relatively new concept in pharma, as many traditional drugs do not need to be transported or stored in a temperature-controlled environment.

Thanks to the advent of a new class of pharmaceuticals – biologics - the cold chain has benefitted recently from greater investment, expansion and tracking innovations. But the challenges of cold chain logistics are ongoing, particularly in lower-income and remote locations, with tough terrain and warmer climates adding an extra element of risk.

Some companies are offering experimental drone deliveries of medicines to cut the time it takes for them to reach remote communities from several days to as little as a few hours. With the threat of COVID-19 being particularly high in remote communities with poor or no healthcare infrastructure, this may become a technique used more widely.

Primary and Secondary Packaging Manufacturing and assembling primary and secondary packaging for the vaccine is also going to be a test. Often, delivery devices and packaging will be manufactured separately before being filled and assembled, bringing together multiple stakeholders and increasing the margin for error.

In terms of primary packaging, pre-filled syringes would be the preferred option as a singular vehicle for, and direct administrator of, the vaccine, protecting its contents from contamination and misuse.

All compounds and primary packaging structures need to be extensively tested for materials, extractables and leachables, durability, shelf-life and more, and tested for suitability with secondary packaging. Certain compounds may be considered non-toxic, but when tested for temperature, failure analysis and more, demonstrate a risk to patients.

A Hybrid Supply Chain Model Given the complexities and urgency in distributing a vaccine globally, a new approach is needed to assess, re-engineer and build upon available logistics assets and systems.

Historically, pharma companies have relied on a network of hundreds of suppliers placed around the world to manufacture, package and deliver different products to market. It’s still not uncommon for multiple teams to be managing multiple international supplier sites. As a strategy, this is overly complex, largely inefficient and very expensive.

A pragmatic solution will be bringing it “under one roof” to deliver a vaccine at such a huge scale and within such a tight timeframe, merging the best of manufacturing, design and innovation, supply chain networking and infrastructure. When doing so, there must be internationally dispersed sales offices, manufacturing cells and storage facilities in strategic locations.

Consolidating the supply chain brings a host of benefits including, but not limited to: reduced risks and overheads, greater innovation, increased speed to market, assurance of supply and compliance, tighter quality control and local availability via regional distribution sites on a global scale.

Limiting Counterfeit Activity As we’ve already seen with COVID-19 testing kits, fake products are flooding the market as criminals attempt to capitalise on the pandemic. As one of the world’s largest industries, the pharma sector is increasingly being targeted by criminals after a slice of this lucrative market. So much so, fake medicine is now the largest fraud market, worth over $200 billion per year.

Falsified medicine is the production of counterfeit pharmaceutical products that do not adhere to the strict regulatory standards imposed by government agencies to ensure the end user’s safety. This can take various forms, with the key factor being they usually contain low quality or incorrect ingredients, or a wrong dose of them.

Falsification can also be in the form of the information surrounding the product’s provenance trail, such as the manufacturer, country of manufacture and commercialisation owner. Similarly, the distribution channels logged in its records and documents can be falsified to cover up the original source.

A crucial part of delivering a safe and effective COVID-19 vaccine will be ensuring falsified and counterfeit versions are not in distribution. The use of intelligent packaging and supply chain tracking software will be key.

Smart tracking systems, built into primary and secondary packaging, is also an exciting area of innovation within the pharmaceutical industry. Managing and recording all the typical activities that occur in the supply chain, or designed to cover special requirements, tracking chips can log events or raise queries that occur across a product's lifespan remotely and in real time.

This is invaluable information for antitampering strategies, allowing companies to locate and interrogate a product anywhere in the supply chain. For example, the geographical location of a product and the route it took to arrive there can all be captured and stored, thus revealing any unauthorised journey routes or interventions.

Communication, Education and the “Anti-vaxxers” There are also further complications to address once a vaccine is approved and distributed, particularly for ongoing communication and education initiatives.

Vaccination isn’t compulsory and the spread of online conspiracy theories is helping to fuel the so-called “anti-vaxx” movement around the world, which could mean take-up will be lower than expected amongst the public when a vaccine against COVID-19 is available.

It’s currently estimated in Britain, up to a third of people are either unsure about or would refuse a vaccine, rising to up to half of people in America. This represents a serious and growing problem that could hamper the success of the COVID-19 vaccine.

Messages spreading across social media portraying the often false negative consequences to vaccinations may be in the minority, but they are exceptionally pervasive.

Clear communication and health education, at both a grassroots and topline level can help to bridge this gap and combat the acceptance of fake news stories surrounding the Coronavirus and its vaccine.

As an alternative to simply listing all the positive facts about a COVID-19 vaccine and saying it’s safe, public health officials and clinicians across all nations need to listen and understand the specific concerns individuals and groups have and respond in a targeted way to change their opinions and dispel misinformation.

A Challenging Path Ahead It’s quite remarkable the speed at which we’re progressing towards a COVID-19 vaccine. The international scientific community, investors and governments alike have come together at this time of crisis for the good of mankind.

The pressure on supply chain networks to deliver a safe and effective vaccine is immense and will continue to grow as we edge closer to an approved product. And at the same time, the pharmaceutical industry has an obligation to maintain and strengthen supply chains for existing treatments and services.

While there is certainly a challenging path ahead, if there is one positive to come from this pandemic, it’s bringing into clear view the vulnerabilities that exist and taking action to strengthen global medicine supply networks for our post-pandemic future.

Rich Quelch

Rich Quelch is an experienced global marketer within the healthcare and pharmaceutical sector. He has led the development of the Origin brand, positioning it as a world-leading supplier of innovative and groundbreaking pharmaceutical packaging devices, as well as offering a unique supply chain model that is disrupting the pharma industry.

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