Here’s Why The Real Challenges Will Unfold Only After A Covid-19 Vaccine Gets Approved
With more than half a dozen vaccines at advanced stages of development, it is critical to start looking at the path ahead once a vaccine gets approval for mass production. How long would it truly take for you and others to get vaccinated once an effective vaccine is developed? Let’s try to answer this question from a global supply chain perspective by exploring key challenges and possible solutions for each aspect of the supply chain.
Before jumping to key challenges and possible solutions, it is worth understanding the context and scope of the problem.
What is the Scale and Scope of the Problem when it comes to Distribution, Delivery and Administration of the vaccine?
We’re dealing with two important aspects — scale (the number of people who need to be inoculated) and speed (inoculation needs to happen almost simultaneously and as soon as possible). In terms of numbers, one or two vaccine doses are anticipated per person, immunising at least 60% to 80% of the world’s population. This means at least 5.6 billion people need inoculations.
The vaccine supply chain involves not only manufacturing the vaccine contents, but storage and packaging components, cold-chain transit, domestic and global shipping, distribution strategies and storage.
What are the challenges related to manufacturing the vaccine?
Typically, drug-makers manufacture only enough doses for clinical trials and make sure the trials are successful before starting mass production. However, in this case, it’s really critical for the vaccine to reach people as soon as possible and hence a sequential process is not advisable. Starting manufacturing in parallel (basically manufacturing at risk) means that developers will instead begin mass production at the same time as clinical trials, which means that if a vaccine fails in human trials, they’ll have to throw away all the product they’ve made, wasting money and materials.
Vaccines are complicated to manufacture, even compared to other pharmaceutical products. Producing the antigen, which provokes the body’s immune response, uses different techniques depending on the vaccine’s design. The vaccine candidates use different technology types, like protein-based, non-replicating viral vectors or DNA vaccines. This means the equipment and processes to produce the vaccine differ.
The filling and packaging materials vary as well, whether in multi-dose vials or single syringes. All of this is done in a highly sterile environment with temperature controls and using skilled personnel. Equipment and processes must be tested and government-approved, along with testing the finished product.
By making the development steps parallel instead of sequential, some of that investment will be wasted as the manufacturing process may differ from the initial set-up. Facilities will not be built to spec for the specific vaccine candidate, but rather built and then modified later on.
There are other products that will have to be manufactured and sourced alongside the vaccine — vials, rubber stoppers, syringes and plungers will need to be available in quantities of billions.
What are the challenges related to storage and distribution?
Typically, vaccines need to be kept at a constant temperature of between 2°C to 8°C . Even a few hours outside of a fridge can render a vaccine ineffective. As the COVID-19 vaccine reaches the market, on-the-ground distribution would depend entirely on cold-chain technology.
This would make it particularly difficult to reach people living in rural areas or populations in remote or hilly terrains. Even hot countries with erratic power supplies can present significant problems.
What are the challenges related to administration?
Ensuring that everyone in the world gets access to a COVID-19 vaccine will require millions of community health workers worldwide to be trained to administer vaccines and perform community outreach.
These workers will also need personal protective gear (PPE), tracking technology, medical gear, funds, and support networks to do their jobs effectively.
Additionally, although there would be guidelines for which categories of people get prioritised for immunisation, implementation and monitoring this would be challenging.
What could be some of the things that could be done to tackle these challenges?
Here are some of my recommendations on what could be done to tackle these challenges:
- Manufacturing: In case of manufacturing, as can already be seen, the best option at this stage is to start mass manufacturing in parallel as soon as a vaccine enters Phase 3. In this way, there will be millions of doses ready to go the moment a vaccine clears Phase 3.
- Storage & Distribution: There could be a lot of innovative solutions to tackle cold storage and distribution problems.
Cold Storage options:
i) Solar direct drive refrigerators would be one of the first options to consider for cold storage of vaccines. “Direct-drive” technology uses the sun’s energy to freeze water or other phase change material and then uses the cooling from that “ice bank” to keep the refrigerator cold during the night and cloudy days. These refrigerators are called “direct-drive solar refrigerators” because they are wired directly to the photovoltaic generators.
ii) Ice-lined refrigerator (ILR) technology is another option that can be explored for cold storage. An ILR can maintain a temperature from 2°C to 8°C with as little as 8 hours of power supply in 24 hours. If the electricity supply fails, then the ice lining maintains the inside temperature of the refrigerator at a safe level for vaccines. Moreover, an ILR has a top-opening lid which prevents loss of cold air during door opening.
i) Drones could be a smart way to reach people living in remote areas or hilly terrains. A powerful example of how drones could be used effectively is a medical product delivery company called Zipline that has reduced the transportation time of key medicines from several days to two hours, saving thousands of lives in Rwanda and Ghana. If cold storage can be integrated with the drone delivery mechanism, it could be particularly effective in transporting vaccines across challenging terrains, such as mountains.
ii) Designing an effective delivery network: Over the last several years, the medical industry has collected a lot of data about past vaccine supply chains, distribution methods, population densities, as well as recently available data surrounding demand and supply of a vaccine. All of this data could be critical in designing an effective delivery network but would take months to analyse the data and generate actionable insights. Instead, by taking advantage of artificial intelligence (AI)-powered advanced analytics, one can design the delivery network with far greater speed and accuracy. For example artificial intelligence company Macro-Eyes uses satellite imagery, digital conversations, and publicly available data to predict with 76% accuracy which child will drop out of routine immunisation programs.
By taking advantage of simulation technology, organisations can virtually test their supply chain strategy to ensure the resiliency of the network. The digital twin will then predict potential failure points in the supply chain, allowing organisations to prepare for any eventuality. Therefore, both an effective supply chain strategy and alternate strategies can be planned in advance in anticipation of the vaccine.
3. Administration of the vaccine:
i) Training of community health workers would need to start in parallel with Phase 3 trials. It will also have to be ensured that PPE, tracking technology, medical gear are available for the workers to do their jobs effectively.
ii) Digital biometric ids could be used to ensure that prioritised groups receive vaccination and there is no fraud or multiplication.
To help you understand the complexity related to vaccine distribution and administration, I’ve tried to cover all the major aspects of the supply chain.
To wrap up this blog, the parting thought that I would like to share is that although vaccine distribution and administration can pose considerable challenges, my personal belief is that there’s no problem that smart technological innovations can’t solve in today’s world.