Although pricing and allocation pose serious challenges to ensuring access to Covid-19 medicines and vaccines globally, as Mike Piccarreta, partner at consulting firm Kearney, notes: “Delivering a vaccine at a truly global scale will present logistical challenges across all steps of the supply chains.”
Big Pharma’s commitments to and mechanisms for equitable access are moot if vaccines and drugs, once approved, cannot actually be manufactured at sufficient scale or be delivered to patients across the world.
Successful distribution globally is the only way to, “avoid pockets of unprotected populations [and thus] protect humanity from the threat at hand,” adds Honeywell vice-president and general manager of life sciences Cynthia Pussinen.
Pandemic manufacturing obstacles
“The amount of capacity required [to end the pandemic] across the value chain is significant, not currently available, and will take time to come online,” says Piccarreta.
He continues: “Given the devastation caused by the disease and the extent of its spread, the world cannot afford to wait for an approved vaccine or drug to build capacity.”
Time is of the essence and industry must act now to reduce Covid-19’s future impact – but it’s not that simple. According to Pussinen, in addition to billions of doses of vaccines and drugs, there is also global demand for sufficient raw materials to deliver them, such as glass vials and stoppers to store vaccines, as well as syringes required to administer treatments.
Pussinen adds: “It would be ideal to have a vaccine in place the day after receiving approval from regulatory bodies.”
Collaboration necessary for scale-up
The need to do the groundwork in advance to significantly scale up manufacturing capacity is not lost on the pharma industry. At significant financial risk to themselves, many companies have already scaled up their manufacturing capacity in advance of approvals of their Covid-19 drugs or vaccines.
Access to Medicine Foundation research programme manager Danny Edwards notes that to build sufficient global capacity to supply billions of doses of vaccines and drugs, there is a need for collaboration in manufacturing like we are currently seeing in R&D and need to see in allocation commitments.
There are already early signs of this with AstraZeneca’s deal with the Serum Institute in India to manufacture doses for low and middle-income countries. The Bill and Melinda Gates Foundation is already preparing to scale up and manufacture vaccines not yet approved and Moderna is collaborating with contract manufacturing organisation Lonza to produce one billion doses of the former’s vaccine candidate at the latter’s Singapore facility.
However, Edwards and STOPAIDS advocacy officer James Coles both believe, like allocation, there needs to be an even more coordinated, centralised approach to sharing manufacturing know-how, rather than individual companies taking the initiative.
While Edwards calls on global vaccine companies to be “creative about how to facilitate collaboration with the developing world” by unlocking as much global vaccine manufacturing capacity as possible, Cole thinks pharma companies should share know-how and intellectual property in the WHO’s Covid-19 technology access pool (C-TAP) or similar pooling mechanisms.
Innovation needed across the supply chain
Innovative technologies will further resolve manufacturing challenges as they help to bring additional capacity to the system, according to Piccarreta.
In an automation-focused vein, Honeywell is on hand to provide its Fast Track Automation system to pharma companies working on Covid-19 products. This platform drives efficiencies and accelerates the movement of vaccines and therapies in early clinical trials into full production within a few months, so it is ready to go if the product is approved by regulators.
Honeywell is already in talks with pharma companies to see how leveraging Fast Track Automation can support “shortening the time-to-patient with Covid-19 vaccines and treatments,” Pussinen notes.
Other important innovations are ongoing in packaging production. One example Piccarreta notes is the US Biomedical Advanced Research and Development Authority (BARDA) signing a $143m agreement with SiO2 Medical to produce glass-lined plastic vials, thereby reducing reliance on the limited supply of glass vials. Pussinen explains Honeywell is also looking at its proprietary Aclar bottles and vials as an alternative to glass to overcome breakage issues.
Covid-19 and the cold chain
The next challenge facing global access and ending the pandemic is physical distribution of these products, once they have been manufactured at scale, around the world. The main distribution barrier for vaccines particularly is the cold chain.
“Most vaccines are temperature-sensitive, requiring constant refrigeration as they travel through the supply chain,” explains Piccarreta. “If exposed to temperature outside the desired range, they can lose their potency.”
He adds that the cold chain poses even more of a challenge when looking at distributing these Covid-19 products to the developing world because of “limited refrigerated storage and reliable electric grids”.
Supply chain-focused Cloudleaf chief evangelist David Parker says: “Every year $35bn in cold chain biopharma products are lost to supply chain issues like these. Emerging markets experience greater levels of ineffective vaccines due to temperature excursions, which one wouldn’t know occurred just by looking at the vial.”
UK-based Stablepharma has come up with a solution for stabilised vaccines so that they are no longer reliant on refrigeration or freezing and can be “stored at room temperature, even if that is a tropical temperature, for many years,” explains the company’s chairman and founder Dr Bruser Roser. It also “enables them to be transported around the world without any damage”, thereby eliminating unnecessary vaccine waste.
Roser explains that StableVax technology does this by drying approved liquid vaccines and stabilising them using the sugar trehalose into a special sponge in a normal vaccination syringe. To administer the dose, the nurse or doctor simply needs to add water to liberate the vaccine from the sponge.
Stablepharma borrowed this concept from the Resurrection Plant found in the Sonoran Desert in the Southern US, and brought it to the lab bench and manufacturing to stabilise unstable products, such as vaccines.
Stablepharma has been in talks with companies developing vaccines for Covid-19. Roser is hopeful that stabilisation pilot vials will be in human trials in 2021 and that StableVax can potentially be rolled out as a practical solution for the pandemic, and vaccine distribution challenges more generally, soon after.
Improving supply chain visibility
A shorter-term solution to help overcome cold chain challenges is better visibility of the supply chain. This would drive efficiencies particularly in “emerging markets where delivery routes are less formal and technologically equipped”, notes Parker; this is an approach Cloudleaf is working on in the context of the pandemic.
Skycell CEO and co-founder Richard Ettl also notes the importance of visibility and supply chain monitoring of containers to overcoming cold chain distribution challenges.
His company’s solution is hybrid, technology-enabled containers. They rely on connected sensors in containers that “log information about temperature, journey and location”. The containers are also able to self-cool, which means “transporting and storing the vaccines becomes easier in developing countries where adequate storage facilities at airports and other transit hubs are not available,” explains Ettl.
Importantly, enabling safe and secure transportation of vaccines through monitoring “leads to immediate product release to patients,” says Ettl. SkyCell already works with five companies developing a Covid-19 vaccine and is preparing to leverage its hybrid containers to the benefit of these companies and the delivery of vaccines to patients all across the world, thereby supporting the quickest possible end to this deadly pandemic.