Q4 2020: The final stretch for vaccines

According to a director at Gavi, The Vaccine Alliance, current vaccine industry throughput stands at about 10 billion doses per year. The volume commitments from the vaccine producers – Pfizer said it would produce 1.3 billion, AstraZeneca two billion, Moderna 500 million, and CanSino around 100 million to 200 million by end-2021 – “suggest significant growth, almost doubling by the end of 2021 and the size of the industry”. Despite this extraordinary jump, the Gavi director believes this is achievable: “Over the next two or three months as EUAs [emergency use authorisations] are issued and as these companies start their manufacturing processes in earnest, I think you’ll see probably roughly one billion doses globally being made available over the next two or three months and then by the end of next year probably the sum total across all these announcements at one point was somewhere around 7.5 billion doses.”

While the vaccine rollout itself contains several unknowns, we already know what is needed to achieve global herd immunity. According to the American Journal of Preventative Medicine, 60% population coverage is necessary if a vaccine has 80% efficacy and 100% coverage if the vaccine has 60% efficacy. 

There will certainly be obstacles for the vaccine industry, and numbering among these is vaccine wastage. “It doesn’t matter whether you’re manufacturing a live virus vaccine or protein or something else, an RNA vaccine, these vaccines are manufactured under highly sterile conditions and these are very brittle manufacturing processes and it is not at all uncommon to see disruptions.” A former VP from Johnson & Johnson echoes this sentiment, explaining further: “There’s going to be spoilage. There are going to be excursions. There are going to be deliveries that don’t have a recipient to take it. If the delivery gets rejected, consider that delivery spoilt, because if it comes back to the distribution centre, it’s considered to go to morgue.” Estimates vary on how much is wasted overall, with one report from WHO putting the number as high as 50%.

There is also the problem of rising anti-vaccination sentiment, particularly in Western countries. In the US, around 5-10% “are just flatly opposed to vaccines. That’s been the historical average over time”, noted the Gavi director. And a study from Europe late last year indicated that just over half would be prepared to take the vaccine. What could be adding to this is the fact that mRNA technology is new and many of the vaccines have had relatively limited testing before receiving EUAs.

Another of the foremost challenges is the cold temperature required for these vaccines. The Pfizer/BioNTech candidate can be stored at ultracold temperatures for up to six months, and between -2℃ and -8℃ for up to five days, but once thawed it cannot be refrozen. Moderna’s option, meanwhile, can be stored long term at -20℃ and remains stable at between -2℃ and -8℃ for 30 days. At present, and considering the global scale at which these are needed, storage and transport capabilities are lacking, which is a key challenge for the vaccine industry. “When it gets all the way down to frozen temperatures, and frozen being in the -25℃, -35℃ range, that exists today and it exists with reasonable scale. I wouldn’t say with great scale,” explained the Johnson & Johnson executive. There is only limited ultracold storage available, but moves are being made to expand this, with UPS and DHL among those stating that they are building freezer farms. However, during transportation these vaccines would require dry ice – of which there is, again, constrained availability, and potential shortages are expected as demand heats up.

As two of our Interviews mentioned, these differing storage requirements point to different use cases. With Pfizer managing the distribution of its vaccine, added to the temperature limitations, this “implies that [the] vaccine will be used at central sites where they do large mass vaccination campaigns”, mentioned the Gavi executive. Meanwhile, the Moderna vaccine, and others with similar temperature requirements, could be more suited to being distributed in more remote locations. As a manager from CCC19 relayed to Third Bridge: “[Moderna’s storage requirements] definitely makes it easier to transport it from the cold facilities down to the level of distribution, so I would say the clinical facilities and the primary healthcare providers and others. Whereas, a vaccine that requires to be delivered within three hours of reconstitution definitely makes it challenging for those places. In that sense, Moderna might have an advantage in the distribution.” 

As testing is ongoing for the ideal storage requirements for the vaccines, these parameters could change in future. There also arises the question of what happens to the ultracold storage created during this pandemic. “They could service the food and beverage industry, and if you think about some of the home delivery of products today, seafood, ice cream, poultry, they are well-suited to be repurposed into another vertical if there seems to be a glut.” The ability to reuse this cold storage “depends on the way they were designed and their ability to be reconditioned”, however. Other areas pointed to by the interviewee using these kinds of temperatures include plasma and cell and gene distribution.

Indeed, this is already a growing area. “Cold chain management has been growing at a substantial CAGR, a reasonable CAGR, let me put it that way. Somewhere between 3.5% and 5.75% CAGR over the last decade, and that’s going to continue to happen.” One gap highlighted by one of our specialists is recirculating materials in the containers used to ship vaccines: “What I do see maybe a bit of an opportunity from an environmental and sustainability perspective, how do we put a recirculation process in place to recondition, not everything, but maybe some parts of those containers? That’s really forced upon us because there’s been a shortage in keeping up with manufacturing them.”

While there is a long road to travel to enable vaccinations to take place around the world, we appear to be heading in the right direction. The challenges are not insurmountable, either. As the Gavi director highlighted, citing the global effort against polio and ebola: “Nobody’s talking about eradication of COVID at this point, just disease control. Nonetheless, we have a history of knowing how to do this as a global help community.”