Scaling up vaccine distribution for COVID-19: Why we shouldn't expect the world to go back to normal any time soon
Now that the first batch of Pfizer-developed vaccines for COVID-19 reached O'Hare airport and two other vaccines already in the late stage of testing, you are probably asking why we aren't expected to be back to normal by, say January, March, or maybe June for summer travel.
The issue is that scaling such a complex operation is much harder than one may think. The GAO released a report earlier last week detailing some of the issues.
The report outlines four key elements:
Limited manufacturing capacity.
Disruptions to manufacturing supply chains
Complicated technology transfer processes.
Gaps in the available workforce.
Limited manufacturing capacity:
The report discusses the challenges of increasing mass production of COVID-19 vaccines and drugs, which includes adding capacity or shifting production from other products because most medicines and vaccines were already in use. This issue has also been raised by Moderna concerning its Vaccine, here: Moderna's coronavirus vaccine maker identifies 'big challenges' to mass production:
"Swiss drugmaker Lonza has partnered with Moderna and says it aims to produce 400 million doses of the vaccine annually. The U.S. firm is aiming for 500 million to 1 billion doses in total for 2021. Anyone receiving the Vaccine will require two doses, as with Pfizer's shot, showing how long it could take, with the current manufacturing capacity, to vaccinate internationally….There are a few issues, the first is speed. We only started 10, 11 months ago and now we are producing the first commercial batches of the drug substance in North America, and we are planning the first batch of commercial volume in one or two weeks in Switzerland, so the speed has been a challenge."
Disruptions to manufacturing supply chains:
Large quantities of vaccines and drugs must be sealed in sterile containers in finish-fill facilities since stocks are limited. Supply of other products necessary for this process, such as glass vials and syringes, is also short. The report warns that manufacturing supply chains could struggle
to keep up with demand due to disruptions caused by the coronavirus, including changes in worker availability, fluctuating demand for certain products, and some countries' export restrictions. Specifically, the report states:
"Vaccine manufacturing supply chains may be strained by disruptions caused by the global pandemic, including changes in the labor market, increases or decreases in the demand for certain goods, or as one DOD official noted, export restrictions implemented by some countries. For example, officials at one COVID-19 vaccine manufacturing facility told us that they have experienced challenges obtaining materials, including disposable reactor bags, reagents, and certain chemicals. They also said that due to global demand, they sometimes must wait 4-12 weeks for items that before the pandemic were typically available for shipment within one week. One expert we interviewed also told us that the supply of the materials used in manufacturing, such as glass vials and pre-filled syringes, is limited."
Complicated technology transfer processes.
It may also be complex to transfer knowledge of how to manufacture COVID-19 vaccines and drugs and expand production to multiple manufacturing sites." Additionally, there has been at least one instance in which the technology transfer process for a COVID-19 vaccine has been hampered by disagreements over ownership of intellectual property rights related to manufacturing technology," the report said.
Gaps in the available workforce.
And finally, recruiting and training workers in specialized skills they need to complete vaccine production processes can be difficult—even for experienced manufacturers.
"For example, we heard from representatives at a COVID-19 vaccine manufacturing facility that is filling open positions for mid-to upper management positions had been a challenge… These positions are significant because manufacturing managers function as the technical points of contact for production questions and are responsible for managing safety, quality, and compliance with current good manufacturing practices."
Moderna has raised a similar issue:
"The second challenge is to find the people. For each manufacturing line you need 60-70 educated persons. We've installed four manufacturing lines so you have to identify and train these people," he said."
In my opinion, we need also to discuss another significant issue, which is our expectations. In other words, our unrealistic expectations. This is very much related to the scalability continuum I discuss in my class:
(1) On the one hand, we live in a digital world of bits and bytes, where we think order things on mobile, and our computer and the purchase are made with one click.
(2) But then there is the world of atoms: the messy world where the number of people that needs to be vaccinated is translated to actual people producing the vaccines, filling real syringes, packing these in actual boxes, and delivering on actual tracks to our real pharmacies, and then injected to real bodies.
We tend to overlook the latter, and the faster and more efficient the former is, the more we expect the latter to be as well. And while it definitely becomes more efficient, there are physical limitations to how fast and efficient and abundant it can be. Of course, that gets into the question of who is getting the vaccine:
"The WHO says it is also working on a plan to ensure the equitable distribution of vaccines. But how that could be enforced in practice It isn't clear. "In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available," says Mariana Mazzucato, an economist who heads the University College London Institute for Innovation and Public Purpose."
For example, The Gates Foundations released a report:
"The report cites modeling from Northeastern University that predicts twice as many people could die from Covid-19 if wealthier countries hoard the first 2 billion vaccine doses rather than distributing them equitably."
So, what can be done? Build more capacity, work on other drugs, and manage expectations. The report indicates that federal agencies and Vaccine manufacturers can increase domestic production capacity, provide critical manufacturing equipment more efficiently, and increase capacity for critical materials through Operation Warp Speed. This is also the case for continuing and working on the other drugs, which seem to be delayed. They may need a more straightforward supply chain, they might provide additional capacity, and they may tell us something we don't know.
There are many other questions: should we trust the vaccines with limited testing of their longevity (I think we do. What other option do we have at this point)? Should airlines or schools force students and passengers to immunize (different questions, I know, but I think they should, once the vaccines are tested for the appropriate age group), and should countries force people to immunize in general (No). But we will have quite a bit of time to resolve these since scaling the vaccination process is going to take us some time until we actually need to resolve these.