“Storage and Shipping Wars” will Add to the Pain of the Pandemic
(Thursday, September 17, 2020] All the vaccines being developed for COVID-19 need to be kept at ultra-low temperatures and have very short shelf-lives raising a logistical nightmare for vaccinating millions of individuals in a short time, as desired for the pandemic. The approval of a vaccine is not the end of the pandemic, far from it. While the vaccine may be approved next month, the best projections show that most people may not be able to get vaccinated for another year or longer. There has been little public discussion on distribution of vaccines by the FDA and CDC, and it seems for good reasons; we don’t have good answers. There are four issues to consider for Covid vaccines. First, the freeze storage space is limited and there isn’t much space. The current pharmaceutical grade storage space is used to store other products which are also critically needed so that space cannot be simply commandeered for Covid vaccines. The non-pharmaceutical storage space is primarily used in the food industry, which is not compliant to the pharmaceutical standards. It can be upgraded at a lower expense than building new facilities but similar issues like pharmaceutical grade space exist. Moving the products currently stored in such space out of storage would create other supply issues for example it could lead to unprecedented food shortage and waste. At best, this is a short-term solution. Second option is to build more capacity. Building new facilities is expensive and needs long-term commitments. One cannot purchase thousands of -80°C freezers and build warehouses to house them, to find out that they will be needed only for the next year or two. We do not know if the Covid vaccines will be needed over long term. Based on the current research, coronaviruses are different from flu virus; it is unlikely that we would do annual coronavirus vaccination like the annual flu vaccination. Unless we can come up with other uses of the newly built ultra-low temperature storage space after the pandemic, it would be hard to justify the cost and effort. Third factor to consider is the shipping containers for getting the vaccines to the population. Similar issues like using the current capacity versus building new ones need to be considered for shipping containers as well. Shipping is harder in many ways because the clinics and healthcare facilities where these would end-up do not have ultracold storage so the containers will stay till the vaccine is used up, blocking such containers from circulation. So, much extra capacity will be needed. The fourth issue is the stability of the vaccine. Several of the vaccines at late stages are mRNA vaccines which have very short shelf-life even at ultracold temperatures and of less than a week once thawed. So, we cannot ship more than a couple of week’s supply to the clinics at any given time. The stored vaccines will quickly expire and will need to be appropriately discarded and replenished with new stock. This would create a biological waste discard plus limited supply issues. The four issues above are the major issues; there are several other issues that will need to be addressed to counter the pandemic but are not being discussed publicly. With multiple vaccine candidates competing for the same ultracold storage warehouses and specialized shipping containers, we are seeing a fierce race to secure vendors for their vaccines by the manufacturers. Without the ability to get their vaccines to the populations, the vaccine manufacturers run the risk of never realizing the full potential for their markets. It has been assumed that any vaccine approved by the FDA would lead to the end of the pandemic, which seems far from the reality. Supply chains are built once we have a product, and since we don’t know which of the multitude of products will cross the finish line, this is a herculean challenge for the planners, one that should get the same attention as the vaccine clinical trials. Otherwise, we would end up with a bigger disaster of having a vaccine but not being able to vaccinate the population. |
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