Much has been written and discussed concerning the current unavailability of adequate doses of the H1N1 vaccine to combat the current swine flu pandemic. As outbreaks of H1N1 influenza continue to peak in the U.S. and other countries, delivery of the vaccine has been falling short of expected levels. In the U.S., government agencies anticipated that 40 million doses would be on-hand by the middle of October, but a mere 13 million doses have arrived, prompting growing fears that the vaccines will arrive too late to stem potential swine flu deaths.
Since this blog is dedicated to commentary related to supply chain business process and information technology, I thought it would be helpful for readers to view the current problem from a supply chain lens. Our loyal readers are welcome to pass along a link to this posting to those that would benefit from education to the magnitude of the effort.
Let’s look at the current problems from the perspective of value-chain scope and complexity.
Vaccine producers are dealing with a production and distribution problem of enormous scope. A medical history expert at the University of Michigan indicated in a press interview “that this is potentially the largest mass vaccination program in human history.” The World Health Organization (WHO) estimates that as much as three billion doses of vaccine could be produced in a single year. That represents an incredible level of production and distribution scope.
To adequately prepare for both a potential H1N1 pandemic, as well as the normal outbreak of seasonal influenza, many countries have pre-ordered two different vaccines, the H1N1 specific, as well as the recurring seasonal flu vaccine. Timing is of course most critical, since the vaccine must be delivered in adequate time to buffer a seasonal outbreak. There are a minimum of three large-scale drug producers working on volume production and global distribution; GlaxSmithKline, Novartis, and Sanofi-Aventis SA. Glaxo alone has invested more than $3 billion on research and incremental manufacturing in anticipation of supporting a flu pandemic.
Vaccine is produced in batch production techniques, with cycle time varying depending on the characteristics of the particular batch. Supply chain planners in process-related industry who deal every day with planning batch production are very familiar with the complex challenges related to having to account for various aspects of variability in scheduling the output of a batch production process. While new production methods are currently being investigated, the majority of the current vaccine demand is grown relying on a fifty year old, egg-based production technique. One of the problems underlying the current delay is that H1NI virus is not growing as quickly as expected in this production process. Apparently, this problem was anticipated as early as this summer, when U.S. government officials were already predicting a shortage of the H1N1 vaccine by mid-October. A good perspective on the current production difficulties can be found in a U.S. News and World Report article, Production Problems Plague Delivery of Swine Flu Vaccine.
Another form of controversy concerning vaccine production relates to the use of adjuvant as an additive. Adjuvants are a class of substances that apparently increase the overall potency of a particular batch of vaccine. A recent and timely New York Times article, Benefit and Doubt in Vaccine Additive, contrasts adjuvant methods with lingering uncertainty regarding the safety or side effects of these substances. According to the article, the WHO and some health experts have been calling for the use of adjuvants to allow more people to be immunized for H1NI with a given amount of vaccine, prompting some governments to order vaccines with adjuvant. Glaxo and Norvatis are selling pandemic flu vaccines containing newer adjuvant made from water emulsions of squalene, or vitamin E. If vaccines with adjuvants were to be administered in the U.S., the Food and Drug Administration (FDA) would have to evoke a so-called emergency use authorization. U.S. officials are currently of the view that that increased potency is not large enough to offset the possible risks and extra complexity of using the adjuvants.
Packaging of vaccines is another factor that manufacturers must address. Priorities and protocols have been outlined by governmental authorities as to which populations will receive the vaccine initially. They rightfully include pregnant women, healthcare workers, and children as the first priority, since these populations are the most vulnerable to the effects of the H1N1 virus.
In order to support high-volume distribution needs, preservatives are added to allow manufacturers to package vaccines in multi-dose vials, as opposed to single-use syringes or nasal sprayers. The U.S. government requested that nasal spray and preservative-free vaccine be the first priority of initial distribution to insure that the populations of pregnant woman and children be serviced by vaccine. As high-volume distribution continues in the coming weeks, manufacturers will have to shift vaccine production to multi-dose vials to service broader vaccine delivery needs, hence more preservatives will need to be incorporated. Consumers remain highly sensitized to the potential effects of vaccine preservatives, which may defer some from actually securing the vaccine.
Vaccine producers are under the gun to dramatically increase production and distribution of all influenza-related vaccines. These producers exist in healthcare-related supply chains that are not currently noted for overcoming complexity in production methods and global packaging and distribution needs. There are certainly needs for more value-chain wide visibility to supply and demand alignment imbalances, along with more-timely information flows to make critical operational decisions.
The current crisis is a symptom of a wider problem. If this crisis provides any benefit, it will be in the understanding that vaccine related supply chains will be our most critical area for future supply chain technology investment. Consider the fact that both consumer goods products and high tech product related supply chains are currently looked upon with track records of world-class capabilities in process and information technology automation. These supply chains morph in terms of the production and order fulfillment requirements that are manifesting in vaccine supply chains. The time for attention and investment is overdue.