Rapid Response

Developing a rapid response capability is one way, and some argue the best way, to overcome the problems associated with stockpiling and being unable to predict what will cause the next pandemic. A rapid response would enable the production of a suitable, effective, and safe vaccine as close to the outbreak as possible, both in terms of time and geography.

Currently, the investment required for a dedicated flu vaccine factory—from commissioning to validation—could run as high as $600 million for 50 million doses, depending on the vaccine technology used, and the time taken to build and start production could be as long as six years.⁴ In addition, although our existing vaccine manufacturing capacity is greater than it was a few years ago, we are still far from being able to produce sufficient vaccines to supply the whole world. We may be able to ramp up production to meet demand if given time, but in reality, in the event of a serious pandemic we would have neither the time nor capacity to cover even a small percentage of the world.

Another option is a mobile manufacturing facility, which involves the use of small-scale, modular manufacturing units that are able to work according to cGMP standards. Each unit could contain a flexible manufacturing structure, which is sufficiently adaptable to produce the particular vaccine required. Although such modular units are still in development, much of the technology contained in them is already established and widely used in the industry. Ready-to-use product platforms are ideally suited for these mobile units because they cut time spent on cleaning between runs and are prevalidated, radically shortening the manufacturing time.

Borders are often closed in a pandemic, which would mean that a community could not rely on cross-border provisions and must have independent vaccine supplies. Also, large countries such as India, China, and the US have widely dispersed populations, often with very remote locations, and therefore would suffer greatly from the problems associated with transportation and storage of vaccines. Mobile manufacturing units would overcome these problems by allowing localized production to tackle an outbreak of disease in an affected country or region. The local manufacturing approach also contributes to long-term investment, creating local capacity, and helping to develop local skills and education, offering poorer countries the facility to manufacture their own vaccine rather than buying in from an outside supplier. However, vaccine-manufacturing solutions must also meet the specific local needs and consider restraints typical in a certain region, i.e., the availability of services such as water, which is vital in vaccine manufacture.

With all of these solutions, it is essential to have a standardized approach and develop solutions that are validated and comply with all safety requirements. To achieve this, countries could benefit from working with a global company that also has the experience and infrastructure to work with partners locally.

Unlocking Future Potential

Although vaccine production methods are constantly improving, there are still many hurdles to overcome. The biggest limiting factor we currently face is the lack of sophisticated technology for rapid vaccine manufacture. One good example is the production method of influenza vaccines that still uses chicken eggs. This is widely considered to be an archaic system with a range of drawbacks including the logistics of egg procurement and a slow production process. As a result, production is shifting toward mammalian cell-based production and new technologies such as virus-like particles. Suppliers are working hard to develop new tools that will not only support existing production methods, but also push them forward to ensure that manufacturing capability is available when the methods are ready.

In addition to significant levels of investment in vaccine-production processes, another area of focus for improving future ability to survive pandemic threats and mutating pathogens is in the research and development of universal vaccines. The universal vaccine approach may improve the chances of marginalizing pandemic diseases. There are many companies attempting to rise to this challenge.

In the near future, it is also hoped that a "template" vaccine will be available that is easily adaptable when a new strain or new mutation arises. Although such template vaccines hold great promise, we are still far from having access to any technology that will protect us from our biggest potential threat—emerging diseases. These are pathogens of which we presently have no knowledge about and which would not behave in the same way as those we have been studying.

Because we cannot know for sure what we might face in the future, investment in education is incredibly important. From informing the general public about how to prevent the spread of viruses and giving them the necessary knowledge to exert pressure on the authorities to facilitate preparedness, to building scientists' knowledge and ensuring the relevant expertise is available to run manufacturing facilities, it is crucial that both industry and government bodies work together for the future.