Complexity of Vaccine Manufacture and Supply

Abstract

There is a shortage of medicines and vaccines on a global scale in the world today. Yet, ensuring a continuous supply of high-quality, safe, effective and affordable medicines is a fundamental component of a good health system, and shortages in medication supply can jeopardize equal access for all to enjoy the highest possible standard of health. The production of drugs and vaccines is a complex journey within a highly regulated industry, and changes or incidents anywhere along the production pathway may affect production capacity and supply chains down the line. The production of vaccines of consistently high quality requires specialized equipment, long and complex manufacturing cycles, in an increasingly regulated environment that meets stringent quality standards that may differ between countries. In view of this lengthy and complex process, it can be difficult to establish exact inventories of vaccine stocks, thus making it hard to anticipate potential shortages. In addition, in times of increased demand for vaccines, manufacturing and supply pathways may not be able to keep pace with the sudden spike in demand. The pharmaceutical industry is making a concerted effort to improve vaccine availability, in concertation with other major stakeholders, such as governments, wholesalers, regulators and the pharmacy profession. A platform for open and continuous dialogue between public health institutions and industry is warranted to discuss strategies for decreasing the complexity of vaccine production and release, as well as reducing the regulatory burden. All stakeholders must seek common solutions for improved vaccine supply, have better anticipation of vaccine needs, encourage innovation and ultimately improve vaccine availability.