by Michael Pfleiderer
Industrialized country markets are generally perceived as being protected from supply shortages and out-of-stock situations. Essential medicinal products, however, seem to become a continuous exception from this rule. Experience from recent years documents that a growing list of important medicines cannot sustainably be provided in sufficient quantities imposing critical burden to patients and public health systems.
To a significant extent this list also includes vaccines which are temporarily unavailable causing turbulences in national vaccination programs resulting in adaptations of official vaccination recommendations, postponement of required vaccinations or no vaccination as the most extreme consequence.
Reasons accounting for this unfortunate situation are multifactorial but can best be explained with the complexity of the products and their manufacture, low number of specialized manufacturers and rapid growth and shift of global markets.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has repeatedly put this topic on their agenda but is now first time ever referring to the dramatic situation emerging even in highly industrialized countries including most EU member states.
Similarly, the European Center for Disease Prevention and Control (ECDC) considers that topic as a top urgency, particularly for combination vaccines used in primary vaccination programs.
WHO and ECDC as well as many other institutions dealing with sustainable solutions for vaccine procurement provide a wide range of options and strategies on how supply shortages and out-of-stock situations might be overcome or could even be avoided. Amongst numerous proposals one of the most straightforward options is to open markets for manufacturers of urgently needed vaccines who so far have no access to a certain market. The EU market is generally difficult for manufacturers operating outside of the EU. This is reflected by the fact that no vaccine manufactured by a developing country manufacturer is currently licensed in the EU, nor is there any indicator that this could happen in the near future. However, many of these manufacturers have huge production capacities and very often do comply with European requirements for vaccine production and licensure, thus representing attractive alternatives to established EU or U.S. manufacturers.
Very often it is just a matter of efficient partnering in order to open doors for vaccine manufacturers unexperienced with the EU market.
Biopharma Excellence has an ample scope of knowledge on infectious diseases, vaccinology and pathways to licensure for vaccines. We can help interested partners to successfully place their vaccines on the EU market as an important prerequisite to mitigate or abolish inconsistent supply with vaccines in Europe.
If you are interested talk to us in order to identify the best possible strategy.