Vaccines Europe - 16 Dec 2021
Almost a year has passed since the approval of the first COVID19 vaccine and this period reminded us that vaccines designed to prevent infectious diseases are one of the most cost-effective healthcare interventions. This year also proved to us once again that vaccines save thousands of lives.
However, the pandemic also revealed the vulnerabilities of the vaccine ecosystem that lead to a decreased availability of high-quality, safe, and effective products for everyone. Vaccine shortages represent an increasing concern in the EU and worldwide and the causes are multiple and inter-connected. Therefore, finding solutions can be done only through a concerted effort and continuous dialogue of all key Stakeholders.
Representatives from several companies within Vaccines Europe conducted an analysis of the main root causes of vaccines shortages in Europe. The 6 main causes identified together with a set of recommendations for solutions were described in a paper on “Addressing Vaccine Supply Challenges in Europe: Expert industry perspective and recommendations” that is now published in the Health Policy Journal.
The article draws attention to the fact that the main causes of vaccines’ shortages are beyond the control of vaccine manufacturers and to the measures the manufacturers are undertaking to control their operations and hence to reduce the risk of shortages.
The main root causes identified are the following:
- Long and complex manufacturing processes including multiple quality controls;
- The unpredictability of timelines and multiplication of independent lot release by National Control Laboratories;
- Complex global regulatory life cycle management;
- Diversity of presentations, packs, and labels in the EU;
- The unpredictability of global demand and absence of mechanisms for early and continuous dialogue between manufacturers and health authorities to better anticipate the evolution of vaccine recommendations and more accurately forecast vaccine demand;
- Suboptimal immunisation budgets and procurement practices.
The European authorities have already launched several initiatives to address the shortages issues. VE companies are keen to contribute by bringing expert industry perspectives to the discussions with the aim of finding feasible solutions that would shorten the journey of the vaccine from production to patients, without any negative effect on safety or quality. Addressing the causes of shortages is important because each delay can lead to lives being lost.