Preparing for an Influenza Pandemic: What Has Been Done and What Needs to Be Done to Provide a Sufficient Quantity of Pandemic Vaccines in Time
Vaccination stands as the most effective means of controlling influenza during interpandemic periods, and during a pandemic, it becomes the most efficient approach to managing the disease. Europe currently serves as the primary source for influenza vaccine production, accounting for approximately 70% of the world’s total influenza vaccine output. The European Vaccine Manufacturers* (EVM) encompass all EU influenza vaccine producers and, therefore, occupy a pivotal role in developing and manufacturing influenza pandemic vaccines for the global population.
The members of the European Vaccine Manufacturers are committed to advancing global public health and addressing the challenges associated with the looming threat of a global influenza pandemic. In February 2004, EVM presented an action plan proposal to the European Commission, which can be accessed at http://www.evmvaccines.org/pdfs/evm_pap.pdf.
Among the numerous activities contributing to influenza pandemic preparedness in Europe, a short-term priority is the development of prototype influenza pandemic vaccines. This development stage serves as a critical intermediary step in establishing the manufacturing process and defining the characteristics of future pandemic vaccines. It necessitates comprehensive preclinical and clinical development, culminating in registration through the centralized procedure, adhering to specific EMEA guidelines already in place.
Among the various initiatives aimed at enhancing preparedness for an influenza pandemic in Europe, one immediate priority centers on the development of prototype influenza pandemic vaccines. This critical step serves as an essential bridge toward establishing the manufacturing processes and defining the attributes of forthcoming pandemic vaccines. It necessitates comprehensive preclinical and clinical development, culminating in registration through the centralized procedure, in accordance with specific EMEA guidelines that are already in place.
In the event of a pandemic, the rapid production of a monovalent vaccine (targeting a single strain as opposed to the three strains included in the annual vaccine) would be imperative and would require the production of exceptionally large quantities. Many EVM members are already engaged in developing prototype influenza pandemic vaccines, a pivotal component of the influenza pandemic preparedness plan. This proactive approach will facilitate a fast-track evaluation process when a pandemic emerges, thereby reducing the lead-time for pandemic vaccines. Nevertheless, the support of public health authorities is needed to incentivize the development of all potential pandemic candidate vaccines, even those that may never be deployed. EU contributions will further enable the equitable distribution of pandemic vaccines throughout Europe and beyond.
However, other factors, such as the necessity to expand production capacity, must also be addressed before a pandemic occurs. Influenza vaccine production capacity is intrinsically linked to annual demand since influenza vaccine composition must be reformulated each year to align with the currently circulating strains. Consequently, stockpiling vaccines for use in subsequent years is not feasible.