EVM Proposal for an Action Plan between European Vaccine Manufacturers (EVM) and Member States with the Support of the European Commission

  1. Anticipate and coordinate to minimize chaos

    This document presents concrete proposals for establishing a long-term commitment between European Vaccine Manufacturers (EVM*) members and Member States, with the support of the European Commission. The commitment pertains to the manufacturing and supply of influenza vaccines in the event of a pandemic. It considers various factors that could influence the development, production, marketing authorization, and distribution of influenza vaccines during a pandemic, along with estimated timelines.

    An influenza pandemic occurs when a novel influenza virus emerges, and most of the world’s population lacks immunity to it. Typically observed in influenza A viruses, a pandemic arises due to a new antigenic variant resulting from changes in the virus’s surface haemagglutinin antigen, often accompanied by alterations in neuraminidase. If such a virus effectively transmits between humans, it can cause a global outbreak with high morbidity and mortality rates worldwide. Historical pandemics (1918, 1957, and 1968) have unfolded in 2-3 waves over 13 to 23 months (Figure 1). Increased international travel has expedited the spread of successive pandemics during the 20th century, and recent events like the 2003 SARS outbreak indicate the potential for rapid dissemination from a point source, though exact timeframes remain uncertain.

  2. General statement

    While this document focuses on the EU context, the vaccine industry is committed to global public health and addressing influenza pandemic threats worldwide. Influenza pandemics pose significant risks to both the general population and public health authorities, as well as challenges to the vaccine industry concerning research and development, marketing authorization, production capacity, and liability issues related to vaccines used in mass vaccination campaigns. EVM members do not consider this situation “business as usual” due to inherent risks and uncertainties, warranting exceptional measures. Successful management of these challenges hinges on shared understanding of roles and responsibilities, anticipation, and active collaboration among Member States and European institutions. Addressing pandemic threats requires cooperation among governments, industry, and academia to ensure the rapid development, production, and deployment of a vaccine candidate, given the unique characteristics of vaccination and prevention policies compared to therapeutic drugs.

3. Situation analysis

Protecting potentially 450 million European citizens during a pandemic presents a significant challenge due to the current mismatch between influenza vaccine production capacity during interpandemic periods and the anticipated demand in a pandemic scenario. Key considerations include:

  1. Anticipating influenza pandemic vaccine production by addressing R&D and regulatory aspects, such as preparing prototype vaccines, developing and authorizing mock-up and variation files, and conducting clinical studies. This involves substantial investments that justify R&D support from national and international entities.
  2. Factors influencing influenza pandemic vaccine availability in Europe:

    a. Presence of vaccine manufacturers in EU territory (currently in France, UK, Netherlands, Germany, and Italy).

    b. Existence and implementation of influenza vaccine recommendations and reimbursement during interpandemic periods to facilitate annual production forecasts and equitable supply of pandemic vaccines.

c. Influenza vaccine coverage during interpandemic periods (average of 22% of the European            population immunized during the winter season of 2002-2003, with variations by age group).

d. Global distribution of influenza vaccines within and outside Europe, with 70% of global                    production originating in Europe, half of which is distributed outside the EU. Balancing equitable        distribution while honoring existing contractual commitments is vital.

e. Anticipated investments in expanding production capacity, which must align with demand and        forecasts. Building and validating new production facilities require 3 to 5 years.