The European sector

The expansion of the vaccines market should bode well for Europe where the vaccines industry is particularly strong — in part thanks to the European Vaccine Manufacturers (EVM) group, which was formed in 1991 and is a specialised group of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The EVM routinely carries out surveys of its members to track the R&D performance of the sector in Europe and to lobby governments where appropriate. EVM members are the largest supplier of vaccines in the world. Although they have a number of international sites, these companies conduct half of their R&D in Europe.^11,12

According to the EVM's latest regional analysis (from 2008),¹³ members were running 122 vaccine R&D projects; among these, 29 had reached Phase III trials. A further 22 projects were undergoing Phase IV testing in the post-approval environment, such as including special populations, which may not have been included in earlier registration trials. The EVM also likes to highlight the emphasis on innovation, explaining that, of the new vaccines introduced since 2003, over 60% have been based on new antigens. EVM data also show that there has been a strong growth in vaccine R&D investment; vaccine R&D investment was around €2.1 billion in 2008, which represented an increase of almost 40% since 2002. Employment in the European vaccines sector also rose between 2002 and 2008 by 58%.¹²

The H1N1 Pandemic

Through 2009, a new influenza virus (H1N1) emerged to which many people had no pre-existing immunity. Considerable media attention focused on cases where the H1N1 virus led to deaths in younger, apparently healthy people. During this period, the H1N1 strain began to crowd out other influenza virus strains leading to WHO declaring a pandemic alert.¹⁶

Although the H1N1 pandemic created a new area of demand for the vaccines industry, it also presented it with developmental challenges in meeting expectations. A complication was that commercial production was already underway for other influenza viruses predicted to make a global impact when the industry was suddenly asked to change course and divert resources to tackle H1N1. However, this could not be done as fast as people expected since a traditional and time consuming process was initially used, where the virus was first grown in chicken eggs and then harvested it into vaccines. It took some time before the major manufacturers were able to successfully demonstrate the advantages of cell-based alternatives. For example, only by June 2009 was Novartis able to announce that its cell-based manufacturing technology system had shaved off weeks from the expected vaccine development time.¹⁷ By this time, it had already received orders from 30 governments. Similarly, GSK was under pressure after signing an agreement with the WHO to donate 50 million doses of its pandemic H1N1 influenza vaccine.¹⁸

However, it now seems that the vaccines industry has become a victim of its own R&D success. Because the pandemic did not reach the severity predicted by WHO, the pharma industry has been accused of exaggerating the threat to secure orders for its pandemic vaccines. In 2009, for example, Reuters calculated that GSK would receive £2.2 billion from government orders for its pandemic vaccine.¹⁹ The vaccines sector in Europe undoubtedly received a boost, with Novartis' manufacturing sites in Marburg (Germany) and Speke (UK), GSK's manufacturing site in Rixensart (Belgium) and Sanofi Pasteur's facility in Val de Reuil (France) being responsible for meeting much of the global demand.

In August 2010, the WHO officially declared the H1N1 pandemic over, but the controversy over the vaccines industry's activities in promoting the use of its products continues. One of the better outcomes of the pandemic situation is that vaccine R&D is now based on cellbased systems rather than traditional egg-based processes. This has been accepted by regulators as the way forward for future vaccine development.