Vero cell culture-derived pandemic influenza vaccines: preclinical and clinical development.

Several subtypes of influenza A viruses with pandemic potential are endemic in bird populations throughout Asia, Africa and the Middle East, and evidence suggests that these viruses are adapting to the mammalian host. As emphasized by the high mortality rate of humans infected with H5N1 viruses, this situation presents a substantial risk to global human health. The Vero cell culture platform has been used to develop whole-virus influenza vaccines that provide broad cross-clade protection against viruses with pandemic potential, at low antigen doses, without the requirement for adjuvantation. The safety and immunogenicity of these vaccines has been demonstrated in studies with more than 10,000 individuals, including healthy adult and elderly subjects, children and various risk groups. These Vero cell-derived vaccines are licensed for prepandemic and pandemic use. The Vero platform is also being explored to develop next-generation live-attenuated and recombinant vaccines.