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

Abstract

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.

Keywords::

• cell culture
• clinical trial
• H1N1pdm09
• H5N1
• H9N2
• influenza
• pandemic
• vaccine
• Vero
• whole virus

Financial & competing interests disclosure

This work was supported by Federal (United States Government) funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority; Baxter Healthcare Corporation is funded via Subcontract S1008307 from DynPort Vaccine Company, LLC (DVC), a CSC Company, under DVC Prime Contract Number HHS0100200600013C. The content of this publication does not necessarily reflect the views or policies of the United States Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. PN Barrett, D Portsmouth and HJ Ehrlich are employees of Baxter, a manufacturer of seasonal and pandemic influenza vaccines. PN Barrett and HJ Ehrlich have equity interests in the company. PN Barrett holds patents on influenza vaccines derived from Vero cell cultures. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.