Safety of MDCK Cell Culture-Based Influenza Vaccines

Abstract

After more than 60 years, the conventional production of influenza vaccines employing fertilized chicken eggs has reached its limits – both in terms of temporal flexibility and vaccine production volume. This problem is compounded by the fact that the pandemic-driven situation in 2009 has roughly doubled the overall vaccine demand. Modern cell culture technology has significant advantages over the conventional method of manufacturing influenza vaccines employing embryonated chicken eggs, and enables manufacturers to respond rapidly to the increasing worldwide seasonal and pandemic-driven need for influenza vaccines. Recent articles in the popular press claiming that cell culture-based influenza vaccines can cause tumors have fomented uncertainty among the general population and physicians, and also discredit officially accepted test results and product licensing. This article provides an overview of the safety profile of the cell culture technology, of the cells and of the final vaccine product.

Keywords:

• cell culture
• influenza
• MDCK cells
• vaccines
• vaccine safety

Acknowledgements

This article is a modified version of a contribution which has originally been published in German in the journal Medizinische Monatsschrift für Pharmazeuten.

Financial & competing interests disclosure

The authors are full-time employees of Novartis Vaccines and Diagnostics GmbH. Part of the work at Novartis described here has been funded with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract No. HHS0100200600012C. 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.

Additional information

Funding

The authors are full-time employees of Novartis Vaccines and Diagnostics GmbH. Part of the work at Novartis described here has been funded with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract No. HHS0100200600012C. 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