Flu / Influenza FDA approved Using Dog Liver to make Flu Vaccine

Production of influenza vaccines requires propagation of large quantities of the specified virus, which requires the use of a live cell substrate. Historically, influenza vaccine strains have been propagated in embryonated chicken eggs. Continuous cell lines (CCLs) such as Madin Darby canine kidney (MDCK), Vero (African green monkey kidney), and PER.C6 (human fetal retina) provide alternatives to embryonated chicken eggs for use as substrates. In contrast to the use of embryonated eggs, cell-based manufacturing allows for a better- controlled substrate and a closed production process utilizing bioreactors. Egg-based influenza vaccine production is dependent on the availability of embryonated eggs, which is at risk in the event of outbreaks of bird diseases. In addition, use of a continuous cell line will allow manufacturers to respond more quickly to the emergence of new strains of influenza in a pandemic situation. Establishment of cell-based influenza vaccine production methods is supported by the National Institutes of Health (NIH), World Health Organization (WHO), and Centers for Disease Control and Prevention (CDC).

Changing from egg-based to cell-based vaccine production requires a thorough investigation of the starting materials and the steps to produce cell derivedñinactivated subunit influenza vaccine (CD-ISIV). Solvay Pharmaceuticals has manufactured and marketed an egg-derived subunit influenza vaccine, tradename InfluvacÆ, for over 50 years. This egg-based vaccine is approved and marketed in 56 countries worldwide. For over 10 years, Solvay
Pharmaceuticals has been conducting research and development on novel influenza delivery and production technologies, in particular cell-based substrates for the production of
influenza vaccine. After a rigorous evaluation of the cell-based substrate options, Solvay Pharmaceuticals sought to further develop the MDCK cell line for its superior growth characteristics for the broadest spectrum of influenza viruses. MDCK cells are also employed by most surveillance laboratories worldwide. Because MDCK cells are of canine origin, the risk that they contain adventitious infectious agents with affinity to humans is lower than
with cells of human or other primate origin. The use of MDCK cells does not raise concerns about diseases like human immunodeficiency virus (HIV) or bovine spongiform encephalopathy (BSE) agents. Furthermore, MDCK cells are not derived from a source that
is subject to ethical debate. To support the use of the MDCK CCL for influenza vaccine production, Solvay Pharmaceuticals has conducted a risk assessment specific to this substrate.

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