EMA opens debate on animal-product use in vaccines
The deliberations are expected to result in the publication of draft guidelines nearly three years after pig-virus DNA was found in vaccines produced by the pharmaceutical giants GlaxoSmithKline and Merck. The find sparked a call for a major retooling of vaccine regulatory policy in Europe, according to FierceVaccines.com.
In April 2010, more advanced, sensitive vaccine testing revealed that a contaminant, porcine trypsin, was present in batches of rotavirus vaccine that were made from pig products. In GSK's case, the contamination dated back to clinical testing of the vaccine. Since the find, the EMA has vowed to tighten its quality controls.
Porcine trypsin is used during the production of certain influenza and rotavirus vaccines as an activating agent. Because it is produced in pig pancreases, however, it runs the risk of contamination with other biological agents, FierceVaccines.com reports.
EMA advises vaccine producers to mitigate risk by adopting tighter screening measures before the glands are pooled and the chances of the contamination spreading increases. It recommends downstream virus inactivation. The agency has warned that failing to detect a contaminant could have serious repercussions for drug makers, including the closing of their manufacturing facilities.