Earlier this week, worldwide deliveries of all vaccines containing the varicella (chicken pox) virus strain manufactured from GlaxoSmithKline’s facility in Wavre, Belgium were put on hold after internal production quality issues were discovered, Reuters reported .
GSK spokesperson Donatella Latocca told Biopharma-Reporter.com the firm had set-up a task force on site to investigate the issues and hoped to resolve the situation as soon as possible.
“The investigation is currently exploring several hypotheses and requires testing to confirm the root cause,” she told us, adding the results “should be ready by February, which should allow us to resume shipment in early Q2 2014.”
Including a cell culture step, the manufacturing process itself for varicella vaccines - like other vaccines - is long and complex, requiring “several months between active ingredient bulk manufacturing and final product fill & finish,” Latocca informed us.
“It includes a number of quality checks performed all along this process,” she added. “Once vaccines have gone through the company quality checks, they also need to be released by the relevant National Control Authorities, before being available on the market.”
The two vaccines affected are Varilrix for chickenpox, and a combined vaccine for measles, mumps, rubella and varicella called Priorix-Tetra.
According to Latocca, Varilrix is distributed to over 90 countries whilst the combination vaccine (sometimes known as MMRV) serves 50 and this halt in production will see no new shipments of either distributed within the first quarter, 2014.
In Germany, health officials have already begun rationing of current vaccine supply, said Reuters, with advice to doctors being to use MMR (measles, mumps and rubella) jabs instead of MMRV, as well as holding back on booster shots until supply recommences.