Fears of an influenza vaccine shortage were heightened recently when the FDA announced irregularities at a major manufacturing plant in Canada operated by GlaxoSmithKline (GSK), a global pharmaceutical company. The GSK plant is contracted to provide 6.36 million vaccine doses to a variety of Canadian government agencies and 23 million to US healthcare providers.
This first warning sign came on June 24 where the FDA published a letter to GSK warning of noncompliant operations and possible contamination. GSK had 15 days to answer the FDA letter to cure the offenses. The FDA also warned that GSK is at risk of losing the license to produce influenza vaccines for the US. This license loss can mean an immediate loss of the 23 million vaccines this GSK facility is expected to provide.
Following the FDA’s investigation, the Canadian equivalent of the FDA, Health Canada, performed their own inspection and also found troubling operating practices. The company received the notice from Health Canada on July 3 and has 30 days to submit an action plan on fixing the noted problems. Unlike the FDA notice, specifics of the problems were not identified, but are believed to resemble the FDA findings.
If GSK is unable to resolve the regulatory infractions, the vaccination supply from this facility may be in jeopardy in both the US and Canada. Although the plant in question is only responsible for 23 million US vaccines, it represents 70% of all GSK provided flu vaccines in the US.
Currently, GSK responded to all notices with confidence that supply will not be affected and all irregularities will be corrected in time for the upcoming influenza vaccination season starting in September 2014.
Mobile Health is a regional occupational health provider in New York City and uses GSK as a major supplier. In preparation of possible shortage, Mobile Health started to accept advanced vaccination orders from businesses interested in vaccinating their employees. This advanced order will guarantee supply in the event of a shortage.
For more information on Mobile Health’s worksite flu program visit www.mobilehealth.net/flu
