Students Will Receive a Meningitis Vaccine Not Yet Approved in the US

By ThinkReliability Staff

In an unusual move, on November 16, 2013 the US Food and Drug Administration (FDA) approved the importation and use of a vaccine not yet approved in the US to attempt to minimize the spread of a rarer – and more difficult to prevent – strain of meningitis on a college campus.

Information about the outbreak, including the effects, causes, and recommended solutions, can be captured in a Cause Map, or visual form of root cause analysis.  This method of problem-solving begins by capturing the background information on the event, then determining the impact of the event on the organization’s goals.

The outbreak began at Princeton University in March of this year.  Meningitis outbreaks can be more common at college campuses because of the close living quarters.  The specific strain involved is known as serogroup, or type B, which has been more difficult to create a vaccine against because the coating on the bacteria is different than that from other types, for which a vaccine was developed in 2005.  Since that vaccine, the number of cases of meningitis on college campuses has declined, though there were 160 cases of B strain meningitis in the US last year.  (In the US, B strain is rarer than other types.)  This is the first outbreak of B strain meningitis in the world since the vaccine was approved.

This outbreak has impacted the safety goal, as the potential for serious injuries and fatalities is high.  The spread of meningitis can be considered an impact to the environmental goal, and the customer service goal is impacted by students being sickened by meningitis.  Treatment and vaccination are an impact to the labor/time goal.

Beginning with the impacted goals and asking “why” questions develops the cause-and-effect relationships related to the incident.  In this case, the outbreak resulted from the spread of meningitis due to coughing or contact among the close quarters common on a college campus, and the fact that students were not vaccinated against this particular strain of meningitis.  A vaccine for the B strain of meningitis has not yet been approved in the US as it was recently developed, although it was approved for use in Europe and Australia earlier this year.  Developing a vaccine for the B strain was difficult (it took over 20 years) because of the differences in bacteria coating from other strains.

Though the vaccine has not been approved for general use in the US, the FDA and Princeton University officials determined that the prevention benefits outweigh the risk of its use.  Specifically, students at Princeton will be offered two doses of the vaccine, paid for by the university.  The vaccines are not mandatory.  In addition, students are being reminded to wash their hands, cover their mouths while coughing, and not to share personal items.  It’s also hoped that holiday travels will end the outbreak as students disperse, though it’s also possible that the travel could spread the disease, though this is considered highly unlikely by health officials.   Time will tell if these actions are adequate to stop the spread on campus.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.