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11/18/2013

Addressing Unapproved Meningitis Vaccine at Princeton

by Arthur L. Caplan, PhD

Emergency doses of a meningitis vaccine not approved for use in the U.S. are likely to be on the way to Princeton University to halt a meningitis outbreak that has already sickened seven students http://www.nbcnews.com/health/emergency-meningitis-vaccine-will-be-imported-halt-ivy-league-outbreak-2D11603651.  There are approved meningitis vaccines available, but they do not protect against Meningitis B—a strain not covered by the shots given in the U.S. and not a strain prevalent here.

Government health officials said Friday they have agreed to import Bexsero, a vaccine licensed only in Europe and Australia that does protect against meningitis B.  And that decision seems entirely reasonable given the threat that this nasty strain of meningitis poses.

That said, the question arises — what should those getting the vaccine be told?  Are they being offered a proven vaccine, an experimental vaccine, a vaccine believed to be the best choice given the threat of an epidemic or something else?  Can a student, campus worker or faculty member refuse the vaccination and stay in school or in a dorm?  Should those who have visited the campus recently be tracked down and offered the vaccine?  If people do refuse should they identify themselves in anyway as unvaccinated and to whom?

In general when using a drug or device that has not been approved by the FDA or other federal advisory agencies those who are offered the vaccine should be treated more as research subjects than patients.  They should be told all the facts about the vaccine, why it has not been approved in the U.S. and about the all too real threat that meningitis poses.  They should be given the opportunity to ask questions.  There is a duty to try and monitor those who get the vaccine or a representative sample of such persons, to watch for both efficacy and safety.  Vaccine refusal might be accepted, herd immunity could help in this regard, but university officials will need a policy concerning refusers and where they ought to go to study, live and work until the potential epidemic subsides.

Using a vaccine very likely to be safe and effective to stave off an outbreak of a nasty disease makes good moral sense.  However, it is important to treat emergency use as such and to do what can be done to inform subjects, track the results in those who are vaccinated and to find a path for those who will not accept vaccination.

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