Emergency doses of a vaccine are on the way to Princeton University to halt a meningitis outbreak there that has already sickened seven students. There are approved meningitis vaccines available, but they do not protect against serogroup B meningitis. New Jersey state law requires college students to receive a licensed meningococcal vaccination although, sadly and sometimes tragically, enforcement is often lacking. However, failure to vaccinate is not the problem with this outbreak. Current FDA-licensed vaccines only protect against meningitis types A, C, Y and W-135, not B — the source of the outbreak at Princeton.
Government health officials said Friday they have agreed to import Bexsero, a vaccine manufactured by Novartis and licensed only in Europe and Australia that does protect against meningitis B. That decision seems entirely reasonable given the threat this strain of meningitis poses.
Meningitis B is a nasty bacterial infection. The B strain is the leading cause of meningitis across Europe, particularly in infants. Although rare, the disease is feared because it can rapidly sicken otherwise healthy people without warning. Symptoms often resemble the flu, making this form of meningitis hard to diagnose. About one in 10 of those who get meningitis B in Europe die despite efforts to treat them. Up to one in five may suffer from brain damage, hearing impairment or lose a limb. Prevention, not treatment, is the best way to go for this disease.
Meningitis B is contracted through prolonged exposure to coughing and sneezing in places like dormitories or military barracks. Bacteria also can spread through the exchange of respiratory and throat secretions — kissing and sex are culprits. Sharing toothbrushes and drinking cups also can spread the illness.
The good news is that the vaccine appears to be very safe. But if you look at the studies that were done to receive approval in Europe, nearly all of them were done in infants or children. One was done in Chile on young adults and that one was on the small side as vaccine trials go.
If my kid was at Princeton, I would want him vaccinated. That said, the question arises: Given the reality of an outbreak, what should those getting the vaccine be told?
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 like 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 B poses. They should be given the opportunity to ask questions. There is a duty to try and monitor those who get the vaccine or, at least a representative sample, to watch for both efficacy and safety even if there is little reason to worry about any problems.
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 outbreak 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 some of those who are vaccinated and to find a path for those who will not accept vaccination.
Arthur Caplan is the head of the Division of Medical Ethics at NYU Langone Medical Center.