Why The Meningitis Vaccine That Princeton University Plans To Use Hasn't Been Approved in the US

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AP Photo/John Raoux

After seven confirmed cases of meningitis in the Princeton University community, the school announced Monday that - pending final approval from the Centers for Disease Control and Prevention - it will distribute a vaccine that has not yet been approved in the United States.

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When the CDC grants its final approval, many members of the Princeton community - including all undergraduate and graduate students on campus - will receive two doses of the vaccine.

A lot of the words being attached to this meningitis vaccine - "unapproved" or "unlicensed," for example - sound fairly ominous, especially in the context of a serious illness. However, the reason that it is not yet approved in the United States is fairly simple - it hasn't really been needed here yet.

Here it is from the CDC's website, in response to the straightforward question "Why is the vaccine not licensed for use in the United States?":

Novartis, the manufacturer of the vaccine, has not applied to get this vaccine licensed in the United States. Novartis has prioritized countries with the greatest need for a serogroup B meningococcal vaccine and is therefore focused on licensure in Europe and a few other key countries where rates of this disease are highest. It is common for different vaccine products to be used in different countries based on their needs.

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This vaccine has already been used to safely treat over 8,000 people, and is currently licensed for use in Europe and Australia. Both the European Union and Australia - "countries [that] have higher rates of meningococcal disease" - approved the vaccine this year.

According to the CDC, "Before these countries approved the vaccine's use, their regulatory agencies - those similar to the FDA in the United States - completed a thorough review and concluded the vaccine was effective and met safety standards."