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

seven confirmed cases of meningitisin the Princeton University community, the school announced Monday that — pending final approval from the Centres for Disease Control and Prevention — it
will distribute a vaccine that has not yet been approvedin the United States.

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 prioritised 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.

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.”

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