CDC to import unapproved Novartis vaccine to stem Princeton meningitis outbreak

As a meningitis outbreak has slowly spread across Princeton University over the past 8 months, the case for vaccinating students has grown stronger. The only hitch is that the vaccine, Novartis' ($NVS) Bexsero, has yet to win approval in the U.S. Now, though, health authorities are willing to work around this obstacle.

The Centers for Disease Control and Prevention (CDC) has agreed to import Bexsero, Novartis' meningitis B vaccine that is approved in Europe and Australia, for use in the Princeton University community. The CDC filed an investigational new drug (IND) application to import the vaccine after the fifth case was confirmed in early October. Since then, another two students have caught the potentially deadly infection, leading to the CDC pushing on with its plans for an immunization campaign at Princeton University.

"This is a bad disease and we know how devastating it is. A lot of us had a gut feeling that there would be more cases and we should get the ball rolling. If you're a student at Princeton University right now, your risk is quite high," CDC meningitis expert Dr. Thomas Clark told NBC News. While the CDC has moved to make limited use of Bexsero possible, Princeton University is still deciding whether to offer the vaccine to students, CNN reports. University trustees were discussing the topic this weekend.

If the university agrees, the CDC will import Bexsero from Australia or Europe, where it is approved but is still the subject of reimbursement negotiations. Some analysts have tipped the vaccine--which protects against the meningitis B strain not covered by vaccines like Sanofi's ($SNY) Menactra--to generate blockbuster sales, but it is off to a slow start. Negotiations with the FDA over Phase III trial designs--and particularly the development of a reliable surrogate for efficacy--delayed progress in the U.S.

- read the NBC News article
- check out CNN's coverage

Related Articles:
U.K. rejection of Bexsero hits Novartis vaccine unit
Novartis lands EU approval of meningitis B vaccine Bexsero
Novartis rides high on Bexsero study results
Novartis vaccines unit's future hangs on Bexsero approval