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CDC expert: Use of unlicensed vaccine, Bexsero, ‘highly unusual’

During a telebriefing yesterday with CDC pediatrician and meningitis expert, Dr Amanda Cohn, a couple of key questions were answered concerning the Novartis meningitis vaccine, Bexsero.

meningococcus

Neisseria meningitidis
Image/CDC

When asked about whether the use of an unlicensed vaccine in the US, as the case will be in Princeton next month, is  unprecedented, Cohn responded:

I think that this is — I can’t respond that this is unprecedented, never happened before in the United States, but certainly in the amount of time, in the ten years I’ve been working at CDC, and certainly for meningococcal disease, we have never had expanded use of an unlicensed vaccine product for use to prevent cases in an outbreak.  So this is highly unusual.  I’m not sure if it’s completely unprecedented.  But I think it speaks to the really very high attack rates that we saw at Princeton University, and how strongly we felt along with our partners in New Jersey and at Princeton that we needed to do something to prevent additional cases.  I also think that now that this product is licensed in a different country, I think that made the path toward expanding access to this vaccine easier than in the past, in licensure in other countries.  There have been a couple of situations where there were smaller scales of outbreaks at universities, that haven’t reached this level.  But because the vaccine wasn’t licensed in a different country, it didn’t seem likely that we would be able to use it.

During the same telebriefing, she was asked about what’s happening to get Bexsero licensed in the US. Her reponse was:

The reason this vaccine is not licensed in the United States is because the company made a decision, in part, due to the low incidence of meningococcal B disease in the United States right now, to move forward with licensure, with a vaccine that includes serogroups A, C, Y and W and B.  They’re combining their currently licensed meningococcal vaccine with one that is licensed in Europe.  So they’re starting sort of — the process will take longer.  There is another product under development that is a stand-alone serogroup B vaccine that is in late stage development in the United States from a different company.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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