As Oliver Hardy often said to Stan Laurel, "Well, here's another nice mess you've gotten me into!
We wonder if the Centers for Disease Control and Prevention (CDC) is thinking the same about the FDA. Because in order to protect students at Princeton University from a particular strain of bacterial meningitis, the CDC had to get special permission from the FDA to import Novartis Bexsero from Europe and Australia. Bexsero is the only vaccine that is effective against the strain (serotype B) that is causing trouble at Princeton. Why was this necessary? Because the FDA has not approved the vaccine in the U.S.
So, why the difference in policy? As explained very thoroughly in the Gala Health blog, the FDA has some concerns about the safety of the vaccine, especially the adjuvant a component of the vaccine that increases the desired immune response.
This is a reasonable concern, but according to ACSH s Dr. Josh Bloom, something doesn t make complete sense. He says, This begs the question of why the vaccine is all of a sudden safe enough to use on college students now when it wasn t safe enough to get approved? Perhaps the FDA is being overly cautious, which is certainly not news. That precaution may not be look like the best idea now.
Bacterial meningitis is much more serious than its viral cousin. According to the CDC there are about 4,000 cases per year in the U.S. leading to 500 deaths a 12.5 percent mortality rate, which is nothing to sneeze at. Moreover, many of the survivors are left with significant neurological deficits, most commonly hearing impairment.
Infectious disease expert, and ACSH advisor Dr. David Shlaes says, If Bexsero works without toxicity, it would be a major breakthrough scientifically and medically. I am guessing that the FDA is worried about potential toxicity of either the adjuvant or the vaccine itself. Obviously, the EU thinks the benefit outweighs the risk. I am inclined to agree with them and so is Princeton.