By Lauren Wanko
Princeton University’s announcement to provide students with a vaccine that helps protect against the Type B strain of meningitis is being called unprecedented by some in the medical community. That’s because the vaccine’s not licensed in the United States but is approved in Australia and Europe.
“I think it’s extraordinary. I haven’t heard this before. It’s probably a procedure that’s in place in case we get some strain of an infectious disease in the U.S. that’s not common here and we need to deal with it immediately,” said David Evans.
“I’ve not really seen an exact precedent that directly correlates, but we have seen the use of unapproved medications that were being trialed in the U.S. when the need was pressing even though trials had not been completed,” said Elliot Frank of Jersey Shore University Medical Center.
Novartis developed the vaccine, known as Bexsero.
“The reason it’s not completely accepted throughout the world probably is a question as to was it cost effective and effective enough but not concerns about its safety. I think it is an appropriate move,” Evans said.
The usual vaccine and drug approval process in the United States can take 15 to 20 years.
“Studies are done by the company that wants to sell the medicine. They initially start with animal studies they then approach, FDA and ask for human trials, then set up an institutional review board that monitors trials — three phases of clinical trials,” Evans said.
When asked if this situation could potentially speed up the approval process for use in the United States, Frank said, “I think it would certainly spur interest on spending the money on the trials that would be necessary to achieve full approval. I don’t think it would bypass the normal channels.”
Frank says some of the data the manufacturer accumulated overseas would be part of the approval process. That means the manufacturer may not have to do as many tests in the United States. Some, not all of the data, would apply to the approval process.
Back at Princeton University, officials hope to make the first of two doses available in early December.