August 29, 2017

FDA doesn’t make vaccine approvals impossible

There’s a trial of a herpes vaccine being conducted on the Caribbean island of St Kitts, because it can be done there without any ethical or regulatory oversight.  This is not a good precedent.

One of the investors involved a well-known NZ not-precisely-immigrant, Peter Thiel. He has said in the past  “you would not be able to invent the polio vaccine today.” Perhaps he should talk to the people who think there are far too many new vaccines nowadays.  They’re both wrong.

Because this is the sort of factoid that gets passed around, I thought a list of some recently approved vaccines  might be helpful.  They’re taken from this list:

20-30 years ago: Hepatitis A vaccine (PDF). Hemophilus influenzae Type B vaccine (PDF)

10-20 years ago: Intranasal quadrivalent flu vaccine (PDF).  Meningococcal Group A, C, Y, W (PDF). Shingles (PDF)

less than 10 years ago: Human papilloma virus (PDF). Injected quadrivalent flu vaccine (PDF). Japanese encephalitis vaccine (PDF) Live-bacteria cholera vaccine (PDF). Meningococcal Group B (PDF). Rotavirus (PDF)

 

And, polio vaccine? If you look at the consultation procedures used in designing the polio vaccine trial, back when randomised trials were new and controversial, you’d be glad to just deal with an ethics committee and an FDA advisory panel.

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Thomas Lumley (@tslumley) is Professor of Biostatistics at the University of Auckland. His research interests include semiparametric models, survey sampling, statistical computing, foundations of statistics, and whatever methodological problems his medical collaborators come up with. He also blogs at Biased and Inefficient See all posts by Thomas Lumley »