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Selection of Challenge Agent is Key to Vaccine Development

Influenza viruses are commonly used in human challenge studies.
Both the viruses and the disease they cause are well understood,
and the induced illness is short-lasting. It is becoming increasingly
diffi cult to gain FDA approval for a disease-preventing vaccine or an
anti-infective drug purely on the basis of biomarker studies. In this
article, Adrian Wildfi re, SGS Infectious Diseases project director,
explains that proof of real-world effi cacy is required, therefore a
challenge trial will give an indication of how eff ectively the vaccine
is preventing infection, or the drug is improving the symptoms of
the disease.