How to license vaccines against new and emerging infectious diseases fast and effective?

by Dr. Michael Pfleiderer

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Recent past has repeatedly taught us that influenza pandemics probably no longer constitute an immediate health threat for the global population. Other infectious diseases have caught up outnumbering pandemic influenza in number and sequence of events. WHO and other public health institutions regularly report on outbreaks mainly caused by viral infectious agents such as MERS, SARS, West Nile Flavivirus (WNV), Ebola, Chikungunya, Zika, Dengue viruses and so on. Barely any of these infectious diseases is preventable by vaccination and none of them is curable by antiviral treatment. Although regulatory authorities offer all their support to facilitate development and licensure of safe and effective vaccines against these diseases there are, with one exception, no appropriate vaccines licensed and available. One likely reason for this unfortunate situation is, that very often regulatory authorities are confronted with the evaluation of candidate vaccines that are not directly affected by the respective emerging infectious disease. Consequently, these authorities have great difficulties calculating an appropriate benefit-risk-ratio of an emergency vaccine given to a population which is rarely or not at all exposed to the corresponding infectious agents. This reluctant behavior has major impact also for regions where one or more of the infectious agents mentioned above are endemic causing recurrent, widespread and long lasting outbreaks. Urgently needed vaccines are not available since regulatory agencies in these regions often do not have the capacity required to cope with all the scientific and regulatory aspects needed to conclude that candidate vaccines filed for review are indeed safe and effective.

However, there are alternative approaches suitable to accelerate pathways to licensure for vaccines urgently needed in endemic regions. WHO has recently published a novel strategy on how to enable regulators from endemic regions to license a novel Dengue vaccine. Assessment of this vaccine was performed by endemic countries’ regulators without prior review process performed by EMA and/or U.S. FDA.

Read the full text article if you are interested and ask us for assistance in case you find this approach interesting also for your vaccine development since we were deeply involved in these activities.