Abstract

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Highlights

  • 1Nadarajah SreeharanThe Covid 19 (COV) pandemic has spread rapidly around the globe and the associated morbidity and mortality have been staggering. [1]

  • Avenues are available during pandemics for the global regulatory agencies such as the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) to invoke special measures [6, 7] to accelerate or short circuit some of the regulatory requirements and timelines to ensure the rapid access to medicines and vaccines

  • Any Medicine which has been found to have an acceptable benefit-risk in some diseases does not automatically become an acceptable medicine for a new indication (i.e. Covid 19)

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Summary

1Nadarajah Sreeharan

The Covid 19 (COV) pandemic has spread rapidly around the globe and the associated morbidity and mortality have been staggering. [1]. The Covid 19 (COV) pandemic has spread rapidly around the globe and the associated morbidity and mortality have been staggering. Fear and anxiety have arisen from the considerable uncertainty a new virus has unleashed into the global society, especially in the absence of approved therapies or a vaccine. The main modality to manage and control the spread of the virus has been the stringent public measures, including physical distancing, lock downs and travel restrictions. It is clear that an effective vaccine will be needed to bring the global pandemic under control. There are significant issues and challenges in the task of finding new therapeutics and vaccines for COV. Until the availability of effective therapeutics or vaccines, it is essential for societies to learn to adapt and manage the uncertainties of the post Covid era

Process For Drug Development In A Pandemic
Development of Therapeutics
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