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Calling for an exponential escalation scheme in vaccine development for COVID-19
1Institute of Clinical Pharmacology Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. martin.wehling@medma.uni-heidelberg.de.
Purpose:
COVID-19 as a pandemic calls for rapid development of vaccines.
Methods:
Here a proposal of a seamless, adaptive, phase 1-3 trial for accelerated vaccine development is described.
Results:
Starting at 10, the number of vaccinated volunteers would exponentially increase by tenfold at an interval of 2 weeks; close surveillance of antibody responses, safety and efficacy is necessary. After only 16 weeks, general vaccination would be feasible if supply meets the demand.
Conclusion:
A COVID-19 vaccine would be rapidly available at a slightly increased risk for undetected late side effects or insufficient efficacy if compared with standard vaccine development schemes.
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