The most encouraging factor for India is that the country will have access to this vaccine, as biotechnology company Serum Institute of India has tied up with its developer, Berlin-based Max Planck Institute for Infection Biology and Vakzine Projekt Management (VPM) Company.
VPM chief executive Leander Grode told ET: “At the moment we are performing two phase-III clinical trials, together with Serum Institute of India, in high-risk populations — one trial in healthcare professionals and the second in elderly population. Both trials have been approved by German national authority, the Paul-Ehrlich-Institut, and the responsible independent ethics boards.
The trials are actively recruiting participants in Berlin, Hamburg, Erfurt, Hannover and Munich. Several other locations will follow shortly.” Grode said the sample size of healthcare professionals was 1,200 and senior citizens 2,200 for the phase-III trials. In India, this project of Serum Institute of India has been chosen for expeditious approvals.