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Biological E has received the apex drug regulator’s approval to conduct early- to mid-stage human trials for its Covid-19 vaccine candidate developed in collaboration with Houston’s Baylor College of Medicine, The Indian Express has learnt.
The nod of the Central Drugs Standard Control Organization (CDSCO) follows recommendations of an expert panel to allow the company to proceed with clinical trials of the vaccine candidate early last week. A letter authorising the trials was issued by Drug Controller General of India Dr VG Somani to Biological E (Bio E) on October 29, said a senior government official close to the development on condition of anonymity.
Bio E is expected to enrol around 400 volunteers for both phases of the trial, which will take place in 4-5 sites in different parts of the country to start with, said an official privy to the matter.
Queries sent to Bio E about how many participants it would recruit in the first phase and when it expects the first set of vaccinations to begin remained unanswered by press time Wednesday.
