BiologicalE Gets Nod For Phase 3 Trials of COVID Vaccine Candidate
The company stated that phase-I and II trials found the vaccine to be “safe and well-tolerated”.
Hyderabad-based pharmaceutical company, Biological E Limited announced on Saturday, 24 April, that it had received approval from the Central Drugs Standard Control Organization’s (CDSCO) subject expert committee (SEC) to start the phase-III clinical trials for its COVID-19 sub-unit vaccine candidate.
The company had completed the phase-I and II trials, after starting them in November last year.
With about 360 healthy subjects, the trials showed that the vaccine was “safe, well-tolerated and immunogenic”, the company said in an official statement.
“We are delighted with the success of the phase-I/II clinical trials of our COVID-19 vaccine candidate. The results of these were very positive and promising,” Mahima Datla, Managing Director of the firm, said.
The study has, so far, included a schedule of two doses for each participant, administered 28 days apart via intramuscular injection.
The phase-III clinical study will be conducted at 15 sites across India and involve 1,268 healthy subjects of ages 18-80. According to the company's statement, "It is intended to be part of a larger global phase-III study."
So far, India has approved three vaccines – Covishield, Covaxin and Sputnik V – for emergency use. While Covishield and Covaxin have been in use for the inoculation drive, the Russian Sputnik V is likely to hit the Indian market by May-end.
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