Bharat Biotech cuts The Covaxin's phase-2 clinical trial size by half: Report Coronavirus vaccine:
Slashing Covaxin's clinical trial size by Bharat Biotech may lead to an expedited phase-2 and a possible early start of the third phase.
Bharat Biotech has cut the size of its phase-2 clinical trial of its COVID-19 vaccine candidate Covaxin by half.
The company will dose only 380 healthy volunteers instead of the planned 750 volunteers. Thus, the number of trial sites would also be reduced accordingly. This may lead to an expedition of phase-2 trials and a possible early start of the third phase – leading to a shortened duration of clinical trials for Covaxin
The potential vaccine against COVID-19, the disease caused by the novel coronavirus, is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The first phase of Covaxin’s clinical trial involved 375 volunteers. Interim data from phase-1 has not been made public yet.
The news report further suggests that no major adverse reactions have been noted so far, apart from minor side effects such as mild fever and body aches.
Researchers are currently in the process of administering the second dose to participants as part of the phase-2 trial. Two doses of the Covaxin vaccine candidate are to be administered with a gap of 14 days between them.