Hyderabad-based drug phrama Bharat Biotech has decided to cut by half its number of volunteers and subsequently reduce trial sites for the Phase II clinical trials of coronavirus vaccine candidate Covaxin. This may lead to an expedition of phase-2 trials, said a few reports.
According to the reports, the biotechnology firm had enrolled 750 volunteers for the Covaxin trials, but has now reduced the number to 380 who will be dosed with the vaccine.
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 report, citing lead trial investigators, suggests that the decision to scale-down the trial size was based on good sero-conversion or immunogenicity seen in volunteers during phase-1.
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 reports 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.