India’s indigenous coronavirus vaccine, Covaxin, being developed by the Hyderabad-based Bharath Biotech, has reportedly reduced the number of volunteers for the Phase II trials by half.
Bharat Biotech had enrolled 750 volunteers for the Covaxin trials, but has now reduced the number to 380. The number of vaccine trial sites has also been 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 decision to scale down the trial size was based on good sero-conversion or immunogenicity seen in volunteers during phase-I.
Bharat Biotech completed the Phase I trials with over 350 volunteers and is now in the second phase. The researchers have maintained that the trials have not suffered any major illness or setback so far while testing the Covid-19 vaccine candidate.
Bharat Biotech, which had sought DCGI’s nod for conducting Phase III clinical trials of its Covid-19 vaccine candidate, has been asked to submit complete safety and immunogenicity data of the ongoing Phase II trial, besides providing some clarifications, before proceeding for the next stage.
Meanwhile, the Oxford-AstraZeneca coronavirus vaccine is undergoing the Phase III trials.
World Bank, on the other hand, has pledged the support of $12 billion to support developing nations finance coronavirus vaccines and support the treatment of its people.
