Sun. Aug 14th, 2022
Bharat Biotech fast-tracks Covid-19 vaccine development; company cuts phase-2 size, will seek nod for phase-3 Instead of testing the vaccine candidate on 750 healthy volunteers in Phase-2, as approved for its clinical trial protocol, the company will now be testing it on just 380 volunteers. The 2019 Clinical Trial Rules require all protocol amendments to be submitted to the DCGI in writing along with the Ethics Committee’s letter of approval.