After completion of 1st stage trials of Covaxin by Bharat biotech in collaboration with ICMR, the phase 2 human trials are now ready, and would begin on Monday.
Reportedly, the Central Drug Standard Control Organization, under the Directorate General of Health Services granted permission to Hyderabad based Bharat Biotech to lead the second phase trials. The endorsement was given as a letter composed by Joint Drugs Controller Dr S. Eswara Reddy to Bharat Biotech.
The stage 2 preliminaries of BBV152, named as Covaxin, will apparently be conducted on 380 members, who should be screened four days after the immunization is administered to them.
In the letter, the Joint Drugs Controller said that the directorate had no issue with leading the trials named ‘An adaptive, consistent Phase I followed by Phase II randomised, double blind, multicentre study to assess the security, reactogenicity, tolerability and immunogenicity of the entire virion inactivated SARS-CoV-2 antibody (BBV152) in healthy volunteers’.
The letter specifies that Bharat Biotech’s solicitation for endorsement to start stage II clinical preliminaries was inspected in discussion with the Subject Expert Committee (COVID-19) specialists held through virtual conference on September 3.