Bharat Biotech to go ahead with Covaxin phase II trials after Centre's nod

Bharat Biotech’s coronavirus vaccine Covaxin will now enter phase II of clinical trials. The firm developing India’s indigenous vaccine candidate for COVID-19 secured the Centre’s nod to begin phase II trials from September 7.

The phase I trials of Covaxin reportedly went as per expectations, with no side-effects being reported in volunteers who were administered the COVID-19 vaccine shots. During the first phase of the trials, 375 people across the country were given Covaxin shots.

As per the letter issued to Bharat Biotech International by Dr S Eswara Reddy, the Joint Drugs Controller of India, phase II clinical trials of the BBV152 coronavirus vaccine, or Covaxin, will be conducted on 380 volunteers. All participants will now have to be screened for four days after they are administered the vaccine shots.

The letter further mentions that the Central Drugs Standard Control Organisation (CDSCO) under the



Directorate General of Health Services, Ministry of Health and Family Welfare, “has no objection for conducting the trial titled ‘An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicenter study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers’.”

Twelve medical centres have been chosen by the Indian Council for Medical Research (ICMR) to conduct the human clinical trials of the vaccine developed by Hyderabad-based Bharat Biotech.

Apart from Bharat Biotech, Zydus Cadila is the other Indian company that has begun human clinical trials of its vaccine candidate. Meanwhile, phase II human trial of the COVID-19 vaccine produced by the Pune-based Serum Institute of India has begun at the BJ Medical College. This vaccine is being developed by Oxford University and Swedish-British drugmaker AstraZeneca.