Prasad said the company is targeting 25,000 to 30,000 volunteers for the phase-3 trial but sample size estimate and locations for the trial are yet to be finalised.
Phase-3 trials are pivotal and companies
need to prove safety and efficacy of the vaccines in those trials.
has two manufacturing facilities in Hyderabad which can produce 100-200 million doses annually. Prasad said the company is in dialogue with partners in India and overseas for manufacture of Covaxin on a technology transfer basis and that will help the company to scale production to one billion doses each year.
Among other conpanies, Serum Institute of India has started phase III trials of Oxford University's Covid-19 vaccine while Dr Reddy Laboratories will be conducting phase III trials for the Russian vaccine.
Zydus Cadila's Covid-19 vaccine is undergoing phase II trials now. " We believe the initial results from the trial are encouraging. We would be completing phase-2 trials in the coming months and then move to phase-3 trials," said Kapil Maithal, president (Vaccines) of Zydus Cadila.
Bharat Biotech has said phase I trial of the intransal vaccine will take place in the US and the company will pursue further clinical trials
and manufacturing in India on receipt of approvals.
"An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc, significantly impacting the overall cost of a vaccination drive," said Dr. Krishna Ella, Bharat Biotech chairman said.
Industry bodies welcome vaccine guidelines
Industry bodies said government's draft Covid-19 vaccine guidelines are in line with global norms and would not require companies
to make changes in ongoing trials.
"On an initial review, the guidelines seem to be in line with the global guidelines for vaccine development. Hence we do not envisage these requiring a change in the direction of current vaccine trials as long as they are in compliance with the New Drug and Clinical Trials Rules," Organisation of Pharmaceutical Producers of India said in a statement.
Earlier in the week the government released draft guidelines which state the vaccine should induce antibodies and protect atleast 50 per cent of those receiving the vaccine.
"The revised guidelines shared are fair and as per the same, no changes to the trials are applicable as of now," Indian Vaccine Manufacturers Association said.