Bharat Biotech aims at billion Covaxin doses a year, phase-3 trials in Oct

Phase-3 trials are pivotal and companies need to prove safety and efficacy of the vaccines in those trials
Bharat Biotech plans to start phase-3 clinical trials of its indegeniously developed Covid-19 vaccine (Covaxin) in October and is in talks with partners to expand its manufacturing footprint to produce one billion doses annually.

The company, on Wednesday, also announced a tie-up with Washington University's school of medicine to develop a novel intransal vaccine for Covid-19 that would enable to overcome challenges in dosage administration. The company will also distribute the intransal vaccine in all markets except US, Japan and Europe.

"We have completed phase I clinical trials of Covaxin and are getting ready to submit data to the Drug Controller General of India. We have also started phase II trials and in October plan to start the phase III clinical trials," Sai D. Prasad, president (quality operations) of Bharat Biotech said today at an industry event. 

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.

Bharat Biotech 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.


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