Second phase human trial of India's 'Covaxin' in Bhubaneswar's SUM hospital in September

The first phase trail was conducted involving 375 volunteers, including five in the Odisha facility.
'COVAXIN' was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley.  (Photo| Special Arrangement)
'COVAXIN' was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley.  (Photo| Special Arrangement)

BHUBANESWAR: The second phase of human clinical trial of India’s indigenous Covid-19 vaccine Covaxin will be conducted by SUM Hospital from next week with the first phase trial suggesting it to be safe to use.

The private hospital was among the 12 sites selected across the country for human clinical trial of Covaxin developed by Hyderabad-based Bharat Biotech International.

The first phase trail was conducted involving 375 volunteers, including five in the Odisha facility. Indicating that Covaxin is safe, a highly placed source told ‘The Express’ that there had been no complaint from the persons who were administered the vaccine.

Principal Investigator of the trials at SUM Hospital Dr E Venkat Rao said blood samples of the volunteers who received the vaccine are being collected to ascertain how effective the vaccine was and the level of antibodies developed.

“We have also initiated process for the second phase trial of the indigenous vaccine and it is likely to be conducted after one week,” Dr Rao informed. Sources said several persons have approached the hospital authorities to volunteer for the second phase clinical trial.

They will be screened thoroughly before being selected for the vaccine shots. Only healthy individuals will be administered the vaccine in the second round.

Though the hospital has not yet officially divulged the details about the candidates vaccinated exactly a month ago, two candidates contacted by ‘The Express’ admitted to having no adverse effects after receiving the vaccine and they have not fallen sick either.

“The hospital had asked us to maintain a dairy listing out the health complications we may face after receiving the vaccine. I have not developed any such complications like headache, fever, body pain or diarrhoea. They have been checking my health condition time to time.

My blood samples were collected five times,” said a candidate. After the second phase trial, the hospital will go for third phase. Once the trials succeed, the vaccine is expected to be ready in early 2021. Meanwhile, the Central Drugs Standard Control Organisation has approved the skin trials of the vaccine, which was injected directly into the muscle during the first phase trial. Along with the intramuscular route, Covaxin can now be administered through the intradermal route.

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