According to reports, a Chennai-based hospital has put out a call for volunteers for the phase-3 trial of Covaxin.

Gloved hand holding COVID-19 vaccine bottle Image for representation. Kunal Mahto/Picxy
Coronavirus Coronavirus Thursday, October 08, 2020 - 12:25

India’s indigenous vaccine candidate – Covaxin – is set to go into phase-3 trials. Per a TOI report, a Chennai-based hospital has put out a call for volunteers for phase-3 trials of the vaccine, and is set to begin them soon.

The SRM Medical College Hospital and Research Centre in Kattankulathur is one of the 12 institutes in India where the Indian Council of Medical Research (ICMR) is running trials for Covaxin, which is being developed by Hyderabad based pharmaceutical company Bharat Biotech in collaboration with ICMR and the National Institute of Virology.

The phase-3 trial may begin in a fortnight after required approvals are received, said Dr Satyajit Mohapatra, the principal investigator for the trials at SRM. The approvals and protocols that need approval from the Drugs Controller General of India (DCGI) include things like the dosage to be given to volunteers.

Dr Mohapatra added phase-3 will be approved by the DCGI subject to the data from the first two phases of trials once submitted. He also said that phase-3 trials will have nearly 40,000 volunteers to whom the vaccine will be administered across India. SRM is looking for 1,500 volunteers who are 18 years or older.

Bharat Biotech had in September announced that it was ready to begin phase-3 trials for Covaxin on October 15 in three government medical colleges in Punjab. The company had earlier shared results of a study done by trialling the vaccine on animals. It had revealed that Covaxin was found safe in the rhesus monkeys that was administered the dosage after being exposed to SARS-CoV-2, the virus that causes COVID-19.

The first phase of human trials for Covaxin was concluded in most of the 12 institutes selected by August 14, and showed positive results with the vaccine being found safe. 

 

 

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