The civic-run Lokmanya Tilak Municipal General hospital, also popularly known as Sion hospital have kick-started the third phase of clinical trials of the first indigenous COVID-19 vaccine -- Covaxin.
After receiving the vaccine from the Central government on Sunday, December 6, Sion hospital started its clinical trial on Monday, December 7. However, in 2 days the hospital has administered the vaccine to around 10 volunteers. The hospital will be administrating vaccine to a total of 1,000 volunteers.
Meanwhile, the government-run JJ Hospital started the trial on November 30, and so far, 180 people have participated in it. So far, 190 volunteers have been administered the first dose of the vaccine, said officials on Tuesday, December 8.
According to the hospital administration, there would be two rounds in Phase 3. After 28 days of the first vaccination, volunteers will be given the second vial.
Moreover, the study of Covishield vaccine is underway at KEM and Nair Hospitals. Alongside, the Brihanmumbai Municipal Corporation (BMC) has started the preparations for the storage of COVID-19 vaccine.
In the last week of October, the Indian Council of Medical Research (ICMR) had selected the two hospitals for the pan-India trial of Covaxin, manufactured by the Hyderabad-based Bharat Biotech.
As per the rules of ICMR, as many as 2,000 volunteers aged between 18 and 60 years will be included in the trial. Of this, 20 per cent will be people with comorbidities while 5 per cent will comprise medical health workers. The volunteers will be tracked for 12 months.
Covaxin has been developed by Bharat Biotech in collaboration with the ICMR. The vaccine was approved by the Drugs Controller General of India (DCGI) and nationwide trials began from July 2020.
The detailed procedure of the clinical trials:
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