Ahmedabad Sola Civil : COVAXIN Phase III trial begins today

Ahmedabad : Twenty-five people have registered at Sola Civil for a trial of COVAXIN made by Bharat Biotech. They will be vaccinated from 9.30 am on Thursday. In the first phase, the vaccine will be tested on 1,000 people. Of these, 25 percent will be patients with various diseases and 75 per cent will be volunteers. The first dose of vaccine will be given after the required test when the volunteers first arrive. A second dose will be given months later. It will be followed up for one year. 500 doses of the vaccine have arrived which will be given to 20-20 people daily.

The names of the volunteers to be vaccinated will also be kept confidential. The vaccine is kept in a deepfreeze at a temperature of minus 2 to 8 degrees. Only special people trained to wear the kit can go to the clinical trial room set up for vaccination.

In this regard, Dr. Parul Bhatt, Head Investigator, Department of Medicine, Sola Civil and Principal Investigator, Clinical Trial Committee, said that a committee of four people, including me, has been formed for the clinical trial of indigenous COVAXIN. 25 people who have registered to be vaccinated will be vaccinated on Thursday from 9.30 am to 12.30 pm and from 3 to 5 pm. The trial will be conducted on 1 thousand people in the hospital for 1 year. Any man or woman between the ages of 16 and 60 can register as a volunteer. The first dose of the vaccine will be given only after all the necessary examinations of the volunteers in the clinical trial and their written approval. A second dose will be given a month later. The vaccine given to the patient will be analyzed after one year. In the first phase, clinical trials of 130 healthy volunteers from 21 centers will be completed. Clinical trials will continue on other volunteers in the meantime.

A 4-member committee was formed for the clinical trial –

1. Dr. Parul Bhatt, Principal Investigator (Senior Professor and Head, Department of Medicine)

2. Dr. Kiran Rami, Co-Investigator (Head of Respiratory Medicine)

3. Dr. Mukesh Vora, Committee Member (Department of Pharmacology)

4. Dr. Rashmi Sharma, Committee Member (Department of Community Medicine)

It is mandatory for the vaccinator to get an RT-PCR test done every month

The process of determining volunteers is underway. Volunteers will be able to register in the morning at the number one first medical OPD on the ground floor in Sola Civil. Where the patient’s history, written approval will be sought. In which, volunteers will have to write, “I am ready to be vaccinated and I guarantee that I will come for follow up of the vaccine for one year.” Volunteers have to come to the hospital once a month and undergo RT PCR test. Volunteers will also be given a travel allowance every month.