Human trials for India's coronavirus vaccine candidate will begin soon at All India Institute of Medical Sciences (AIIMS) in New Delhi. Speaking to media, AIIMS Director Dr Randeep Guleria said that the results for the first phase of testing are expected to come in September or October.
COVAXIN is the first indigenous coronavirus vaccine, being developed by Hyderabad-based Bharat Biotech and Indian Council of Medical Research (ICMR). AIIMS, Delhi is one of the 12 facilities shortlisted by ICMR for conducting clinical trials of Covaxin.
So far, 1,800 volunteers have registered to participate in the COVAXIN human trials at AIIMS, Delhi alone. However, only 100 healthy volunteers will be recruited at the hospital. The first dose of COVAXIN under Phase I trials will be administered to 50 volunteers at first, and to the remaining 50 after confirming that the vaccine candidate is safe.
Overall, 375 volunteers between the aged 18-55 years will take part in Phase I trials for COVAXIN. Only people with no co-morbidities and women with no pregnancy will be allowed to to be part of the trial in the first phase. In the second phase, 750 people will be recruited between 12-65 years, Dr Guleria said.
"If the first phase we see if the vaccine is safe and how much of the dose can be administered. Multiple doses will be tried. First, low doses will be administered, and if it's safe then we will increase the dose and see if it's effective," Dr Randeep Guleria said.
"We will work on everything step by step and on a protocol based manner. The efficacy of the vaccine and expediting the trail would depend on if everything goes well- or else we will be back to the drawing board - so we are6 taking that risk. But we will work towards simultaneous manufacturing also, as the vaccine shows promising results, we will also look at a manufacturing base," he further added.
Phase I results are expected to arrive in two-three months, Dr Guleria said. After administering the doses, the volunteers will be monitored to see how many anti-bodies were created and check for side effects in Phase II. In Phase III, larger trials will be conducted to see large population efficacy and therapeutic benefits of the vaccine.
"The efficacy of the vaccine and expediting the trial would depend on everything going well, or else we will be back to the drawing board. But we will also work towards simultaneous manufacturing. As the vaccine shows promising results, we will also look at a manufacturing base," Dr Guleria said.
COVAXIN is a coronavirus vaccine candidate developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research.
Work on developing COVAXIN began in May this year, based on the COVID-19 strain isolated at the National Institute of Virology, Pune. In June, Bharat Biotech announced that it completed pre-clinical studies, and managed to demonstrate "safety and immune response". Following this, Bharat Biotech was given the go-ahead by the government to test COVAXIN on human volunteers.