Covaxin: Human trials of India’s first Covid-19 vaccine on 375 people to begin soon

New Delhi: India’s first potential coronavirus vaccine candidate Covaxin is expected to begin human trials next week. Covaxin has been jointly developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL). It will be tested on more than 1,000 people in two phases.

The Central Drug Standard Control Organisation–the office of Drug Controller General of India (DGCI)-has granted permission to initiate Phase-1 and Phase-2 clinical trial of Covaxin. A total of 12 institutes have been selected to conduct clinical trials for Covaxin, including AIIMS Delhi.

According to a report in Bloomberg, an ICMR spokesperson said that Bharat Biotech plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies.

Zydus Cadila has also got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for ZyCov-D, its indigenously developed vaccine candidates against Sars-Cov-2, which causes Covid-19.

According to the World Health Organisation (WHO), there are 19 vaccine candidates currently in the clinical evaluation as of July 6. Out of the 19 vaccine candidates, AstraZeneca/University of Oxford, and Sinovacare are the two developers that have entered Phase 3 trials.

The University of Oxford and AstraZeneca’s phase 3 clinical trial involves assessing how the vaccine works in a large number of people over the age of 18. Adult participants will receive one or two doses of ChAdOx1 nCoV-19 vaccine. According to Oxford University, “ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees”. If the trial is successful, then the Oxford Vaccine Group expects to launch the COVID-19 vaccine by the end of this year.

What are clinical trials?

Clinical trials involve inoculating people with an experimental vaccine to test whether it is safe and effective, a process that, on average, takes at least 10 years.

According to the World Health Organization (WHO), people volunteer to take part in clinical trials to test medical interventions, including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start, WHO says.

People of all ages can take part in clinical trials, including children.

What are the four phases of clinical trials?

* Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.

* Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.

* Phase III studies are conducted on larger populations and in different regions and countries and are often the step right before a new treatment is approved.

* Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.