India’s first potential indigenous coronavirus disease (Covid-19) vaccine, Covaxin, has been jointly developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL).
ICMR had written to 12 institutes where human trials are to be held for the vaccine, Covaxin, ordering them to secure necessary approvals from internal committees and recruit people for clinical tests by July 7 with a warning that “non-compliance will be viewed very seriously”.
Hyderabad-based Bharat Biotech is among the seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials to test the vaccine for efficacy and safety.
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.
Before the two Indian vaccines, Covaxin and ZyCov-D, 18 experimental Covid-19 vaccines are in various phases of human trials across the world.
One of the leading candidates is AZD1222, which has been developed by the Jenner Institute of University of Oxford and licensed to AstraZeneca, a British-Swedish multinational pharmaceutical and biopharmaceutical company.
Behind AZD1222 is the MRNA-1273 vaccine developed by Kaiser Permanente Washington Health Research Institute and taken up for production by the US-based Moderna pharmaceutical.
AstraZeneca and Moderna have already entered into an agreement with Indian manufacturers for production of the Covid-19 vaccines.
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.