With the Covid-19 taking a toll on deaths and infections worldwide, the race for developing a Covid-19 vaccine has become more intense. There are currently three candidates globally who have reached the third phase of human trials.
The vaccine candidates from AstraZeneca and University of Oxford, Sinopharm and CanSino are the ones among 19 which have reached the human trial stage to reach the third phase.Sinopharm and Cansino are from China where the virus originated. Now, two of India’s candidates have also reached the human trial stage.
Regulations for a firm to conduct human trials
As per World Health Organization’s regulations for vaccines, there are three stages for the approval of a vaccine: Developmental, licensure and post-licensure. The developmental stage consists of preclinical and clinical trials.
Pre-clinical testing is carried out in laboratory using in vitro or in vivo techniques in animals in controlled manner. If proven fit then clinical study in humans is started.
Clinical testing has three phases.
Phase 1: It consists of initial testing in small number of healthy adults in a controlled manner.
Phase 2: After clearing the first phase, the tests are conducted on a relatively higher number of people to assess the desired results and effects, precisely immunology is observed. This phase ensures the safety of the candidate vaccine.
Phase 3: This is the phase of study conducted on a larger set of people–thousands in number–which determines the decision to whether grant license to a particular candidate. Sufficient data is required to assess that the product is safe and fulfills the intended purpose.
After passing the developmental stage, the manufacturers apply for a license. After licensing process is completed, the manufacturing is started to meet the demand.
India’s Covid-19 vaccine, Covaxin, manufactured by Bharat Biotech along with Indian Council of Medical Research(ICMR) and ZyCov-D (Zydus Cadila) have been granted permission by Drug Controller General of India(DCGI) to conduct human trials. Covaxin will conduct trial in 1,100 people in two phases and ZyCov-D on 1000 people. The first phase of Covaxin will include 375 people. Both got a nod from DCGI last week.
Role of DCGI
Drug Controller General of India(DCGI) is department of Central Drugs Standard Control Organization which ensures the quality of drugs and cosmetics in the market and is responsible for approval and licensing of new drugs and clinical trials, including vaccines.
Currently, Bharat Biotech and Zydus Cadila are the only Covid-19 vaccine candidates from seven firms who have got the nod for human trials. Both of them are set to begin the trials in July itself. Bharat Biotech had earlier announced to launch the vaccine by August 15 2020. However the claim is being scrutinized by global scientists. Zydus Cadila has claimed to give positive results in next few months.
Zydus Calida claimed that the pre-clinical tests of the vaccine have shown Strong immune response without any potential harm. Bharat Biotech’s Covaxin is being prepared along withICMR’s National Institute of Virology and showed safe and immune results in pre-clinical testing.