The year 2020 indeed started on a very distinctive note that has altered the human history of all ages. The advent of the latest pandemic, Corona Virus has been the most definite outbreak to have broken all records with over 10 million cases being reported globally, over only a span of a few months. The massive epidemic is in need of a path-breaking solution, a vaccine that can go a long way in helping individuals acquire treatment and get cured.
The epidemic has had its fair share in India as well with the country been registered for an evolving 18,522 new cases every single day, and with it, the death tolls are escalating to another level. Amidst the ever-increasing cases of the pandemic in the country, the first indigenous vaccine of the country, COVAXIN has received the nod for undergoing human clinical trials.
With respect to the impending number of coronavirus infection cases, a number of organizations have been working towards acquiring the vaccine for the deadly disease. With several vaccines on the rat race, a major one has got everybody talking, and we cannot wait to explore it more. Let us unfold it in-depth and know as much as we can.
Things you need to know about COVAXIN:
No vaccine has been yet approved in the realm of commercial use; however, over a dozen vaccines are being evaluated to be brought to the forefront. This is when India has made its headway in the race of vaccine with allowing one of the vaccine candidates, COVAXIN to step up the game of clinical trials.
2. Bharat Biotech is one of the seven firms in India working towards introducing the vaccine in the country and worldwide. It was also the first-ever company that has received the regulatory nod to start with phase 1 along with phase 2 of human trials.
3. This vaccine is also the very first of its kind to being developed in the country which is also being overseen by the Government as the topmost priority.
4. The vaccine, COVAXIN is scheduled to be launched by August 15, 2020, with the Indian Council of Medical Research (ICMR) confirming its release date out to the public.
5. COVAXIN has been researched and developed at the high containment facility of Bharat Biotech’s BSL-3 (Bio-Safety Level 3) which is situated in Hyderabad, in Genome Valley.
6. The Ministry of Health and Family Welfare along with The DGCI, CDSCO had granted permission to start with human clinical trials taking place across Phase I and Phase II, after substantial results to being submitted by the company. The results reflected upon the preclinical studies, which vividly demonstrated all responses in regards to safety and immunity.
7. The vaccine has been essentially derived from the SARS-CoV-2 strain that has been isolated by the popular institute, ICMR, in Pune. BBIL and ICMR have been working in close collaboration for ensuring both preclinical and clinical development.
8. Twelve clinical trial sites have been identified by ICMR that comprises medical institutions and hospitals where the investigators have been asked to initiate the subject enrolment by latest July 7.
9. Human trials are scheduled to start in India by July 2020.
10. The Central Drugs Standard Control Organization along with the DFSI and Ministry of Welfare has laid out permission to start with Phase I and II of human clinical trials, with the organization submitting results as generated from the preclinical studies that demonstrate ultimate safety and immunity.
11. The two phases of clinical trials of the vaccines are scheduled in the month of July.
12. In addition to two significant Indian vaccines out, COVAXIN along with ZyCov-D, there are 11 out of 140 vaccine candidates to have entered the realm of human trials.
13. Zydus Cadila Healthcare group has also reported to having indigenously developed COVID-19 vaccine candidate, ZyCoV-D. It has been successful in completing the preclinical phase while receiving permission from several human authorities to perform human trials.
Understanding clinical trials:
Clinical trials involve the inoculation of individuals with a particular experimental vaccine that efficiently tests the safety and efficiency of it. This is a process which on average takes a span of about ten years.
In accordance to the World Health Organization, (WHO), there are a significant number of individuals who volunteer to participate in the trials in order to evaluate the medical interventions which include cells, drugs, in addition to other surgical procedures, biological products, radiological procedures, preventive care and device several behavioral treatments.
These trials are efficiently designed, developed with being reviewed, and completed well with the need to being approved before they are levied across patients and places. There is no limitation on the number of people taking part in the trials which also includes children.
Phases of clinical trials
While we are talking about vaccines and trials, we cannot miss out on discussing clinical trials and their phases. There are four distinct phases of the tests, as mentioned in the following:
Phase I studies to evaluate the new drugs for the very first time, which is performed in a small group of individuals in order to test the safe dosage range while evaluating the side effects.
Phase II studies the treatments found to be safe in the first phase; however, needs a large group of individuals to efficiently monitor adverse effects, if any.
The third phase, Phase III, is performed on a larger population and in a distinct region and population.
The last phase or phase IV takes place after the approval of the country, with the further need for evaluation among a wider population and over a longer period of time.
Now that we are ready with the vaccine and the trials are all geared to initiate across phases, it is the final countdown for embracing the new and the healthy. The vaccine is thus going to be the biggest boon of all times, a miracle augmenting humanity and health.
Also, Read Pandemics That Changed History.
Subscribe our newsletter to stay updated