The first indigenous vaccine to enter the human trial in India is Bharat Biotech’s “COVAXIN“. India has joined the league with top countries worldwide, racing to provide vaccine as soon as possible for controlling the pandemic. A Hyderabad based company, Bharat Biotech International Limited has been approved to conduct a human trial with their new vaccine “COVAXIN”. The trails are set to start across India from July. Bharat Biotech has partnered with ICMR (Indian Council Of Medical Research) in developing the COVAXIN vaccine. On the global level, AstraZeneca, Moderna are two vaccine companies whose vaccine is way ahead and entered the phase 3 Human trail making them the world’s leading candidate with most advanced in terms of development and expected to enter the market soon.
Is India rushing?
As today India aims for coronavirus indigenous vaccine, Experts are questioning the ICMR’s expertise of the vaccine, calling the deadline and, how letters are sending out completely unrealistic. A letter written by ICMR’S director general asking participating hospitals to speed up the human trail for Bharat Biotech’s indigenous vaccine has stirred a massive controversy. The letter states ” It is envisaged to launch the vaccine for public health use latest by August 15, 2020, after completion of the trail”. For this, it is ” advised to Fastrack all approval needed to ensure subject enrollment is initiated no later than July 7, 2020“. The letter ends with a warning “Non-compliance will be taken very seriously“. Sources in the ICMR have confirmed the letter to be authentic. Experts are now raising questions over ICMR’S effort to expertise the vaccine. The clinical trial registry of India’s document reveal trail was registered on 01/07/2020 for phase 1 and phase 2. Bharat Biotech plans to test 1125 people in their trail and plan to enroll people on 13th July. Dr. M. Walli, the former physician informs to the president of India that “this is a massive step and people will willingly come forward as we are in par in the race with Moderna and AstraZeneca’s Oxford vaccine that this is very stimulating a d good news”
In emergencies like the pandemic, clinical trials can be accelerated. In such a case, phase 1 trial which is for safety study is conducted on 50-500 people taking up to 4 months while phase 2 is for dosage checking of vaccine which might take another 4 months. But in the case of COVAXIN, these two phases will happen together to save time. They seemed to be working sincerely as the virus takes 2-3 weeks to multiply, so every test takes 2.3 weeks for the results to comes. Many are questioning the fast-tracking of the human trail because they ask does it signify and assure the safety and efficacy of a vaccine that is finally being given to millions to fight the coronavirus. Dr. David Nabarro, special envoy to W.H.O has informed that it might take at least 2-3 years to find a vaccine that ensures immunity and safety from pandemic to 7.8 billion people in the world. So, he advised everyone to plan to live with the virus and getting on top of it for a 2-year minimum. But the contrasting view of ICMR setting deadline for August 15 is raising questions to whether ICMR is acting under pressure.
There are four aspects to consider in this case. First is the urgency of the vaccine as India eventually has to develop a vaccine for itself as soon as possible. Second is that this particular COVAXIN is a pretty good candidate as Bharat Biotech has a history of making the dependable vaccine. But the point here is that it took them 13+ years to provide valuable products and that’s the timeline for a reliable vaccine to show up but the vaccine candidate is not bad. The third is that some-how they thought, they can be sure the vaccine will ready within a few days. The truth is the vaccine didn’t work on our timeline, as it relies on the functions of science. If we line up all the vaccines that ever been developed, mostly 90% of the vaccine will fail. It’s not because of the lack of effort or lack of money or the lack of intent, it’s just that vaccine development is a very hard business. The last point is safety. Most children vaccine is given to a small amount of population but this vaccine needs to be given to the entire population. So the vaccine is to be safe for children, adults, elderly. So the Bar for this vaccine is much higher than even the regular vaccine. This all adds up to the time required to develop the vaccine hence it might take up to 2 years and there is also the scaling of population.
There are certainly few things in ICMR’S letter that sound surprising in its assumption that they would be able to finish phase 1 and phase 2 studies, as well as efficacy studies and, have results by 15 of August which is highly unlikely. The time-frame looks very ambitious in terms of vaccine research or clinical trials. Another element is that given this is a COVID-19 vaccine, you would want to ensure that process and standards are followed in terms of protocol and in terms of ensuring safety. The timeline that Is made up, makes it very difficult to follow it. These trails are planned to be done nationally across many sites and it does require time for both the institution as well as the committee of institutions to analyze at the end of each phase to decide whether it could proceed. All of this does take a typical amount of time so to expect all of it to be done and results to be ready to share in the public domain in over a month is highly surprising. Especially for vaccine research in an area of a novel virus, were the vaccine candidate has not been used before makes it very difficult. Because to do proper research scientifically to get a result which is meaningful and which can be reliable like whether the vaccine is fit to be introduced in public health prevention purposes require you to do good quality research and such results do take time. Some processes could be made short but you cannot skip the key elements.
Now with this letter from ICMR out, there is extreme pressure to meet the deadline. There is the entire world saying it might take 1-2 years for vaccine production and here India saying It will be ready in a month can be quite skeptical. And the reputation of India is also in line, because even if one in a hundred people have any effect because of the skipping procedure then all the benefits of the vaccine would be undone. If would not only harm public confidence in COVID-19, but it’ll affect the confidence in science, all vaccines, and even the reputation of India. So, the procedural process of vaccines is needed to be right for producing a vaccine even if it takes time. We could only wish COVAXIN to meet up to its expectations.