Researchers around the globe have been attempting to develop over 150 different vaccines against the deadly Coronavirus. While such vaccines take several years of research and massive testing before reaching the final stages, more than 20 vaccines are already in human trials. And India is not far behind in the race to quickly come up with a vaccine to fight against COVID-19. And as it joins the global race to develop a vaccine, researchers also have to keep in mind that the vaccines have to first clear the safety and efficiency tests.
Let’s have a look at India’s quest for a COVID-19 vaccine — where we are at currently and how’s the future looking like.
Despite complete lockdowns around the world and in India for almost the past three months or more, the Coronavirus has shown no signs of peaking yet in the country — every state’s statistical curve in India is different which makes it even harder to predict when the virus is likely to peak accumulatively. “It’s a 21st-century virus — smart, savvy and tough, and the challenge it poses should not be underestimated,” says Pankaj Patel, chairman, Zydus Cadila, the Ahmedabad based pharma major that is researching ways to combat it. We can all agree to Mr Patel’s comments, as we can see the significant surge in the number of cases across the country and across the world as people have begun stepping out and going back to business as usual. With no possible cure or drug in sight to combat the spread of this virus, pharmacists, doctors, researchers, medical companies have been trying at a faster pace to look for other possibilities that can help. The only solution and currently, the best bet seems to be developing a global vaccine that can be mass-produced easily, is affordable and be given to the public to build herd immunity against the Coronavirus.
When can a vaccine be finally given to people?
There are specific steps that the vaccine manufacturers have to follow before it is completely ready for inoculation.
Step 1: Preclinical testing where scientists first give the vaccine to animals such as mice or monkeys to monitor and see if it produces an immune response.
Step 2: Phase 1 safety trials- Scientists then give the vaccine to a marginal number of people to test its safety and dosage as well as to confirm the fact that it can stimulate the immune system.
Step 3: Phase 2 expanded trials- Scientists give the vaccine to a larger group of people who are split into groups on the basis of age or some other determining factor they deem fit, such as children and the elderly. This is to see if the vaccine acts differently among people. These trials again test the vaccine’s safety and efficacy in humans and their ability to stimulate the immune system.
Step 4: Phase 3 efficacy trials- Scientists now administer the vaccine to thousands of people and wait to see how many become infected with the virus, compared to volunteers who are given the placebo. These trials typically can determine if the vaccine protects a person against the Coronavirus.
Final step: In the approval stage, regulators in each country review the vaccine trial results, according to which they make a decision on the vaccine’s approval. However, there is also an exception during pandemics — a vaccine might be given permission to be administered before formal approval.
Where is India in the vaccine race?
Recently, the World Health Organisation announced, which might seem like a bit of good news — out of the total number of vaccines being developed across the world, 21 have reached the stage of human trials. In the past few weeks, two Indian companies namely Hyderabad-based Bharat Biotech and Zydus Cadila are also a part of this race with the Indian government’s support who has cleared their respective vaccines — COVAXIN and ZyCOV-D — for the early phases of human trials. Zydus Cadila has said that they have been creating a DNA-based vaccine. On July 3, they had announced that their vaccine was approved for conducting human trials. With that, they became the second company in India to enter the COVID-19 vaccine quest after Hyderabad’s Bharat Biotech.
In Geneva, WHO Chief Scientists Dr Soumya Swaminathan told India Today, “It’s excellent that Indian R&D is coming with vaccine candidates because earlier it was considered only a manufacturing hub of generic pharmaceuticals. The more participants we have, the better. Along with many other participants across the world, they would help in finding out a vaccine or vaccines that will have lasting immunity and are for safer use.”
In collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Hyderabad-based Bharat Biotech COVAXIN has raised a significant amount of controversy in the past few weeks. Phase 1 and 2 trials have been scheduled to begin during this month. When the ICMR sent out notes to the company that Phase 1 and 2 trials are to be completed by August 15, India’s Independence Day, there has been massive uproar and criticism among the medical fraternity. The Indian Academy of Science has protested against this move by the ICMR and stated that one should not impose baseless deadlines upon such critical medical research. K.I. Varaprasad Reddy, Chairman, Shantha Biotechnics, Hyderabad, has warned, “You cannot gloss over protocols and forego sequential safety in developing a vaccine. We cannot make a mockery of science. It will take at least 18 months to two years even in an emergency-like situation. What is dangerous is the practice of drug controllers shortchanging on procedures to unveil a vaccine in a hurry.”
Adar Poonawalla, CEO, Serum Institute, Pune also agrees, “We should not be rushing through any of these stages. Nor should we be focusing on who is the first to bring out a vaccine; rather it should be which candidate vaccine is the safest and most efficacious.”
Challenges in developing a safe vaccine
The efficacy or safety are not the only factors that experts are worried about — if India or any other country in the world becomes successful in developing a vaccine to fight the Coronavirus, equitable distribution and affordability are the major concerns then. Several countries such as the United States has already tied up with manufacturers to purchase the vaccines as soon as they are out. “Middle-income countries will be at greater risk if we don’t ensure equitable distribution and collaborate on a global level. Even in India questions remain on how much will be pledged domestically and how much will be exported,” says Dr Leena Menghaney, South Asia head of Medicines Sans Frontieres.
These challenges are quite relevant whether India becomes successful or not in the long run. While experts worry, people are waiting with baited breathe hoping any of the countries will be able to introduce a vaccine at least by the end of 2020. Let’s keep our fingers crossed until then.
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