July 28, 2020 9:11:19 am
As part of our continuing efforts to make sense of this life-altering pandemic, we are, beginning today, starting this new column to keep you informed about all the latest on the Covid vaccine front. This column will track laboratory research to field trials, publications and regulatory approvals, and also the logistical exercises of production and distribution of these vaccines. All, in an explanatory fashion that you, as an Express reader, are now familiar with, and have come to expect from us. A lot of these activities will happen in India as well. Two vaccine candidates in India are currently being tested on humans, and more are in the pipeline. India is also key to the global vaccine supply chain. Today we explain why that’s so — and bring you the latest vaccine updates from the field.
India one of the largest producers of vaccines
Irrespective of how the vaccine candidates developed by Indian companies eventually perform, India would remain a central player, both as one of the biggest manufacturers of vaccines in the world, and also one of the biggest markets. As pointed out by the Dr Balram Bhargava, director general of the Indian Council of Medical Research (ICMR), the other day, India controls nearly 60 per cent of the global supply of all kinds of vaccines.
Pune-based Serum Institute of India happens to be the largest manufacturer of vaccines in the world, and the company has entered an agreement to produce the vaccine being developed by Oxford University and AstraZeneca. That vaccine candidate is supposed to be the one that a lot of scientists and health experts are currently betting on. The vaccine is currently undergoing phase III trials in at least two countries and is about to get into similar late stage trials in India soon.
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There are several other Indian pharmaceutical and biotechnology companies that are prominent players in the production and supply of vaccines. Hyderabad-based Bharat Biotech, which is developing its own vaccine as well, Panacea Biotech, Shanta Biotech, Biological E Limited, are some of the other big names with large production capacities.
Irrespective of which vaccine gets ready first, a bulk of the production is likely to happen in India. These companies already have hold over a substantial chunk of the foreign markets. And this is likely to be more so during the current pandemic due to increasing distrust for Chinese companies in several countries, which are the biggest rivals.
Besides, as the second-most populous country in the world, India also happens to be one of the biggest markets for vaccines.
Moderna Therapeutics begins phase-III trials
As many of you might already be aware, more than 160 vaccines for novel Coronavirus, also known as SARS-CoV2, are currently being developed across the world. According to latest information from World Health Organisation, 25 candidate vaccines are in one of the three stages of human trials. These include the two being developed by Indian companies, Zydus and Bharat Biotech. As of today, another 139 are in pre-clinical evaluation, meaning that they are still being tried out on animals.
Some of these have excited the scientific world more than the others, for the promise that they have shown so far. The one being developed by US-based Moderna Therapeutics was the earliest mover, its phase-I human trials having started as early as middle of March. It has now completed phase-I and phase-II trials and, on Monday, entered phase-III trials, for which 30,000 volunteers have been roped in. Not all of them would be administered the vaccine. In phase-III trials, some of the volunteers are injected with the vaccine while the others are given a dummy. The volunteers do not know. They go about their normal lives, and after a few weeks, they are checked to see if they have been infected.
Researchers expect to see a significantly lower infection rate in the group that was given the vaccine. That is the test of the effectiveness of the vaccine. This process usually takes several months. The phase 3 of Moderna, technically, will complete in October 2022. However, whether the vaccine candidate will make the cut and become one of the first vaccines to be launched commercially early next year will depend largely on the preliminary data on efficacy, safety and immunogenicity that will emerge after the second dose is given to the volunteers on day 29 of the trials. Also, the levels of neutralising antibodies, that render the virus inactive, generated between day 1 and day 57, will be the most crucial data that researchers will closely watch.
Gennova to be third Indian firm to bring vaccine candidate
Pune-based Gennova Biopharmaceuticals is planning to start testing its candidate vaccine on human beings by October. Right now it is carrying out pre-clinical trials. Two Indian candidates have just begun phase-I clinical trials earlier this month. One of them is being developed by Hyderabad-based Bharat Biotech, in collaboration with Pune-based National Institute of Virology, which is part of the network of laboratories of the Indian Council of Medical Research. The other one is being developed by Ahmedabad-based Zydus Cadila.
Unlike the other two, Gennova is trying an mRNA vaccine, which is just one of the several ways in which vaccines trigger immune response in human beings against a virus. It involves injecting a messenger RNA that is coded to tell the cells to recreate a crucial part of the virus that the body needs to build immunity against.
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The other two Indian candidate vaccines are taking different approaches. The Bharat Biotech vaccine will insert an ‘inactivated’ virus into the human beings to trigger the response system, while the one being developed by Zydus Cadilla uses a genetically engineered DNA molecule coded to make a replica of the virus. There are other ways to trigger the immune response.
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