In the age of social media, digital technology, IoT and 3D printers, it is difficult for a lot of people to understand the delays in creation of a vaccine for the new disease.
By Dheeraj Jain and Rakesh Maurya
COVID-19 has turned out to be a global pandemic of a scale never seen or heard about in the past. The virus has killed people in more countries and regions than the second world war. There is a lot of panic and with the number of infected people approaching 1.4 million, most people are anxiously waiting for a vaccine that can offer protection from this viral outbreak.
In the age of social media, digital technology, IoT and 3D printers, it is difficult for a lot of people to understand the delays in creation of a vaccine for the new disease. What most people need to acknowledge is that despite all the urgency associated with the coronavirus, there is a certain stepwise process that needs to be followed to create a vaccine. It is not as simple as mixing certain medicinal ingredients and preparing a mixture that will cure people. Before being mass produced and introduced in the public, vaccines need to be developed, tested and regulated just like any other drugs. After research on the disease and the causes of infection, a short-listed vaccine needs to undergo exploratory, pre-clinical stage to the phase 1/2/3 vaccine trials. In fact, they undergo more stringent testing compared to a non-vaccine drug like tablet or capsules. Usually, trials are conducted on a larger number of human subjects than a regular medicine. Apart from this, post licensing, the vaccine’s performance is closely monitored by authorities such as the Centres for Disease Control and the FDA in US.
The various steps, protocols and clinical trials of a vaccine is usually a long and laborious process due to the in-depth testing and approval protocols involved. During the research stage, it must be ensured that researchers work on the latest strain of the virus. They should also be able to grow the virus in the lab which might manifest itself in host organisms, but, remains fragile in the cell form. During the pre-clinical trials, the researchers conduct tests on an animal species. Multiple versions of the vaccine are then developed to find out which vaccine has the ability to build immunity against the virus without causing any damage to the body.
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Subsequently, the vaccines undergo different phases of extensive clinical trials wherein each stage is progressively more stringent than the last one. It is only upon completion of the drug trials that licensing for production and release of the vaccine for general public is permitted. This process usually takes 3 to 5 years.
These are extraordinary circumstances, forcing the authorities all over the world to hasten up the vaccine development process. Cutting edge technologies such as Genome Mapping are also aiding in the accelerated development of a vaccine for this viral outbreak. According to reports, scientists in China have already completed successful mapping of the coronavirus’ genome and research is on in other countries as well. The steps involved in all this are important in order to determine how a particular vaccine is likely to work on different people and strains of the virus or in different geographic and climatic conditions. Without adequate testing, we might see the vaccine pose a problem to the global public instead of protecting them from the infection.
The past experiences with various other strains of coronavirus induced infections such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) are of great value in this quest. The COVID-19 virus shares up to 90% of its genetic structure with the earlier virus, hence, research done previously can prove crucial in finding the right vaccine.
A few days ago, dozens of healthy volunteers in Seattle, Washington, underwent a US government sponsored phase 1 safety trial of the vaccine. We are hopeful of seeing numerous other vaccines enter similar safety trials soon. However, there is one critical question which remains unanswered presently: what kind of response the vaccine will receive from our body’s immune system. We might find the answer soon after the animal trials and case studies of various coronavirus infected people. In the best possible scenario, where everything goes as planned and the vaccine proves its efficacy and safety, it will take at least a year before it becomes available globally to cure the COVID-19 pandemic. Until then, taking precautions and ensuring we adhere to protocols is key.
(The authors, Dheeraj Jain is Founder of Redcliffe Life Sciences and Rakesh Maurya is Chief of Scientific Affairs at Redcliffe Life Sciences. Views expressed are personal.)