In conversation with Dr. Dhirendra Kumar, Senior Microbiologist and Research Scientist
The rate at which the Covid-19 pandemic is spreading leaves the world with no choice but to have an emergency-use vaccine ready as soon as possible.
1. A vaccine could be a game changer for any country to contain this pandemic. What according to you is the role that the vaccine can play apart from behavioral change and other aspects of mask and social distancing?
The world is eagerly awaiting a vaccine for Coronavirus disease (COVID-19) to contain the pandemic. Since, it is a novel virus, there is no immunity among the people across the world and treatment of COVID-19 positive patients is also currently just limited to managing symptoms and preventing of complications. In such a situation, vaccines become the most viable option in the fight against the vaccine. Moreover, there are many asymptomatic persons in the community who may not show any sign of COVID infection but may easily become the carrier of the deadly virus. Such as scenario can only be tackled by an effective vaccine.
2. Early vaccine approvals are being debated globally. In a limited time and given the urgency to have the vaccine as a viable solution, how can we be sure about its safety and efficacy?
The rate at which the Covid-19 pandemic is spreading leaves the world with no choice but to have an emergency-use vaccine ready as soon as possible. Scientists and researchers are working across the world to try and get ahead of the deadly virus and develop an effective vaccine as soon as possible based on prior experience and new evidence. In the past, the Ebola vaccine has been rapidly made available. So, the world already has some experience with coronavirus vaccines against viruses that cause Severe Acute Respiratory Syndrome (Sars) and the Middle East Respiratory Syndrome (Mers). The platforms and proven adjuncts being used for vaccines development are established and have been used to deliver other vaccines. Since we are not starting from scratch, an early vaccine is possible. Having said that, the Drugs Controller General of India (DCGI) has issued a new set of guidelines, focusing on safety, immunogenicity and efficacy parameters for pharma giants who are developing COVID-19 vaccines. The DCGI has said that a COVID-19 vaccine candidate should have at least 50 per cent of efficacy in the Phase-III clinical trial for it to be widely deployed and adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) needs to be generated.
For instance, in September, Russia launched world’s first COVID 19 vaccine based on its prior experience of designing adenovirus vectored MERS and Ebola Vaccines.
The prosing thing is that the vaccine has shown a humoral and cellular immunal response during initial trails. It is also expected to produce robust neutralising antibodies against SARS COV-2 virus
3. There are players who are testing vaccines based on different approaches. What considerations need to be in place for ensuring the safety and immunogenicity of the vaccine?
There are clear parameters of safety and efficacy of a COVID vaccine. Firstly, there must be clear recommendations for vaccine performance prior to the initiation of Phase 3 trials. Secondly, use of a tried and tested platform to develop the vaccine and the vaccine should not demonstrate any serious adverse events during Phase I -II trials. For example, look at the current scenario of vaccine development, Russia’s Sputnik V that has recently got approval from the DCGI (Drug Controller General of India). First, the approach adopted by the Russian scientists is tried and tested as it is using a well-known platform of human adenovirus to develop the vaccine. This is reassuring. The country also published the findings of the phase 1 and 2 in the leading scientific journal, The Lancet where researchers reported that the vaccine was safe and effective. The Lancet’s article contains both the key qualitative and quantitative characteristics of the Sputnik V vaccine, favourably distinguishing it from other vaccines that are only just undergoing clinical trials in various countries and have no data on carcinogenicity or the effects on fertility. Although it will be impossible to know how effective and safe each vaccine is without well-designed phase 3 trials with thousands of patients, the above-mentioned criteria can be the guideline to select a vaccine.
4. What do you think about Russia’s application to the WHO for accelerated registration and prequalification of Sputnik V? How will it impact the overall pandemic scenario worldwide?
WHO prequalification of medicines assesses the quality, safety and efficacy of medicines. The mission of this division of WHO is to work in close cooperation with the national regulatory agencies across countries and other partner organizations to make quality priority medical products available for those who urgently need them. A successful prequalification will enlist the qualified vaccine in the category of the medicines used by international procurement agencies and countries to guide bulk purchasing of medicines.
5. Apart from vaccine production, planning the roll out is equally important. How well is India prepared to make that happen seamlessly in India?
India has several successful past experiences of rolling out country-wide immunisation programmes. Having said that, Covid-19 is a different much more challenging situation because of several obvious limitations such as the need for social distancing. Other challenges would include availability of storage facilities for the vaccine, transportation of the vaccine to the site of vaccination among others. The government is gearing up to roll out the Covid-19 vaccination plan using innovative technologies and digital trackers in addition to the tried and tested practices of vaccines distribution.
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