VACCINE TECHNOLOGY

BY DAKSHITA NAITHANI

ABSTRACT

The immune system is a system that operates 24 hours a day, seven days a week to keep assaults at bay and diseases at bay. The whole system is made up of organs, tissues, and a variety of cell types that work together to defend the body. Immune cells must be able to tell the difference between native and non-native cells and proteins. Microbial cells have antigens that serve as identifiers. Antigens can induce an immune response in the human body. Each species has its own set of characteristics. Vaccines function by inducing an antibody memory response in the body without producing illness. As a result, you build immunity without becoming sick. It must include at least one antigen from the target species to trigger a response.

INTRODUCTION TO VACCINE TECHNOLOGY

A vaccination, often known as an immunisation, is a biological substance that protects people from disease-causing microorganisms. They make advantage of our immune system’s built-in ability to fight infection.

They’re produced from the same pathogens that cause the disease. They have, however, been destroyed or reduced to the point that they are no longer a source of it. Certain medicines just contain a part of the microorganism.

This is why they work so well as medications. They don’t treat or cure diseases like conventional medications; instead, they prevent them. They deceive the immune system that it has been invaded by a real intruder. When real germs enter our bodies, the same thing happens, but you don’t become ill. If you ever come into touch with a pathogen, your immune system will remember it and eradicate it before it can damage you.

TYPES

Vaccines are made using a number of techniques. Various vaccine types need different techniques to development. Antigens can be used in a variety of ways, including:

These can be delivered by a needle injected into the human skin, or ingested orally or through the nasal route.

LIVE (CHICKEN POX AND MMR)

Attenuated vaccines can be made in a variety of ways. All methods involving the transmission of a virus to a non-human host result in a virus that can be recognised by the immune system but cannot replicate in humans. When given to a human, the resulting will not be able to proliferate sufficiently to cause disease, but it will protect the individual from infection in the future. Its protection outlasts that of a dead or inactivated vaccination in most cases.

INACTIVATED (POLIO VIRUS)

A pathogen is inactivated using heat or chemicals to create this sort of vaccination. Because destroyed viruses are unable to replicate, they cannot revert to a more virulent form capable of causing disease. They are, however, less effective than live vaccines and are more likely to require renewals in order to acquire long-term protection.

RECOMBINANT (HPV)

They have been genetically modified in a lab. This method may be used to duplicate a certain gene. The HPV vaccine may be tailored to protect against strains that cause cervical cancer.

SUBUNIT (INFLUENZA AND ACELLULAR PERTUSSIS) AND CONJUGATE VACCINES (HAVING ONLY PIECES OF THE PATHOGEN)

Subunit vaccines use only a fraction of a target pathogen to elicit a response. This can be accomplished by isolating and administering a specific pathogen protein as a stand-alone antigen.

Conjugate vaccines, like recombinant vaccines, are made up of two different components. The “piece” of microbe being supplied would not typically elicit a substantial reaction on its own, but the carrier protein would. The bacterium is not the sole cause of the disease, but when combined with a carrier protein, it can render a person resistant to subsequent infections.

TOXOIDS (DIPHTHERIA AND TETANUS)

Some diseases are caused by a toxin produced by bacterium rather than by the bacterium themselves. Toxoids are inactivated toxoids that are used in vaccinations. Toxoids are classed as killed vaccines, although they are sometimes given their own category to emphasise the fact that they include an inactivated toxin.

DEVELOPMENT AND PRODUCTION

Vaccine development is a lengthy process that involves both public and private parties and takes almost a decade. Millions of individuals receive them each year, and the most of them have been in use for decades. Before being included in a country’s vaccination programme, they must undergo extensive testing to ensure their safety. Each vaccine in development must first go through screenings and evaluations to determine which antigen should be utilised to elicit a reaction. This step is completed without the use of humans. Animals are used to assess the safety and disease-prevention potential of experimental vaccinations.

STAGE 1

It takes around 2-4 years to produce and necessitates some fundamental research. Antigens, whether natural or synthetic, are identified by scientists and may help in disease prevention or therapy. Antigens might be virus-like particles, attenuated viruses or bacteria, weakened bacterial toxins, or other pathogen-derived substances.

STAGE 2

Using tissue or cell-culture techniques and animal testing, studies assess the candidate vaccine’s safety or ability to elicit an immune response. Animal topics include fish, monkeys, and mice. These studies give an idea of what to expect in terms of cellular responses in people. This period often lasts 1-2 years.

PHASE I TRIALS

The vaccine is administered to a small number of volunteers to determine its safety, confirm that it induces a reaction, and determine the optimum dosage. This round of testing is carried out on young, healthy adult participants. The goals are to determine the type and number of reactions generated by the candidate vaccine, as well as to assess the candidate vaccine’s safety.

PHASE II TRIALS

The vaccine is then given to several hundred participants to assess its safety and ability to elicit a response. Participants in this phase share the same traits as the vaccine’s intended recipients. Several studies are often undertaken during this phase to test various age groups and vaccination formulations. In most studies, a non-vaccinated group is included as a comparison group to check if the changes in the vaccinated group were due to chance or medicine.

PHASE III TRIALS

The goal is to assess vaccine safety in a large group of patients. Certain rare side effects may not have showed themselves in the low numbers of people tested in the first phase. Thousands of volunteers are given the vaccination compared to a similar number of individuals who did not receive the injection but received a comparator product to assess the vaccine’s efficacy against the illness. It is meant to protect against and to examine its safety in a much bigger group of people. To guarantee that the performance findings are applicable to a wide variety of persons, the bulk of phase three trials are conducted across various countries and different sites within a country.

PHASE IV TRIALS

Firms may conduct optional studies following the launch of a vaccine. The producer may do additional testing to determine the vaccine’s safety, efficacy, and other potential applications.

REVERSE VACCINOLOGY

Reverse vaccinology is the use of genetic information combined with technology to make vaccines without the use of microorganisms. It assists in the study of an organism’s genome for the purpose of identifying novel antigens and epitopes that may be utilised as prospective candidates. This method has been around for at least a decade. By unravelling the entire genomic sequence, it is possible to determine what molecules make up the genomic sequence. Without needing to grow the pathogen for a longer amount of time, candidate antigens can be discovered.

Reverse vaccinology has been used to create vaccines for meningococcal and staphylococcal diseases all over the world. Infections are caused by Staphylococcus bacteria, which can be found on the skin or in the nose of even healthy persons. The bacteria Neisseria meningitidis causes a serious infection of the thin covering of the brain and spinal cord.

PRODUCTION QUALITY CONTROL AND COMMERCIALIZATION

Vaccines are biological compounds that are frequently hybridised and complex to understand. They are made through a succession of manufacturing and formulation steps, with the finished product often containing a large number of component items. As a result, unlike a tiny molecule medicine, the finished product is impossible to classify. This needs a highly controlled production system as well as a personnel capable of performing such processes on a continual basis. Control testing takes over two years and occupies more than half of the time in the subsequent manufacturing process.

 STEP 1- PRODUCTION

Following clinical trials, when a vaccine reaches the pre-approval stage, it is evaluated by the applicable regulatory authority for quality, safety requirements.

STEP -2 MAKING

Businesses will create development plans for a vaccine on their own. Once a vaccine is approved, production begins to pace up. The antigen has been rendered inactive. All of the components are mixed to make the final product. The entire process, from testing to manufacturing, can take a lengthy time to complete.

STEP- 3 PACKAGING

It is then bottled in glass vials and packed for safe cold storage and transportation once it is produced in bulk. It must be able to resist severe temperatures as well as the dangers associated with international shipping. As a result, glass is the most often used material for vials since it is robust and can keep its integrity under severe extrinsic factors.

 STEP- 4 STORAGE

When it is excessively hot or cold, it loses its effectiveness and may even become inert. Vaccinations can be destroyed or rendered dangerous to use if kept at the improper temperature. Most vaccinations must be kept chilled between 2 and 8 degrees Celsius, necessitating the use of specialist medical freezers.

STEP-5 SHIPPING

They are transported out using particular equipment so as to maintain its integrity. Lorries deliver them from the airport to the warehouse cool room after supplies arrive in the market. New innovations have resulted in the development of portable devices that can keep vaccines cold for several days without the need of power.

QUALITY CONTROL

Once they are given out, authorities continuously check for – and assess the severity of – any potential side effects and responses from the recipients. Safety is a top priority, with frequent reviews and post-approval clinical trials reporting on its effectiveness and safety.

CAREER SCOPE

There are several prospects in vaccine research and development, clinical trials, vaccine manufacturing, and public distribution. These jobs are available at universities, companies, government laboratories and agencies, hospitals, and on the front lines of vaccine distribution all around the world. When different components of a project are handled by different groups at the same time in industry, greater teamwork is usually required, whereas a scientist in an academic lab may be a lone worker overseeing all parts of a project.

The balance between creative science and all of the business administration that comes with securing money, maintaining a budget, and overseeing other scientists or assistants is the most challenging aspect.

 Research allows scientists to work on a project that has the potential to have a direct influence on public health, whether it’s on a lab bench, a production line, or to support a clinical trial.

ROLE OF INDIA IN QUAD

BY DAKSHITA NAITHANI

The Quadrilateral Dialogue was established in 2007 when four countries—the United States, India, Japan, and Australia—joined forces. However, it did not take off at first due to a variety of factors, and it was resurrected in 2017 after almost a decade due to factors such as growing country convergence, the expanding importance of the Indo-Pacific area, and rising threat sentiments toward China, among others.

Since then it has evolved into a platform for diplomatic discussion and coordination among participating countries, who meet on a regular basis at the working- and ministerial levels to discuss shared interests like ensuring a rules-based international order.

SIGNIFICANCE FOR INDIA

The Quad, ASEAN, and the Western Indian Ocean are the three groupings in which India participates as a partner in the Indo-Pacific area.

India as a Net Security provider

In the region of Indian Ocean India must be a Net Security Provider. Its supremacy in the IOR must be maintained and sustained if it is to claim this position as a Region. QUAD offers India with a platform to strengthen regional security through collaboration while also emphasising that the Indo-Pacific concept stands for a free, open, and inclusive area.( Inclusive here refers to a geographical notion that encompasses all countries inside it as well as those having a stake outside of it)

Countering China

The Quad offers India with a forum to seek collaboration with like-minded countries on a variety of problems, including maintaining territorial integrity and sovereignty, as well as peaceful dispute settlement. It also shows a united front against China’s unceremonious and aggressive actions towards the nation which is especially important now, since ties between India and China have deteriorated as a result of border intrusions along the Tibet-India boundary in many locations. The Chinese policy of encircling India with the String of Pearls poses a direct threat to India’s maritime sovereignty, which must be addressed.

Framing post-COVID-19 international order

QUAD can assist India in not just recovering from the pandemic’s impacts through a series of integrated measures, but also in securing a part in the modern international order. Enhancing such cooperation was one of the first actions made in 2021. The vaccination initiative will serve as a good litmus test for the QUAD administrations’ ability to work together.

Convergence on other issues

On a range of topics, India shares common interests with other Quad members, including connectivity and infrastructure development, security, especially counter-terrorism; cyber and maritime security; multilateral institutions reform, and so on. Assistance from members on these problems might help India achieve its strategic and economic objectives.

Supplementing India’s defence capabilities

Assistance in the sphere of defence among Quad countries, such as joint patrols, strategic information exchange, and so on, can help India overcome its disadvantages in terms of naval capabilities, military reconnaissance, technology, and surveillance systems.

Ensuring a free Indo Pacific

The Indo-Pacific region must be accessible and vibrant, regulated by international norms and bedrock values such as freedom of navigation and peaceful resolution of conflicts, and the nations involved must have the right to make decisions, free of coercion.

Counter-terrorism Table top Exercise for QUAD nations to improve collaboration and common capabilities in dealing with potential terrorist threats, as well as examine CT response systems.

INDIA’S ROLE IN THE INDO-PACIFIC

In the Indo-Pacific, India’s geographic and geopolitical importance provides a counterbalance to China’s rising influence in the Indian Ocean. India’s security concerns, centred primarily on China’s encirclement policy through port facilities in India’s neighbourhood mainly Gwadar and Hambantota and the desire to maintain and protect open and free sea lanes of information exchange against concerns about China’s chokepoint in the South China Sea and increasing maritime presence in the ocean

India’s critical significance in the Indo-Pacific may be seen as a multiple framework. First, unlike the Asia-Pacific architecture, the Indo-Pacific architecture allows New Delhi to move above its long-held standing as a middle-power. This is bolstered by India’s admission to the League of big powers especially the United States and Japan and the development of tight strategic ties with Washington and its regional allies. This promotes India’s great-power ambitions and force projection capability inside the Indo-Pacific and beyond.

Second, India’s Act East Policy and Extended Neighbourhood Policy benefit from New Delhi’s strong participation in the Indo-Pacific. New Delhi’s stronger relations with ASEAN members have also bolstered this boost.

Third, the development of India-US strategic relations, particularly in military, works as a significant counterweight to India’s adversaries. Increased engagements between New Delhi and Washington are exemplified by the four foundational contracts signed between the two countries, which include the General Security of Military Information Agreement, Logistics Exchange Memorandum of Agreement, Communications Compatibility and Security Agreement, and Basic Exchange and Cooperation Agreement—all of which promote in-depth partnership Most significantly, the improved partnership boosts India’s military capacity, particularly when it comes to striking targets with precise accuracy.

Fourth, under India-Australia ties, which were elevated to a Comprehensive Strategic Partnership in 2020, India’s strategic position is bolstered yet further. In fact, Canberra and New Delhi inked nine agreements, the most important of which are the Australia-India Mutual Logistics Support Arrangement and the Defence Science and Technology Implementing Arrangement, both of which provide a framework for the two nations’ security cooperation.

Fifth, and most significantly, during COVID-19, India demonstrated its ability to be a first responder to a regional disaster by giving medical assistance to its near neighbours, including the Maldives, Sri Lanka, and Seychelles. In addition, India sent medical quick response teams to Comoros and Kuwait to help them prepare for the epidemic. In addition, nine Maldivians were evacuated from Wuhan, China, the site of the pandemic.

In addition, India pushed for virtual summits like the South Asian Association for Regional Cooperation web conference on March 2020 and the “Extraordinary Digital G20 Leaders’ Summit” to help develop a worldwide reaction to the epidemic on 26 March 2020. In addition, New Delhi established a SAARC Emergency Response Fund for Coronavirus, with India contributing an initial 10 million USD.

In addition, as countries attempt to move manufacturing away from China, India is viewed as one of the world’s new “favoured” investment destinations. The enormous scale of India’s marketplace as well as the low labour costs, make it a desirable destination. Apple, for example, created a production facility in India in partnership with Foxconn, while Samsung, of South Korea, ceased operations in China and moved manufacturing units to India.

There is little dispute about India’s rising position in the Indo-Pacific, not just as a significant participant but also as a responsible actor.  As a result, India’s manoeuvring room in the post-COVID international order is anticipated to expand, as India is seen as one of the major movers in guiding policy and protecting allied interests in the Indo-Pacific. COVID-19 has, in fact, expanded the Quad framework, allowing important parties to play a more active role in addressing critical conventional and unconventional regional issues.

Digital divide in vaccination

The second wave of Covid-19 has unleashed carnage in many states of India. As of the end of May 2021, India registered nearly 25.2 million cases and 2,83,248 deaths. Infections first grew in urban areas and then spread to rural areas. This pattern was mapped in both, the first as well as the second wave.

India’s rural areas cover 66.5 percent of the country’s population. However, nearly 60 percent of hospitals, 80 percent of doctors, and 75 percent of medical facilities are situated in urban areas. This shows the lack of medical infrastructure in the rural areas. The cause for concern is the fact that surge in registered cases and infections did not see a parallel rise of vaccination in these rural regions. This will result in rapid spread of this virus, and lesser number of inoculations to prevent the spread.

Many factors have contributed towards this divide between rural and urban areas when it comes to vaccination. One of the most important one being digital divide. Here are some statistics to show the wide disparity between the 2 regions in issues pertaining to digital knowledge.

When India has 450 million smartphone users as of 2019, only 25percent of it’s rural citizens had a device. Only 4 percent of Indians in rural areas has access to computers. Internet connections were not prevalent in all regions, in fact, only 34 percent of Indians have one.

Hence, it is understandable to assume that many people in rural areas do now know or cannot access the digital portal systems like Co-WIN and Aarogya Setu, which helps citizens of this country book vaccination slots and complete the entire procedure online. The inoculation drive is being pushed backwards.

This platform favors internet-savvy urban population with access to the advanced technology, further excluding less aware rural people with lack of digital know-how, out of the safety net. Such a digital divide has forced digitally illiterate people to either visit registration centers or book vaccinations on the app with the help of some facilitator or be left out of the vaccination process.

The requirements of this app are a phone or a laptop to open the particular website which is not available with all. Even if they do have a digital device, many people do not have data packages to browse and book the slots. Hence there are many obstacles for rural people in the inoculation procedure.

Further, the portal requires uploading the identification proof. For certain people-street vendors; dwellers of urban slums, and remotely inaccessible areas; people engaged in begging and the like-identification proof is hard to come by even during normal times, where they struggle to avail benefits from the social protection schemes introduced by the government.  Also, a few months back, the portal only published all the information in English language without taking into account the people who did not know this language,.

Also, for the informal work force, where every day’s wage is important for providing food and resources to their family on a daily basis, taking a day off is very difficult. The entire procedure of vaccination for people having all the resources may be considered pretty simple. But for the poor households, this is not possible. They cannot afford to forgo a day’s wage in such times, and perhaps even more if they are responsible for the vaccination of all the family members.

The Supreme Court states that India’s vaccine policy was against the rights of the poor and marginalized. They considered the policy as extremely disproportionate and not in terms with societal realities. Such problems should be addressed so that no more lives are lost at the cost of digital disparity.