Day 47 – Q 1. What are the stages in the development of a vaccine? Why are the ongoing efforts to develop a vaccine for the Coronavirus unprecedented? Discuss. 

1. What are the stages in the development of a vaccine? Why are the ongoing efforts to develop a vaccine for the Coronavirus unprecedented? Discuss. 

टीके के विकास में कौन से चरण होते हैं? कोरोनावायरस के लिए एक टीका विकसित करने के लिए चल रहे प्रयास अभूतपूर्व क्यों हैं? चर्चा करें।

Demand of the question:

It expects students to give a clear account of the stages in the development of a vaccine. It also expects students to present a case for unprecedented efforts to develop a vaccine for the corona virus and finally arrive at a conclusion.

Introduction:

The outbreak of the novel coronavirus has triggered an international effort to develop a safe and effective vaccine against COVID-19, perhaps at breakneck speed. Several experimental vaccines have shown promising results in early trials, rising hopes that one will exist before the end of the year.

Body:

Stages in the development of a vaccine:

According to the Centres for Disease Control and Prevention (CDC), there are six stages of vaccine development: exploratory, pre-clinical, clinical development, regulatory review and approval, manufacturing and quality control.

• Exploratory: This is research-intensive phase of the vaccine development process which is designed to identify “natural or synthetic antigens that might help prevent or treat a disease.”
• Pre-clinical: During this phase, researchers use tissue-culture or cell-culture systems and animal testing to determine whether the candidate vaccine will produce immunity or not.
• Clinical development: It is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
• Regulatory review and approval: If a vaccine passes through all three phases of clinical development, the vaccine developer submits a Biologics License Application (BLA) to the licensing authority.
• Manufacturing: Major drug manufacturers provide the infrastructure, personnel and equipment necessary to create mass quantities of vaccines.
• Quality control: Stakeholders must adhere to procedures that allow them to track whether a vaccine is performing as anticipated.

With respect to COVID-19 vaccine development. The adenoviral vector-based vaccine is currently in the phase II trials. The vaccine is being developed by Russian military and government researchers. The ongoing efforts to develop a vaccine for the Corona virus are unprecedented due to the following reasons:

• The World Health Organisation listed 160 vaccines in development at various stages of research and development. This makes it the biggest vaccine development effort in the history of mankind while a pandemic is still on.
• The COVID-19 pandemic has had far-reaching consequences beyond the spread of the disease itself and efforts to quarantine it, including political, cultural, and social implications.
• The focus of manpower and resources on vaccine development for covid-19 is unparalleled because of no availability of any effective vaccine or medicine to fight the Coronavirus.
• Till today, Coronavirus has infected nearly 18 million people and took death toll of nearly 6,93,000  people worldwide. Hence, its sheer impact on the health of the people worldwide is disastrous.
• In the global economic sector lockdowns have resulted in disruption of supply chain leading to halt of the economic activities.
• According to a study by world bank, a severe pandemic can cause economic losses equal to nearly 5% of global GDP. 
• The pandemic has affected educational systems worldwide, leading to the widespread closures of schools and universities. According to data released by UNESCO, school and university closures due to COVID-19 were implemented nationwide in 165 countries. Including localized closures, this affects over 1.5 billion students worldwide, accounting for 87% of enrolled learners.
• Low income groups are disproportionately hit by coronavirus cases. e.g. Migrant crisis in India.
• The pandemic has impacted religion in various ways, including the cancellation of the worship services of various faiths, as well as the cancellation of pilgrimages surrounding observances and festivals.
• The coronavirus pandemic has been followed by a concern for a potential spike in suicides, exacerbated by social isolation due to quarantine and social-distancing guidelines, fear, and unemployment and financial factors.
• Many countries have reported an increase in domestic violence and intimate partner violence attributed to lockdowns amid the COVID-19 pandemic. Financial insecurity, stress, and uncertainty have lead to increased aggression at home, with abusers able to control large amounts of their victims’ daily life. Older people are particularly affected by COVID-19 as older age group has registered more number of deaths due to coronavirus infection.

Conclusion:

Hence, we can observe that coronavirus pandemic has impacted almost every sector and left a disastrous impact on the affected sector or groups. Due to this sheer scale of impact it becomes imperative to expedite the vaccine development to unprecedented level so that its impact will be minimised and a pre-covid-19 normalcy can be brought in to lives of people.