Accelerating a safe and effective covid-19 vaccine

Aditi Yadav

Author:


CONTENT


Introduction

How vaccine is made

Vaccination in India

Conclusion

Bibliography


INTRODUCTION

Society has been significantly disrupted by Covid- 19, and closure of school, colleges, businesses and other aspects of daily life have mentally, physically and emotionally affected everyone. With necessary social distancing and other covid protocol to protect against infection and support return to normal, the government has focused on developing a vaccine for covid-19. The development of safe and effective vaccines is a global effort and well recognised addition to end the pandemic and doing the things we enjoy with people we love. Vaccines are a game changing vital tool against covid virus. According to the Ministry of Health and Family, a total of 45,07,06,257 have been vaccinated in India.

The pandemic has greatly affected the country with two complete lockdown periods in the past 2 years. The state even after providing their greatest efforts the pandemic not only affected the country economically but more importantly affected the lives of many individuals.The second wave of the pandemic has been more devastating than the first.The pandemic in the past two years has affected over 3.15 crore individuals and has led to the death of more than 4.23 lakhs .

HOW DOES VACCINE WORKS

Our immune system is composed of a specialized network of cells, organs and tissues which work together to protect the body against disease. When a virus or bacteria enters one’s body the immune system recognizes the germ as forign body and respond to destroy it and remembers how the virus made you sick and how to fight it. This protection is called immunity.

Vaccine trains the body’s immune system to fight the disease it has not come into contact with earlier. They are not designed to treat the disease once they are caught rather they prevent the disease. Vaccine contains the weekend version of antigen which does not cause the disease in the person but it triggers the immune system to respond to produce antibodies. It develops the body's immunity by imitating the infection. Minor symptoms like fever etc. can be seen after getting a vaccine but such symptoms are normal and are expected to build immunity in the body. Usually it takes a few weeks to build antibodies but once the infection goes away the body is left with the memory which helps it fight the disease in future.

HOW VACCINE IS MADE

The steps involved in the making of a vaccine are extremely lengthy and rigorous. There are multiple steps that must be taken into account while a vaccine is being developed.The vaccine while going through development goes through the various stages. The stages are development , trials , authorization and distribution.

INITIAL DEVELOPMENT

A new vaccine is first developed in the laboratories. First scientists identify the natural or synthetic antigen which might help in preventing or treating the disease. This antigen can be a weakened form of virus, virus like particle, or any other substance derived from pathogen. The next step is to remove the antigen from the cell and isolate it in a growth material. After this the antigen is purified and an adjuvant is added. Finally all other components are mixed and a vaccine is produced.

CLINICAL TRIAL

After initial development every vaccine under development undergoes evaluation and screening. The preclinical trial of an experimental vaccine is done on animals to evaluate its potential and safety to prevent disease. If the vaccine triggers an immune response it is then tested in humans in three phases.

Phase 1

To confirm whether the vaccine generates an immune response and to determine right dosage, first the vaccine is given to a small number of people (young healthy adults).

Phase 2

The safety of the vaccine is then tested on a larger group of individuals after the vaccine has cleared its first test.The ability of the vaccine is then determined by its reaction to a group of several hundred volunteers .To ensure the safety of the vaccine it is tested on individuals of various ages to see its reaction under different conditions .

Phase 3

To certify that the vaccine is effective and to ensure the safety of the citizens the vaccine is given to a larger crowd of individuals being thousands of volunteers. The vaccine is tested in various countries and in multiple sites within the country to ensure and analyze the performance of the vaccine among a greater variety of individuals.The test is meant to test the vaccine in various bodies to ensure the vaccine works in a large variety of individuals and not restricted to a group of individuals .

AUTHORIZATION

The guidelines for the vaccine states that the vaccine shall only be made available to the public once its safety has been ensured by the authority. Based on the results of the clinical trials that have taken place in previous phases and only on the vaccine which has been approved after previous trials get authorization from the appropriate authority.

DISTRIBUTION

The vaccine after clearing the stages is then sent out and distributed to the public and thereby starts the vaccination process of the citizens.

VACCINATION IN INDIA

To provide the guidance for covid vaccination in India the government has established the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). According to the guidelines issued by NEGVAC, the COVID vaccine will be first offered to the healthcare and frontline workers, and then to persons above the age of 50 years. A committee comprising experts from various specialties including pulmonology, nephrology, oncology, and cardiology was also set up by the government to define the criteria one which people with comorbidities will be vaccinated. The Committee has also recommended that any person with a congenital heart disease that leads to end-stage kidney disease, pulmonary arterial hypertension, or cancers such as leukemia, lymphoma, myeloma,  sickle cell anemia, primary immune deficiency conditions, and decompensated liver cirrhosis should be included in the priority.

In the initial phase, COVID-19 vaccination will be totally under government control. Among the key departments involved in COVID-19 vaccination, high-level coordination and cooperation have been established at national, state, and district levels. For the COVID vaccine introduction Twenty- three ministries and numerous other developmental partners were involved in planning whose role was described by the ministry of Health and Family Welfare in the operational guidelines.

India began vaccine drive with covexin and covishield. Both vaccines are manufactured in India. Covaxin is developed by Hyderabad-based Bharat Biotech International Limited in collaboration with National Institute of Virology, Pune (NIV) and the Indian Council of Medical Research (ICMR). It has to be administered in two doses at an interval of 28 days. Covishield was developed by Oxford University in partnership with British-Swedish firm AstraZeneca and was manufactured in India by Pune-based Serum Institute of India (SII). Covishiled also has to be administered in two doses at an interval of 12 - 16 weeks.

Co - WIN portal was established which was linked with the existing UIP programs and which is also used to follow up and monitor the individuals immunized. The Co - WIN system is not only used for tracking enlististed beneficiaries but also ensures prioritization of the pre- registered beneficiaries. Enlisted beneficiaries are given an option to select the vaccination centre closest to their home. Auto Generated email and message intimations are sent to the vaccinators, beneficiaries, supervisors, and mobilizers notifying the time, date and place of the vaccination session. To prevent overcrowding at the vaccination session site beneficiaries are advised by the mobilizers to visit the vaccination centre at the specified time slot. In the first phase according to the guidelines issued by the centre for vaccination drive only 100 people were injected in every session per day. After administration the vaccination dose people are being monitored for 30 mins for any adverse effect. After the completion of phase 1, to speed up the vaccination process some sites have been permitted to inject 200 people in each session and work for 24 hrs everyday. In late March vaccine eligibility was lowered to the age to 45 years, that is people above the age of 45 were allowed to get their 1 st dose of vaccination.

The next phase of the vaccination programme started on May 1 in which eligibility for vaccination was extended to all residents above the age of 18 years. In phase 3 more flexibility was given to the individual stakeholders for the conduct of the vaccination programme. In this plan the central government only distributes half of the vaccines procured by Central Drugs Laboratory (CDL) from manufacturers. The government run clinics are offering vaccines free of charge to priority workers and residents over the age of 45 years and the rest are being distributed to different states on the basis of active cases and the rate at which vaccines are being administered. And the rest are being purchased in the open market including private hospitals.

GLOBAL DISTRIBUTION

On humanitarian initiative known as Vaccine Maitri(vaccine friendship), India In January 2021 with an aim to leverage India’s pharmaceutical industry started exporting vaccines manufactured by India to other countries. According to survey by Ministry of External Affair since January 20 India has donated over 5.5 million vaccines to neighbouring countries such as Bangladesh, Bahrain, Mauritius, Bhutan, Sri Lanka, Myanmar, Seychelles, Nepal, and Maldives, and the country was also planning to send doses to Nicaragua, Africa, Oman, etc[1].

Through the scheme over 58 million vaccine doses have been distributed by India to over 65 countries[2]but these exports have been suspended due to India's domestic need for vaccines.

VACCINE ACCEPTANCE IN INDIA

According to a study on vaccine acceptance it was observed that people from Delhi are showing 75% acceptance and want to take vaccine for covid. Another study on vaccine acceptance from West Bengal, it was observed that 77.27% of people are willing to take covid vaccine. On the basis of these two studies it was expected that about 75% of people want to take covid vaccine.

LEGAL BACKGROUND

The constitution of India empowers the authority to be responsible for the maintenance of a health and for the welfare of its citizens.The vaccine is a key component towards ending the war against COVID and the government is duty bound to secure vaccines for its citizens to ensure loss of life . The same has been prescribed under Article 21 of the Constitution which focuses on the right to life. While securing the vaccine is need of the hour the government shall impose certain standards to ensure that vaccine being administered is safe for the public at large. Under Article 19 of the constitution it has been defined that the right to profession can be restricted on the grounds of maintenance of public safety . The same gives the state the authority to prevent manufacturing of untested vaccines in order to maintain the safety of its citizens. Article 47 states it the duty of the state to ensure that there is improvement of public health. In the present times the allocation of vaccines plays a crucial role and a means to ensure improvement of living conditions of the citizens.

However the pandemic has led to the death of lakhs of individuals across the country. Thus the country is in desperate need of vaccination in order to have some degree of immunity to the virus. The state taking the same into account allowed the fast track approval of the vaccine that was being developed. The statute enabling the state to do the same is the Epidemic Diseases Act, 1897. According to Section 2 and Section 3 of the act which empowers the central government and state government to take special measures to ensure the safety of its citizens .

CASE LAW

In Consumer Education and Research Centre v. Union of India[3], the Supreme Court observed that the Right to Health is a fundamental right and is an integral part of the Right to Life (Article 21) under the constitution of India

This also means that the right to vaccination is included in the right to health but if it is provided through coercive means then it defeats the very fundamental purpose of this health care.

In Registrar General, High Court of Meghalaya v. State of Meghalaya[4], the High Court of Meghalaya held that forceful or compulsory vaccination does not have any holding in law, and such vaccination becomes unconstitutional.

In an English case of Airedale NHS Trust v. Bland, the Court observed that if an adult with his will is made to have the vaccination through force, then it amounts to a tort/civil wrong and crime.

CONCLUSION

The covid- 19 has turned into an economic devastation and a human tragedy. Various measures like lockdown, etc were adopted by the government to control corona cases. With necessary social distancing and other covid protocol to protect against infection and support return to normal, the government has focused on developing a vaccine for covid-19. No other drug or medicine is able to treat the disease so vaccines are the only viable solution. Vaccine contains the weekend version of antigen which does not cause the disease in the person but it triggers the immune system to respond to produce antibodies. It develops the body's immunity by imitating the infection and protects from the disease. To provide the guidance for covid vaccination in India the government has established the National Expert Group on Vaccine Administration for COVID-19. Unprecedented fasttrack was adopted for research and development of vaccines and many innovative methods were used. Article 21 of the constitution ensures the right to health which includes the right to vaccination. The Supreme Court has also observed that the Right to Health is a fundamental right and is an integral part of the Right to Life (Article 21) under the constitution of India. This also means that the right to vaccination is included in the right to health but if it is provided through coercive means then it defeats the very fundamental purpose of this health care. The Government of India under Article 47 of the constitution has an obligation to improve and maintain public health. According to Ministry of Health and Family total 45,07,06,257 have been vaccinated[5]. According to survey by Ministry of External Affair since January 20 India has donated over 5.5 million vaccines to neighbouring countries such as Bangladesh, Bahrain, Mauritius, Bhutan, Sri Lanka, Myanmar, Seychelles, Nepal, and Maldives, and the country was also planning to send doses to Nicaragua, Africa, Oman, etc. It can be concluded that vaccinae is a game changing tool and development and distribution of safe and effective vaccines is a global effort and well recognised addition to end the pandemic.

BIBLIOGRAPHY

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/accelerating-a-safe-and-effective-covid-19-vaccine

https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccine-research-and-development

https://www.who.int/news-room/feature-stories/detail/how-do-vaccines-work

https://www.unicef.org/coronavirus/what-you-need-to-know-covid-vaccine

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/distributing/steps-ensure-safety.html

https://www.historyofvaccines.org/content/how-vaccines-are-made

https://www.healthaffairs.org/do/10.1377/hblog20200814.996612/full/

https://www.livemint.com/news/india/india-announces-next-phase-of-covid-vaccination-all-above-18-yrs-eligible-11618839943036.html

[1]https://www.livemint.com/news/india/vaccine-maitri-consignment-of-covid-vaccines-airlifted-for-guyana-jamaica-nicaragua-11614930238803.html

[2]https://www.indiatoday.in/coronavirus-outbreak/video/vaccine-maitri-5-8-crore-made-in-india-covid-vaccine-doses-supplied-to-over-65-nations-1777871-2021-03-10

[3] 1995 AIR 922 1995 SCC (3) 42

[4] PIL No.6/2021

[5] https://www.mohfw.gov.in/

Aditi Yadav