Concerns Over Public Trust in Vaccines

1. Recently, In India, there have been several court cases related to vaccines.
2. Most of these are about the COVID-19 vaccine, but there are also concerns about other vaccines like rabies and rotavirus.
3. These cases raise questions about how vaccines are approved, their safety, and whether the public can trust them.
    

What is a Vaccine?
 

1. A vaccine is a biological substance that helps the body’s immune system to recognize & fight harmful pathogens like viruses or bacteria.
2. Vaccines typically contain a component that resembles a part of the pathogen (like a protein or a weakened version of it), which stimulates the immune system to produce antibodies without causing disease.
   1. A pathogen is any organism that causes disease. Viruses, bacteria, fungi, and parasites are all examples of pathogens.
3. This enables the body to recognize and respond quickly if it encounters the actual pathogen in the future.
    

Types of Vaccines:
 

Vaccines can be classified based on how they are made and how they trigger an immune response. The main types include:
 

Type of Vaccine	Description	Example
Inactivated (Killed) Vaccines	These vaccines are made from viruses or bacteria that have been killed or inactivated so that they cannot cause disease. They stimulate an immune response without causing harm.	Polio vaccine (IPV)
Live Attenuated Vaccines	Contain live, but weakened forms of the virus or bacteria. These weakened pathogens are still alive but are not strong enough to cause illness in healthy people.	Measles, Mumps, and Rubella (MMR) vaccine
Subunit, Recombinant, or Conjugate Vaccines	These vaccines contain only specific pieces of the pathogen, such as proteins or sugars. They trigger the immune system without using the entire pathogen.	Hepatitis B vaccine, Hib (Haemophilus influenzae type B) vaccine
mRNA Vaccines	These vaccines use messenger RNA (mRNA) to instruct cells to produce a protein similar to one found on the pathogen. The immune system then responds to this protein.	COVID-19 vaccines like Pfizer-BioNTech and Moderna
Viral Vector Vaccines	Use a harmless virus (not the disease-causing virus) to deliver genetic material into cells. This genetic material prompts the immune system to recognize and fight the actual pathogen.	Johnson & Johnson’s COVID-19 vaccine

 

Recent Vaccines in India and Their Types
 

1. COVID-19 Vaccines:
   1. India played a significant role in developing and distributing COVID-19 vaccines both domestically and globally.
   2. Covishield (AstraZeneca/Oxford Vaccine):
      • Type: Viral Vector Vaccine.
      • Developed by the Serum Institute of India in collaboration with AstraZeneca
      • Covishield became one of the primary vaccines used in India’s vaccination drive.
      • It uses a modified adenovirus (viral vector) to deliver the spike protein gene of SARS-CoV-2, stimulating an immune response.
   3. Covaxin:
      • Type: Inactivated (Killed) Vaccine.
      • Developed by Bharat Biotech, Covaxin uses the killed version of the SARS-CoV-2 virus to trigger immunity.
      • It was one of the first vaccines approved in India for emergency use.
   4. ZyCoV-D:
      • Type: DNA Vaccine.
      • Developed by Cadila Healthcare, ZyCoV-D is the world’s first plasmid DNA vaccine for COVID-19.
      • It uses a small, circular piece of DNA to instruct cells to produce the spike protein and stimulate an immune response.
         

Main Concerns Raised in the Court Cases
 

1. Vaccine Safety
   1. Some petitions mention deaths or serious side-effects linked to vaccines, like the anti-rabies vaccine.
   2. Concerns include:
      1. Lack of transparency about vaccine testing.
      2. Not enough information on possible side-effects.
      3. How adverse events (like health problems after vaccination) are monitored.
2. Lack of Transparency in Approval
   1. The Central Drugs Standard Control Organisation (CDSCO), which approves vaccines, is criticized for not sharing enough information about how decisions are made.

About Central Drugs Standard Control Organisation (CDSCO) Overview: CDSCO is the National Regulatory Authority (NRA) of India. It operates under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Key Responsibilities: The Drugs & Cosmetics Act, 1940 and the Rules of 1945 define the roles of central and state regulators in regulating drugs and cosmetics in India. Functions under the Drugs and Cosmetics Act: Drug Approval: Approves drugs for use in India. Clinical Trials: Oversees the conduct of clinical trials. Setting Standards: Lays down standards for drugs. Quality Control: Controls the quality of imported drugs in the country. Coordination: Coordinates the activities of State Drug Control Organizations, offering expert advice to ensure uniform enforcement of the Act. Licensing Responsibilities: CDSCO, in collaboration with state regulators, is jointly responsible for granting licenses for specialized categories of critical drugs, including: Blood and blood products I.V. Fluids Vaccines Sera

2. 2. People want to know who approves the vaccines and if they have any conflicts of interest.
   3. Clinical trial data (research about the vaccine) should be made public to ensure trust.
3. Informed Consent
   1. When people get vaccinated, they need to understand the risks (side-effects).
   2. Right now, the information about side effects isnt always clear or easy to understand at the time of vaccination.
4. Weak System for Tracking Side-Effects
   1. India doesn’t have a strong enough system for tracking and reporting adverse events after vaccinations.
   2. There are no clear laws in place to ensure that this system works well.
       

Compensation for Vaccine Side-Effects
 

1. Some people who lost family members due to side-effects from COVID-19 vaccines are asking for compensation.
2. Courts are deciding whether the government or vaccine manufacturers should pay for this.
3. There are questions about whether the government promised to protect vaccine makers from such claims (this is called “indemnity”).
    

India's Vaccine Diplomacy and International Initiatives:
 

Despite domestic concerns, India has played an important role in global vaccine distribution, particularly during the COVID-19 pandemic, showcasing its leadership in vaccine diplomacy. Key initiatives include:
 

1. Vaccine Maitri (Vaccine Friendship):
   1. Launched in January 2021, India’s Vaccine Maitri initiative aimed to provide COVID-19 vaccines to neighboring countries and other developing nations.
   2. Under this initiative, India supplied vaccines to over 70 countries, including key allies like Bangladesh, Nepal, Myanmar, Sri Lanka, and even African nations.
   3. India primarily provided vaccines produced by Serum Institute of India (Covishield) and Bharat Biotech (Covaxin), significantly contributing to global vaccination efforts, especially in regions with limited access to vaccines.
2. COVAX Facility Support:
   1. India’s collaboration with the COVAX initiative, led by the WHO, GAVI, and the Coalition for Epidemic Preparedness Innovations (CEPI), was another significant aspect of its global vaccine efforts.
   2. The country played a major role in supplying vaccines to low-income countries through this platform, ensuring that nations with limited resources had access to lifesaving vaccines.
3. Global Vaccine Production Hub:
   1. India is often referred to as the "pharmacy of the world" due to its extensive vaccine production capacity.
   2. During the pandemic, Indian vaccine manufacturers ramped up production to meet global demand.
   3. India remains one of the largest suppliers of vaccines globally, accounting for nearly 60% of the world’s vaccine supply, contributing significantly to immunization programs worldwide.
4. Support to Neighbors:
   1. India also provided vaccines as part of bilateral agreements with neighboring countries like Bhutan, Maldives, and Bangladesh, strengthening regional cooperation and solidarity.
   2. This not only showcased India’s commitment to global health but also helped enhance its diplomatic ties with neighboring nations.

Immunization in India

Background on Immunization	Expanded Programme on Immunization (EPI) launched in 1978. Renamed as Universal Immunization Programme (UIP) in 1985, expanding coverage to both rural and urban areas. Included in Child Survival and Safe Motherhood Programme (1992) and National Reproductive and Child Health Programme (RCH, 1997). Became an integral part of the National Rural Health Mission (NRHM) in 2005.
Scope of UIP	Target Population: 2.67 crore newborns and 2.9 crore pregnant women annually. Key Goal: Reducing vaccine-preventable diseases and under-5 mortality rates. Coverage: Free immunization against 12 diseases (9 national + 3 sub-national).
Diseases Covered under UIP	Nationally (9 diseases): Diphtheria Pertussis (Whooping Cough) Tetanus Polio Measles Rubella Severe Childhood Tuberculosis Hepatitis B Meningitis & Pneumonia (Hemophilus Influenza type B) Sub-nationally (3 diseases): Rotavirus Diarrhoea Pneumococcal Pneumonia Japanese Encephalitis (limited to endemic districts)
Fully Immunized Child	A child is considered fully immunized if they receive all scheduled vaccines by their first year of age.
Major Milestones of UIP	Polio Elimination (2014) Maternal and Neonatal Tetanus Elimination (2015)
New Vaccines Introduced	Inactivated Polio Vaccine (IPV): Launched as part of the Global Polio Endgame Strategy in 2015. Expanded nationwide by April 2016. Rotavirus Vaccine (RVV): Introduced in March 2016 to reduce mortality from Rotavirus Diarrhoea. Nationwide expansion by 2019-20. Measles Rubella (MR) Vaccine: Launched in 2017 as part of Measles Elimination & Rubella Control campaign. Targets 41 crore children. 2 doses at 9-12 months and 16-24 months. Pneumococcal Conjugate Vaccine (PCV): Launched in May 2017 to reduce Infant Mortality due to pneumococcal pneumonia. Introduced in select states (Bihar, Himachal Pradesh, Madhya Pradesh, etc.). Tetanus and Diphtheria (Td) Vaccine: Replaced TT vaccine to combat diphtheria in older age groups. Administered to adolescents (10 & 16 years) and pregnant women.
Mission Indradhanush (MI)	Launched in December 2014 with the aim to increase immunization coverage to 90%. Focus on hard-to-reach areas and underserved populations. Six phases completed, covering 554 districts. Integrated with Gram Swaraj Abhiyan (16,850 villages) and Extended Gram Swaraj Abhiyan (48,929 villages). Impact: 6.7% increase in coverage after first 2 phases; 18.5% increase in coverage after the 5th phase (compared to NFHS-4, 2015-16).
New Initiatives in Vaccine Logistics & Cold Chain Management	Capacity Building: National Cold Chain Training Centre (NCCTE), Pune and NCCVMRC, New Delhi, train cold chain technicians. System Strengthening: eVIN (Electronic Vaccine Intelligence Network): Digital system for vaccine stock management and temperature tracking across all storage levels (national to sub-district). Completed in 12 states; second phase ongoing in 9 states. Scaling up to cover the entire country. National Cold Chain Management Information System (NCCMIS): Tracks cold chain equipment inventory, functionality, and availability.

 

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