IMMUNIZATION PROGRAMMES (PART 1)

REQUEST AN APPOINTMENT OR BOOK A CONSULANT – Sargam.dange.18@gmail.com

INTRODUCTION-

Immunization saves 2 to 3 million lives each year. By protecting children against serious diseases, vaccines play a central role in ending preventable child deaths. UNICEF’s immunization programme helps identify children who have been left behind by health systems, and brings them life-saving care.

Vaccines now protect more children than ever before, but in 2019, approximately 14 million infants did not receive any vaccines. Low immunization levels among poor and marginalized children compromise gains made in all other areas of maternal and child health. Over 1.5 million people die annually from diseases that can be prevented by vaccination.

Vaccination is one of the great public health achievements of human history. Vaccines used in national immunization programmes (NIPs) are considered safe and effective when used correctly. Vaccines are, however, not risk-free and adverse events will occasionally occur following vaccination. Public trust in vaccine safety is key to the success of vaccination programmes.

Goal

This course aims to establish a shared understanding among professionals whose work is linked to vaccine safety issues. This may include nurses/midwives/community health workers, as well as pharmacists medical doctors and programme or technical officers.

Rationale

Professionals involved in vaccine safety come from different backgrounds. As their jobs are all interrelated and co-dependent, they need a ‘common language’ in order to ensure smooth collaboration.

The E-learning Course on Vaccine Safety Basics meets different starting points, learning needs and country contexts. It offers the learner options to work at the speed and depth he prefers, recognizing his prior knowledge. Accommodating the different mechanisms between regions and nations is a challenge to any global course. For this reason we ask you from time to time to shift your focus to your own local context and look how vaccine safety is ensured in your country.

WHO RESPONSE

MODULE 1

This module serves as an introduction to the whole course. You will learn about the importance of immunization programmes and how vaccines work. You will understand the relationship between vaccine coverage, adverse events and disease spread. You will also learn about the importance of vaccine regulations in ensuring the effectiveness of vaccine initiatives.

Module outcomes

By the end of this module you should be able to:

• 1Explain the importance of vaccinationVaccinationInoculation with a vaccine for the purpose of inducing immunity. in the control of infectious diseases,
• 2Describe the basic principles of vaccination,
• 3Explain how the public are less tolerant of the risksRiskThe probability that an individual will experience a certain event during a defined period of time. associated with vaccinesVaccineA material containing live attenuated or inactivated (killed) microorganisms, or constituents of microorganisms, capable of eliciting protection against infection. (although very low) than they are of those associated with drugsDrug (or medicine)Any substance in a pharmaceutical product that is used to modify or exploit physiological systems or pathological states for the benefit of the recipient. The term drug/medicinal product is used in a wider sense to include the whole formulated and registered product, including the presentation and packaging, and the accompanying information. Vaccines are drugs/medicines. used to treat disease,
• 4List the main types of vaccine and illustrate them with examples,
• 5Describe the importance of post marketing vaccine safety surveillance,
• 6Identify some vaccines that have been associated with adverse vaccine reactions.

MODULE 2

There are many types of vaccines. Different types or formulations affect how they are used, how they are stored, and how they are administered. If they are to be safe and effective, it is vital to be familiar with the different types and to know how to handle them.

Different vaccines can cause different adverse reactions, and it is important to recognize what these may be. Can you identify the contraindications for vaccination and know which present an additional risk? What special considerations should you make when immunizing pregnant women or immunocompromised clients?

This module will explain the different types of vaccine and the main routes of administration. You will learn about the main vaccine reactions and the importance of understanding contraindications – as ignoring these could lead to vaccine reactions. Finally, you will look at public concern over vaccines and consider some rumours about vaccine safety that have been disproved by research.

Module outcomes

By the end of this module you should be able to:

• 1Explain the modes of action of live attenuated vaccines, conjugate vaccines, subunit vaccines, and toxoid vaccines,
• 2List types of vaccine components, including adjuvants and preservatives, and explain their functions,
• 3Explain the difference between live attenuated and inactivated vaccines,
• 4Identify the contraindications for vaccination that may present an additional risk.

MODULE 3

Under recommended conditions, all vaccines used in national immunization programmes are safe and effective if used correctly. In practice, however, no vaccine is completely risk-free and adverse events can occasionally result after an immunization.

Adverse events can range from minor side-effects to more severe reactions. They can be a cause of public concerns about vaccine safety. To understand a specific event and to be able to respond appropriately, there are several questions that you need to answer:

• What caused the reaction?
• Was it related to the vaccine or the way it was administered, or was it unrelated?
• Are the reactions minor or severe?

This module will help you to answer these questions. You will look at the main types of adverse events and the situations in which they may occur. You will also be introduced to the challenges and opportunities of mass vaccination campaigns. Because of the nature of these campaigns, adverse events may be more noticeable.

Module outcomes

By the end of this module you should be able to:

• 1Define the main types of adverse events following immunization (AEFIs),

• 2Differentiate between a reaction related to the vaccine itself, to the vaccination procedure (immunization error), or to coincidental events that are not linked to the vaccine,

• 3Differentiate between minor and severe vaccine reactions,

• 4Describe potential underlying causes for each type of AEFI, and understand the link between the AEFI and its cause,

• 5Summarize the expected incidence of the different types of AEFI.

MODULE 4

Pharmacovigilance is the practice of detecting, assessing, understanding, responding and preventing adverse drug reactions, including reactions to vaccines. It is now an integral part of the regulation of drug and vaccine safety. Surveillance systems exist at national and international levels to ensure effective monitoring and prompt actions in response to AEFIs.

Pharmacovigilance requires that incidents of adverse events are followed up in the correct way. Some adverse events need to be reported and/or investigated, and you will need to know which to report, how and to whom. Causality assessment procedures also need to be carried out effectively.

This module introduces you to the concept of pharmacovigilance and describes national and international surveillance systems. It helps you to assess how to report an AEFI in the correct way and explains the procedure of causality assessment. Finally, you will look at the subject of risk/benefit assessment, including the factors that influence the balance between risks and benefits of vaccines, risk evaluation and options analysis.

Module outcomes

By the end of this module you should be able to:

• 1Describe the basic principles of pharmacovigilancePharmacovigilanceThe science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. and the special considerations that apply to vaccination programmes,
• 2Use AEFI case definitions to evaluate which AEFIs should be detected and reported to the National regulatory authority (NRA)National regulatory authority (NRA)The regulatory body that approves procedures to ensure that medicines, including vaccines, are of adequate safety and potency. The vaccine manufacturer is responsible for demonstrating that the vaccine batch produced meets the requirements, based on the test specifications given by the NRA. The NRA is also responsible both for the official vaccine lot release process, based on the data and information provided by the manufacturer and, eventually, for confirmatory testing. or its equivalent,
• 3Describe the principles of risk-benefit analysisRisk-benefit analysisEvaluation and assessment of the relative risks and benefits of an intervention, e.g. the potential benefit of protection from measles and its complications due to vaccination, relative to the potential risk of adverse reactions to the vaccine. relative to the protective effect of immunization and the importance of causality assessmentsCausality assessment (or causality association)The systematic review of data about an AEFI case to determine the likelihood of a causal association between the event and the vaccine(s) received. to evaluate possible links between AEFIs and a vaccine or vaccine lot,
• 4Explain how investigation of AEFI reports and vaccine testing can contribute to surveillanceSurveillanceThe systematic collection, analysis, interpretation, and dissemination of health data on an ongoing basis, to gain knowledge of the pattern of disease occurrence and potential in a community, in order to control and prevent disease in the community. that ensures vaccine safety.

MODULE 5

The general principles for the surveillance of adverse events following immunization (AEFIs) are similar in all countries. However, approaches may differ due to factors such as how immunization services are organized and the level of resources available.

The first half of the Module describes the central role of the national regulatory authority (NRA) and the national immunization programme (NIP) along with the role of the AEFI review committee; other participants are also briefly introduced.

In the second half of the Module you will look into the international services available to support vaccine safety in countries. You will understand how national and international agencies work together and how information flows between them and countries.

Module outcomes

By the end of this module you should be able to:

• 1List the main functions or services for vaccine safety, including national and international bodies, as well as manufacturers,
• 2Describe the relevant areas of responsibility and (if applicable) the areas of collaboration between the National regulatory authority and immunization programmes within your own country,
• 3Identify the mechanisms by which an AEFI seen in a clinic can be reported to the national regulatory authority,
• 4Summarize information flows between institutions at national level (immunization clinics, NRAs, etc.) and international bodies.

MODULE 6

Every year, billions of doses of vaccine are given in immunization programmes around the world. Vaccines are designed to provoke an immune response in the body, and it is inevitable that this reaction carries a small attributable risk to the health of a tiny minority of recipients. This risk is hugely outweighed by the very significant benefits of immunization in terms of protection from vaccine-preventable diseases and their wide-ranging consequences.

Explaining risks and benefits of vaccines clearly to parents, guardians and vaccine recipients requires effective communication and interpersonal skills from trained health professionals in immunization programmes and educators such as school teachers.

This module will help you to understand public fear and concerns, and how you can improve your communication skills on the subject of vaccine safety.

Module outcomes

By the end of this module you should be able to:

• 1Understand the need for improved communication on vaccine safety,
• 2Critically evaluate and assess new information about vaccines before communicating to the target audience,
• 3Gather information about the various target audiences, who they are, how they perceive vaccine risk and their knowledge about vaccines and safety,
• 4Outline the fears and concerns of different groups associated with, or likely to be affected by, an immunization programme,
• 5Design simple, clear and tailor-made messages to communicate information about vaccine safety to your target audience (e.g. parent, vaccinee, clinic staff, media, health professional, drug regulatory authority, health minister, etc.),
• 6Identify the most suitable means and channels of communication to convey information to different target groups,
• 7Understand the media as being an important ally in vaccine safety.

REQUEST AN APPOINTMENT OR BOOK A CONSULANT – Sargam.dange.18@gmail.com

UNICEF

UNICEF works with partners in governments, NGOs, other UN agencies and the private sector to provide immunization to the children who need it the most.

Vaccinating children in every community: Wherever children are not immunized, their lives and communities are at risk. UNICEF tailors new approaches to vaccinate every child in every community – no matter how remote or challenging.

The cold chain: UNICEF and partners harness solar power, mobile technology and telemetrics to make sure vaccines reach all children without losing their effectiveness from exposure to extreme heat or cold weather conditions.

Vaccine supply: With UNICEF efforts, the price of many essential childhood vaccines has reached all-time lows. This has facilitated the introduction of new vaccines to children living in the poorest countries.

Innovation: Working with private and public partners, UNICEF steers investment towards new vaccines, and diagnostic and health technologies.  

Disease eradication and elimination programmes: Thanks to steady progress on expanding vaccination, the world has never been in a better position to eradicate polio. Immunization against measles, rubella and tetanus are bringing the world closer to eliminating these devastating diseases.

Background note on Immunization :-

• Expanded Programme on Immunization was launched in 1978. It was renamed as Universal Immunization Programme in 1985 when its reach was expanded beyond urban areas. In 1992, it became part of Child Survival and Safe Motherhood Programme and in 1997 it was included in the ambit of National Reproductive and Child Health Programme. Since the launch of National Rural Health Mission in 2005, Universal Immunization Programme has always been an integral part of it.
• Universal Immunization Programme (UIP) is one of the largest public health programmes targeting close of 2.67 crore newborns and 2.9 crore pregnant women annually.
• It is one of the most cost-effective public health interventions and largely responsible for reduction of vaccine preventable under-5 mortality rate.
• Under UIP, immunization is providing free of cost against 12 vaccine preventable diseases:
• Nationally against 9 diseases – Diphtheria, Pertussis, Tetanus, Polio, Measles, Rubella, severe form of Childhood Tuberculosis, Hepatitis B and Meningitis & Pneumonia caused by Hemophilus Influenza type B
• Sub-nationally against 3 diseases – Rotavirus diarrhoea, Pneumococcal Pneumonia and Japanese Encephalitis; of which Rotavirus vaccine and Pneumococcal Conjugate vaccine are in process of expansion while JE vaccine is provided only in endemic districts.
• A child is said to be fully immunized if child receives all due vaccine as per national immunization schedule within 1st year age of child.
• The two major milestones of UIP have been the elimination of polio in 2014 and maternal and neonatal tetanus elimination in 2015.

New vaccines

• Inactivated Polio Vaccine (IPV): IPV has been introduced in UIP as part of Global Polio end-game strategy, to mitigate the risk associated with tOPV to bOPV switch. IPV was introduced in November 2015 initially in 6 states, which was expanded across the country by April 2016.
• Rotavirus vaccine (RVV): RVV has been introduced to reduce mortality and morbidity caused by Rotavirus diarrhoea in March 2016. It has been introduced in 11 states (Andhra Pradesh, Haryana, Himachal Pradesh, Jharkhand, Odisha, Assam, Tripura, Rajasthan, Tamil Nadu, Madhya Pradesh and Uttar Pradesh). The vaccine will be expanded across the country in 2019-20.
• Measles Rubella (MR) vaccine: India is committed to the goal of measles elimination and rubella control and to achieve the goal MR vaccine was introduced in the country through a campaign mode in a phased manner in 2017. MR campaign target around 41 crore children in the age group of 9 months to 15 years (covering ⅓ of the total population of the country) followed by 2 doses in routine immunization at 9-12 months and 16-24 months. Rubella component is now under routine immunization as MR vaccine.
• Pneumococcal Conjugate Vaccine (PCV): PCV has been launched in May 2017 for reducing Infant mortality and morbidity caused by pneumococcal pneumonia. It has been introduced in Bihar, Himachal Pradesh, Madhya Pradesh, 19 districts of Uttar Pradesh and 18 districts of Rajasthan.
• Tetanus and adult diphtheria (Td) vaccine: TT vaccine has been replaced with Td vaccine in UIP to limit the waning immunity against diphtheria in older age groups. Td vaccine to be administered to adolescents at 10 and 16 years of age and to pregnant women.

Mission Indradhanush

• Mission Indradhanush (MI) was launched in December 2014 and aims at increasing the full immunization coverage to children to 90%.
• Under this drive focus is given on pockets of low immunization coverage and hard to reach areas where the proportion of unvaccinated and partially vaccinated children is highest.
• A total of six phases of Mission Indradhanush have been completed covering 554 districts across the country.
• It was also identified as one of the flagship schemes under Gram Swaraj Abhiyan (16,850 villages across 541 districts) and Extended Gram Swaraj Abhiyan (48,929 villages across 117 aspirational districts).
• While the first two phases of Mission Indradhanush resulted in 6.7% increase in full immunization coverage in a year, a recent survey carried out in 190 districts covered in Intensified Mission Indradhanush (5th phase of Mission Indradhanush) shows 18.5% points increase in full immunization coverage as compared to NFHS-4 survey carried out in 2015-16.

New Initiatives in Vaccine Logistics & Cold Chain Management

1. Capacity building

• National Cold Chain Training Centre (NCCTE), Pune and National Cold Chain  & Vaccine Management Resource Centre (NCCVMRC) -NIHFW, New Delhi have been established to provide technical training to cold chain technicians in repair & maintenance of cold chain equipment

1. System strengthening

• Electronic Vaccine Intelligence Network (eVIN) rollout:
• The Government of India has rolled out an Electronic Vaccine Intelligence Network (eVIN)system that digitizes the entire vaccine stock management, their logistics and temperature tracking at all levels of vaccine storage – from national to the sub-district.
• This enables program managers to have real time view of the vaccine stock position and their storage temperature across all the cold chain points providing a detailed overview of the vaccine cold chain logistics system across the entire country.
• eVIN system has been completed in 12 states in the first phase – Assam, Bihar, Chhattisgarh, Himachal Pradesh Gujarat, Jharkhand, Madhya Pradesh, Manipur, Nagaland, Odisha, Rajasthan, and Uttar Pradesh.
• Second phase is ongoing in 9 states – Andhra Pradesh, Daman & Diu, Dadra & Nagar Haveli, Goa, Karnataka, Maharashtra, Telangana, Tripura and Uttarakhand.
• eVIN is to be scaled up to entire country.
• National Cold Chain Management Information System (NCCMIS)to track the cold chain equipment inventory, availability and functionality.

History of vaccine development

Although inoculationInoculationThe practice of intentionally exposing someone to matter from smallpox pustules in order to initiate a mild, protective response to the disease. against smallpox was practiced over 2000 years ago in China and India, a British physician, Edward Jenner, is generally credited with ushering in the modern concept of vaccination. In 1796 he used matter from cowpox pustules to inoculate patients successfully against smallpox, which is caused by a related virusVirusAn ultramicroscopic infectious agent that consists of genetic material surrounded by a protein coat. A virus can replicate themselves only within cells of living hosts..

By 1900, there were two human virus vaccines, against smallpox and rabiesRabiesA potentially fatal viral infection spread through the bite of certain warm-blooded animals. It attacks the central nervous system and, if left untreated, is highly fatal in animals., and three bacterial vaccines against typhoidTyphoid (typhoid fever)A serious disease caused by a bacteria called Salmonella Typhi. Typhoid causes a high fever, weakness, stomach pains, headache, loss of appetite, and sometimes a rash. If it is not treated, it can kill up to 30% of people who get it. There are different vaccines to prevent typhoid: inactivated vaccines that require injection, and live attenuated vaccines that are taken orally (by mouth)., choleraCholeraAn acute infectious disease of the small intestine, caused by the bacterium Vibrio cholerae and characterized by profuse watery diarrhea, vomiting, muscle cramps, severe dehydration, and depletion of electrolytes., and plaguePlagueA serious, potentially life-threatening infectious disease that is usually transmitted to humans by the bites of rodent fleas. It was one of the scourges of early human history..

A worldwide case detection and vaccination programme against smallpox gathered pace and, in 1979, the World Health Assembly officially declared smallpox eradicated — a feat that remains one of history’s greatest public health triumphs.

During the 20th century, other vaccines that protect against once commonly fatal infections such as pertussisPertussis (also known as whooping cough)An infectious bacterial disease caused by Bordetella pertussis that produces violent, spasmodic coughing; also called whooping cough., diphtheriaDiphtheriaA disease caused by toxigenic strains of Corynebacterium diphtheriae. Often marked by the formation of a false membrane in the throat, diphtheria is a serious vaccine-preventable disease that can cause death in unvaccinated children., tetanusTetanusA disease caused primarily by toxigenic C. tetani. The rare but often fatal disease affects the central nervous system by causing painful muscular contractions., polio, measlesMeaslesA contagious viral disease marked by fever, the eruption of red circular spots on the skin that can be deadly to young and weakened individuals., rubellaRubella (German measles)A viral infection that is usually milder than measles but can cause serious damage or death to a fetus when a pregnant woman is infected., and several other communicable diseases were developed. As these vaccines became available, high-income industrial nations began recommending routine vaccination of their children. There are now over 20 vaccine-preventable diseases.

REFERANCE-https://vaccine-safety-training.org/home.html

REQUEST AN APPOINTMENT OR BOOK A CONSULANT – Sargam.dange.18@gmail.com