India’s national immunization programme

AJAY KHERA, ANURADHA GUPTA, HEMA GOGIA and SUJATHA RAO

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THE success of smallpox eradication in the mid-1970s drew attention to the immunization programme in India. The Expanded Programme on Immunization (EPI), developed for immunizing children during the first year of life was launched in 1978 mainly in the urban areas. Through the subsequent years, more vaccines were included in the programme, e.g. OPV in 1979 and the vaccine to immunize pregnant mothers with tetanus toxoid (TT) vaccine in 1983. In 1985, the programme was revised and renamed as the Universal Immunization programme (UIP), focusing more on infants and pregnant mothers, and the measles vaccine was included in the programme; by 1990, the programme had been expanded to spread across the country.

The stated objectives of UIP are to rapidly increase immunization coverage, improve the quality of services, establish a reliable cold chain system to the health facility level, introduce a district-wise system for monitoring of performance, and achieve self-sufficiency in vaccine production.

UIP was given the status of a National Technology Mission in 1986. Later on in 1992, UIP became a part of Child Survival and Safe Motherhood (CSSM) programme and then of Reproductive and Child Health (RCH) programme in 1997. A specific Immunization Strengthening Project (ISP) was designed to run from 2000-2003, which included three main components (polio eradication, strengthening routine immunization, and strategic framework for development).

The overarching goal of the UIP is to reduce morbidity and mortality due to vaccine preventable diseases (VPD). While surveillance information for specific VPDs is limited, the steady fall of IMR from 123 to 50 deaths per 1000 live-births (SRS 2011) does in part reflect the impact of the UIP. Besides, in the past 15 years, a decline in the reported number of cases of the main VPDs (diphtheria, tetanus, pertussis and measles) has been observed. The same data though does show an increase in the number of reported measles, diphtheria and pertussis cases in recent years with measles continuing to be responsible for 6% of childhood mortality or 80,000 deaths annually. The decision taken in 2010 to introduce a second dose of measles containing vaccine (MCV2) through mass vaccination campaigns is expected to help decrease the burden of measles in India.

Since its launch in 1995, the Polio Pulse campaign aimed at eradicating polio from India, has begun to show results. Government at the national and state levels is implementing strategies on a scale and intensity that is unprecedented in the history of polio eradication. These efforts have brought India closer to the goal of polio eradication than ever before in history with only 42 confirmed cases in 2010 and only one in 2011.

The key to the progress made has been continued aggressive supplementary immunization activities conducted throughout the country, sensitive acute flaccid paralysis (AFP) surveillance to provide evidence of progress and early detection of the circulation of virus, in addition to the more effective bivalent vaccine.

Reported Cases of Diphtheria, Total Tetanus and Poliomyelitis

Source :CBHI

* Data for 2010 is provisional.

 

Reported Cases of Pertussis and Measles 1990-2010

Two other vaccines that have been added to the original six under the UIP are vaccine for protection against Hepatatis B and Japanese Encephalitis. An estimated 40 million (4 crore) people in India are positive for hepatitis B surface antigen (HBsAg) and 15-25% of them suffer a lifetime risk of chronic liver disease and dying prematurely. Each year, one million infants run the life time risk of developing chronic HBV infection. Recently, a vaccination campaign against JE was conducted in 112 endemic districts of 15 states of the country. The reported annual cases of acute encephalitis syndrome (AES) and JE in India have ranged from 2000-7000 with up to 2000 deaths.

 

Technological advances have today provided an opportunity to further reduce childhood mortality due to other infectious diseases which can be averted with immunization. However, their introduction under the UIP have been delayed due to lack of conclusive evidence of their relevance to India, largely due to a lack of systematic, quality surveillance including laboratory confirmation throughout the country. These new vaccines are for pneumococcal disease, rotavirus diseases, typhoid diseases, rubella disease and the meningococcal disease and seasonal and pandemic (H1N1) influenza.

Monthly Incidence of Polio in India, January 1998-July 2010

Currently, pentavalent vaccine (vaccine against Diphtheria, pertussis, tetanus, Hepatitis B and Haemophilus influenzae type B infection) has been introduced in Kerala and Tamil Nadu and is proposed to be introduced in other states of the country as well.

Location of Wild Poliovirus Cases by Type, 2010

States

WPV1

WPV3

West Bengal

6

2

Maharashtra

5

0

Bihar

3

6

Jharkhand

3

5

Jammu & Kashmir

1

0

Uttar Pradesh

0

10

Haryana

0

1

Total

18

24

 

Location of Wild Poliovirus Cases by Type, 2011

Onset of paralysis 13th January in Howrah district of West Bengal

States

WPV1 WPV3

Total

West Bengal

6

1

Total

18

1

The HPV vaccines and Cholera vaccines are licensed in the country and available for use in the private sector but are not currently part of the Universal Immunization Programme.

 

The performance of UIP is measured in terms of the vaccination coverage attained and dropout rates of children. Coverage rates, particularly of the first series of antigens as per the immunization schedule (i.e., BCG and DTP1 and HepB), are used as a proxy measure of access to immunization services. Alternatively, the trend of dropout rates is indicative of the strength of the system including the quality of service provision and utilization.

Reported National Coverage Rates by Antigen, 1990-2008

Source: Evaluation and Intelligence Division, MoH&FW.

The accompanying figure shows national reported administrative coverage of UIP antigens since 1990. Reported vaccination coverage by antigen has traditionally been higher than survey evaluated coverage at the national, state and district levels.

Variations between districts: Comparison between District Level Household Surveys (DLHS) II (2002-04) and III (2007-2008) shows that:

* In 379 (68%) districts surveyed (of total 555 for which data is available) there was an increase in the proportion of fully immunized since the last DLHS. The average increase was 19.0% (ranging from 0.1% to 74.6%);

* In 159 (29%) districts surveyed there was a decrease in the proportion of fully immunized between two surveys; the average decrease was 10.0% (range from 0.1% to 63.8%).

* 17 (3%) districts showed no change in full immunization rates.

Evaluated Coverage Rates for Full Immunization by District Comparing the 2002-03

Survey With 2006-07

The implementation of the UIP is a joint responsibility of the government at all three levels, namely central, state/union territory and district. The relationships between central and state immunization departments and between state and district immunization officers are all critical for efficient and effective service delivery. Though the detailed roles and responsibilities at different levels are defined, yet they are often difficult to implement due to unclear communication, rapid turnover of government staff and weak coordination at all levels.

 

Implementation of the UIP entails close monitoring of the availability of various inputs ranging from vaccine procurement and ensuring timely supply of vaccines at the delivery points; ensuring the optimal functioning of the cold chain; enforcing injection safety and waste disposal; closely monitoring the VPD and AEFI surveillance system, like for example the National Polio Surveillance Project, a joint World Health Organization-Government of India endeavour that maintains a nationwide network of more than 30,000 reporting units to detect cases of acute flaccid paralysis (AFP), the syndrome associated with poliomyelitis. In addition, NPSP provides technical support to eight states (Andhra Pradesh, Gujarat, Karnataka, Kerala, Madhya Pradesh, Rajasthan, Tamil Nadu and West Bengal) to conduct measles outbreak surveillance with laboratory confirmation. This is a very critical aspect of the UIP and accordingly, the surveillance for Adverse Events Following Immunization (AEFI) that was set up in 2006, reported more than 400 serious AEFI cases from 120 districts in 2010. Finally, the components related to supervision for which IT is used extensively and advocacy and communication for behaviour change.

 

A national review of UIP was carried out in 2004. Subsequent reviews at national and state levels, Joint Review Missions (JRM) and Common Review Missions (CRM) sent by GoI on a regular basis have noted the programme to have improved, but also indicated some constraints affecting its continued sustainability and momentum:

a) There is limited technical and operational human resource capacity at various levels. These vacancies are more in the poor performing states and especially at field level.

b) The coverage with vaccines is not uniform across the country. There are rural-urban, poor-rich and other related differences in immunization coverage. The immunization coverage reported by districts and states is always higher than actually found in the surveys.

c) There are many areas with high left outs. The dropout rate between BCG and measles (or for DPT3 and measles) is unacceptably high in some states. When the actual rate of immunization is already low, the high drop-out rate reduces the number of fully immunized children to a small proportion.

d) Organized immunization planning was missing from service delivery. It has been noticed that many a times, there is no micro-plan to provide health services to the community.

e) There is a need to strengthen monitoring and supervision.

f) There is a weak surveillance network in the country for vaccine preventable diseases and AEFIs as well. There is insufficient laboratory capacity in the districts to carry out the surveillance.

g) The immunization staff is often unaware of safe injection practices and the facilities for waste generated from immunization are also not available. This leads to unsafe injections and improper waste disposal.

h) There have been limited social mobilization efforts to both increase demand for immunization coverage and acceptability for immunization.

i) There is a need to set up an accountability mechanism to improve performance of the immunization programme at various levels.

j) There has been a limited focus on operational research for immunization and finding locally suitable solutions to problems.

 

The Universal Immunization Programme (UIP) in India is one of the largest immunization programmes in the world, in terms of quantities of vaccine used, number of beneficiaries, number of immunization sessions organized, and the geographical spread and diversity of areas covered. India has achieved full immunized coverage of 61% according to CES 2009 survey. There is, however, a large variation in the immunization coverage across states, ranging from 24.8% to 87.9%. To understand the reasons for persisting inequities, a critical appraisal of various parameters related to the implementation of the immunization programme was undertaken, as described below.

The appraisal was based on secondary data from the District Level Household Survey (DLHS-1, DLHS-2 and DLHS-3), the Coverage Evaluation Survey (CES 2009), HMIS data, and primary data that included collated states data of the Immunization Division of MoHFW. For the purpose of analysis, the states were categorized into two groups: well performing and poorly performing, with the former group defined as those that had full immunization coverage (FIC) greater than the national average of 61% as listed above. The parameters used for appraisal were awareness about immunization, micro-planning, capacity building, monitoring and evaluation, cold chain handling and AEFI surveillance system.

Well Performing States

FIC %

Poorly Performing States

FIC %

Andhra Pradesh

68.0

Arunachal Pradesh

24.8

Delhi

71.5

Manipur

51.9

Goad

87.9

Meghalaya

60.8

Haryana

71.7

Nagaland

27.8

Himachal Pradesh

75.8

Assam

59.1

Jammu & Kashmir

66.6

Bihar

49.0

Karnataka

78.0

Madhya Pradesh

42.9

Kerala

81.5

Orissa

59.5

Maharashtra

78.6

Rajasthan

53.8

Punjab

83.6

Uttar Pradesh

40.9

Tamil Nadu

77.3

Chhattisgarh

57.3

Mizoram

73.7

Gujarat

56.6

Sikkim

85.3

Jharkhand

59.7

Tripura

66.0

   

Uttarakhand

71.5

   

West Bengal

64.9

   

 

An analysis of such triangulated data showed the following:

1. Correct knowledge of vaccines to be given to the child by one year of age and the number of doses and age at which first dose is to be given, plays an important role in protecting children against vaccine preventable diseases. As per CES-2009, around three-fifths (or 58.1%) of the mothers knew about all the four vaccines to be given to child by one year of age. It underscores the fact that even after the enormous effort by the government to popularize child-hood immunization, a lack of awareness among parents remains a dominant reason for not vaccinating the child.

 

Since the state specific data on awareness about immunization was not available, hence, for analysis purpose, data on the ‘percentage of children aged 12-23 months who showed an immunization card’ was taken as an indirect indicator reflecting the sensitivity and awareness of the mothers or caregivers towards immunization. Around 90.8% of mothers reported receiving an immunization card for their children and 51.5% were able to show the immunization card. Further relating this variable with group of states, it was observed that in nine out of the thirteen poorly performing states, the percentage of children aged 12-23 months who showed an immunization card was less than 50%. Also the percentage of children who showed an immunization card varied from state to state, the lowest being in Rajasthan (24%) while the highest was in Kerala (78.9%).

2. Microplanning is an integral part of the process of doing things effectively. It ensures optimum use of available manpower and resources to bring maximum results. In order to assess the impact of micro planning on immunization among the states, the availability of ANM at sub-centre was considered a predictor for good microplanning. It was observed that in six of the nine well performing states, all sub-centres had at least one ANM or health worker posted, whereas in eight out of the eleven poorly performing states, no ANM or health worker was posted in more than 100 sub-centres.

3. Capacity building is critically important to the success of the Universal Immunization Programme. Given the total number of ASHAs, ANMs, nurses and medical officers that are available across all the states, continuous skill development is needed. It is seen from the table above that most of the poorly performing states have achieved training coverage of less than 50%.

4. The follow-up of children for achieving full immunization coverage is an important strategy. In this regard monitoring and supervision plays a critical role. In order to understand the implementation of this strategy various related factors were reviewed and these were sessions held v/s planned, dropout rate and supervisory visits by state and district officials. It was observed that the percentage of sessions held v/s planned was less than 90% in many of the states. Further, the dropout of children from BCG to measles ranged from 8 to 31% in poorly performing states in comparison to well performing states where dropout rate ranged from 0.1 to 14%.

5. The cold chain is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to point of use. Different cold chain equipments are used for this purpose. It is essential to store a proper stock of vaccines at every stage of the cold chain. Keeping vaccines at the right temperature is not an easy task, but the consequences of not doing so can be disastrous.

Once vaccine potency is lost, it cannot be regained. The damaged vaccines must be destroyed leading to inadequate vaccine stock and wastage of expensive vaccines. Moreover, children and women who receive a vaccine that is not potent are not protected. The key elements of the cold chain are: personnel to manage vaccine storage and distribution, equipment to store and transport vaccine and to monitor temperature, and procedures to ensure that vaccines are stored and transported at appropriate temperatures. The cold chain handling system was assessed by reviewing factors like population covered by each cold chain point and number of sub-centres served by each cold chain point.

 

It was observed that among the poorly performing states, Uttar Pradesh, Rajasthan and Orissa have a higher population covered by each cold chain point. In six out of the ten well performing states, the population covered by each cold chain point is less than 30,000 whereas in all of the nine evaluated poorly performing states, the population covered is greater than 30,000. Further Uttar Pradesh, Bihar and Jharkhand among the poorly performing states have relatively higher number of sub-centres served by each cold chain point. In eight out of the ten well performing states, the number of sub-centres served by each cold chain point is less than the national average of six, whereas in only two out of the nine poorly performing states, it is less than the national average of six.

State-Wise Population Covered by Each Cold Chain Point

 

Number of Sub-Centres Served by Every Cold Chain Point

6. AEFI surveillance is defined as monitoring, detecting and responding to adverse events following immunization (AEFI), and implementing appropriate and immediate action to correct unsafe practices detected through the AEFI surveillance system. It is critical to the successful implementation of the immunization programme because it helps lessen the negative impact on the health of individuals and protects the reputation of the immunization programme. Keeping this in view, the AEFI reporting system was reviewed. It was observed that well performing states showed higher number of cases due to a strong AEFI surveillance system, four out of the thirteen poorly performing states and three out of the sixteen well performing states did not report any serious AEFI cases; five out of the thirteen poorly performing states and two out of the sixteen well performing states only reported deaths in terms of serious AEFI cases and the state of Maharashtra, among the well performing states, reported a relatively higher number of serious AEFI cases because of a robust system of AEFI surveillance.

 

A critical analysis of various operational factors related to differential immunization coverage in various geographical areas of the country showed the positive role of community awareness, presence of health staff at sub-centres, capacity building efforts, follow-up of dropouts and population covered through cold chain points and AEFI reporting system. Based on these observations, a medium-term plan has now been drawn up for the five year period 2012-2017. It is hoped that with these measures, India will be able to achieve the goal of universal coverage under all antigens and a further reduction in morbidity and mortality due to vaccine preventable diseases with polio, NNT and measles becoming history.

 

References:

M. Kane and H. Lasher, ‘The Case for Childhood Immunization’, Occasional paper, No.5. Children’s Vaccine Program at Path, Seattle, WA, 2002.

L.D. Frenkel and K. Nielsen, ‘Immunization Issues for the 21st Century’, Ann Allergy Asthma Immunol 90(6): Suppl 3, 2003, pp. 45-52.

Coverage Evaluation Survey 2009: All India Report, Government of India and UNICEF, 2010.

Health Management Information System, Ministry of Health and Family Welfare, Government of India.

Immunization Division, Ministry of Health and Family Welfare, Government of India.

Evaluation and Intelligence Division, Ministry of Health and Family Welfare, Government of India.

District Level Household Survey-2 and District Level Household Survey-3.

Central Bureau of Health Intelligence (CBHI), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

 

Annexure No. 1

Good Performing States – Immunization Coverage and Status of Various Variables Related to Immunization Programme Implementation

               

States

Full immunization coverage (%)

Children aged 12-23 months having an immunization card (%)

No. of sub-centres without ANM/HW***

MOs trained (%)

Sessions held vs planned(%)*

Dropout rates in age group12-23 months for BCG- measles (%)

No. of severe AEFI cases reported**

Andhra Pradesh

68.0%

64.9%

0

93.7

N/A

8.3%

21

Delhi

71.5%

50.7%

0

55.5

92.8%

6.5%

12

Goa

87.9%

60.6%

0

93.7

99.2%

1.4%

4

Haryana

71.7%

42.7%

N/A

72.8

93.9%

5.3%

10

Himachal Pradesh

75.8%

60.3%

178

4.0

98.2%

2.2%

3

Jammu & Kashmir

66.6%

60%

N/A

7.3

90.5%

9.4%

N/A

Karnataka

78.0%

52%

N/A

44.8

95.4%

7.4%

9

Kerala

81.5%

78.9%

0

50.5

N/A

8.3%

1

Maharashtra

78.6%

58.8%

N/A

51.8

80.2%

3.7%

71

Punjab

83.6%

53.2%

N/A

95.8

95.1%

9.6%

4

Tamil Nadu

77.3%

44.8%

140

82.2

99.1%

0.6%

5

Mizoram

73.7%

77.9%

N/A

48.3

66.7%

7.3%

N/A

Sikkim

85.3%

85.2%

0

75.0

N/A

0.1%

N/A

Tripura

66.0%

75.9%

0

30.0

92.9%

7.3%

4

Uttarakhand

71.5%

41.1%

34

19.5

91.8%

14.2%

1

West Bengal

64.9%

77.8%

N/A

19.7

91.6%

13.6%

28

* Data from the HMIS web portal April to October, 2011; ** Severe AEFI cases reported to GoI by the states till mid-December, 2011; *** Collated data from state review meetings on immunization obtained from MoHFW, GoI.

 

Annexure No. 2

Poor Performing States – Immunization Coverage and Status of Various Variables Related to Immunization Programme Implementation

States

Full immunization coverage (%)

Children aged 12-23 months having immunization an card (%)

No. of sub-centres without ANM/HW***

MOs trained (%)

Sessions held vs planned(%)*

Dropout rates in age group 12-23 months for BCG- measles (%)

No. of severe AEFI cases reported **

Arunachal Pradesh

24.8%

41.9%

N/A

43.8

81.5%

27%

N/A

Manipur

51.9%

55.6%

N/A

49.4

89.6%

12.9%

N/A

Meghalaya

60.8%

63.8%

0

93.4

80.8%

9.4%

3

Nagaland

27.8%

45%

0

40.1

93.7%

11.5%

N/A

Assam

59.1%

66.9%

0

84.7

97.4%

7.2%

7

Bihar

49.0%

43.1%

200

18.3

95.1%

29.3%

19

Madhya Pradesh

42.9%

45.8%

119

32.5

96.1%

24%

8

Orissa

59.5%

58.3%

535

44.9

96.0%

17.6%

5

Rajasthan

53.8%

24%

392

33.4

113.9%

20.6%

3

Uttar Pradesh

40.9%

35.9%

1,776

32.1

89.8%

30.9%

21

Chhattisgarh

57.3%

46.3%

458

8.7

90.3%

13.8%

N/A

Gujarat

56.6%

49.5%

488

24.7

97.2%

8.1%

3

Jharkhand

59.7%

63.1%

0

36.3

94.4%

22.8%

11

* Data from the HMIS web portal April to October, 2011; ** Severe AEFI cases reported to GoI by the states till mid-December, 2011; *** Collated data from state review meetings on immunization obtained from MoHFW, GoI.

 

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