Indian Pediatrics

Adverse Event Following Immunization (AEFI) Surveillance in India: IAP's Perspectives--Manuscript Draft--

Manuscript Number:

Full Title: Adverse Event Following Immunization (AEFI) Surveillance in India: IAP's Perspectives

Article Type: Perspective

Corresponding Author: Vipin M Vashistha, MDMangla hospital & research centerBijnor, Uttar pradesh INDIA

Corresponding Author SecondaryInformation:

Corresponding Author's Institution: Mangla hospital & research center

Corresponding Author's SecondaryInstitution:

First Author: Amarjeet Chitkara, MD, DNB.

First Author Secondary Information:

Order of Authors: Amarjeet Chitkara, MD, DNB.

Naveen Thacker, MBBS, MD

Vipin M Vashistha, MD

Sujeet Jain, MBBS

Stephen Sosler, MD

Ajay Khera, MBBS, MD

Order of Authors Secondary Information:

Abstract: Abstract:

'Adverse event following immunization' (AEFI) is a critical component of immunizationprogram. The risk of AEFI with vaccination is always weighed against the risk of notimmunizing a child. The vaccination programs work in a paradox and when thevaccination coverage increases and disease burden reduces drastically, more cases ofAEFI attract the attention of the people than the disease in the community. AEFIsurveillance, therefore, helps to preserve public confidence in the immunizationprogramme. There is an evolving AEFI surveillance system in India for the vaccinesdelivered through 'universal immunization program' (UIP) of government sector, but thereporting remained suboptimal for long in the country, and there is almost noparticipation from private sector. The AEFI reporting from private sector will providevital information on the safety of new and underutilized vaccines, not part of the UIP inIndia. The national guidelines are recently revised and updated. The pediatricians, ingeneral, are not aware, and rather apprehensive about the existing AEFI reportingsystem and national guidelines on AEFI surveillance in India. This article is aimed tosensitize practitioners both in private and government sector on how to report cases,and outline the steps needed to improve AEFI surveillance and reporting bystrengthening public private partnership in India.

Key words: Adverse Event Following Immunization, surveillance, UniversalImmunization Program, public private partnership India.

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Perspective

Adverse Event Following Immunization (AEFI) Surveillance in

India: IAP’s Perspectives

Chitkara AJ*, Thacker N*, Vashishtha VM*, Jain S**, Sosler S**, Khera A***.

* From IAP Committee on Immunization, Indian Academy of Pediatrics;

**From National Polio Surveillance Project, Government of India;

***From Ministry of Health & Family Welfare, Government of India

Correspondence to:

Vipin M. Vashishtha,

Convener, IAP Committee on Immunization,

Mangla Hospital& Research Center,

Shakti Chowk,

Bijnor, Uttar Pradesh, 246701,India

Fax : 01342-265102

E mail: vipinipsita@gmail.com

*Title Page

Adverse Event Following Immunization (AEFI) Surveillance in

India: IAP’s Perspectives

Introduction:

Immunization is one of the safest most cost effective interventions to improve child survival (1).

The advent and growing availability of new vaccines which target major childhood diseases such

as pneumonia, meningitis and rotavirus have the potential to save an additional 1.7 million child

lives. In India, with approximately 26 million infants born each year hundreds of millions doses

of vaccines are administered annually (2). Although vaccines are proven to be extremely safe,

there is risk of a potential adverse reaction as with any other drug or medication. The Adverse

Event Following Immunization (AEFI) is defined as ‘A medical incident that takes place after

immunization, causes concern and is believed to be caused by the immunization’ (4-5). This risk

of AEFI with vaccination is always weighed against the risk of not immunizing a child. It is only

when the benefit outweigh the risk, a vaccine is considered safe. However, even at a relatively

low rate, because of the high absolute number of beneficiaries, there is risk of a few serious

adverse events in the vaccinated children. This article to sensitize practitioners both in private

and government sector (including pediatricians) on how to report cases, and outline the steps

needed to improve AEFI surveillance and reporting by strengthening public private partnership

in India.

Why ‘Adverse Events Following Immunization’ are important?

The vaccines are foreign for human bodies, given to healthy infants and children. In the natural

process of developing immunity, a vaccine may cause fever, erythema, local pain etc. Besides,

*Blinded ManuscriptClick here to view linked References

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there is a slight risk of foreign body reaction to the components in the vaccines. These factors are

likely to cause some concerns in the caregivers/parents. Whatever the cause, an AEFI may upset

people to the extent that they may refuse further vaccination for their children. This may lead to

the children much more likely to get a vaccine preventable disease, become seriously ill,

disabled, and risk death. AEFI surveillance, therefore, helps to preserve public confidence in the

immunization programme (4). Though, the majorities of AEFIs are mild, settle without

treatment, and have no long term consequences; very rarely, serious adverse reaction can occur.

The vaccination programs work in a paradox and when the vaccination coverage increases and

disease burden reduces drastically, more cases of AEFI attract the attention of the people than the

disease in the community (6).

AEFI surveillance strengthening in India:

AEFI surveillance in India started with the launch of Universal Immunization Program (UIP) in

1985. However, the AEFI reporting remained suboptimal for long in the country. In 2005/2006,

the Govt. of India, with technical assistance from the World Health Organization/National Polio

Surveillance Project India and other development partners, prepared the National AEFI

Surveillance and Response Operational Guidelines (7). These guidelines were widely

disseminated across the country among medical officers in Government sector. Since then many

state National, state and district level AEFI surveillance workshops for immunization program

managers have been conducted. The national guidelines were further revised and updated in

2010. These efforts have contributed in improving AEFI surveillance in India and the country

reported the highest ever of serious AEFI cases in 2010 (395 vs. 55 in 2006) (Figure 1).

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National AEFI guidelines in India:

There are 2 sets of national guidelines are available in India. The detailed version is called

operational guidelines, and a shorter version is for Standard Operating Procedures (8, 9). These

guidelines, based upon World Health Organization suggested framework (4), were developed

through a consultative process with various stakeholders, including various Government

departments involved in immunization program, state Govt. program managers, academic

institutions, independent subject experts, DCGI officials, development partners etc.

The AEFI reactions can broadly be classified as serious AEFIs (Death, disability &

hospitalization) which need to be reported immediately and investigated as per the laid down

procedures. The other AEFIs are reported through monthly reporting systems in UIP in GoI .

From the programmatic purpose, the AEFIs are classified in 5 broad categories of programmatic

error, vaccine reaction, injection reactions; coincidental and unknown.

How to report AEFI from private sector?

The majority of children in India receive immunization through public health facilities. However,

it is estimated that approx 10-20% of total immunization is provided through private sector and

by pediatricians (10). Moreover, the vaccines not part of the UIP in India are provided by the

private sector only. There is an evolving AEFI surveillance system in India for UIP vaccine from

Government sector; however, the reporting from private sector is limited so far. It is important

that AEFI from this sector are also reported and investigated, as per the laid down national

guidelines, which are applicable to private sector also. Additionally, the AEFI reporting from

private sector will provide vital information on the safety of new and underutilized vaccines in

India. Once a serious AEFI happens in the private sector at a clinic of pediatricians, in the rural

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area, she/he should immediately inform medical officer in charge of nearest Primary Health

centre or other health facility. In the Urban area, either she/he can inform Medical Officer In

charge of nearest Urban Health Centre or to the District Immunization officer (DIO). By all

channel, the information should reach DIO as soon as possible.

The private practitioners (including pediatricians) should use the FIR form for reporting serious

AEFI cases to the district officials. Once an AEFI is reported from private sector, the DIO and

district AEFI committee members would then investigate the reported AEFI case. The

Pediatricians should help the investigation team in collection of all the related information.

It has come out from various interactions at different forums that the pediatricians, in general, are

not aware and apprehensive about the existing AEFI reporting system and national guidelines on

AEFI surveillance and response in India.

The way forward:

Based upon the understanding of the AEFI surveillance and case investigation in India and a

series of interactions with members of professional bodies, there are a few possible ways to

strengthen AEFI reporting from private sector in India:

Stronger collaboration: Considering a large number of pediatricians provide

immunization service, their involvement in AEFI surveillance is crucial. A stronger

collaboration between Govt. of India and Indian Academy of Pediatrics (IAP) will be a

right platform to strengthen AEFI surveillance in India. The possible role of IAP can be

as follows:

Sensitizing members about AEFI surveillance in monthly IAP meetings

and through their state and national level conferences;

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Disseminating information through IAP publications

Sensitizing members through annual conferences etc.

Reporting AEFIs and supporting case investigation

IAP members actively participating in District and state AEFI committee

activities

Supporting causality assessment at the state level.

Online AEFI reporting platform for private practitioners: A possible solution for

AEFI reporting from private sector is providing online platform through which

practitioners can report from the comfort of their clinic. This platform may ask for First

investigation report to be provided by Private Practitioner (PP) and then Government

counterpart can take lead and collaborate for further investigating and taking up the AEFI

case investigation and reporting.

IAP through its IAPCOI has resolved to collaborate with the National AEFI

program by suggesting the following measures:

o Integrate IAP disease surveillance project IDSURV with AEFI reporting for a

web based and IVR reporting (Already incorporated: idsurv.org).

o The IDSURV program is fine tuned to automatically send information to the

concerned DIO/SIO for prompt action.

o In due course SMS reporting shall also be integrated within the program for

preliminary reporting but shall have to be followed up by proper FIR.

The proposed PPP has been enthusiastically received by MOH, GOI for prompt

implementation.

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The PPP envisages continuous monitoring by all the stake holders for a meaningful

outcome.

Bringing the confidence amongst Pvt. Practitioners: Once the practitioners are

sensitized about the AEFI surveillance, they might have better confidence to report the

cases. Inculcating confidence in the private practitioners will contribute to strengthen

AEFI surveillance in India.

Conclusions:

The immunization coverage in India is slowly increasing and additional new and underutilized

vaccines are being administered to the children by private practitioners. While there is a system

for AEFI reporting from Govt. sector in India based on the operational guidelines, there is

limited awareness about the reporting system in the private sector resulting in inadequate

reporting. There is, thus, a perceived need for improving AEFI surveillance in the private sector.

This is possible through information dissemination and better collaboration with professional

bodies and GoI. The improved AEFI surveillance and reporting system in India will go in a long

way to increase and retain the faith of the community in the existing and new vaccines and

increasing the immunization coverage in India.

Conflicts of interests: None declared

Funding: None

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REFERENCES:

1. WHO, UNICEF, World Bank. State of World Vaccines and Immunization. 3rd

Edition,

Geneva, World Health Organization, 2009.

2. CDC. Global routine vaccine coverage, 2010. Mord Mort Wkly Rep 2011; 60: 1520-5.

3. Black RE, Counsens S, Johnson HL, Lawn JE, Rudan I, Bassani DG et al. Global,

regional and national causes of child mortality in 2008: a systematic analysis. Lancet

2010; 375: 1969-87.

4. World Health Organization. Surveillance of Adverse Events following Immunziation:

field guide for managers of immunization programs. World Health Organization, Geneva.

1997.

5. World Health Organization. Aide memoir on AEFI investigation. World Health

Organization, Geneva. 2005.

6. Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA et al. The vaccine

adverse event reporting system (VAERS). Vaccine 1994; 12: 542-50.

7. Government of India. Adverse Events Following Immunization: surveillance and

response operational guidelines. MoHFW, GoI, 2006.

8. Government of India. Adverse Events Following Immunization: surveillance and

response operational guidelines. MoHFW, GoI, 2010.

9. Government of India. Adverse Events Following Immunization: surveillance and

response Standard operating procedures. MoHFW, GoI, 2010.

10. Government of India. Multi Year Strategic Plan (MYP) for UIP of India 2005-10.

MoHFW, GoI, 2010.

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Figure 1: Reported Serious AEFIs in India (2005-11)

Reported Serious AEFI Cases (1999 - 2011) ( th Data as on Jan 2012)

0 3 9 9

29 48

80

170

32

290

199

395

301

0

50

100

150

200

250

300

350

400

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

*data does not include serious AEFI cases reported in JE campaigns conducted in endemic states

Source : As per available records with MOHFW, GoI

AEFI state workshops

Figure

Annexure I

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Manuscript Title: Adverse Event Following Immunization (AEFI) Surveillance in India: IAP’s

Perspectives

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Authors’ name(s) in order of appearance in the manuscript Signatures (date)

1-Amarjeet Chitkara

2-Naveen Thacker

3-Vipin M. Vashishtha

4-Sujeet Jain

5-Stephen Sosler

6-Ajay Khera

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