Lok Sabha Question No. 2251 (UNSTARRED), answered on 2015-12-11
Subject: Adverse Events following Immunization
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SANJAY JAISWAL

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2251 TO BE ANSWERED ON 11 TH DECEMBER, 2015

## ADVERSE EVENTS FOLLO WING IMMUNIZATION

## 2251. DR. SANJAY JAISWAL:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  the  number  of  Adverse  Events Following  Immunization  (AEFI)  reported throughout  the country during each of the last three years and the current year, State/ UT - wise;
- (b) the remedial steps taken by the Government in this regard;
- (c) whether the Government maintains a centralised registry of all such cases; and
- (d) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

- (a): The number of Adverse Events Following Immunization (AEFI) reported during each of the last three years and the current year, State/UT -wiseare annexed.
- (b): Vaccines are safe and effective. AEFIs are not always related to vaccines or process of vaccination  and  are  coincidental  many  a  times.  To  maintain  public  confidence,  ÄE surveillance program has been strengthened to detect report and investigate such events carry  out  remedial  measures,  if  any.  AEFI  surveillanc e  program  indicates  the  government's intent to ensure quality and safety of the vaccines given in the country. Furthermore, th stresses on immediate case management following adverse events so as to prevent any untow mortality.

Following stepshave been taken by  the  Government of  India  to  detect,  report  and investigate AEFIs to establish the cause for taking remedial steps:

- Setting up of an AEFI Secretariat and AEFI C ommitteeat the national level to support the states and districts to improve AEFI reporting, investigation and causality assessment .
- N ational AEFI surveillance guidelines revised in 2015 followed by trainings for thestates and districts .
- State  and  district  AEFI committees have  beenset  upfor  investigation  and  causality assessment .
- Leveraging of W HO P olio surveillance etworkto improve AEFI surveillance and support the states and districts in capacity building, reporting and investigations.
- Initiated weekly zero reporting formats for ser ious AEFIs .
- Toolsdeveloped and disseminated to the states to improve communication response during AEFI crisis and advocate for vaccines in routine circumstances .
- The reports of serious AEFI being shared with office of Drug Controller General of (DC GI) at national level for requisite regulatory actions.

(c)& (d): Yes. T he Government maintains centralized dataof all such cases. The centralised data  contains  information  on personal  details , vaccines  received,  clinical case  information , details ofinvestigation conducted ,outcome,etc.

State/UTwisenumber of reported AEFIfrom 2012 to2015*

| STATE/ UTs        |   2012 |   2013 | 2014   |   2015 |
|-------------------|--------|--------|--------|--------|
| A&N Islands       |      0 |      0 | 0      |      0 |
| Andhra Pradesh    |     19 |     21 | 8      |     20 |
| Arunachal Pradesh |      0 |      0 | 0      |      0 |
| Assam             |      5 |     12 | 106    |     52 |
| Bihar             |     53 |     56 | 34     |     17 |
| Chandigarh        |      2 |      1 | 1      |      2 |
| Chhattisgarh      |      3 |      3 | 3      |      8 |
| D&N Haveli        |      0 |      0 | 0      |      0 |
| Daman & Diu       |      0 |      5 | 0      |      3 |
| Delhi             |     17 |     21 | 22     |     18 |
| Goa               |      7 |     19 | 30     |     24 |
| Gujarat           |     23 |      8 | 15     |     16 |
| Haryana           |      5 |     10 | 35     |     20 |
| Himachal Pradesh  |      0 |      0 | 2      |      1 |
| Jammu & Kashmir   |      0 |     23 | 17     |      6 |
| Jharkhand         |      5 |      2 | 4      |      3 |
| Karnataka         |     22 |     20 | 20     |     48 |
| Kerala            |     58 |    121 | 131    |     91 |
| Lakshadweep       |      0 |      0 | 0      |      0 |
| Madhya Pradesh    |      5 |      6 | 50     |     37 |
| Maharashtra       |     69 |     70 | 33     |     36 |
| Manipur           |      0 |      0 | 0      |      0 |
| Meghalaya         |      0 |      1 | 1      |      8 |
| Mizoram           |      0 |      0 | 9      |      8 |
| Nagaland          |      0 |      0 | 1      |      0 |
| Odisha            |      3 |      7 | 17     |      6 |
| Puducherry        |      0 |      6 | 4      |      7 |
| Punjab            |      5 |      2 | 8      |      9 |
| Rajasthan         |      4 |      1 | 10     |      2 |
| Sikkim            |      0 |      0 | 0      |      0 |
| Tamil Nadu        |     12 |     22 | 64     |     68 |
| Telangana         |      0 |      0 | 3      |      6 |
| Tripura           |      8 |      2 | 10     |     75 |
| Uttar Pradesh     |     41 |     43 | 77     |     57 |
| Uttarakhand       |      2 |      1 |        |      4 |
| West Bengal       |     30 |    113 | 72     |     58 |
| Total             |    398 |    596 | 787    |    710 |