Lok Sabha Question No. 6601 (UNSTARRED), answered on 2018-04-06
Subject: Pentavalent and DPT Vaccine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: VINAYAK BHAURAO RAUT, ANANDRAO  ADSUL, B.V. NAYAK, DHARMENDRA YADAV, SHRIKANT EKNATH SHINDE

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

LOK SABHA UNSTARRED QUESTION NO. 6601 TO BE ANSWERED ON 6 TH APRIL, 2018

## PENTAVALENT AND DPT VACCINE

## 6601. SHRI VINAYAK BHAURAO RAUT:

SHRI ANANDRAO ADSUL:

SHRI B.V. NAIK:

SHRI DHARMENDRA YADAV:

DR. SHRIKANT EKNATH SHINDE:

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

- (a)  whether  Pentavalent  Vaccine  (PV) against  Haemophilus  influenza  Type - B (HIB)  and Hepatitis - B,  has  led  to double the  number  of  deaths  of  children  compared to  DPT (Diphtheria - Pertussis - Tetanus) vaccine and if so, the details thereof;
- (b) whether vaccination of 26 million children each year in India will result in 122 additional deaths within 72 hours, due to switch from DPT to PV;
- (c) if so, the details thereof and the reaction of the Government thereto;
- (d) whether there was sudden spike in deaths following immunisation in 2017 to 1,139 from 176 in 2016 and 111 in 2015;
- (e) whether the Government has conducted any study in this regard; and
- (f) if so, the details and the outcome thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): The Adverse  Event  Following  Immunization  (AEFI)  surveillance  system has  been established to monitor any AEFI . The surveillance system encourages reporting of any death, hospitalization, clusters, disabilities, etc. following vaccination .Every AEFI case report ed are investigat ed bytrained experts of the State and National AEFI committees us inga scientific, globally  accepted  method  to  do  the  casualty  assessment  to  know  the  cause  of  the  e including death. Mere reporting does not mean that the vaccine caused the ev nt including death.

Therehas been an increase in reporting of adverse events including deaths every year. The  reported  rise  in  the  number  of  Adverse  Events  Following  Immunization  (AEFI) because of better reporting as part of AEFI surveillanc e system strengthening measure un der t aken,  like  trainings, report ing AEFI  with  Standard  Operating  Procedure, formation  of District  and  State  AEFI  committees , National  AEFI  secretariat  and  strengthened  with additional manpower to encourage states/UTs for AEFI reporting and analyses of such ca Thisincrease in reporting of adverse events trend continues even after pentavalent vaccine introduction.

(b) &(c): The assumption of additional 122 deaths within 72 hours due to switch fro DPT to Pentavalent vaccine is not based on the scientific facts.

(d): As  per  the Adverse  Event  Following  Immunization  (AEFI)  surveillance  system reporting  received  from  various  States/UTs, there  has  been  no  spike  in  deaths  following immunization in 2017 as compared to 2016 and 2015. As per reports available (as on March 2018) 355 AEFI deaths were reported in 2017 compared to 345 deaths in 2016 a nd 311 deaths in 2015.

(e)& (f): An  independent  study has  beenconducted  by  INCLEN  in  partnership  with Ministry of Health & family Welfare, Government of India and Departments of Health & family Welfare ,Government of Tamil Nadu and Kerala .The studytr acked 30,688 infants who received 3 - primary doses of Pentavalent vaccine at 1.5 months, 2.5 months, 3.5 month and demonstrated that there is no increase in the death and hospitalization rates reported in the first week after vaccination as compared to fou rth week after vaccin ationimplying that the pentavalent vaccine is completely safe.