Public Interest Petition (PIL) Vaccine case 8th affidavit 23/07/12

Writ Petition (Civil) No. 13698 of 2009 PUBLIC INTEREST LITIGATION

Prashant Bhushan on behalf of the petitioners


Writ Petition (Civil) No. 13698 of 2009




I, Dr. Jacob M Puliyel S/o Late Shri P. M. Mammen, Head, Dept. of Pediatrics, St. Stephens Hospital, Tis Hazari, New Delhi-110054, do hereby solemnly state and affirm as under:
1. That I am the Petitioner No. 8 in the above writ petition and being conversant with the facts and circumstances of the case, am competent to swear this Affidavit. I have also been authorized by other petitioners to file this affidavit on their behalf.

2. Petitioners had filed the above writ petition highlighting how in the absence of a rational evidence-based vaccine policy, newer and newer vaccines are being pushed into the public health system at the behest of pharmaceutical industry and international bodies like World Health Organization (WHO). Petitioners had specifically challenged the proposed introduction of Pneumococcal, Hepatitis B, Hib and Pentavalent vaccines into the country’s Universal Immunization Programme.

3. Petitioners have filed an application (C.M. 18416/2011) putting on record the disturbing developments and seeking specific directions pursuant to the earlier orders of this Hon’ble Court passed in the above proceedings. This Hon’ble Court was pleased to issue notice on the above application. The Government of India then filed its response to the said application. Petitioners had then in February 2012 filed a detailed rejoinder to the Govt.’s response. The above facts are not being detailed herein for the sake of brevity. Petitioners are filing this supplementary affidavit to bring on record some of the developments that have occurred over the last few months.

4. Given the evidence provided to this court of how the NTAGI had recommended the vaccine without taking into consideration the evidence from a multi-centre study done by the ICMR, and several instances of sudden unexplained deaths within 48 hours of receiving Pentavalent vaccine in neighboring countries (Bhutan, Sri Lanka, Pakistan, Japan), the Government promised to set up an ‘Expert committee’ to re-evaluate its decision to introduce Pentavalent vaccine in the country.

5. After this re-evaluation the NTAGI, in revised its recommended (Minutes 26 August 2010): “As the vaccine has not been introduced there is not enough data on vaccine safety therefore the vaccine should be initially used in the states with better AEFI management and surveillance system to monitor the vaccine safety” The NTAGI noted that the Government appointed ‘Core committee’ had “felt that the vaccine should be introduced in selected few well performing states and further roll out should be based on the impact assessment of the vaccine including safety aspects…’ The final NTAGI recommendation was “Pentavalent vaccine is to be introduced in Immunization programme in the states of Tamil Nadu and Kerala. Thereafter data may be reviewed after 1 year of introduction before expanding the vaccine to other states.” It is thus evident that AEFI (Adverse Effects Following Immunization) was a serious concern of the Expert Committee, the Core Committee and the NTAGI, and therefore the need to strictly monitor the AEFI in the above 2 states.

6. But the Government in its counter had vouched for the safety and efficacy of the Pentavalent vaccine without the “study” underway in 2 states is even complete. In its affidavit Government said that the study is being conducted “to dispel the fear of increased AEFI due to Pentavalent vaccine unnecessarily created, perpetuated by petitioner 8.” This shows that Government has prejudged the issue and is also not interested in monitoring the after-effects of the administration of vaccine on children in 2 states at huge cost to the public exchequer. Petitioners had shown in their rejoinder that Government has completely ignored serious reports of deaths and adverse side-effects of Pentavalent in countries like Japan, Sri Lanka, Bhutan and Pakistan.

7. After this petition was filed, the Government of India developed a Standard operating procedure for AEFI. Relevant pages of the SOP are annexed as Annexure A. It details that the Brighton Classification of AEFI must be utilized for uniform reporting. It lists seizures within 3 days, Hypotonic hypo responsive episode (HHE) within 24 hours and Encephalopathy within 3 days as ‘Serious Side Effects’ of DPT vaccine (one of the components of the Pentavalent vaccine). It further states that there would be 570 cases of Seizure, 570 cases of HHE and 20 cases of encephalopathy per 1 million doses of the DPT. The SOP explicitly states that ANMs, HAs and other field level health workers and Medical Officers of Primary Health Centers MO(PHC) should follow-up all children and mothers they vaccinated during the next vaccination session or follow-up field visits (or post and ante-natal visits), to monitor the occurrence of any AEFI.

8. The decision to introduce the vaccine in Kerala resulted in agitations across the state against the vaccine. The Government of Kerala set up an expert Group under Dr Noel Narayanana to look into the matter. The Noel committee recommendation specifically states that all vaccinated children are to be monitored for any adverse events at least 48 hours following vaccination. A copy of the said report is annexed as Annexure B. Therefore the NTAGI, the Government’s SOP on AEFI and the Dr. Noel Committee Report for introduction of Pentavalent vaccine, all demand that every child who was vaccine is followed up for side effects and possible death. The SOP clearly gives the rate of serious side effects with DPT – a component of Pentavalent vaccine. If ‘no serious side effects’ are noted with Pentavalent vaccine, it is an indicator of the poor quality of surveillance.

9. By various reports it appears there have been at least 7 deaths following pentavalent vaccine. 1 death was reported in the Noel committee report before the government programme started in Mallaparum district. 4 other deaths were reported in the first 2 months of introducing the vaccine in Kerala. 2 deaths are reported from TN making the total of 7 deaths. Given that the surveillance is so poor, that not one case of serious side effects like Seizures and HHE was recorded, it is likely that the 7 deaths is an underestimation of the problem. As vaccines are a special group of drugs given to health children to prevent illness, according to the US FDA, thus vaccine safety is paramount. Thus not even 1 death is acceptable from immunization. An article on this published in Annals of Medicine is annexed as Annexure C. Response received under RTI showing that serious side-effects are not being noted is annexed as Annexure D. News reports and articles on the above issue are annexed as Annexure E (Colly). Petitioner No. 8 who is also a Member of NTAGI had written to the Health Secretary on this issue. His letter dated 10.04.2012 is annexed as Annexure F.

10. The Government should therefore be instructed to follow its own SOP and record side effects from each child vaccinated after 48 hours as per the Noel report. Any child who was vaccinated but cannot be traced must be recorded. It is only then that an accurate picture of the safety of the vaccine can be obtained. This was the purpose for which the NTAGI instructed that the vaccine be trialed in 2 well performing states of Kerala and Tamil Nadu which have good surveillance systems in place. In the remaining 6 months the government must be instructed to collect the data as prescribed in its SOP and the Noel Committee and present it to the court.

11. In spite of the explicit instructions of the NTAGI that the benefits and harms of Pentavalent vaccine must be studied in 2 states for a year before it is introduced to other states it is proposed to introduce it in 6 states starting in October 2012 well before the data from the 1 year trial is over. According to documents obtained under the RTI, GAVI had threatened to withdraw a grant of US$ 118 500 000 (Rs 529.93 crores). Document received under RTI is annexed as Annexure G. To obtain this grant the country will have to be spent Rs 1372.60 crores. In contrast, the basic immunization programme against 6 killer disease costs less than Rs 600 crores and over 40% of the population does not receive these basic vaccines. This seems to be a blatant attempt to foist the vaccine on the country in the face of the mounting deaths related to the vaccine. Counsel for the petitioner had also written to the Health Secretary in this regard. The said letter dated 20.04.2012 is annexed as Annexure H.

12. This Court in the instant case had directed the Government to formulate a rational evidence based vaccine policy. Thereafter a policy that was not even approved by NTAGI and was not in tune with the spirit of the orders of this Hon’ble Court was prepared and published by the Government. An article published in Current Science by two prominent experts in this regard is annexed as Annexure I. The petitioners have challenged the policy in the form of an application in this case. This Hon’ble Court was pleased to issue notice on that application vide its order dated 30.11.2012.

13. Thereafter, the Government has stated that the said policy is only a draft and has placed the said draft before NTAGI. Minutes of the NTAGI meeting dated 18.05.2012 are annexed as Annexure J. NTAGI members can give comments and others can also send in their suggestions. Pursuant to this petitioner no. 8 (Member of NTAGI) had written to NTAGI on the draft policy. His submissions are annexed as Annexure K. Submission made by Jan Swasthya Abhiyan which is a network of over 20 health organizations are annexed as Annexure L. That is indeed a welcome step, but the entire exercise should be done in a time-bound manner, because otherwise we are back to the old situation of no policy.


I, the deponent above-named, do hereby verify that the contents of the above affidavit are true to my knowledge, no part of it is false and nothing material has been concealed therefrom.
Verified at New Delhi on 23rd day of July 2012.