Public Interest Petition (PIL) Vaccine case 5th affidavit 5/5/11
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
Writ Petition (Civil) No. 13698 Of 2009
PUBLIC INTEREST LITIGATION
IN THE MATTER OF:
DR. K. B. SAXENA & ORS. …PETITIONERS
VERSUS
UNION OF INDIA & ORS. …RESPONDENTS
SUPPLEMENTARY AFFIDAVIT ON BEHALF OF THE PETITIONERS
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 have 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 have specifically challenged the proposed introduction of Pneumococcal, Hepatitis B, Hib and Pentavalent vaccines into the country’s Universal Immunization Programme.
3. National Technical Advisory Group on Immunization (NTAGI) is the apex advisory group on vaccination and immunization for Universal Immunization Programme (UIP). Petitioner No. 8 was inducted as a Member of the said group during the pendency of the instant petition. The proceedings and the minutes of NTAGI meeting exemplifies clearly the reasons for which the petitioners came to court – how irrational expensive vaccines are being introduced in the public health system by the Government, without proper epidemiological and medical studies in a country where needed inexpensive vaccines are being denied to 50% of the population. Decisions are made before-hand based on extraneous considerations. Data is provided only to give it a veneer of objectivity. When such data if shown to be wrong, other equally fanciful data is provided but the determination to introduce the vaccine persists. The NTAGI had previously recommended universal immunization with the Pentavalent vaccine. But then it was pointed out to this court that the data from a multi-center study done by the Government of India was deliberately left out because it did not support the need for the vaccine. After this the Government set up an ‘Experts Group’ to look at this and followed it with a ‘Core Committee’ recommendation After all this, the NTAGI met on 26 August 2010. The NTAGI again recommended introduction of Hib and Hepatitis B vaccine in 2 states but now gave different reasons and quoted other data. The new ‘evidence’ is as fallacious as before and this has been clearly pointed out to the Government in a presentation to the Planning Commission. A copy of the presentation made to the Planning Commission is annexed as Annexure A.
4. The numbers benefiting (deaths avoided by vaccination) from Hepatitis B was based on ‘personal communication’ from Prof Acharaya of AIIMS Dept of Gastroenterology. Professor Acharaya is now being investigated by the Society for Scientific Values. He claimied to have done liver biopsies on all Hepatitis B carrier patients going to AIIMS over one and a half years. Such an invasive and potentially lethal investigation on all patients would be gravely unethical. One can surmise that Dr Acharaya wanted to project the data of patients going to him in the Gastroenterology Unit on the whole population of India. It must be for this reason, he stated that liver biopsy was done in all patients (consecutive patients) going to AIIMS. The figure of 3 lakh cases of cirrhosis a year in the country is based on this fiction.
5. Other than this the only other data on deaths averted nationally by Hepaptitis vaccination that is presented is ‘22238 cases of Hepatocellular Carcinoma from the ICMR cancer registry. Here again the figure has been exaggerated by over 200%. The correct figure from the ICMR cancer registry is 10,000.
6. In the same way the recommendation for Hib vaccine was made on the projection that 52000 cases of Hib meningitis occur in the country each year. The projection for the whole country is made from 9 cases of ‘presumed Hib meningitis’ in one year in one district in Kerala! The same paper which reported 9 ‘presumed Hib’ also reported 3 presumed Hib in the same district in the next year. No explanation is given of why this figure was not used for making national predictions. Selective use of data flies in the face of the basic tenets of ‘Evidence Based Medicine’. The numbers needed to vaccinate to prevent one death is crucial to make informed decisions on the cost benefit of introducing a new vaccine. The fanciful figures that were used in the ‘expert committees recommendation’ and the NTAGI recommendation, supports the contention of the petitioners that the vaccine is being introduced at the behest of various vested interests without clear evidence that it will be useful or that it is needed.
7. The procedure of selection to NTAGI and the processes followed at the meeting was witnessed by Petitioner No. 8 who was inducted into the NTAGI without any examination of his credentials - based perhaps on the basis of the fact that he is a petitioner in this case. A request by the petitioner to have the proceedings recorded, so that members can be held accountable for what they say, was denied on the grounds that members would not voice their views freely if it were recorded. No explanation was given why members on a vaccine advisory group may need secrecy for the recommendations they make.
8. The wisdom of denying the request of recording was plain when the minutes of the meeting were circulated. The minutes are manipulated to selectively quote members statements as consensus statements.
9. The NTAGI resolved that Petitioner No. 8 must help Dr N K Ganguly to draft the Vaccine Policy. This was recorded as such in the first draft of the minutes circulated to members and attached. A copy of the draft minutes is annexed as Annexure B. The name of Petitioner No. 8 was removed in the final version of the minutes in blatant violation of the expressed wishes of the NTAGI. A copy of final version of the minutes is annexed as Annexure C.
10. The objections to the policy have been raised and it shows why the author of the minutes was keen to exclude the Petitioner no. 8 from the drafting. The NTAGI according to the original minutes was due to meet in 1 month (in September). The final minutes had to be passed at this meeting. A call for such a meeting has not been made even till date (May 2011). Similarly member’s suggestions on the draft Vaccine Policy were to be incorporated before it was brought to the NTAGI. It is improper on part of the Government to present “draft policy” to this Hon’ble court without incorporating suggestions of NTAGI as promised.
11. The petitioner has pointed out numerous flaws with the draft policy which was presented to this Hon’ble court. The main objection to the said policy is that while it maintains that decisions on vaccination and immunization should be guided by disease burden, surveillance, date etc. but contradicts itself elsewhere by recommending specific vaccines without any such qualifying data. A copy of the response made by Petitioner No. 8 to the policy drafted by Dr. Ganguly is annexed as Annexure D.
12. The petitioners had drawn attention of this Hon’ble court to the deaths from Pentavalent vaccine in Sri Lanka. The Government provided the Court with a report about these deaths to say that deaths were investigated and were found not to be related to the vaccine. Petitioners had highlighted how the standard classifications of adverse effects were changed so that reactions which should have been classified as ‘probably related’ were classified as ‘unlikely’ as ‘probably related’ was deleted as a classification itself. WHO has now stated that it still stands by its full standard classification. An interview given by WHO representative to Times of India is annexed as Annexure E. The draft policy on the other hand uses the watered down version as if side effects and deaths from the vaccine are not of any importance. The same ToI correspondent draws attention to numerous deaths from vaccines and that many expert committees has been set-up to investigate them. None of these expert committees have ever submitted a report.
13. It must be mentioned that there were 4 deaths in Lucknow on 22.08.2010. Some newspapers suggested that Pentavalent vaccine was used there. A copy of the report published in The Hindu is annexed as Annexure F. The petitioner asked the Government under RTI of the vaccines used in the children who died but this information was denied on the ground that an FIR has been registered and the matter is under investigation. A copy of the RTI reply is annexed as Annexure G.
DEPONENT
VERIFICATION
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 day of May 2011.
DEPONENT
Beguiling Half Truths and Vaccine Policy
A number of new vaccines have been introduced in the international market. Many of these are being recommended for the immunization schedule in the country. Notable among them are:
1. Pentavalent vaccine (DPT + Hepatitis B + Hib),
2. Pneumococcal conjugate vaccine
3. Rotavirus vaccine
Half truths are being deployed to convince policy makers. Below are 4 examples of the half truths that are used by vaccine manufacturers and persons lobbying on their behalf. According to the Marrian Webster definition, a half truth is a deceptive statement that includes some element of truth. The statements are partly true, or the statement may be totally true but only part of the whole truth and they are used with intend to deceive or to misrepresent the truth.
1. The Million Death Study by Prabath Jha suggest that pneumonia and diarrhoea are responsible for 24.5% of the death of children 1-59 months in India. “Addition of vaccines against pneumonia (pneumococcal conjugate , Haemophilus influenza type B) and diarrhoeal diseases (rotavirus) to outreach home-based immunization programmes would reduce child deaths,” says the study published in the Lancet (Lancet 2010;376:1853-60)
2. “Even though a safe efficacious and cheap Hepatitis B vaccine is available and in spite of the carrier rate of around 4% in the country, the vaccine is still not part of the universal immunization programme.” Even if most carriers are asymptomatic and only 10,000 of these cases go on to develop hepatocellular carcinoma nationally, each year (ICMR data), “the cost of treating chronic hepatitis B cases will come to Rs 12 to 14 billion” (Core Committee on Vaccines: http://www.icmr.nic.in/minutes/Minutes%20Core%20Committee%20on%20Vaccines.pdf) (Treatment probably includes cost of liver transplantation for some of these patients). This huge cost justifies the cost of prevention by immunization with Hepatitis B vaccine.
3. The vaccine reduces the number of injections from 9 injections to 3 injections and reduces need for additional cold chain requirements.
4. GAVI is willing to give funds to allow the introduction of Pentavalent vaccine in India.
What is left unsaid
Diarrhoea and pneumonia are caused by a number of etiological agents and there is no vaccine against all causes of diarrhea or pneumonia that has been manufactured nor is there one anywhere in the pipeline. It is fraudulent to give the figures for diarrhea deaths and pneumonia deaths from all these causes and project pneumococcal, Hib and rotaviral vaccines (that too covering only few strains of three pathogens) as if the vaccines can prevent all cases of pneumonia and diarrhea.
The Planning Commission needs to know how many deaths can be prevented by each of these vaccines
Numbers Needed to Treat (NNT) is statistical measure of the effectiveness that can be used here. How many children need to be vaccinated so that one life is saved - the NNT of the vaccine.
How much does it cost to vaccinate one child with this new vaccine?
From this the Planning Commission can evaluate the cost per life saved and look at it against other life saving measures competing for resources.
Hepatitis B
In the past it used to be said that 250,000 people die in India each year from Hepatocellular carcinoma related to Hepatitis B. This was a good figure from which to calculate benefits from vaccination. This was the figure used by the Indian Association for study of the Liver (INSAL Ind J Gastroenterol 2000;19 (Suppl3):C54-74)) to suggest the vaccine was cost effective. The author of the ‘250,000 deaths’ figure said they had used a model ‘stratified by income group and geographic region’. However when challenged to produce the model or to retract the paper, the author wrote that his model was lost! (Miller MA Health Economics 2004;13:1147-8). The figure 250,000 deaths are now no longer used. Instead it is said that 4% of the population is carriers and that some develop Hepatocellular carcinoma.
This figure of 4% carriers is not useful to estimate NNT. Most carriers are merely asymptomatic carriers. The situation is akin to H pylori infection. 84% of the population is H pylori carriers in India. ( Joshi. J of Ind Acad Clin Med 2000;5:149-57). H pylori infection can cause acid peptic disease in some and this can sometimes lead to cancer. The fact is that the vast majority are asymptomatic carriers. No one suggests that all carriers must be treated. The 84% carrier rate with H pylori is not persuasive reasons for universal eradication of the pathogen. Neither is the 4% carrier rate with Hepatitis B a compelling reason for universal immunization with Hepatitis B vaccine.
Yet based on the carrier rate (without data on NNT) this vaccination program is being pushed, saying the vaccine is not expensive. A country that is expected to be able to vaccinate the birth cohort of 25 million babies each year, 3 times with the Hepatitis B vaccine, can easily afford to collect concrete data on NNT of the vaccine before embarking on this programme.
It is not entirely true that there are no figures on the risks of chronic liver disease among Hepatitis B carriers in India besides the ICMR Cancer Registry data. The ‘Expert group on Hepatitis’ refers to a personal communication from Dr SK Acharya of AIIMS about an unpublished study where liver biopsies were allegedly performed on all Hepatitis B carriers, who visited AIIMS between January 2008 and June 2009. (http://www.icmr.nic.in/minutes/Minutes%20Expert%20Group%20%20Hepatitis%20B%20and%20Hib%20vaccines.pdf). As such a study would have been gravely unethical to perform, one must assume there is some error in the records of this ‘Expert’s group meeting’. However it is quoted again uncritically in the Core Committee’s recommendation for Hepatitis B. (http://www.icmr.nic.in/minutes/Minutes%20Core%20Committee%20on%20Vaccines.pdf). Data from the study has not been taken into consideration in this discussion.
H influenza b (Hib)
These are a number of studies from India and also from other countries in Asia that are of relevance to India.
a) The Invasive Bacterial Infection Surveillance Group (IBIS) Study, for example, cultured only 125 cases of Hib over 4 years (in 6 large hospitals in the country). (IBIS Group Clinical Infect. Dis 2002;34:949-57).
b) The WHO sponsored prospective community study found incidence of Hib meningitis in Tamil Nadu was as low as 0.007%. (Minz Indian J Med Res 2008; 128 : 57-64). This works out to less than 8750 cases in all children under 5, nationwide. This figure of 8750 cases of Hib meningitis. Yet the Core Committee on Vaccines projects this figure as 52,000 cases of Hib meningitis. (http://www.icmr.nic.in/minutes/Minutes%20Core%20Committee%20on%20Vaccines.pdf).
c) Finally ‘Probe studies’ where Hib vaccine was given to one population and others acted as controls, showed that Hib did not reduce pneumonia in Indonesia or Bangladesh. (Indonesia: Gessner et al Lancet 2005;365:43-52. Bangladesh: Baqui Ped Infect Dis 2007;26:565-71). Gessner has categorically stated after his study, “Hib vaccine will not have a major role in efforts to reduce the overall burden of respiratory illness…..”
If the vaccine will not reduce the incidence of pneumonia (or meningitis according to the Bangladesh study) there is no justification for the cost of including the vaccine in the programme of universal immunization.
‘Core Committee on Vaccines’ makes its recommendation for inclusion of Hib, saying that Hib vaccine can prevent 52,000 cases of Hib meningitis. (http://www.icmr.nic.in/minutes/Minutes%20Core%20Committee%20on%20Vaccines.pdf). It is instructive to look at how the nationwide projection of 52,000 cases was arrived at, by the Core Committee. The figure 52,000 is based on just 9 cases of ‘presumed Hib meningitis’ seen in one district in Kerala in 1999. The same district had only 3 cases of ‘presumed Hib’ in the following year, and it was reported in the same paper, but this was not used for making nation-wide projections. (John IJMR 2004;120:86-93) No justification is given for this selective use of data. This is against the basic principles of evidence based medicine. It again reflects on the quality of the recommendations of the Core Committee.
Pentavalent Vaccine: 3 injections instead of 9
50% of the population does not receive the basic EPI vaccines against 6 diseases that together cost Rs 30.
The Pentavalent combination vaccine costs Rs 525/child. It increases the price of DPT 20 fold and adds vaccines with little utility. There is a GAVI subsidy of Rs 145 so the price comes down to Rs 380/child as long as the subsidy lasts for 5 years. The full cost of Rs 525/childwill have to be paid after that. The details of how combination vaccines piggy-back new and relatively useless vaccines, on the standard vaccines like DPT has been discussed by Madhavi in Current Science (Madhavi, 2006, Current Science).
It used to be said that when more countries begin using a vaccine the prices will come down, (by the time GAVI subsidy is withdrawn in 5 years). A study by GAVI actually found the opposite. Vaccine prices went up in the five years after GAVI subsidy was started. (Kamara L. Vaccine 2008; 26: 6717–26)
According what the ICMR has published on the Cochrane Collaboration web site, DPT vaccine in the combination vaccine (DPT + Hib + Hepatitis B) is less effective than the components given separately and the side effects are also more. (http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD008658/frame.html)
Pneumococcal vaccine
With regard pneumococcal vaccine, there is data on NNT provided in the WHO Bulletin (Madhi et al WHO Bull 2008;86). Pneumococcal vaccine reduces 4 cases of pneumonia for every 1000 children vaccinated. The vaccine costs Rs 12,000 per child and so vaccinating 1000 children costs Rs 120 lacs and this prevent 4 cases of pneumonia which can be treated with WHO recommended Co trimoxazole for Rs 40 (Dabade Lancet 2009;373:2195-6 ). Assuming the prices come down to one tenth of the present prices, it will still cost Rs 12 lacs to save Rs 40.
Rotavirus vaccine
Studies done before introduction of the vaccine in India, showed the strains prevalent in India are different from that in the vaccine and further that the strain is different in different parts of the country and there is constant re-assortment of bovine and human strains that it will be impossible to provide a vaccine for the strain in different places at different times. (Ramani IJMR 2007;125:619-32). There is not one study from India to show that vaccine reduces incidence of diarrhea in this country.
Costs in context
50% of the population doesn’t receive the basic EPI vaccines all of which together costs Rs 30/child.
• HPV costs Rs 9000/child
• Rotavirus costs Rs 2000/child
• Pneumococcal vaccine Rs 12000/child
• Pentavalent vaccine Rs 525/child
We are told that investment in new vaccine will automatically improve uptake of the basic vaccines. This is of course reminiscent of what was told about investment in polio eradication – that it will magically improve overall immunization rates but what happened actually was that universal immunization fell from over 60 - 70% to less than 50% in the ensuing 10 years. There is a surge in the incidence of deaths due to diphtheria which is prevented by DPT vaccine. There are no real advocates asking to make sure the basic vaccines are available to the un-reached 50% of the population. Many of the challenges for the 12th plan for better health can be met by provision of clean water, sanitation and nutrition. There are no short cuts or magic bullets and vertical single disease vaccination programs are not the way forward.
Other Asian countries like Japan and China that have an independent method to evaluate costs and benefits of vaccines have all rejected introduction of these Hib and Hepatitis B vaccines in their country.
Half Truths The rest of the facts
24.5% U5MR due to pneumonia and diarrhea so pneumococcal, Hib and rotavirus vaccines must be introduced. There is no vaccine against all causes of diarrhea or pneumonia (and the available vaccines have not been shown to reduce pneumonia or diarrhea)
4% of the population is Hepatitis B carriers and a relatively inexpensive vaccine is available so Hepatitis B vaccine must be used. 1. Asymptomatic carriers come to no harm usually.
2. We need to know NNT for lives saved by vaccine. The Cancer Registry data is the best we have.
3. The AIIMS study reported by the ‘Expert group on Hepatitis’ seems seriously flawed ethically, as not to merit consideration.
Pentavalent (5-in-one) vaccine must be introduced for its programmatic convenience:
3 injections instead of 9 1. Combination vaccine jacks up cost of DPT 20 fold. The additional vaccines have little utility.
2. The combined vaccine is less effective according to the ICMR.
GAVI will pay 1. Cost of vaccination goes up from Rs 30 per child to over Rs 525/child.
2. Of this, GAVI pays only Rs 145, and that for 5 years only.
3. 50% of India don’t receive the currently mandated vaccines that all together costs only Rs 30/child.
1. We are concerned that these new vaccines will swallow up funds so crucial for real achievements of the 12th Challenge.
2. We would like to plead that the EPI vaccine coverage be increased to near 100%
3. No new vaccines be introduced without proper cost benefit assessment or scientific rationale justifying the costs.
4. We would welcome universal introduction of newer vaccines that are efficacious and cost effective and request funding for research in this area.
5. Adequate resources need to be provided so the public sector could supply good quality, life saving vaccines, adequate for the countries needs, to insure against the vagaries of supply and costs (as when the programme is entirely dependent on private players).
6. From a governance standpoint, it will be worthwhile to investigate how misleading errors have crept into the recommendations of the Core Committee on Vaccines.
Jacob Puliyel MD MPhil
Head of Pediatrics
St Stephens Hospital
Delhi 110054
puliyel@gmail.com
Professor S. K. Mittal MD
Director of Pediatrics at Pushpanjali Crosslay Hospital.
Former Head of Pediatrics Department
Maulana Azad Medical College, Delhi.
Formerly Member of Medical Council of India
skmittal44@yahoo.com.
Phone 9818372811
Dr Mira Shiva MD
Founder Coordinater All India Drug Action Network
Member, Central Social Welfare Board, Government of India
A-60 Hauz Khas New Delhi 110016
mirashiva@gmail.com
Phone 9810582028
Professor K B Saxena
Former Union Health Secretary
Council for Social Development
53 Lodhi Estate
New Delhi
saxenakb2@gmail.com
Phone 246926655, 24693065 (Council for Social Development).
Professor N J Kurian
Former Advisor to Finance Ministry & Planning Commission
Council for Social Development
53 Lodhi Estate
New Delhi
njkurian@yahoo.com
Phone 9871595816
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
Minutes of Meeting
The meeting of National Technical Advisory Group on Immunization was held on 26th August 2010 chaired by Secretary (H&FW) and co-chaired by Secretary (DHR) & DG (ICMR). The list of participants is annexed.
The meeting started with a welcome note by Secretary (H&FW) who highlighted the fact that NTAGI has been reconstituted with representation from the specialist from Paediatrics, Public Health, Researchers, program division etc to encourage healthy technical discussions in an open and transparent manner.
On suggestion for audio-recording of the proceedings, the house felt that NTAGI should be a forum where the technical experts can provide inputs in an open and free manner; and such recording might preclude such open discussions. Further it was agreed to circulate the detailed minutes of the proceedings at the earliest.
Secretary (H&FW) also expressed concern at the recent incident of Adverse Event Following Immunization (AEFIs) in UP and its significance in view of the introduction of newer vaccines and therefore urged the NTAGI to consider such issues while recommending new vaccines under the National Program.
The key recommendations of last NTAGI meeting held on 3rd Aug’09 and action taken note was presented. Thereafter the meeting deliberated on the agenda items.
Agenda Item1- Introduction of Pentavalent vaccine
The house was informed that Hib vaccine has been introduced in 137 countries of the world and out of these the vaccine is part of the programme as Pentavalent vaccine in 56 countries and remaining countries use Hib vaccine in different combination. There are multiple studies providing data in support of Hib vaccination. The studies like Million Death Study by Dr Prabhat K Jha et al and on status of Millennium Development Goal (MDG) by Prof V. K. Paul et al have raised the concern on continued burden of lower respiratory illness as one of the major cause of child mortality and morbidity, thereby precluding achievement of the MDG goals. Dr. Ganguly mentioned that there have been various studies from Lambok (Indonesia), Bangladesh, Sri Lanka, Myanmar and Pakistan on efficacy of Hib vaccine. Further Cochrane review also strengthens the fact that vaccine is efficacious in reducing morbidity and mortality burden due to Hib pneumonia and meningitis. Dr. Jacob Puliyel pointed out that this contradicts what has been published in BMJ & IJMR which showed that there was no statistical difference between those vaccinated and the non- vaccinated.
The house also deliberated upon as to why some of the developed countries are not using Hib combination vaccine as Pentavalent vaccine while it is being used in developing countries. In response, various experts cited that the different situation in immunization delivery system in developed and developing countries as one of the reasons for adopting Pentavalent vaccine. As introduction of newer vaccine in developing countries is always a challenge to cold chain with weaker immunization delivery systems therefore Pentavalent vaccine is preferred which provides operational advantages - one vaccine conferring protection against five diseases, with no change in immunization schedule thus no needs for beneficiary to approach health facility at different time interval , saves cold-chain space and logistics. While in developed countries, the vaccine schedule is different based on local epidemiology, market dynamics and also influenced by Advisory Committees on Immunization. Also these developed countries are using DTaP, (having acellular Pertussis vaccine which is costlier as compared to DTP containing whole cell pertussis vaccine), where combination vaccine has reduced seroconversion. In addition these developed countries are using Hib and Hep-B vaccine. The pentavalent vaccine used in the developing countries are combination of Hepatitis B, Hib and DPT (having whole cell Pertussis vaccine).
In the ensuing discussion, concern was raised regarding the safety and efficacy of the Pentavalent vaccine in view of the AEFIs reported following usage of this vaccine in Sri Lanka, Bhutan and Pakistan. The vaccination in Sri Lanka and Bhutan was stopped following these incidents of AEFI, however, after investigation; Srilanka has resumed vaccination in 2010 and Bhutan have decided to resume the Pentavalent vaccination. The available reports published by WHO have concluded that these events are unlikely due to Pentavalent vaccine, some of the members felt that the complete report of these incidents should be accessed for analysis. Keeping in view the number of children vaccinated in these countries, the background rate of these AEFI may not be significant and the benefit gain may not have raised alarm to stop vaccination. As the vaccine has not been introduced in India, there is not enough data on vaccine safety therefore; vaccine should be initially used in the states with better AEFI management and surveillance systems to monitor the vaccine safety. The house was of unanimous opinion on the use of Hib vaccine, but few members had reservations about using the formulation combination vaccine of Pentavalent vaccine. The house considered that lives saved by the Pentavalent vaccine far outnumber the few AEFI deaths reported in the neighbouring countries and therefore has favourable risk-benefit ratio. However Dr. Puliyel said that if Hib vaccine was to be introduced to look for utility, it may be introduced as a standalone vaccine.
The house also deliberated upon the immunogenicity of combination vaccines and it was felt that the available evidence based on Cochrane review reveals that although there is reduced immunogenicity of some of the components of vaccine when compared to given separately, this reduction in sero-conversion is not significant enough to affect protective levels of antibodies.
The Core Committee recommendations on Pentavelant Vaccines were discussed and based on the recommendations the committee members felt that vaccine should be introduced in selected few well performing states and further roll-out should be based on an impact assessment of vaccination including safety aspects. The house also discussed the selection of states for studying the impact of Pentavalent vaccine introduction. Though some of the northern states are having high burden of Hib disease, the introduction in these states with poor coverage would not be able to demonstrate significant impact and also these states have poor monitoring of AEFI. Further, the introduction of newer vaccine requires good delivery systems and some of the states with high vaccination coverage like Tamil Nadu and Kerala may be selected. The house also considered the options of limited introduction of the vaccine in the hospitals (rather than in outreach sessions) or in selected districts; however it was felt that this would not provide the sufficient sample size to study the impact of the vaccine.
It was stressed that clinical trials for impact assessment is difficult in view of the large sample size that would be required and high cost that would be incurred for such study. It was pointed out that data from Hib probe study by ICMR is available for some of the areas in Tamil Nadu which can be taken as baseline data and will facilitate the study of post-vaccination impact. In the ensuing discussion the house was informed that vaccine is already available in private sector in many parts of the country and has brought about decline in cases of Hib disease over a period as observed in PGI Chandigarh, though the private vaccination does not contribute much in the National scenario.
Recommendations:
• Pentavalent vaccine 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 into other states.
• A protocol will be prepared by the ICMR for surveillance of Hib meningitis in selected hospitals to understand the trend over time. This will be circulated to NCDC and NTAGI members through email; once the protocol is finalized, the surveillance will be carried out by ICMR.
• Since AEFI is a concern hence same will be monitored and also system will be strengthened so as to ensure immediate management of AEFIs; NCDC to lead this activity.
Agenda Item 2- Introduction of Hepatitis B vaccination
The house discussed expansion of Hepatitis B vaccine in the entire country under immunization programme. It was pointed out that even though safe, efficacious and cheap Hepatitis B vaccine is available and in spite of carrier rate of around 4% in India the vaccine is still not part of Universal Immunization programme although all the countries have been using this vaccine under the national programme. This vaccine is manufactured in the country and exported to many countries. There have been enough data showing impact of Hepatitis B vaccination on disease burden due to hepatitis B infection like acute hepatitis, as well as its long term sequel like chronic hepatitis, cirrhosis and liver cancer. Therefore it is high time that this vaccine is introduced all over the country at the earliest. Over the period the cost of the Hepatitis B vaccine has dropped and is one of the cheaper vaccine available in the market.
As the vaccinated cohort is only protected, any change in morbidity and mortality would take 10-15 years to be detected. However, the impact assessment on carrier rate may be carried out and the house was informed that ICMR has already initiated a study for the same. It was also brought to notice that there may be possibility of escape mutation of hepatitis B virus and this may also be monitored.
The experts also stressed that it is critical to give the vaccine at birth to cut down the vertical transmission and to impact the carrier rate. The house was informed that under the immunization programme of Hepatitis B in the selected States/Districts/Cities the Hepatitis B vaccine is given at birth (in institutional deliveries) and thereafter at 6th, 10th and 14th week of age of the child. The Janani Suraksha Yojana (JSY) has been launched to improve institutional delivery and this may further boost the coverage of Hepatitis B vaccination at birth.
Recommendation
• In view of the disease burden and availability of safe and efficacious vaccine, the expansion of Hepatitis B vaccine should be carried out all over the country as part of Universal Immunization Programme. Before rolling out in newer areas there should be a plan for trainings, microplanning etc.
• Simultaneously, multi-centric impact study on carrier rate of hepatitis B will be conducted by ICMR.
Agenda Item 3- Introduction of Rubella vaccination
The house deliberated upon the risks and benefits of introduction of rubella vaccine in the immunization programme. If the vaccine is introduced in form of MR and targeting to vaccinate children at 16-24 months of age, then it is critical to ensure coverage above 80% failing which the rubella will shift to older age group of susceptible cohort and this may lead to paradoxical increase in congenital rubella syndrome (CRS). The manufacturing capacity and availability of MR and rubella vaccines are need to be considered before introducing the Rubella vaccination in the National programme.
In view of the above, the house felt that Rubella vaccine may be introduced in adolescent girls of 10-15 year old so that those who have not acquired the natural immunity due to infection are also protected. This would reduce the risk of getting this infection during the pregnancy and thereby reduce CRS cases.
Recommendation
• The NTAGI recommended the introduction of rubella vaccination for 10-15 year old adolescent girls under the Universal Immunization Programme in the entire country.
Agenda Item 4- Draft Multi Year Strategic Plan 2010-17 for UIP
The house was unanimous that there is need for a Multi-year strategic Plan 2010-17 for UIP. The document does not comprehensively address Vaccine preventable disease surveillance; some of the points at page 58 in the document for setting up a new body with development partner to review, utilized information for deciding introduction of new and under-utilized vaccine were objected and house felt that this draft needs editorial corrections before any further discussion.
Recommendation:
• The draft MYP is to be revised for further discussion.
Agenda Item 5- National Vaccine Policy
Secretary (H&FW) raised the need for a national vaccine policy and NTAGI unanimously agreed to the suggestion. There have been some attempts in drafting vaccine policy earlier, also a regional vaccine policy has been developed by WHO recently which may be used for developing this draft.
The need for a National Immunization Authority was also felt as the current technical structure of only 3 technical officers managing the immunization programme in the entire country like India is a daunting task. In this regard, the house was informed that IIM-Ahmedabad is conducting a study on the HR structure required for immunization programme in the country; it was felt that this study should be expedited.
Recommendation
• Dr. NK Ganguly, Ex-DG, ICMR agreed to draft a National Vaccine policy. Thereafter the policy document will be circulated to all members for their inputs before the final draft is discussed in the NTAGI meeting.
Secretary (H&FW) also suggested members to suggest names of more experts to prepare broad contours of composition of NTAGI so that the terms of reference for NTAGI may be suitable amended including memberships. Dr. Jacob Puliyel suggested that appointment of members may be for two years and it must be specified that no person can serve more than three terms (except for Ex-officio appointments). For institutional memory, one third of the members must be replaced every two years. It was also suggested that the committee should also have experts from the background of statistics, economist and public health nurse
The meeting was concluded with vote of thanks. The NTAGI is to meet again after 1 – 2 months.
Annexure
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
1. Chairperson : Ms. Sujatha Rao, Secretary, Health & Family Welfare, Govt. of India
2. Co-Chairperson : Dr. V.M Katoch, secretary, (Department of Health research), Govt. of India & director general, ICMR,
List of Participants
1. Prof. (Dr.) M. K. Bhan, Secretary (Department Bio-technology)
2. Dr. R. K. Srivastava, Director General Health Services
3. Mr. P. K. Pradhan, Additional Secretary & Mission Director, NRHM
4. Mr. Amit Mohan Prasad, Joint Secretary, RCH programme
5. Dr. N.K. Ganguly - Ex DG, ICMR
6. Prof. (Dr.) V. K. Paul, Prof.& Head, Dept. of Pediatrics, AIIMS, New Delhi
7. Dr. N. K. Arora, Paediatrician, & ED, INCLEN
8. Prof. (Dr.) A. P. Dubey, Head, Dept of Pediatrics, MAMC
9. Prof. (Dr.) Rajesh Kumar, Prof. & Head School of Public Health, PGIMER, Chandigarh
10. Dr. J. Pulliyel, Head, Deptt. of Pediatrics, St. Stephen's Hospital, Delhi
11. Dr. Shahid Jameel, Prof. of Virology, ICGEB, New Delhi
12. Dr. Sudhanshu Vrati, Dean, THSTI, Faridabad.
13. Dr. R. L. Icchpujani, Director, National Centre for Disease Control, Delhi
14. Dr V. G. Somani, Dy. Drugs Controller (India), CDSCO
15. Dr. A. C. Bannerjea, Staff Scientist, National Institute of Immunology
16. Dr Shyam Kukreja, Executive Director, Indian Academy of Paediatrics
17. Dr Henri van den Hombergh, Chief, Health, UNICEF, India office
18. Dr. Satish Gupta, Health Specialist(Immunization), UNICEF
19. Dr. Sangey Thinley, WHO Representative (Act), India office
20. Dr. Hamid Jafari, Project Manager, WHO-NPSP
21. Dr. Pradeep Haldar, Assistant Commissioner, (UIP)
22. Dr. N. K. Dhamija Assistant Commissioner,(I)
23. Dr. V. K. Mishra, SMO(Immunization)
24. Dr. Siddhartha Saha, Consultant, Immunization
25. Dr. Ajay Khera, Deputy Commissioner, member secretary
Annexure
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
3. Chairperson : Ms. Sujatha Rao, Secretary, Health & Family Welfare, Govt. of India
4. Co-Chairperson : Dr. V.M Katoch, secretary, (Department of Health research), Govt. of India & director general, ICMR,
List of Participants
26. Prof. (Dr.) M. K. Bhan, Secretary (Department Bio-technology)
27. Dr. R. K. Srivastava, Director General Health Services
28. Mr. P. K. Pradhan, Additional Secretary & Mission Director, NRHM
29. Mr. Amit Mohan Prasad, Joint Secretary, RCH programme
30. Dr. N.K. Ganguly - Ex DG, ICMR
31. Prof. (Dr.) V. K. Paul, Prof.& Head, Dept. of Pediatrics, AIIMS, New Delhi
32. Dr. N. K. Arora, Paediatrician, & ED, INCLEN
33. Prof. (Dr.) A. P. Dubey, Head, Dept of Pediatrics, MAMC
34. Prof. (Dr.) Rajesh Kumar, Prof. & Head School of Public Health, PGIMER, Chandigarh
35. Dr. J. Pulliyel, Head, Deptt. of Pediatrics, St. Stephen's Hospital, Delhi
36. Dr. Shahid Jameel, Prof. of Virology, ICGEB, New Delhi
37. Dr. Sudhanshu Vrati, Dean, THSTI, Faridabad.
38. Dr. R. L. Icchpujani, Director, National Centre for Disease Control, Delhi
39. Dr V. G. Somani, Dy. Drugs Controller (India), CDSCO
40. Dr. A. C. Bannerjea, Staff Scientist, National Institute of Immunology
41. Dr Shyam Kukreja, Executive Director, Indian Academy of Paediatrics
42. Dr Henri van den Hombergh, Chief, Health, UNICEF, India office
43. Dr. Satish Gupta, Health Specialist(Immunization), UNICEF
44. Dr. Sangey Thinley, WHO Representative (Act), India office
45. Dr. Hamid Jafari, Project Manager, WHO-NPSP
46. Dr. Pradeep Haldar, Assistant Commissioner, (UIP)
47. Dr. N. K. Dhamija Assistant Commissioner,(I)
48. Dr. V. K. Mishra, SMO(Immunization)
49. Dr. Siddhartha Saha, Consultant, Immunization
50. Dr. Ajay Khera, Deputy Commissioner, member secretary
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
Minutes of Meeting
The meeting of National Technical Advisory Group on Immunization was held on 26th August 2010 chaired by Secretary (H&FW) and co-chaired by Secretary (DHR) & DG (ICMR). The list of participants is annexed.
The meeting started with welcome note by Secretary (H&FW) and highlighted the fact that NTAGI has been reconstituted with representation from the specialist from Paediatrics, Public Health, Researchers, program division etc to encourage healthy technical discussions in an open and transparent manner.
On suggestion for audio-recording of the proceedings, the house felt that NTAGI should be forum where the technical experts can provide inputs in an open and free manner; and such recording might preclude such open discussions.
Secretary (H&FW) also expressed concern at the recent incident of Adverse Event Following Immunization (AEFIs) in UP and its significance in view of the introduction of newer vaccines and therefore urged the NTAGI to consider such issues while recommending new vaccines under the National Program.
The key recommendations of last NTAGI meeting held on 3rd Aug’09 and action taken note was presented. Thereafter the meeting deliberated on the agenda items.
Agenda Item1- Introduction of Pentavalent vaccine
The house was informed that Hib vaccine has been introduced in 137 countries of the world and out of these the vaccine is part of the programme as Pentavalent vaccine in 56 countries and remaining countries use Hib vaccine in different combination. There are multiple studies providing data in support of Hib vaccination. The studies like Million Death Study by Dr Prabhat K Jha et al and on status of Millennium Development Goal (MDG) by Prof V. K. Paul et al have raised the concern on continued burden of lower respiratory illness as one of the major cause of child mortality and morbidity, thereby precluding achievement of the MDG goals. There have been various studies in Lambok (Indonesia), Bangladesh, Sri Lanka, Myanmar and Pakistan on efficacy of Hib vaccine. Further Cochrane review also strengthens the fact that vaccine is efficacious in reducing morbidity and mortality burden due to Hib pneumonia and meningitis. Although, there was a difference of opinion in interpretation of findings of Lambok study, citing that the difference between those vaccinated and non-vaccinated is not significant.
The house also deliberated upon as to why some of the developed countries are not using Hib combination vaccine as Pentavalent vaccine while it is being used in developing countries. In response, various experts cited that the different situation in immunization delivery system in developed and developing countries as one of the reasons for adopting Pentavalent vaccine. As introduction of newer vaccine in developing countries is always a challenge to cold chain with weaker immunization delivery systems therefore Pentavalent vaccine is preferred which provides operational advantages - one vaccine conferring protection against five diseases, with no change in immunization schedule thus no needs for beneficiary to approach health facility at different time interval , saves cold-chain space and logistics. While in developed countries, the vaccine schedule is different based on local epidemiology, market dynamics and also influenced by Advisory Committees on Immunization. Also these developed countries are using DTaP, (having acellular Pertussis vaccine which is costlier as compared to DTP containing whole cell pertussis vaccine), where combination vaccine has reduced seroconversion. In addition these developed countries are using Hib and Hep-B vaccine. The pentavalent vaccine used in the developing countries are combination of Hepatitis B, Hib and DPT (having whole cell Pertussis vaccine).
In the ensuing discussion, concern was raised regarding the safety and efficacy of the Pentavalent vaccine in view of the AEFIs reported following usage of this vaccine in Sri Lanka, Bhutan and Pakistan. The vaccination in Sri Lanka and Bhutan was stopped following these incidents of AEFI, however, after investigation; Srilanka has resumed vaccination in 2010 and Bhutan have decided to resume the Pentavalent vaccination. The available reports published by WHO have concluded that these events are unlikely due to Pentavalent vaccine, some of the members felt that the complete report of these incidents should be accessed for analysis. Keeping in view the number of children vaccinated in these countries, the background rate of these AEFI may not significant and the benefit gain may not to raise alarm to stop vaccination. As the vaccine has not been introduced in India, there is not enough data on vaccine safety therefore; vaccine should be initially used in the states with better AEFI management and surveillance systems to monitor the vaccine safety. It was pointed out that there may be some co-incidental deaths and morbidity in this age-group during the implementation of the Pentavalent vaccination which might be wrongly get implicated to vaccine. However, the house was of unanimous opinion on the use of Hib vaccine, but few members had reservations about using the formulation combination vaccine of Pentavalent vaccine. The house considered that lives saved by the Pentavalent vaccine far outnumber the few AEFI deaths reported in the neighbouring countries and therefore has favourable risk-benefit ratio.
The house also deliberated upon the immunogenicity of combination vaccines and it was felt that the available evidence based on Cochrane review reveals that although there is reduced immunogenicity of some of the components of vaccine when compared to given separately, this reduction in sero-conversion is not significant enough for protective levels of antibodies.
The Core Committee recommendations on Pentavelant Vaccines was discussed and base on the recommendations the committee members felt that vaccine should be introduced in selected few well performing states and further roll-out should be based on an impact assessment of vaccination. The house also discussed the selection of states for studying the impact of Pentavalent vaccine introduction. Some of the northern states are having high burden of Hib disease however, introduction in these states with poor coverage would not be able to demonstrate significant impact. Further, the introduction of newer vaccine requires good delivery systems and some of the states with high vaccination coverage like Tamil Nadu and Kerala may be selected. The house also considered the options of limited introduction of the vaccine in the hospitals (rather than in outreach sessions) or in selected districts; however it was felt that this would not provide the sufficient sample size to study the impact of the vaccine.
It was stressed that clinical trials for impact assessment is difficult in view of the large sample size that would be required and high cost that would be incurred for such study. It was pointed out that data from Hib probe study by ICMR is available for some of the areas in Tamil Nadu which can be taken as baseline data and will facilitate the study of post-vaccination impact. In the ensuing discussion the house was informed that vaccine is already available in private sector in many parts of the country and has brought about decline in cases of Hib disease over a period as observed in PGI Chandigarh, though the private vaccination does not contribute much in the National scenario.
Recommendations:
• Pentavalent vaccine 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 into other states.
• A protocol will be prepared by the ICMR for impact study; this will be circulated to NCDC and others through email; once the protocol is finalized, the study would be carried out by ICMR.
• Since AEFI is a concern hence same will be monitored and also system will be strengthened so as to ensure immediate management of AEFIs; NCDC to lead this activity.
• There may be an insurance scheme for the beneficiaries against the AEFIs.
Agenda Item 2- Introduction of Hepatitis B vaccination
The house was unanimous on expansion of Hepatitis B vaccine in the entire country under immunization programme. It was pointed out that even though safe, efficacious and cheap Hepatitis B vaccine is available and in spite of carrier rate of around 4% in India the vaccine is still not part of Universal Immunization programme although all the countries have been using this vaccine under the national programme. This vaccine is manufactured in the country and exported to many countries. There have been enough data showing impact of Hepatitis B vaccination on disease burden due to hepatitis B infection like acute hepatitis, as well as its long term sequel like chronic hepatitis, cirrhosis and liver cancer. Therefore it is high time that this vaccine is introduced all over the country at the earliest. Over the period the cost of the Hepatitis B vaccine has dropped and is one of the cheaper vaccine available in the market.
As the vaccinated cohort is only protected, any change in morbidity and mortality would take 10-15 years to be detected. However, the impact assessment on carrier rate may be carried out and the house was informed that ICMR has already initiated a study for the same. It was also brought to notice that there may be possibility of escape mutation of hepatitis B virus and this may also be monitored.
The experts also stressed that it is critical to give the vaccine at birth to cut down the vertical transmission and to impact the carrier rate. The house was informed that under the immunization programme of Hepatitis B in the selected States/Districts/Cities the Hepatitis B vaccine is given at birth (in institutional deliveries) and thereafter at 6th, 10th and 14th week of age of the child. The Janani Suraksha Yojana (JSY) has been launched to improve institutional delivery and this may further boost the coverage of Hepatitis B vaccination at birth.
Recommendation
• In view of the disease burden and availability of safe and efficacious vaccine, the expansion of Hepatitis B vaccine should be carried out all over the country as part of Universal Immunization Programme. Before rolling out in newer areas there should be a plan for trainings, microplanning etc.
• Simultaneously, multi-centric impact study on carrier rate of hepatitis B will be conducted by ICMR.
Agenda Item 3- Introduction of Rubella vaccination
The house deliberated upon the risks and benefits of introduction of rubella vaccine in the immunization programme. If the vaccine is introduced in form of MR and targeting to vaccinate children at 16-24 months of age, then it is critical to ensure coverage above 80% failing which the rubella will shift to older age group of susceptible cohort and this may lead to paradoxical increase in congenital rubella syndrome (CRS). The manufacturing capacity and availability of MR and rubella vaccines are need to be considered before introducing the Rubella vaccination in the National programme.
In view of the above, the house felt that Rubella vaccine may be introduced in adolescent girls of 10-15 year old so that those who have not acquired the natural immunity due to infection are also protected. This would reduce the risk of getting this infection during the pregnancy and thereby reduce CRS cases.
Recommendation
• The NTAGI recommended the introduction of rubella vaccination for 10-15 year old adolescent girls under the Universal Immunization Programme in the entire country.
Agenda Item 4- Draft Multi Year Strategic Plan 2010-17 for UIP
The house was unanimous that there is need for a Multi-year strategic Plan 2010-17 for UIP. The document does not comprehensively address Vaccine preventable disease surveillance; some of the points at page 58 in the document for setting up a new body with development partner to review, utilized information for deciding introduction of new and under-utilized vaccine were found to be objectionable and house felt that this draft needs editorial corrections before any further discussion.
Recommendation:
• The draft MYP is to be revised for further discussion.
Agenda Item 5- National Vaccine Policy
Secretary (H&FW) raised the need for a national vaccine policy and NTAGI unanimously agreed to the suggestion. There have been some attempts in drafting vaccine policy earlier, also a regional vaccine policy has been developed by WHO recently which may be used for developing this draft.
The need for a National Immunization Authority was also felt as the current technical structure of only 3 technical officers managing the immunization programme in the entire country like India is a daunting task. In this regard, the house was informed that IIM-Ahmedabad is conducting a study on the HR structure required for immunization programme in the country; it was felt that this study should be expedited.
Recommendation
• Dr. NK Ganguly, Ex-DG, ICMR would draft a National Vaccine policy; Dr. Jacob Puliyel, will also provide his inputs in facilitating the drafting the policy document. Thereafter the policy document will be circulated to all members for their inputs before the final draft is discussed in the NTAGI meeting.
• The policy would also suggest suitable structure for National Immunization Authority.
Secretary (H&FW) also suggested members to prepare broad contours of composition of NTAGI so that the terms of reference for NTAGI may be suitable amended including memberships.
The meeting was concluded with vote of thanks and the NTAGI is to meet again after 1 month.
Annexure
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
List of Participants
51. Prof. (Dr.) M. K. Bhan, Secretary (Department Bio-technology)
52. Dr. R. K. Srivastava, Director General Health Services
53. Mr. P. K. Pradhan, Additional Secretary & Mission Director, NRHM
54. Mr. Amit Mohan Prasad, Joint Secretary, RCH programme
55. Dr. N.K. Ganguly - Ex DG, ICMR
56. Dr. Ajay Khera, Deputy Commissioner
57. Prof. (Dr.) V. K. Paul, Prof.& Head, Dept. of Pediatrics, AIIMS, New Delhi
58. Dr. N. K. Arora, Paediatrician, & ED, INCLEN
59. Prof. (Dr.) A. P. Dubey, Head, Dept of Pediatrics, MAMC
60. Prof. (Dr.) Rajesh Kumar, Head of Community Medicine, PGIMER, Chandigarh
61. Dr. J. Pulliyel, Head, Deptt. of Pediatrics, St. Stephen's Hospital, Delhi
62. Dr. Shahid Jameel, Prof. of Virology, ICGEB, New Delhi
63. Dr. Sudhanshu Vrati, Dean, THSTI, Faridabad.
64. Dr. R. L. Icchpujani, Director, National Centre for Disease Control, Delhi
65. Dr V. G. Somani, Dy. Drugs Controller (India), CDSCO
66. Dr. A. C. Bannerjea, Staff Scientist, National Institute of Immunology
67. Dr Shyam Kukreja, Executive Director, Indian Academy of Pediatrics
68. Dr Henri van den Hombergh, Chief, Health, UNICEF, India office
69. Dr. Satish Gupta, Health Specialist(Immunization), UNICEF
70. Dr. Sangey Thinley, WHO Representative (Act), India office
71. Dr. Hamid Jafari, Project Manager, WHO-NPSP
72. Dr. Pradeep Haldar, Assistant Commissioner, (UIP)
73. Dr. N. K. Dhamija Assistant Commissioner,(I)
74. Dr. V. K. Mishra, SMO(Immunization)
75. Dr. Siddhartha Saha, Consultant, Immunization
Response to the Draft Vaccine Policy of Dr. Ganguly
A ‘Policy’ is a "Statement of Intent" or a "Commitment". Policy is the principle(s) that guide(s) decision and actions that are most likely to achieve a desired outcome. Policy guides all subsequent decisions that are made. Policies are adopted by the governance body within an organisation. This must not be confused with manuals of procedures and protocols. Procedures and protocols are developed and adopted by senior executive officers based on the policy. Organizations can be held accountable for its ‘Policy’. Executives are held responsible if the deviate from policy in their protocols.
The compromised process (of drafting a policy)
NTAGI at its last meeting had resolved that Dr Jacob Puliyel with Dr NK Ganguly shall facilitate the drafting of the policy document. The Health Secretary who chaired the meeting will bear witness to it and it is mentioned in the first draft-minutes circulated for approval to the members. (Subsequent changes to the minutes can only be approved at the next full NTAGI meeting). I wish to state categorically that I had no role in preparing this draft policy, as I was not consulted for this purpose at all. It needs to be established at whose behest the collective decision of the NTAGI was overruled in the letter of the Ministry of Health and Family Welfare (MoH&FW) dated 23rd September 2010.
The compromised product (Draft Policy)
Regardless of my role, I would have welcomed a policy document of unmistakable clarity of purpose and unquestionable focus on principles. However, this “draft policy” is a good example of a compromised product that emerges out of a compromised process and therefore I am constrained to denounce it. The present document cannot be construed as a ’Policy document’ by any stretch of imagination. It does not even read like a manual of procedures or protocols. Instead it appears merely to be recommendations by the author in favor of some vaccines like the Pneumococcal vaccine, rotaviral vaccine and some combination vaccines, without stating rationale and without any cost benefit analysis (despite the lip service paid to such criteria elsewhere in the ‘policy’). It makes a passionate plea to allow international agencies to influence the immunization agenda of the country, and seeks abundant funding for ‘foreign trips’ of ‘would-be experts’. It also suggests numerous steps to make private vaccine manufacturers feel secure and insulated from the rough and tumble of market forces, while being lackadaisical about the role of the public sector. I have highlighted a few specific instances that illustrate my general comments above, after the following paragraphs.
The section on ‘Adverse Events follows Immunization’ looks like a policy statement, but it is seriously misguided policy. It states that ‘establishing / dissociating a causal link between the event and immunization should be established based on laboratory findings and baseline demography data from the region’. By analogy, using these criteria, deaths due to Penicillin-reactions have never occurred anywhere in the world, because the vials have not been shown to be contaminated and the death of that one person has not altered the baseline demographics of the region! This flies straight in the face of the recommendations of the Brighton Collaboration – to which the document makes a passing reference. This is policy that cannot be allowed to pass
Regarding the National Technical Advisory Group on Immunization (NTAGI) the author has said that there must be epidemiologists and public health persons etc on the committee but has not suggested how they are to be selected. It does not suggest advertising vacancies like in the USA. Further it says the term of the member must be 2 years but in the same sentence says they can be reappointed indefinitely, defeating the very purpose of having a fixed term.
The way forward
The policy needs to be redrafted. I am willing to participate in the process as desired by the NTAGI. The draft policy must take into account all available policy literature, relevant developments and government documents. It must then be open to other experts, intellectuals, think tanks, civil society organizations and even corporations and lobbyists for their inputs. The draft policy can then be finalized for approval after considering all their inputs. Public Health policy is the domain of the public and their participation is crucial for its successful passage through the parliament and subsequent implementation.
Specific comments illustrating some of the points made above
1. The moot policy question is not whether a vaccine works, but whether that vaccine is necessary for all in India, and how many cases/deaths can be prevented by vaccinating how many people and at what cost. This basic logic is missing throughout this policy document. Is this deliberate? (See section 4.3)
A hundred years ago George Bernard Shaw had written
‘Suppose it were ascertained that every child in the
world could be rendered absolutely immune from
all disease during its entire life by taking half an
ounce of radium to every pint of its milk. The
world would be none the healthier, because not
even a Crown Prince – no, not even the son of a
Chicago Meat King – could afford the treatment.
Yet it is doubtful whether doctors would refrain
from prescribing it on that ground. The recklessness
with which they now recommend wintering
in Egypt or at Davos to people who cannot afford
to go to Cornwall, and the orders given for champagne
jelly and old port in households where such
luxuries must obviously be acquired at the cost of
stinting necessaries, often make one wonder
whether it is possible for a man to go through a
medical training and retain a spark of common
sense’
Shaw GB. The Doctors Dilemma.
Penguin Books, London, UK, 33 (1957)
(First published 1911).
2. Executive summary (Page 7 first para): It is fraudulent to project pneumococcal and rotaviral vaccines (that too covering only few strains) as vaccines against pneumonia and diarrhea, as these diseases are caused by many more etiological agents and there are no vaccines against all causes of these two diseases. This is a common and deliberate mischief played by people who push some vaccines. The policy should have specified how to avoid such mischief in public interest. Instead, it plays into the hands of such mischief mongers.
3. Product development (Page 8 first para): Why should product development be only in PPP mode? Why should a policy limit its options to one such mode? Why can’t government learn from the dubious PPP deals in the vaccine park, and the MOUs between PII and Green Signal Biopharma and Vatsan Biopharma?
4. (Page 8, last para): The opening line “Vaccine Policy is a guiding document for maximizing the use of vaccines available globally” is a patently wrong and objectionable objective. The policy should encourage development, production, adoption and administration of NECESSARY vaccines, rather than maximize the use of all vaccines available globally. One wonders if this is a Freudian slip where the author of this policy has revealed his true intentions in making this document.
5. (Section 4.1.) The policy mentions how vaccine decisions should be gui