Petition Against the Pentavalent: The Sordid Story.


C.M. No.                             OF 2011

Public Interest Litigation

In the matter of:

Dr. K. B. Saxena & Ors.                                                                 …Petitioners

Union of India & Ors.                                                                      …Respondents


     The Hon’ble Chief Justice of Delhi And
     His Hon’ble Companion Justices of the Hon’ble High Court of Delhi

           The humble application of the petitioners above named:

  1. The Petitioners had filed the instant writ petition in public interest highlighting how irrational vaccines were being introduced in the public health system by the Government, under the influence of vaccine manufacturers and international agencies like World Health Organization (WHO), without proper epidemiological and medical studies. Petitioners (who are generally pro-vaccine and pro-modern medicine) were appalled at how in the absence of a rational vaccine policy, newer and newer vaccines were being pushed by the Government into the national immunization programme. Vaccines which are either of little utility or which are not required at all were being introduced and promoted by the Government at the behest of these vested interests and, at the same time, basic vaccines that are the right of every child are not being made available under the Universal Immunization Programme (UIP) to 53% of the population – mostly poor living in rural areas who should be the priority for any immunization program as the poor cannot afford the consequences of disease.

  1. Though this petition caused a temporary halt to Government’s ill-conceived plans, yet now the Government is again pushing for the introduction of new vaccines, especially Pentavalent (5-in-one) vaccine. Pentavalent combines the essential EPI vaccines of DPT with non-EPI non-essential and expensive vaccines of Hib and Hepatitis B. Thus the new vaccines for which there is low demand and which are expensive, would piggy-bank on the essential DPT vaccine (which is of extremely low price). This will make the plain DPT vaccine unavailable and every child would have to take Pentavalent to get access to DPT. Introducing Pentavalent in the UIP would mean that UIP would have extremely low coverage and would cost tens of thousands of crores of public money. This is a giant scam in the making.

  1. This is happening at a time when the Government has shut down virtually all public sector units that were supplying the essential vaccines at a cost that is a fraction of the cost at which same vaccines are produced by the private sector. There were no complaints against these units and the general view was that these units were doing exemplary work. No question was ever raised regarding the quality of vaccines produced in these centres. Yet, without any provocation they were closed down on the pretext that they were not following “good manufacturing practices” which related to their building set-up. Even if they required upgrade, government should have sanctioned some funds for the purpose. More and more information has come in the public domain to highlight how this was a systematic attempt to benefit private companies. Now, response under RTI has clearly shown that after the above public sector facilities were shut down, there has been a huge increase in the number of deaths of children due to vaccination side effects. RTI reply and reports on this are annexed as Annexure A1 (Colly). This shows how the Government played with the health of children just to benefit private companies. After the closure of public sector units became a big public scandal and this fact was highlighted in the instant petition, Government announced its decision to reopen the 3 vaccine manufacturing facilities. But the 3 units have still not been opened. A news report on this is annexed as Annexure A2.

  1. 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 is 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 A3.

  1. The numbers benefiting (deaths avoided by vaccination) from Hepatitis B was based on ‘personal communication’ from Prof Acharaya of AIIMS Dept of Gastroenterology. He claimed 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 and inconceivable. 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 that 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. Other than this, the only other data on deaths averted nationally by Hepatitis 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 about 10,000.

  1. 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 that reported 9 ‘presumed Hib’ also reported there were only 3 cases of presumed Hib in that district, in the next year. No explanation is given of why this figure of 3 cases 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.

  1. 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’. To enable them to do it the ‘experts’ temporarily deleted the category ‘probably related’ from the  classification itself for use in this report. WHO has now stated that it still stands by its full standard classification and does not use the mutilated format for reporting adverse effects. A report on this is annexed as Annexure A4. The draft policy, that was submitted to this Hon’ble Court by the Government, on the other hand uses the watered down, mutilated version; as if serious side effects and deaths from the vaccine are not of any importance to this government. Concerns were raised on the above issues in a special mention in the Rajya Sabha on 12.08.2011. A copy of the special mention made in Rajya Sabha on Pentavalent vaccine is annexed as Annexure A5.

  1. The National Technical Advisory Group on Immunization (NTAGI) noted that the utility of the two new components of the Pentavalent vaccine (Hib and Hepatitis B) is not known in India. Furthermore there have been deaths with the use of this combination vaccine in neighboring countries Sri Lanka, Bhutan and Pakistan. The cost of the standard DPT vaccine will go up 10 fold with this vaccine. 50% of India’s children already do not receive the inexpensive DPT. However, NTAGI inexplicably still recommended that the vaccine be tried in 2 states – in Kerala and Tamil Nadu to evaluate the impact and side effects before introduction in other states. There is considerable disquiet in the 2 states at being selected as guinea pigs for this experiment. Special mention was made of this in the Rajya Sabha. Tremendous international pressure is being brought to bear on India to introduce the expensive Pentavalent vaccine in India. This was also the agenda of a meeting of WHO, pharmaceutical companies and Bill Gates Fund in Delhi on 2 August 2011. Although the NTAGI recommended introducing the vaccine in 2 states to study its adverse effects and benefits, and the programme is said to be on the verge of being rolled out, no mechanism has been put in place check with recipients of the vaccine after a week about the side effects or to study objectively if there is any benefits.

  1. The entire exercise is reminiscent of the HPV study by PATH where the Expert committee found that 4 of the 5 objectives were to study safety of the vaccine but no diary or log of adverse effects was maintained. The Government cannot be allowed a repetition of that situation. Wherever study of efficacy, adverse affects and general safety of a drug or vaccine is conducted, it is always done in a small district and the after-effects of that drug or vaccine are surveyed, house to house. Studying the after-effects of a vaccine would require frequent follow-up visits of all the children, which is impossible if the vaccine is introduced in the whole state. By introducing the Pentavalent in the entire states of Tamil Nadu and Kerala, the Government is not only allowing the pharma companies to make huge profits, but also leaving no scope for study of affects of the vaccine. Thus, only if newspapers break news of serious adverse effects and it becomes a public scandal, then and  only then, would the Government reluctantly state that trial did not prove efficacy and safety of the vaccine. There have been protests in the above states by people stating that they are being used a guinea pigs. This unethical trial of Pentavalent in the 2 states without any monitoring of its aftereffects has met stiff resistance from the local populations. Reports on this are annexed as Annexure A6 (Colly).

  1. The procedure of selection to NTAGI and the processes followed at the meeting was witnessed by Dr. Puliyel (Petitioner No. 8) who was inducted into the NTAGI without any examination of his credentials - perhaps on the basis of the fact that he is a petitioner in this case. A request by Dr. Puliyel 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. 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.

  1. This Hon’ble Court had asked the Government to frame an appropriate policy for vaccination and immunization. Pursuant to the orders of this Hon’ble Court, NTAGI resolved that Dr. Puliyel would 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. The name of Dr. Puliyel was removed in the final version of the minutes in blatant violation of the expressed wishes of the NTAGI. A copy of the letter written by Dr. Puliyel protesting against the removal of his name is annexed as Annexure A7.

  1.  After this manipulation, a draft policy was prepared by Dr. Ganguly that was submitted to this Hon’ble Court by the Government. A copy of his response of the Dr. Puliyel to the above draft policy is annexed as Annexure A8. According to a story published in CSE’s Down to Earth the draft policy backed new expensive vaccines without study. A copy of the said article is annexed as Annexure A9. This shows that right from the very beginning there were systematic attempts to push newer expensive vaccines under corporate pressures.

  1. Now Dr. Ganguly has on his own drafted a vaccine policy. There are serious issues that the petitioners have with this policy which defeats the objective with which petitioners had approached this Hon’ble Court. The policy document states it will be “mandatory for the government to support advance market commitments and honor the commitments”. Advance market commitments (AMC) are made even before the prototype of the vaccine is produced. The commitments are made before the vaccine is tested for its efficacy/effectiveness in the local population. A copy of the said policy drafted on the directions of this Hon’ble Court is annexed as Annexure A10.

  1.  The policy goes further to suggests the government use ‘innovative finance mechanisms’ (GAVI terminology that means the Government must take loans by the issue of bonds) to pay the World Bank in advance. By including the line making AMC mandatory on all future Governments, the authors of this policy propose to bind the hands of all future governments.

  1.  In an interview to Centre for Science and Environment (CSE)’s fortnightly magazine Down to Earth, author of the policy, Dr. Ganguly says “The government will commit to the manufacturers so that they invest in vaccine production. If governments do not commit, the company which will set up the plant exclusively for the need of the country, may sink because no one else would want that vaccine and the company would be producing it exclusively for the country which demanded it…” This statement is self-explanatory.   In the same article he also says that, “…One contract will last for a year for one programme. Once the programme is over, the government will revise the programme and select new companies. If the government wants to discontinue a particular vaccine after a year, it can easily do that…” The above statements contradict each other. While in the first he is worried about the vaccine companies, in the second he withdraws from this, knowing that the former position cannot be defended even to a press reporter. This clearly shows that the policy is made in the interest of and at the behest of private pharmaceutical companies. A copy of the said story titled ‘Experts contest new vaccine policy document’ is annexed as Annexure A11. National daily ‘Mail Today’ has done a story highlighting how the vaccine policy has come under criticism for favouring manufacturers and not the general public. A copy of the said story is annexed as Annexure A12.

  1.  According to the above article in Down to Earth, this policy was approved by UN agencies. On the other hand there was no open consultation with experts in India nor was the Indian public taken into confidence. A recent publication authored by 8 international experts on behalf of 140 organizations of the world has drawn attention to the fact that UN is playing into the hands of all kinds of industry with huge conflicts of interests. A copy of the said article published in ‘The Lancet’ is annexed as Annexure A13. The swine-flu vaccine scam is too well known where swine-flu was declared as a pandemic by the WHO which turned out to be a false-alarm that only benefited vaccine manufacturers. Reports on this are annexed asAnnexure A14 (Colly). A letter written by prominent political leader Ms. Brinda Karat who has been closely monitoring the HPV vaccine trials, to the Health Minister highlights the unethical practices by WHO in developing countries. A copy of the said letter dated 27.10.2011 is annexed as Annexure A15. An editorial published in The Hindu called the said trial as “shockingly unethical”. A copy of the said editorial is annexed as Annexure A16. Newspaper The Tribune has also written a detailed report highlighting the serious lapses in the HPV vaccine trial. A copy of the report published in The Tribune dated 09.05.2011 is annexed asAnnexure A17. There have been several other reports on the way trials are conducted in India and the way vaccines are being pushed onto Indian children. The said reports are annexed as Annexure A18 (Colly). The Government of India has now admitted lapses in the HPV vaccine trial. A copy of the report on this is annexed as Annexure A19. This has also exposed the dubious designs of international donor organizations as stated above.

  1.  Dr. Puliyel, Member NTAGI has registered his strong protest at the final version of the policy. In a latter to the Health Secretary who is also the Chairperson NTAGI he has stated: “The vaccine policy ideally would state how the government proposes to universalize the benefits of immunization to the large sections who don’t receive the basic vaccinations. It would also describe how new vaccines are to be selected for introduction in the programme for universal immunization. Ideally it would lay down the process of selection of members to the NTAGI and how the procedures of this committee are to be recorded and made open to the public. Methods of estimating disease burden, vaccine efficacy, and assessment of costs, benefits and adverse effects of newer vaccines; and the process of how new vaccines are to be introduced, should have found a place in the policy. Unfortunately the draft is non committal on almost all of these issues.” A copy of his letter is annexed as Annexure A20. EPW has also published a detailed article against the new vaccine policy stating that it puts the interest of industry over the public health. A copy of the said article dated 05.11.2011 is annexed as Annexure A21.

  1.  Earlier, in response to our petition Government has stated that it would conduct trials in 2 states of India: Tamil Nadu and Kerala, to determine the efficacy and the need of Pentavalent vaccine. It is now clear that this push was made for eventual introduction of Pentavalent in the country’s UIP at the behest of international agencies like UN and Bill Gates Fund. There is now ample evidence to show that vaccination policies and funding is being driven on the basis of industrial pressures and misplaced priorities. Studies and reports on this are annexed asAnnexure A22 (Colly). Now there is clear evidence that cost of pneumococcal vaccine was underestimated by 10 times. A published letter of Dr. Puliyel is annexed as Annexure A23. Now, even the WHO has been forced to accede to concerns of doctors that there is not adequate data to push for Hepatitis B vaccine. A report on this is annexed as Annexure A24.

  1.  In the face of the above facts, the vaccine policy prepared on the directions of this Hon’ble Court does not address the concerns of millions of children who have been left out from receiving even basic essential vaccination and instead tries to protect the vested interest of vaccine manufacturers, it violates Article 14 and Article 21 of the Constitution and therefore deserves to be set-aside by this Hon’ble Court. The said policy has been made without any transparency, without even the pretence of public consultations, has not been approved by NTAGI, does not have approval of Union Cabinet or of the Parliament, and yet it tries to steer the country’s immunization programme in the wrong direction, tries to make commitments of thousands of crores of rupees binding future governments, into purchase of newer expensive vaccines whose prototype has not even been modeled alone tested, from foreign private companies. Such a policy is therefore void ab initio.

  1.  There is no transparent method to select members to the NTAGI. As such, the government does not get independent advice but it merely hears what it wants according to the persons that they have appointed to the committee. It is clear that there needs to be an open and transparent selection process for appointing members to this advisory body. The Government may appoint an expert committee to select the best persons from among applicants for the job in a transparent manner. The duration of the appointment must be fixed, and to ensure organizational memory, only a part of the committee must retire each year. The discussions in the NTAGI meetings must be open to the public so that each member is accountable for the advice they proffer. Only this can ensure that public health policies are not hijacked by vested interests in the future.

  1. That the present Application is being made bona fide and in the interest of justice.
In these circumstances the Petitioners pray that your Lordships may be pleased to pass following ad-interim directions:
(i)                    Set aside the vaccine policy (Annexure A10) and direct the Government to set up a committee to transparently select members of NTAGI for a fixed term from credible public health experts and pediatricians with no conflict of interest, to formulate new vaccine policy and study the effects of introduction of Pentavalent in the 2 states
(ii)             Pass further orders as may be deemed fit and proper.


                                                                       Through: PRASHANT BHUSHAN
                                                                              Counsel for the Petitioners

Filed on:         November 2011
New Delhi