Tag Archives: WHO

Open letter to DG, WHO – Pentavalent vaccine related deaths in India


Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 2012

Open letter to WHO on Pneumococcal Vaccine

February 16, 2009

Dr. Margaret Chan,
Director-General of WHO,

Dear Dr. Chan,

Greetings from All India Drug Action Network – AIDAN !

All India Drug Action Network is an all India network of organization and concerned individuals who have been advocating for more than twenty five years on issues related to the access, prices, safety , quality and rationality of medicines in India and their appropriate use by both health professionals and consumers.  Our activities have included publications, campaigns, media briefings, meetings, and even public interest litigations. It is due to the efforts of AIDAN, that many unsafe and irrational medicines have been removed from the Indian market.

We were delighted to read your comments in the ‘The Lancet’ dated 15th January 2009, titled “Primary health care as a route to health security”. We quote here a statements you have made about Primary health care in the Lancet “This approach to health is people-centred, with prevention considered as important as cure. As part of this preventive approach, primary health care tackles the root causes of ill health, including in non-health sectors, and offers an upstream attack on threats to health. As the report1 noted, better use of existing interventions could prevent 70% of the global disease burden.”

But unfortunately this perspective is not reflected in some of your actions. For example you have not responded positively to the request one of our AIDAN members sent you in the case of pneumococcal vaccine, based on the Primary Health Care perspective. The Drug Action Forum – Karnataka (DAF-K) which is a constituent organization of AIDAN had communicated to you the concern in a letter dated 2nd September 2008, regarding the “revelation that for every four children in whom pneumonia is prevented, two children develop asthma because of the vaccine”. This is because the pneumococcal vaccine in question is the one that is being promoted by WHO globally and in India. A copy of the letter sent by DAF-K is attached with this letter for your reference.

Your personal assistant Alison Porri, has acknowledged having received DAF-K’s letter on 4th September 2008, with a promise to “to acknowledge receipt of this e-mail”. And that “Your letter will be carefully reviewed and a response will be forthcoming”. But unfortunately DAF-K has not heard from your office. The issue was discussed at the 14th November 2008 of AIDAN and members expressed grave concern over the issue. Your eerie silence is creating a doubt in the mind of the health conscious members of AIDAN whether you mean what you wrote in The Lancet article mentioned above. (AIDAN is the larger national body, whereas DAF-K is a state level organisation and member of AIDAN along with several other nation wide constituents).

We the under signed express grave concerns about this whole issue.  If by 27th February 2009 we do not hear from you then many of us will walk into the WHO office at Delhi and demand for the same information.

Hoping to hear from you soon,

Yours truly
Dr Gopal Dabade, (drdabade@gmail.com)
Dr Mira Shiva, (mirashiva@gmail.com)
Mr. Srinivasan S, LOCOST (sahajbrc@youtele.com)
Dr Anurag Bhargava (anuragb17@gmail.com)
Dr C Sathyamala (csathyamala@gmail.com)
Dr Jacob Puliyel (puliyel@gmail.com)
Dr. Anant Phadke (anant.phadke@gmail.com)

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

The Economic Times, Delhi edition dated Sep 18, 2008 (Page Number 26) carried news about Drug Action Forum of Karnataka (DAF-K) open letter to World Health Organisation (WHO) regarding the pneumococcal conjugate vaccine.

GLOBAL pharma major Wyeth’s vaccine Prevenar is caught in dispute as the Drug Action Forum of Karnataka (DAF-K), a member of All India Drug Action Network (AIDAN), has asked the World Health Organisation (WHO) to withdraw its support for the pneumococcal conjugate vaccine.

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

In an open letter to WHO, the Karnataka-based forum said a recent study revealed that the vaccine does not reduce clinical pneumonia and is likely to cause asthma in children. “It has been found through studies that the vaccine reduces a rare type of pneumonia called radiological pneumonia and only about 4 cases are prevented for every 1,000 children immunised and what is even more dangerous is that for every four in whom pneumonia is prevented, two children develop asthma because of the vaccine,” DAF-K president Dr Gopal Dabade said. Prevenar is the only licensed…. To read more, click here

To read the open letter sent by DAF-K, click here

Profit making vaccine companies and WHO -Open letter


2nd September 2008

Drug Action Forum – Karnataka (DAF-K)*,
57, Tejaswinagar, Dharwad 580002, Karnataka, India.
Fax & telephone +91 (0)836 2461722, Mobile +91 (0)9448862270
Email; – drugactionforumkarnataka@gmail.com, Web; – http://www.daf-k.cjb.net

World Health Organization
Avenue Appia 20
1211 Geneva 27, Switzerland,
Fax number +41 22 7913131
Dear Ma’am,

Drug Action Forum – Karnataka (DAF-K), from India would like to bring to your notice facts which are really alarming and indicate the strong influence that profit making vaccine companies have on the esteemed WHO. These unhealthy nexus between WHO and the vaccine industry, we fear will have far reaching negative influence on the lives of millions of children all over the world. With these major concerns we lay down before you facts which are as follows:

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