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