12th March 2012
Please reply to
Dharwad 580 002
Dr Margaret Chan
Dear Dr Margaret Chan,
All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has – 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 (http://pharmabiz.com/
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.
 Food and Drug Administration (FDA).