8 July 2019.
Vaccine Deaths in India Have Not Been Evaluated: Uppsala Monitoring Center
Government records show there have been many deaths after Pentavalent vaccine (PV) administration. Not one of these deaths has been investigated as a ‘vaccine reaction’, according to Rebecca Chandler of the Uppsala Monitoring Center in Sweden - the global hub for drug reaction monitoring.
Chandler revealed this shocking information in the British Medical Journal (BMJ), responding to Jacob Puliyel (pictured) who has asked for a revision of the way adverse events after immunization (AEFI) are investigated in India using the WHO-AEFI classification.
Chandler clarified that the WHO-AEFI classification used in India is deployed only in developing countries. This classification helps to identify reactions caused because of the improper administration of vaccines and the use of a contaminated multi-dose vial; but not new vaccine-product-related reactions. Vaccine-product-related reactions occur even when the vaccine has been administered properly. The WHO-AEFI classification reports are not fed to databases that allow pharmacovigilance for these rare occurances.
In developed countries, on the other hand, adverse-event-reports for drugs and vaccines are maintained within a single database and this allows for pharmacovigilance – to pick up an increase in the frequency of unusual symptoms.
Chandler’s response explains why the numerous deaths after the administration of the Pentavalent vaccine (combined diphtheria, pertussis, tetanus, H influenza b and Hepatitis B vaccine) in India and Asia have not been acknowledged as a possible ‘signal’ for investigation.
Puliyel notes that data from states with good reporting of adverse events imply that there are likely to be 7020–8190 additional deaths each year in the country, because of the shift from DPT to Pentavalent vaccine. This is a huge mortality burden.
He has called for the Uppsala Monitoring Centre to examine the data from the Government of India (and other Asian countries where the vaccine is used) and confirm or deny a possible causative association with vaccination.
“If not the Uppsala Monitoring Centre, then who? If not now, then when?” writes Jacob Puliyel
Also, the Indian Government must stop using WHO-AEFI classification and develop a proper database for pharmacovigilance like all developed countries.
“Only such a transparent appraisal can reassure the public and build trust, and only this will reduce vaccine hesitancy,” Puliyel said. (END)
The correspondence in the British Medical Journal can be accessed here.
Jacob Puliyel MD MRCP M Phil