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Adverse Events Following Pentavalent Vaccination In Kashmir

By D. Manjit and Asish Gupta

12 November, 2013
Peoples Union for Democratic Rights (PUDR)

The pentavalent vaccine for protection against five childhood diseases was introduced in Jammu & Kashmir in February 2013, as part the Universal Immunization Programme (UIP). Three doses of this vaccine replace the conventional DPT vaccine which protects against three diseases, diphtheria, pertussis (whooping cough) and tetanus. The newer pentavalent vaccine includes the DPT as well as vaccines against pneumonia-meningitis (Hib) and hepatitis B.

In Srinagar eight infant deaths were reported between September and October this year in the press following immunization with this vaccine. Soon after these reports appeared a team from the Ministry of Health & Family Welfare, Delhi, headed by Dr N.K.Arora of INCLEN (International Clinical Epidemiology Network), visited Srinagar to investigate into these deaths. While the final report of this team is awaited, their preliminary report has already stated that the children have died from causes like septicemia and pneumonia, and are unrelated to the vaccine. This conclusion fails to explain why or how the babies were administered the vaccine in the first place if they were seriously ill at the time of immunization.

It was in this context that the PUDR, Delhi (People’s Union for Democratic Rights), put together a team comprising public health experts, including clinicians, to look into these incidents. The team which was in Srinagar between 8th to 10th November, visited some of the affected families and conducted a verbal autopsy of the infant deaths to look for antecedent illnesses as well as enquire about other adverse events (as per the Advesrse Events Following Immunisation (AEFI ) guidelines.

This team came across infants who had developed serious adverse events after the immunization and had been admitted in the children’s hospital in Srinagar. It was found that the FIR (First Information Report by a doctor or health worker for reporting AEFI) had been recorded only in the cases of death and not in cases of those infants who survived; in other words FIR was prepared after death of the child and not on admission. Most of the infants had received the vaccine in a dispensary or health centre near their homes during the regular immunization day (Wednesdays), with a doctor in attendance in most cases. However, some of the children developed serious reaction later in the day or the following day but could not be taken to the nearby dispensary as there was no doctor there. The parents rushed them to the GB Pant Hospital in Srinagar, the tertiary level children’s hospital attached to the Government Medical College. In at least one case this travel took up to two hours, and by the time the baby reached the hospital the hospital reported the case as `brought dead’. The team was told of about at least 9 deaths following immunization and could meet with some such families.

The team also visited GB Pant hospital, which has been in the news in Srinagar since 2012 due to the large number of infant deaths there. Inquiry reports into these deaths have pointed to the abysmal conditions in the hospital arising from lack of facilities, understaffing, overload due to non-functioning of the peripheral health facilities, and general mismanagement. The team witnessed the difficult circumstances in which some of the doctors were working to provide care to the large number of sick children being brought there.

It needs to be mentioned that such allergic responses to this pentavalent vaccine, including deaths, have been reported also from Kerala, Tamil Nadu, as well as from Bhutan, Vietnam, and Sri Lanka. It had been discontinued in Vietnam in May for these reasons and was re-started in October, following which adverse reactions were once again reported. It is being used largely in several developing countries only and is not licensed for use in the USA by the US FDA. This vaccine is being promoted vigorously by several international agencies, specifically World Health Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI), an international network of vaccine manufacturers and philanthropic organizations such as Gates Foundation.

Concerns regarding the safety and efficacy of this vaccine, as well as the very need for it, have been repeatedly pointed out by public health professionals to the health authorities, which have been brushed aside. Given these problems with this vaccine, one is left questioning the wisdom and this urgency in promoting this vaccine, especially through ill-equipped peripheral health facilities such as dispensaries and sub-centres, which cannot manage the adverse reactions in the immunized infants. A detailed report of the fact finding will be released soon by the team.

D. Manjit and Asish Gupta
pudr@pudr.org, www.pudr.org


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