Times of India
By Umesh Isalkar
Pune, India

Infant deaths after immunization in Maharashtra have been steadily rising over the years, a fact admitted by the state health department itself. The department’s report, released in May this year, pegs infant deaths after immunization in 2009–10 at 33 in the state, up from 26 and 15 in 2008–09 and 2007–08 respectively.

Union health ministry statistics obtained under the Right to Information Act show that 128 children died in 2010 in the country due to adverse effects after immunization (AEFI). That count has risen in the past three years, with 111 such deaths in 2008 and 116 in 2009.

"Infant deaths after immunization are usually coincidental," said V M Kulkarni, assistant director of the state health services and in charge of the immunization programme. "These deaths have some other co–factors linked to them than vaccination. Still, the reason for these deaths is being investigated by the Adverse Effects Following Immunization (AEFI) committees set up in all the 34 districts in the state."

AEFI is a general term that covers various reasons, including bad vaccine quality due to breaks in the cold chain, contamination and complications due to pre–existing conditions of the child.

"Each vaccine has its share of adverse effects, howsoever minimal, and death of the beneficiary may result in extremely rare cases. It can be seen that the number of deaths following routine immunization (BCG, DPT, OPV and Measles vaccines) have gone up in the last few years in Maharashtra," states the health department’s report.

M D Gupte, chair (epidemiology), Indian Council of Medical Research, said, "The majority of events thought to be related to the administering of a vaccine are actually not due to the vaccine itself. Many are simply coincidental events, others are due to human or programme error."

Gupte pointed out that freeze–dried vaccines which are reconstituted need to be utilized within six hours. "If they aren’t, there are possibilities of contamination and serious adverse effects. The issue of cold storage is more or less taken care of due to the effective cold chain established throughout Maharashtra with the help of icelined refrigerators and vaccine boxes. However, the use of reconstituted vaccine beyond the time limit remains a concern. Frequent orientation workshops and training programme of health workers who administer these vaccines should be conducted to rule out such error," he said.

The Pune Municipal Corporation (PMC) has reported no infant death following immunization since the last three years. "One baby had developed a minor complication last year after being administered the triple polio dose. The infant developed a local abscess and was treated immediately," said PMC immunization officer Sunil Tore.

"Often, when a child dies after receiving routine immunization, the immunization is assumed to be the cause of the death. But this is not always true," said senior paediatrician Sharad Agarkhedkar, former president of the city chapter of the Indian Medical Association (IMA).

Infant deaths due to AEFI are a rare but well–documented fallout of vaccination. Calling vaccines safe, paediatricians say that while sideeffects such as mild fever or redness at the site where the shots have been administered are common, adverse reactions occur in one out of 10 to 20 million doses globally.

Times View
Rinfant esponding deaths to reports in the state of following vaccinations, experts insist these deaths may be due to a number of factors, and not necessarily from adverse reactions to immunisation. Still, after 33 deaths in 2009–10, there is an urgent need to find out what exactly went wrong, whether it be pre–existing conditions in the children, issues with cold storage or not using reconstituted vaccines within the time limit. The state’s immunisation drive needs to be free from stigma and suspicion. And crucially, when it comes to vaccination of infants, there is no room for human error.