128 kids died after vaccine in 2010, govt can’t say why

Arun RamArun Ram, TNN | May 29, 2011, 11.53pm IST

CHENNAI: More children in India are dying every year soon after being vaccinated, and the government has no clue why. Union health ministry statistics obtained under the Right to Information Act show that 128 children died in 2010 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.

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. Coincidentally, AEFI deaths in 2008, when the government closed down all three public sector vaccine units and began buying from private suppliers, were three times the figure for 2007. TOI first reported in March this year that up to 2009, the toll was moving upwards. The 2010 figures confirm the trend.

“We are very concerned,” Union health secretary K Chandramouli said, “but we can’t attribute all such deaths to one reason.” Asked specifically if the vaccines were responsible for the deaths, he replied: “I can’t say that offhand.”

Refusing to point out specific reasons, he said “lack of diligence at the field level and carelessness” could be among the reasons.

Of the 218 deaths last year, reasons for 72 have been categorized under ‘unknown’, 48 as ‘coincidental’, four as due to ‘vaccine reaction’ and two due to ‘injection reaction’ and ‘programme error’. Maharashtra registered the largest number of deaths (28), followed by Uttar Pradesh (18) and Andhra Pradesh (11). Tamil Nadu registered eight deaths.

“The number of deaths went up from 32 in 2007, the last year when the government procured vaccines from PSUs, to 111 in 2008. Out of the 140 crore doses of vaccine used in the post-PSU closure period, only 4.25 crore were procured from the Central Research Institute,” says Dr K V Babu, a physician from Kerala who filed the RTI.

Experts feel the actual number could be even more than what government statistics show. “Many vaccine deaths reported in the media do not find a mention in the government statistics,” says Dr Jacob M Puliyel, head of paediatrics at St Stephen’s Hospital, Delhi. He says the government doesn’t follow the Brighton Collaboration criteria on AEFI deaths adopted by WHO, under which the vaccine should be considered a “probable reason” for death if no other is established.

“The government tries to pass on every death as unrelated to vaccine. It sometimes merely does a culture of the vaccine in question. Just because a vaccine is not found to be contaminated, it doesn’t mean the vaccine has not caused the death,” says Dr Puliyel.

There is also an ethical issue. “We don’t know the exact cause of the deaths and the government is doing nothing to find the cause,” says Dr George Thomas, editor of Indian Journal of Medical Ethics. “Whenever there is a vaccination-related death, it’s ethically essential for the government to probe and find the reason.”

The government closed its three vaccine labs — Central Research Institute in Kasauli, BCG Laboratory in Chennai and Pasteur Institute of India in Coonoor — in January 2008, citing non-compliance of good manufacturing practices. To make up for the demand of 75 lakh doses of vaccines of six kinds needed for its universal immunization programme, the government has been procuring vaccines from private manufacturers. Now,