Coincidence with closure of vaccine-making public sector units

Vaccine-related deaths have shown an increase in the country since 2008, according to the information provided by the Ministry of Health and Family Welfare in response to an application filed under the Right to Information Act, 2005.

The total number of deaths reported due to adverse effects from immunisation (AEFI) from 2001 to 2007 was only 136, whereas it went up to 355 in the following three years.

The information has come in response to an RTI application filed by K.V. Babu of Kannur district in Kerala.

As per the Ministry of Health and Family Welfare, there were no AEFI deaths in 2001. There were six deaths reportedly after immunisation in 2002, which went up to 13 in 2003. As many as 23 children died following immunisation in 2004, 18 in 2005, 54 in 2006 and 32 in 2007. In 2008 alone, 111 AEFI deaths were reported. There was a marginal increase to 116 in the following year, and in 2010 there were 128 deaths.

“There seems to be some coincidence with the increase in the AEFI deaths and the period when the three major public sector undertakings at Kasauli, Coonoor and Chennai were closed,” Dr. Babu said.

The 103-year-old Central Research Institute (CRI), Kasauli, the 100-year-old Pasteur Institute of India (PII), Coonoor, and the 60-year-old BCG Vaccine Laboratory (BCGVL), Chennai, were shut down in January 2008 after their manufacturing licences were cancelled for not being compliant with “good manufacturing practices” as per the World Health Organisation (WHO) guidelines. This had resulted in acute shortage of life-saving vaccines under the universal immunisation programme (UIP) as the bulk of vaccines for the programme was manufactured by these units. Following the closure, the vaccines were procured from the private sector in addition to those supplied by the WHO.

According to the response of the Ministry, no AEFI death has been “attributed directly to vaccine'' as the cause of death. At one point of time a child is administered one or more than one vaccine and at times along with vaccine Vitamin A is also administered. Hence, the number of deaths vaccine wise cannot provided as there are (BCG, DPT, OPV, measles, TT and JE in select districts, Hepatitis B is also given in some districts). Many permutation and combination of these 8 antigens and Vitamin A syrup are also given.

The government's response to the number of AEFI deaths in 2010 said there were 48 ‘coincidental' deaths with Maharashtra topping with eight such deaths; two children (one each in Maharashtra and Delhi) died on injection reaction; two died of program error (one each in Chhattisgarh and Maharashtra) and four had died of vaccine reaction. As many as 72 deaths have been attributed to ‘unknown' cause. Again Maharashtra topped with 18, followed by Uttar Pradesh and seven in Andhra Pradesh.

“The surprise aspect is that deaths immediately after measles vaccination in Madhya Pradesh, and Uttar Pradesh in 2010 have not been labelled as death due to vaccination,'' Dr. Babu said.

The Central team inquiring into the AEFI deaths in Lucknow has not yet completed its work and the matter is also subjudice in the High Court. The final inquiry report of deaths in Damoh district of Madhya Pradesh is also not available, the RTI reply says.