Immunisation-associated problems have come to the fore yet again. A Delhi-based report gave the shocking news that the number of children who die soon after being administered vaccine shots more than doubled in the last three years compared with the previous seven years. The information was provided by the Union Ministry of Health and Family Welfare in response to an application under the Right to Information Act, 2005 from Dr. K.V. Babu, a public health activist and a Central Council member of the Indian Medical Association (IMA).
The finding is significant inasmuch as the sudden spurt in the number of vaccine-related deaths has happened during a three-year period (2008 to 2010) when three reputed public sector vaccine-manufacturing institutes functioning at Kasauli (Himachal Pradesh), and Coonoor and Chennai (both in Tamil Nadu) had been forced to suspend vaccine production. The three units accounted for over 70 per cent of the vaccines needed for the country's Universal Immunisation Programme (UIP). The Central government withdrew the orders of suspension of production in the three units only in 2010.
The public health establishment ordered the closure of the three public sector undertakings on the ground that the World Health Organisation (WHO) had faulted these units “for not adhering to the compliance of Good Medical Practice (cGMP).” Experts averred that cGMP was not related to the quality of the vaccines produced in the three units; it was rather about the infrastructure such as staff strength and air-conditioners. This could have been complied with had the Central government pumped in enough funds to the three units engaged in the production of vital vaccines. Despite the units' repeated appeals, the financial assistance was not forthcoming. On the other hand, the Health Ministry was keen to promote private ventures in the field of vaccine production and supplies.
Severe shortage of vaccine
Significantly, an earlier (2010) RTI response from the Union Health Ministry to Dr. Babu revealed that owing to severe shortage of vaccines 522 children died during the years 2008 and 2009 in the several Central government-run hospitals across the country, which account for only 15 per cent of the total government and other public hospitals. The period also saw a steep rise in the prices of vaccines, which threw the immunisation programme out of gear. The revelations had only proved that the fears of the public health and human rights activists, the leaders of the Left parties and a section of the media, both print and broadcast, had been genuine. The media warned the government of the severe shortage of vaccines if it went ahead with stoppage of production in the three vaccine units. Apart from this, the people's response to the UIP started dwindling and vaccine prices touched a new high.
The media's detailed, relentless, and responsible coverage of the government's harassment of and tirade against the scientists, researchers and employees of the three vaccine units and the employees' mobilisation of public support have paid dividends. The need for continued media watch cannot be underestimated, if the UIP benefits should reach all children.
According to the recent RTI response from the Health Ministry, the total number of deaths owing to adverse events following immunisation (AEFI), the technical term WHO uses to denote such deaths, was only 146 in the seven-year period from 2001 to 2007. However, the casualties steeply rose to 355 in the subsequent three years (2008–2010).
The Ministry's note said that there was no AEFI death in the year 2001, but 2002 saw six deaths, followed by a jump to 13 in 2003. The casualty figures for the years that followed were 23 in 2004, 18 in 2005, 54 in 2006, and 32 in 2007. The subsequent three years, however, saw a steep rise to 111 AEFI-related deaths in 2008, 116 in 2009 and 128 in 2010.
“Coincidental deaths”
Dr. Babu rightly drew attention to the fact that the jump in the AEFI death figures coincided with the forced closure of three vaccine units. Although the government, as expected, was reluctant to admit its misadventure in stopping vaccine production in the PSUs, it had to admit that the increased loss of lives “coincided” with the closure of government-owned vaccine units. The government was forced to depend upon WHO and private sector units, both Indian and foreign, for vaccine supplies to meet its UIP commitments, foregoing its earlier advantages in respect of price and quality.
The Health Ministry's response to the RTI queries from Dr. Babu indicated that no AEFI death had been attributed to vaccine. Explaining why one single factor such as the quality of the vaccine used could not be specifically identified as the cause of death, the government in its response said that in certain cases more than one vaccine might have to be administered along with the programmed one or some nutrients such as vitamin A were to be added, depending upon individual needs.
The government's response to Dr. Babu's RTI petition said that there were 48 “coincidental deaths,” with Maharashtra at the top with eight such deaths; two children (one each in Maharashtra and Delhi) died on “injection reaction”; two died of “programmed error” (one each in Chhattisgarh and Maharashtra) and four died of “vaccine reaction.” Of the total deaths, about 70 were attributed to “unknown” causes.
The risk factor
As vaccine-preventable infectious diseases continue to decline, people have become increasingly concerned about the risks associated with vaccines. Moreover, technological advances and people's awareness about vaccines have led to investigations focused on the safety of existing vaccines, which have sometimes created a climate of concern.
The concern over the increasing number of deaths among children following vaccination is not confined to India. Many countries have been facing this problem and the governments and the WHO have started addressing the risk factor with a view to enlarging its use among larger sections of children all over the world. Social activists and the media are going all out to mobilise public support for such initiatives.
Japan is a recently affected country. Even before five children were recorded dead soon after vaccination, the government started taking preventive operations. It immediately suspended sale of two branded vaccines manufactured by global corporates based in France and the United States. The Japanese media are solidly behind their government.
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