The directives of the commission has came in response to the complaint filed by the Odisha based Human Rights Activist Akhand. Since 2011, the Indian Union Government introduced pentavalent vaccine in a phased manner in Kerala, Karnataka, Pondicherry, Goa, Gujarat, Haryana, Jammu & Kashmir and Delhi.
Recently, the Union Government decided to scale-up administration of the pentavalent vaccine throughout the country from this October. Pentavalent is a combination of five vaccines in one: diphtheria, tetanus, whooping cough, hepatitis B and haemophilus Influenza Type B (the bacteria that causes meningitis and pneumonia).
The vaccine created a furore after many infants from across the country were reported to have died after the vaccination. The latest RTI reply by Union Ministry of Health and Family Welfare has revealed that the Pentavalent vaccine has been associated with 76 deaths and 227 hospitalizations.
Another disturbing factor is that many children (around 300 as per figures obtained) have also been hospitalized in a serious condition after being administered this vaccine. No one is transparent about the adverse events that have led to the hospitalizations. The components of this vaccine – the DPT, Hep-B, Hib, etc – are highly controversial for adverse events individually and the combination is proving deadly.
Akhand alleged that in India, it is health workers and not doctors who give this vaccine, no screening of children can be done leading to unnecessary deaths. Facts are also not forthcoming as to what are the adverse effects noted in the children who have been hospitalized. He has sought it to be made mandatory for all deaths and adverse effects to be reported by doctors and health authorities. The vaccine should be withdrawn till all facts are examined and the vaccine is proved safe.
Controversy over Pentavalent :
The National Technical Advisory Group on Immunization (NTAGI) recommended the introduction of the Pentavalent vaccine into the Universal Immunization Programme (UIP) in India in the year 2010. This was questioned by two eminent members of the NTAGI who pointed out that the vaccine, which is a combination vaccine for DPT, Hep-B and Hib, was being pushed despite controversies. The rates of Hib in India did not warrant a vaccine and the fact that the Pentavalent vaccine has caused deaths in all countries where it has been introduced was ignored. They also pointed out that the vaccine was ineffective. They filed a PIL in the Supreme Court to this effect.
Initially the vaccine was launched in two states of the country and reports of deaths from the vaccine soon surfaced. This prompted another PIL in the Supreme Court by Dr Yogesh Jain who insisted that the vaccine should be banned in India as it has caused deaths also in
neighbouring countries of Sri Lanka, Bhutan and Pakistan and in Vietnam. The vaccine is already banned in US, Japan, Canada, Europe, Australia, UK and some other developed nations who reacted to cases of deaths and adverse reactions. The Supreme Court issued a notice to the centre and the manufacturer of the vaccine in India in 2013.
However despite these controversies the Government of India has gone ahead and introduced this vaccine into six more states leading to an increase in the number of deaths and adverse effects reported. In response to an RTI filed, the Government has admitted to 76 deaths associated with the vaccine and 227 adverse effects requiring hospitalization as on 19th August 2014. Since then two more deaths have been reported in the press.
The Government is denying the deaths, except for two cases, but cannot furnish an alternative reason for the deaths! It is therefore highly surprising that instead of banning the vaccine the Government has declared that the vaccine will be introduced in all states during October 2014. According to doctors in India this vaccine will kill 1 in every 10,000 children vaccinated.