Pentavalent takes its toll

The vaccine is suspected to have killed at least 13 infants. Experts want data analysed

By Kundan Pandey
Published: Friday 15 February 2013


ON JANUARY 10, a day after a 42-day-old was administered pentavalent vaccine in Kerala, the infant developed fever and died. This was a repeat of what happened at Chalakudy Taluk Hospital on December 30. A 47-day-old was injected the same vaccine; it slept at night but did not wake up. Parents of both the infants suspect the vaccine caused the deaths. A doctor at the forensic department of Thrissur Medical College, where the post-mortems were conducted, said on condition of anonymity that the vaccine may be the cause as there was no other reason for the death.

At least 13 deaths have been reported from Kerala, Tamil Nadu and Haryana, all pointing towards pentavalent vaccine. Demanding analysis of mortality data from the two states, academicians, health activists and paediatricians wrote a letter to the health secretary, Ministry of Health and Family Welfare, on January 15. They pointed out that the National Technical Advisory Group on Immunization (NTAGI) had stated that the vaccine would be extended to other states only after data from Kerala and Tamil Nadu were reviewed and the vaccine was proved safe.

The vaccine was introduced in Kerala and Tamil Nadu as a pilot project before being introduced in the country’s universal immunisation scheme. But before analysing data from the two states, the Centre ordered its introduction in five states and a Union Territory—Gujarat, Haryana, Karnataka, Goa, Jammu & Kashmir and Puducherry. Haryana has already introduced it, while Puducherry plans to introduce it by January-end.

The vaccine is designed to provide protection from diphtheria, pertussis, tetanus, HiB and Hepatitis-B. It has replaced DPT in the country’s immunisation programme, which protects only against diphtheria, pertussis and tetanus.

There has been a long-standing demand to check the vaccine’s efficay in India. In the letter to the health secretary experts wrote, “When each death is seen in isolation it is reasonable to consider them as mere coincidences, but it is not acceptable if it happens repeatedly.”

Hidden facts

Replies to an RTI application filed by Jacob Puliyal, head of paediatrics department, St Stephen’s Hospital in Delhi, reveals there is more to extension of the vaccine in other states than meets the eye. In November 2010, GAVI Alliance, an international body, had threatened NTAGI of diverting the money sanctioned to India for introduction of the vaccine, to other countries. GAVI Alliance had approved US $46.50 million to introduce the vaccine in Tamil Nadu and Kerala. It threatened to divert US $118.5 million to other countries if India failed to introduce it in other states within six months. Just before the lapse of six months, the government decided to introduce the vaccine in six more states.

Puliyel says the vaccine is killing more children than the diseases it is supposed to protect the children from. Replies to the RTI application reveal that in the first six months of the introduction of the vaccine in Kerala, 24 children developed reactions after being vaccinated. Of these, five died.

Using this data, Puliyel analysed the mortality trend. According to him, if five children died for every 40,000 vaccinated, there would be 3,125 deaths due to the vaccine in India. It is estimated that 25 million children will be administered pentavalent across the country.

An ealier study shows that Hib meningitis affects seven in 100,000 children below the age of five. Considering a 10 per cent mortality rate, there would be 1,750 cases of HiB in the country.

Thus, vaccine-related deaths are much higher than the deaths likely to be prevented from meningitis. Puliyel’s report was published in British Medical Journal on December 20.

Use of vaccine has caused deaths in Sri Lanka, Bhutan and Pakistan as well. In November, three deaths were reported in Vietnam due to use of this vaccine. The Vietnam government stopped the programme with immediate effect. Will India take action, too?

Subscribe to Daily Newsletter :

Comments are moderated and will be published only after the site moderator’s approval. Please use a genuine email ID and provide your name. Selected comments may also be used in the ‘Letters’ section of the Down To Earth print edition.