A campaign against the Haemophilus influenzae type b (Hib) vaccine in India launched by some medical professionals has delayed a government plan to introduce the vaccine through its free national immunisation programme for children.
The health ministry had last year announced that it would replace the standard vaccine for diphtheria, pertussis, and tetanus with a pentavalent vaccine that would also protect children against hepatitis B and Hib.
The Global Alliance for Vaccines and Immunisation (GAVI), after consultation with the Indian health ministry, had pledged in August 2009 a grant of $165m (£110m; 135m) to roll out the new vaccine to cover 10 million children in 10 of India’s 28 states in 2010.The Hib organism, which can cause severe bacterial meningitis and pneumonia, is estimated to kill more than 370 000 children worldwide each year, GAVI said. Nearly 20% of these deaths occur in India.
But the campaign mounted against the Hib vaccine prompted the health ministry to set aside recommendations from its own technical advisory group on immunisation and to ask an independent panel of experts to examine the need for the Hib vaccine in India’s national immunisation programme.
The expert panel has now endorsed the advisory group’s decision and asked the health ministry to introduce the vaccine in selected states and to assess its effect on the incidence of meningitis before it is expanded to other states.
However, a member of the expert panel who asked to remain anonymous told the BMJ: "Concrete steps to introduce the pentavalent vaccine into the immunisation programme are still not visible. India’s antivaccine lobby appears to have succeeded in influencing the health bureaucracy."
Campaigners against the Hib vaccine have argued that India lacksepidemiological data to justify its introduction into the public health programme.
Jacob Puliyel, a paediatrician at St Stephen’s Hospital, New Delhi, who has spearheaded the campaign against the vaccine, said, "The incidence of Hib appears low; immunisation against Hib would be a waste of scarce public resources."
Critics of the pentavalent vaccine have also said that it would mean India abandoning inexpensive vaccines for an expensive one.
Madhavi Yennapu, a health policy analyst at the National Institute of Science Technology and Development Studies, New Delhi, said, "The vaccine against diphtheria, pertussis, and tetanus costs less than three rupees; the pentavalent vaccine could cost 300 rupees [£4; 5; $6]."
But many paediatricians and experts on infectious disease have decried what they have described as the government’s vacillation on the pentavalent vaccine.
Panna Choudhury, chairman of the Indian Academy of Pediatrics’ committee on immunisation, said, "It is true we don’t have hard data on Hib disease incidence, but the absence of evidence does not mean the infection is absent. No one can deny that pneumonia is a leading cause of death among children below 5 years of age in India."
A health ministry committee set up to assess India’s immunisationrequirements has said, "Conservative estimates from available data in India on disease burden suggest that 52 000 cases of meningitis and 260 000 cases of pneumonia occur each year due to Hib."
A vaccine against Hib has been available through private health care for more than a decade and is used almost exclusively by the rich in India.
Thekkara Jacob John, a member of the expert panel and the former head of virology at the Christian Medical College, Vellore, said, "It would be unethical to deny this vaccine to the poor by blocking its entry into the national immunisation programme."
However, critics who have filed a public interest litigation against the pentavalent vaccine say they will continue their campaign through medical journals and the courts. A group of doctors and health activists who call themselves the All India Drug Action Network wrote an open letter earlier this year to the World Health Organization claiming that WHO has misrepresentedthe findings of Hib studies in Bangladesh and Indonesia.
Dr Puliyel said, "The Indonesian study showed more cases of pneumonia among vaccinated children, and the Bangladesh study showed no significant efficacy in radiologically confirmed pneumonia or meningitis. But these studies have been used to promote the vaccine."
Dr Puliyel also claims that a WHO investigation into the deaths of children who had received the Hib vaccine in Sri Lanka in 2008 had ignored its own system of classification of serious adverse events and labelled the deaths as unlikely to have been linked to the vaccine.
While Sri Lanka resumed use of the pentavalent vaccine in March 2010, Bhutan is currently investigating the deaths of four children who had received the pentavalent vaccine.