Touted as a “life-saver for India’s 18 million children”, the pentavalent vaccine project, which was to be introduced as part of the Centre’s Universal Immunisation Programme this year, is on hold.
The five-in-one vaccine promises immunity against diphtheria, whooping cough, tetanus, hepatitis B, and pneumonia and meningitis caused by the Haemophilus Influenzae type B (Hib).
It has been in the Indian market since 2005.
On February 3, the Delhi High Court admitted an additional PIL questioning the efficacy and rationale for introducing the vaccine. The government is due to file a reply on February 24.
“A high-level committee is looking into this,” a health ministry official said, on condition of anonymity. “Plans to introduce this vaccine are on hold.”
The project was to be funded by a $165 million (Rs 766.5 crore) grant from the Global Alliance for Vaccination and Immunisation, an association of donor countries; international organisations such as the WHO, UNICEF and World Bank; and vaccine manufacturers.
“Most countries do not use the pentavalent (vaccine) for primary immunisation,” said Dr Jacob M. Puliyel, consultant paediatrician at Delhi’s St Stephen's Hospital. Puliyel is one of the eight petitioners, including former union health secretary K.B. Saxena, who filed a PIL in the high court in December and, later, the additional PIL.
The PIL states that even the National Technical Advisory Group on Immunisation subcommittee’s recommendations on the Hib vaccine in November 2009 ignored a study done by the Indian Council of Medical Research (ICMR). “The (ICMR) study says that the incidence of pneumonia deaths is only 0.3 per thousand in India. International agencies claim a figure of 14 deaths per thousand,” said Puliyel, who accessed the information through an RTI.
Another WHO-funded study found the incidence of Hib meningitis was 0.007 per cent and said the low infection rate in India may be due to natural immunity in children.
An analysis published by the Cochrane Collaboration — an agency that reviews published research —states that it could not conclude that the immune responses elicited by the combined vaccine are equivalent to the separate injections.
“The cost of the DTP vaccine goes up by 17 to 100 fold when given in combination,” Dr Y. Madhavi, a scientist at Delhi's National Institute of Science, Technology and Development Studies, said.
But Dr Rajesh Jain, joint managing director at Panacea Biotech, one of the Indian manufacturers of the vaccine, said, “We have received encouraging feedback from the government. The vaccine has been pre-qualified by the WHO.” He said if the vaccine “can save even one child”, it should be given. “Once the government includes it in its programme, costs will also come down,” Jain said.