(IPS NEW DELHI) – – A spate of sudden infant deaths following vaccinations in India has prompted leading paediatricians to call for stronger regulatory mechanisms to evaluate new vaccines for safety and efficacy before their acceptance into the national immunisation programme.
According to data obtained from the Union Ministry of Health and Family Welfare, over the last one year 54 babies are recorded to have died soon after receiving the newly introduced “pentavalent” vaccine that is designed to prevent infection by five disease-causing microbes.
“If the birth cohort in India of 25 million is vaccinated with pentavalents, 6,250 babies will die each year from adverse effects following immunisation.” — Dr. Jacob Puliyel
Rolled out gradually in different Indian states since December 2012, the pentavalent vaccine is a combination which seeks to confer immunity against Haemophilius influenzae type B and Hepatitis B, in addition to the protection afforded by the traditional trivalent vaccine against Diphtheria, Pertussis and Tetanus (DPT).
“Going by the ministry’s figures, an average of one death has occurred for every 4,000 babies vaccinated with pentavalents,” says Dr. Jacob Puliyel, who heads paediatrics at the St. Stephen’s Hospital here. “If the birth cohort in India of 25 million is vaccinated with pentavalents, 6,250 babies will die each year from adverse effects following immunisation (AEFI).
“The huge cost in terms of lives lost from AEFI on being given the combined pentavalent vaccine is difficult to justify,” Puliyel tells IPS, adding that the time-honoured DPT vaccine had a far better record for safety.
Given that the reporting of AEFI in many Indian states is unreliable, paediatricians believe that many more deaths may have occurred than recorded, and recommend a ban on the use of pentavalent vaccines until there is a thorough investigation of the policy change that allowed their entry into India.
In September 2013 Dr. Yogesh Jain, former assistant professor of paediatrics at the All India Institute of Medical Sciences and currently expert at India’s Planning Commission on developing universal health, filed a public interest litigation in the Supreme Court seeking a ban on pentavalent vaccines.
Jain’s lawyers argued at preliminary hearings that the “five-in-one” vaccine is banned in Canada, the United States, Europe, Australia, the United Kingdom, and Japan as also in the developing countries Pakistan, Bhutan, Sri Lanka, and Vietnam, following infant deaths.
Puliyel says that pentavalents gained entry into India as the government chose to bypass the National Technical Advisory Group on Immunisation (NTAGI) that was set up in 2001 to advise on the introduction of new vaccines.
“NTAGI instructions for evaluation were not done after the first year.”
In most countries vaccines are introduced into the national programme after an expert committee has studied the burden of the disease, the safety and efficacy of the vaccine and affordability. If these are satisfactory the vaccine may be considered for inclusion in the routine immunisation schedule.
“Of late, the World Health Organisation has been recommending vaccines that are accepted without regard to local cost effectiveness,” says Puliyel. “Organisations like the Global Alliance for Vaccines and Immunisation (GAVI) have also been pushing new vaccines into India and other developing countries by providing substantial donor grants at the introductory stage.”
Typically, according to Puliyel, once a vaccine gains entry into the Universal Immunisation Programme (UIP), funding is withdrawn and the government finds itself saddled with the full costs of supporting a vaccine of doubtful value and, in some cases, dangerous.
In India, until recently, when a vaccine was proposed to be introduced into the UIP, a subcommittee of the NTAGI would review the available literature and consult experts to make an informed decision. In the interests of transparency the minutes of the meetings and recommendations would be uploaded onto the ministry’s website.
In 2013, an Immunisation Technical Support Unit funded by the Bill & Melinda Gates Foundation was set up to “help” NTAGI in its work, but a new confidentiality clause was inserted to protect the “proprietary” interests of commercial, academic and research institutions.
“In fact, the confidentiality clause is not limited to proprietary matters and NTAGI members are barred from divulging discussions, opinions or decisions for 10 years after leaving the committee that decides on the new vaccine,” Puliyel says.
“Vaccines being introduced in the UIP must be cost effective and look at the disease pattern and load in the country, rather than ape models from other countries,” says Sumbul Warsi, leading city paediatrician and medical director of the well-known Holy Family Hospital.
“The NTAGI must be a totally independent body which is capable of resisting pressures from outside and be transparent,” she tells IPS. “It seems that of late there has been a lot of interference in the process leading up to the introduction of vaccines.”
Puliyel says the government must publish information about a vaccine under consideration for inclusion in vaccination schedules. Stakeholders, including patient groups, health professionals, academic institutions, vaccine companies and organisations like the WHO and GAVI can then register their interest.
“Transparent processes would gain the confidence of the public, which is vital in any mass immunisation programme,”
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Tags: AEFI, diphtheria, DPT, Dr Jacob Puliyel, five-in-one vaccine, GAVI, Global Alliance for Vaccines and Immunization, Haemohilius influenzae type B, hepatitis B, National Technical Advisory Group on Immunisation, NTAGI, pertussis, tetanus, UIP, Union Ministry of Health and Welfare, Universal Immuisation Programme