| No Immunity
A pneumonia vaccine the government wants to introduce into the immunisation programme is suspect: - The vaccine, Prevenar, is not effective against the most common form of pneumonia
- It just prevents 3.6 instances of radiological pneumonia, a rarer form of pneumonia, in every 1,000 children vaccinated
- It causes severe respiratory disease in every 1.3 cases per 1,000 vaccinated
- The vaccine, costing Rs 12,000 for three required doses, is supported by foreign donor agencies and the WHO
*** How would you react if you were told that your child had contracted a lifelong ailment because of the side-effects of a vaccine that is part of the government's immunisation programme? And what if it's discovered that the vaccine didn't even offer protection in the first place against the disease it was meant to provide immunity from? It all sounds incredible, but may well be true if foreign donor agencies and pharmaceutical firms have their way with the government.
It has been revealed that the pneumococcal conjugate vaccine (PCV), a vaccine against pneumonia that the Union ministry of health and family welfare reportedly plans to include in a year's time in its universal immunisation programme, causes severe respiratory disorder in every one child among a thousand vaccinated. For India , that could potentially mean several thousands of victims of asthma and respiratory diseases.
Not only that, the vaccine, which covers seven strains of the pneumococcus bacteria, has been found to be ineffective against the most common form of pneumonia—clinical pneumonia. PCV7, as the vaccine is commonly referred to, also happens to be very expensive. Launched in the Indian market in 2006 under the brand Prevenar, it is available at a cost of about Rs 12,000 for the three required doses. On the other hand, the standard treatment of pneumonia using Septran, as recommended by the WHO, costs only Rs 10.
Highlighting these facts, Jacob Puliyel and Sona Chowdhary, both paediatricians at New Delhi 's St Stephen's Hospital, have written to the WHO, questioning claims of the vaccine's efficacy. Their letter has just been published in the WHO bulletin. The two culled the facts from studies analysed by the Cochrane Collaboration, a voluntary global network that reviews healthcare interventions. "We found this vaccine does not reduce incidence of clinical pneumonia. It just prevents 3.6 cases of radiological pneumonia per thousand children vaccinated and that too if they are under the age of two, after which the vaccination is ineffective," says Puliyel. Even this marginal benefit comes at a high price, leave aside the additional cost of treating 1.3 cases of asthma per thousand caused by the vaccine.
In response, the WHO bulletin has also published a reply from a panel of three experts who admit the vaccine does not reduce instances of clinical pneumonia, but, paradoxically, cite the 155.8 million worldwide cases of clinical pneumonia as good reason to introduce the PCV. They, however, argue that the vaccine is effective in preventing radiological pneumonia and that the respiratory side-effect should be weighed against this benefit. Clinical pneumonia is the kind that can be diagnosed with the help of symptoms such as breathlessness and cough. Radiological pneumonia, on the other hand, can only be detected through an x-ray that shows the infected patch in the lungs. The former form of the disease is far more common than the latter..
Prevenar, manufactured by US-based Wyeth, has been propped up internationally by GAVI Alliance, a group that funds immunisation initiatives.It has been supported by the WHO. The two have been urging developing countries to adopt and integrate the PCV7 into their immunisation programmes. India seems to be getting there. Health secretary Naresh Dayal, in an interview to The Times of India in April this year, had declared the vaccine would be introduced in the immunisation programme in a year's time. Dayal did not reply to the questions Outlook sent him by fax. GAVI, on the other hand, in an e-mailed reply, confirmed the government's intent to introduce the pneumococcal vaccine. "Earlier this year, the Indian National Technical Advisory Group for Immunisation subcommittee recommended introduction of pneumococcal vaccine beginning in one state in 2010 and reaching universal coverage by 2015," wrote Ranjana Kumar, who's on GAVI's country support team.
M.K. Bhan, secretary, department of biotechnology and head of the immunisation subcommittee, says he is surprised: "I don't know where GAVI got that information from. We recommended the use of a vaccine against pneumonia whenever an affordable, locally manufactured, safe and efficacious vaccine is available. It should also cover at least 70 per cent of the strains in India ."
This brings up a prickly and emotive issue in India 's public health discourse, where many feel that vaccines are thrust upon countries by donor agencies and pharmaceutical firms with no concern for the local disease burden and other factors such as varying natural immunity. The extensive immunisation programme, they feel, is under constant pressure as it assures a captive market. "Local factors are important for a vaccine's introduction," says Y. Madhavi, a vaccine policy analyst at Delhi-based National Institute of Science, Technology and Development Studies. "There is growing evidence that a vaccine that is suitable elsewhere may not be effective here. For instance, children with poor immunity may fail to react positively to a vaccine," she adds.
WHO estimates that each year pneumonia kills about 4,08,000 children under the age of five in India but authentic data from local population-based studies is missing. "In the absence of any such data, a vaccine's introduction is questionable," says C.M. Gulhati, editor of Monthly Index of Medical Specialties. "And in any case, this vaccine doesn't merit consideration because it doesn't cure all kinds of pneumonia and its benefits (3.6/1000) are marginal compared to the severe side-effects it has (1.3/1000)."
The campaign by GAVI and WHO to introduce the PCV7 in India 's immunisation programme has been going on for a while. In 2007, writing in the journal Indian Pediatrics, Thomas Cherian of the WHO's department of immunisation and Orine S. Levine of GAVI's PneumoADIP wrote that the Indian government, if it chooses, could obtain the vaccine with financial aid from GAVI till 2015. The latter also wrote to the government in April 2007 asking for "non-binding expressions of interest" in introducing pneumococcal vaccines. To which, Puliyel responds sarcastically, "Is this an introductory offer for a product that they want to sell?" GAVI's Kumar confirmed that the Indian government has to specify while applying for support on how it plans to secure funds for sustaining the vaccine costs beyond the period of GAVI's funding.
Observers hope that a debate on the issue brings about a more stringent and reliable mechanism of deciding on vaccines being introduced in the country. While it's imperative that children need to be protected against pneumonia, the choice of the vaccine is critical. If it does not even provide immunity, then why should public money be wasted on it? |
