E-DRUG: Pneumonia vaccine
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OUTLOOK, India, Sep 08, 2008
DEBARSHI DASGUPTA
http://www.outlookindia.com/fullprint.asp?choice=1&fodname=20080908&fname=Vaccine+(F)&sid=1
India plans to adopt a pneumonia vaccine that doesn't work and has ill side-effects
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?
Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
www.aidanindia.org
www.daf-k.cjb.net