E-DRUG: Pneumonia vaccine

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Vijay

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E-DRUG: Pneumonia vaccine

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[Copied as fair use]

OUTLOOK, India, Sep 08, 2008

DEBARSHI DASGUPTA

http://www.outlookindia.com/fullprint.asp?

choice=1 & fodname=20080908 & fname=Vaccine+%28F%29 & 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, Puliyel and Sona Chowdhary, both

paediatricians at New Delhi's St '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, 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