Bending the truth ostensibly for public good: The case of the pneumococcal conjugate vaccine

Medical Journal of Dr. D.Y. Patil University | January-March 2013 | Vol 6 | Issue http://www.mjdrdypu.org/temp/MedJDYPatilUniv613-3047544_082755.pdf

Jacob Puliyel

Medical Journal of Dr. D.Y. Patil University | January-March 2013 | Vol 6 | Issue 1 3
The Pune Mirror of the 26
th
of August 2012 reports that
the Indian Academy of Pediatrics (IAP) has declared that
pneumonia is a leading cause of death (responsible for
410,000 childhood deaths annually) and recommended that
the Government of India should include free vaccines for
pneumonia and rotavirus in their immunization schedule.
The reporter noted that the IAP’s 2-day training program
at the Hyatt Regency in Mumbai was sponsored by three
foreign-based pharmaceutical companies who make
pneumonia vaccines.
[1]
Two questions spring to mind. Why did the Academy
of Pediatrics recommend rotavirus vaccine to prevent
pneumonia and why would pneumonia vaccine
manufacturers want to promote rotavirus vaccine? Dr.
Sailesh G Gupta, Honorary Secretary General, IAP, has since
clari
fi
ed that it was wrongly reported that three vaccine
companies that supported the meeting were pneumonia
vaccine manufacturers. He said the meeting was supported
by four pharmaceutical companies and only two of those
manufacture pneumonia vaccine, while the other two were
rotavirus vaccine manufacturers.
Given this background, this editorial is not about the con
fl
ict
of interests involved in the recommendation made by the
IAP to the Government of India, but merely discusses some
of the evidence why this is not such a good idea.
In the
fi
rst place, it is both unscienti
fi
c and misleading to
suggest pneumococcal vaccine must be introduced because
pneumonia is a leading cause of death in childhood. The
pneumococcal vaccine is effective only against one of the
many pathogens that cause pneumonia and that too against
a very limited number of serotypes of that one organism.
The number of deaths caused by these serotypes is what is pertinent. That data are not available. However, data on
number of deaths prevented by vaccine can be used as a
substitute. The WHO Bulletin suggests that vaccinating 1000
children will prevent 3.6 cases of pneumonia.
[2]
The observed
death rate for pneumonia in the multi-center study in India
ranged between 0.77% and 2.35%.
[3]
For our calculations, let
us assume the highest mortality of 2.35%. This means that of
the entire population of 25 million infants born this year, it
would prevent 90,000 cases of pneumonia and 2115 deaths.
If the mortality were 10%, it would avoid 9000 deaths. This
is a far cry from the 410,000 deaths quoted as the reason for
introducing pneumococcal vaccine.
At present, the cost of vaccinating one child (3 doses) is about
6000 to
12,000. Assuming the price comes down to
1200 per child, the cost of immunization of 25 million
children born in India each year to prevent the 2115 deaths
will be
3000 crores. Another calculation from an
international perspective put the cost per life saved at
US $ 47,220.
[4]
Even at one-tenth the cost, this is not an
attractive option according to the professor of comparative
health care, Professor D. W. Light.
[5]
Vaccine-induced strain shifts and
risk of asthma
That is not all. The use of the vaccine in the West has caused
strain shifts of an ominous nature. Widespread use of the
7-valent vaccine in the US has resulted in the emergence of
serotype 19A as a major pathogen. Whereas the strains that
were common previously were penicillin sensitive, 30% of the
new strain is actually penicillin resistant.
[6,7]
Furthermore, the
vaccine doubles the chances the children will develop asthma.
[8]
Given these dangers and the nebulous bene
fi
ts, it de
fi
es
reason that the vaccine is being promoted in India by the IAP.
4 Medical Journal of Dr. D.Y. Patil University | January-March 2013 | Vol 6 | Issue 1
Puliyel: Pneumococcal conjugate vaccine
References
1. L ata Mishra IAP pushes for pneumonia vaccine P une Mirror.
Available from: http://www.punemirror.in/article/2/2012082
620120826084500635b60c2199/IAP-pushes-for-pneumonia-
vaccine.html. [Last accessed on 2013 Feb 17].
2. S habir A Madhi, Orin S Levine, Thomas Cherian. Pneumococcal
conjugate vaccine is ef
fi
cacious and effective in reducing the
burden of pneumonia. WHO Bull 2008;86. http://www.who.int/
bulletin/volumes/88/2/09-068239/en/index.html [Last accessed
on 2012 Oct 16].
3. Gupta M, Kumar R, Deb AK, Bhattacharya SK, Bose A, John J,
et al
. Santosham M on behalf of Hib study working group*
Multi-center surveillance for pneumonia & meningitis among
children (<2yr) for Hib vaccine probe trial preparation in India.
Indian J Med Res 131, 2010;131:649-58.
4. Puliyel J. The cost of pneumococcal vaccine underestimated
ten-fold. Hum Vaccine 2011;7:590.
Light DW. Saving the pneumococcal AMC and GAVI. Human
vaccines 2011;7:138-41.
6. Kaplan SL, Barson WJ, Lin PL, Stovall SH, Bradley JS, Tan TQ,
et al
. Serotype 19A Is the most common serotype causing
invasive pneumococcal infections in children. Pediatrics
2010;125:429-36.
7. Gladstone RA, Jefferies JM, Faust SN, Clarke SC. Continued
control of pneumococcal disease in the UK - the impact of
vaccination. J Med Microbiol 2011;60(Pt 1):1-8.
8. Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle
N, Pierce N. Vaccine Trialists Group. A trial of a 9-valent
pneumococcal conjugate vaccine in children with and those
without HIV infection. N Engl J Med 2003;349:1341-8