Mis - information campaigns against Hib
Vaccine introduction in NIP
Prof. A. PARTHASARATHY
Distinguished Professor of Pediatrics, The Tamil Nadu Dr. MGR Medical
University, Chennai - 600 032
Former Senior Clinical Professor of Pediatrics, Madras Medical College &
Deputy Superintendent, Institute of Child Health And Hospital for Children, Chennai 600008.
National President (1997), Indian Academy of Pediatrics,
Regional Advisor (1997–1999) Association of Pediatric Societies of South East Asia Region,
Editor-in-chief, IAP Text Book of Pediatrics since 1997
Associate Editor, Color Atlas of Tropical Pediatrics, AAP publication (2009)
Advisor, IAP Committee on Immunization, (2011-2013)
Email: apartha2020@gmail.com
8-Apr-15
4/8/2015
Mobile: 090422 60053
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Agenda
Combination Vaccines-Concept and concerns
IAPCoI recommendations in 2000 & 2011
 Evidence based Safety Profile
The PIL in Delhi High Court on the paucity of
Epidemiologic Data
The misinformation Campaigns, Rejoinders &
Expert opinions in Regional and National News
Papers in Kerala and Tamil Nadu
4/8/2015
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COMBINATION VACCINES – DEFINITION, CONCEPT
 DEFINITION:
 A Combination Vaccine consist of 2 or more separate
Immunogens that have been physically combined in a
single vaccine formulation.
 These Immunogens may pertain to the many antigens /
serotypes of one given pathogen (Eg: Polio Virus
Vaccine) or of multiple pathogens (Eg: DTP Vaccine)
 CONCEPT:
 This concept differs from that of simultaneous
administration of vaccines, which, although administered
concurrently are physically separate.
 The combining of multiple related or unrelated antigens
into a single vaccine is NOT New.
COMBINATION VACCINES –HISTORY, CAUTION
 HISTORY:
 The 1st combined vaccine was trivalent Influenza vaccine
developed in 1945, Hexavalent Pneumococcal vaccine was
developed in 1947 & DTP vaccine was developed in 1948.
 Subsequently many other vaccine combinations (Bacterial /
Viral) were developed.
 DTP became a vehicle for vaccine like Hep B / Hib / IPV,
etc. Eg:DTwP – Hep B,DTwP – Hib,DTwP – Hep B – Hib,
DTaP – IPV, DTaP – Hep B – Hib.
 Even 3 / 4 Live Viral Immunogens were combined
subsequently. Eg: MMR Vaccine, MMR-V Vaccine.
 CAUTION:
 The Manufacturers recommendation should be followed
strictly while extraneously mixing the lyophilized
preparation with a liquid formulation or while administering
a ready to use liquid vaccine.
COMBINATION VACCINES - I
‘Lyophilized / Liquid’ combinations
Why combination vaccines?
 Comprehensive: Incorporates many essential vaccines,
as well as offer the opportunity to introduce newer
vaccines
 Concise: Delivers various antigens in the recommended
quantity and timing for their age and ensure timely
immunization
 Compliance: Improves adherence to immunization
schedule
 Convenience: Convenient for the physician, parents and
children
 Cost effective: Transporting, handling and storage of a
plethora of vaccines are burdensome and expensive
Pediatr Infect Dis J 2001; 20:S10-S18
COMBINATION VACCINES - II
‘Lyophilized / Liquid’ combinations
Endorsement from Scientific Bodies
• ACIP, AAP and AAFP
have stated that the
use of licensed
combination vaccines
is preferred over
separate injections of
their equivalent
component vaccines
J Pediatr Health Care 2003; 17: 53-57
• IAP
recommends
that
wherever
combination vaccines are available, they
can be substituted for monovalent
formulations in the National Immunization
Schedule.
IAP guidebook on immunization ;76 2001.
• The IAPCoI concludes that all currently
licensed combination vaccines in India have
an immunogenecity, efficacy and safety
profile
comparable
to
separately
administered vaccines as of currently
available data. However the manufacturer’s
recommendations for mixing the vaccines
in the same syringe should be strictly
followed.
IAP Guide Book on Immunization:85: 2011
COMBINATION VACCINES – III
‘Lyophilised / Liquid’ combinations
What we need to know?
 Is immunogenicity disturbed?
No
 Are they safe?
Yes
 Have they been tested in Indian infants?
Yes
 Can we use them even for booster series?
Yes
COMBINATION VACCINES - IV
‘Lyophilised / Liquid’ combinations
Percentage of infants having post immunization antibody titres
above minimum protective levels – Asian and Indian experience
Diptheria(>0.01 IU/ml)
100%
Tetanus (>0.1 IU/ml)
100%
Pertussis (>3.92 EU/ml) - AF
Antifimbrial
Pertussis (>2.24 EU/ml) - AP
Antipertactin
97%
81%
Hib (>0.15 g/ml)
100%
Hib (> 1.00 g/ml)
90%
100%
Hepatitis B (>10 IU/ml)
0
8 April 2015
20
40
60
80
% children with protective titres
100
FP-F-22, 12th Asian Pediatric Conf 2004
8
COMBINATION VACCINES - V
Current state of development
Vaccine
Developed
DTaP - IPV
DTaP - Hib
DTwP - HB
DTwP - Hib
DTaP - IPV - Hib
Hep A - Hep B
DTaP - Hib - IPV - HB
MMR - V
DTaP - Hib - IPV - HB - HA
Measles - BCG recombinant
+
+
+
+
+
+
+
+
-
Under development
+
+
TRIPLE “I” STRATEGY
Integrated Infant Immunization Strategy
• 7 – 4 – 9 concept
• 7 Vaccine formulations
• Before the Infant attains 4 months of age
• To prevent 9 Vaccine Preventable Diseases
• ???
8 April 2015
10
GoI’s Pentavalent Introduction Plan
 Pentavalent vaccine
(DTP-HepB-Hib)
will be introduced
initially in 10 states
in India
 National roll out to
follow
States where pentavalent
vaccine with Hib will be
introduced
8 April 2015
11
5-in-one Vaccine to be rolled
out in Tamilnadu and Kerala
>The original decision to introduce Penta vac in 10 Pilot
states of India was reversed following a PIL filed in the
High Court of Delhi by two Pediatricians.
>Mr Bill Gates, Chairman,Gates & Mellinda Foundation,
partner in GAVI,offered to bear total cost of the vaccine
requirements in two states TN & Kerala for 3 years to
start with before the National Roll out when he visited
India on 17Oct’11.
Source ToI,Chennai edn. 18 Oct’11
TN, Kerala to introduce controversial Vaccine
• Dr.Jacob Puliyal, NTAGI Member New Delhi
•
•
gave a press release in TOI on 19.10.2011 that
the 5 in one vaccine is being considered for
introduction for NIP with out sufficient clinical
trials.
Kerala based RTI Activist and physician
Dr.K.V.Babu in another press release in TOI and
Mathru Bhoomi on 19.10.2011 claimed that the
Penta vac could have caused deaths in Sri Lanka
and Bhutan where it was introduced in the NIP.
Hon.Shri Ghulam Nabi Azad denied this
allegation in the parliament
5-in- one vaccine to be launched
in TN & Kerala in December 2011 - 1
• New Delhi: The much awaited five-in-one vaccine will be
•
rolled out from December. To begin with, Tamil Nadu
and Kerala, which have high routine immunization
coverage rate, will use the penta valent vaccine in their
universal immunization drive.
Six other states - Gujarat, Karnataka, Haryana, Goa,
Jammu and Kashmir and Himachal Pradesh - have
expressed their interest to use the five-in-one vaccine.
The ministry will take a final call on allowing these states
to roll out penta valent vaccine over the next few
months.
• Source;ToI,Chennai Edn,18 Nov,‘11
5-in- one vaccine to be launched
in TN & Kerala in December 2011 - 2
• Union health secretary P.K.Pradhan said the GAVI
Alliance, (a Geneva based public-private partnership
aimed at improving health in the world's poorest
countries), is supplying the penta valent vaccine to lndia
for free. "GAVI” is giving us vaccines worth > Rs. One
crore for three years for 10 states. The consignment will
arrive by the end of next month.
• However we are first rolling it out in two states. We will
decide on the request of the other six states by
analyzing their capability to handle adverse effects of
vaccination. Most of these states have high routine
immunization rates.
• India will bear the expense for procuring the penta
valent vaccine after three years," Pradhan said. The
introduction of a pentavalent
vaccine was
recommended by the National Technical Advisory Group
on Immunization (NTAGI on June 16, 2008.)
5-in- one vaccine to be launched
in TN & Kerala in December 2011 - 3
• The pentavalent vaccine will reduce chances of dropout,
will need no additional cold chain space and the number
of syringes used will dip as well. lndia plans to vaccinate
16 lakh children in these two states in the first year.
• The five-in-one vaccine will have diphtheria, pertussis,
tetanus (DPwT), Hepatitis B and HIb (Haemophilus
influenzae type b – (the bacterial micro organism that
causes several serious childhood illnesses like meningitis
and pnetrmonia). Children will also get their oral polio
doses as part of the routine immunization program.
• Source;The T0I,Chennai edn.,18 Nov’11
Pentavalent vaccine to be introduced
today (17.12.2011) - 1
• NEW DELHI: Dismissing reports of the deaths of children
•
•
after administration of pentavalent vaccine in Sri Lanka,
Bhutan and Pakistan as unrelated, the Centre has
decided to introduce this vaccine as part of the routine
immunization program in Kerala on 14 Dec’11.
The vaccine, that will prevent children from five lifethreatening diseases, will be introduced in Tamil Nadu
on December 17.
12 lacs doses of the pentavalent vaccine has been
supplied to both the States and all preparatory activities
including training and logistics are completed, a
statement issued by the Ministry of Health and Family
Welfare said.
• Source;The Hindu,Chennai edn.,14 Dec’11
Pentavalent vaccine to be introduced
today (17.12.2011) - 2
• The
•
•
vaccine will protect children from
Diphtheria,
Pertussis,
Hepatitis
B
and
Haemophilus influenzae Hib disease which is in
addition to the routine immunization program in
the country.
It is administered to children at 6, 10 and 14
weeks of age and will replace the existing DPwT
and Hepatitis B vaccines, the primary dose of
which is given at the same age.
At present, there are I70 countries using the
penta valent vaccine of the 193 World Health
Organization member states.
Pentavalent vaccine to be introduced today
(17.12.2011) - 3
• Goa has been administering the vaccine from
the State budget since 2008, initially introduced
in selected blocks covered the entire State in
2011. As on November 2011, more than 28,000
doses of the penta valent vaccine have been
administered in Goa with no adverse events
following immunization (AEFI) reported.
• Introduction of Hib vaccination as a combination
vaccine carries the added advantage of reducing
the number of injections given to a child from
nine (three each for DPwT, Hepatitis B and Hib)
to only three shots.
Pentavalent vaccine to be introduced today
(17.12.2011) -
4
• It is estimated that 40 per cent of all under-five
mortality in India is attributed to pneumonia,
meningitis and diarrhoeas. Hib disease is
estimated to cause 2.6 lakh cases of pneumonia
and 52,000 cases of meningitis every year.
• Haemophilus influenza B is difficult to culture
from pneumonia and meningitis cases due to
prior use of antibiotics and stringent culture
conditions. The facility for collecting the sample
for culture is available only in tertiary care
hospitals.
Pentavalent vaccine to be introduced today
(17.12.2011) -
5
• Based on the recommendations of WHO and the
National Technical Advisory Group onImmunization
(NTAGI), the penta valent vaccine will be introduced in
these two States with the Global Alliance for Vaccines
and Immunization (GAVI) assistance and will provide
'free vaccine for three years following which the Centre
will take over the program.
• Pointing out that there had been reports of AEFI in three
countries, the statement said that Sri Lanka and Bhutan
had resumed vaccination after investigation of these
cases while Pakistan continued with the vaccination.
• "The reports on the said deaths following penta valent
vaccine were assessed for casualty by respective
countries and WHO and concluded that there is no real
evidence of a link between the use of the vaccine and
deaths," it read.
SUMMARY & RECOMMENDATIONS
• >The safety of Hib Component in Penta vac formulation
•
•
•
has been well established without any significant AEFI in
various clinical trials and by introduction in their NIP by
170 member countries of the WHO.
>Members of IAP are using Penta vac formulation in
their day to day Immunization Practice with utmost
safety profile since 2001.
>Mis-Information Campaigns have been countered by
IAP,GoI,UNICEF and WHO sources.
> A Media Subcommittee of IAPCoI should be formed to
counter such mis-information in future.