3. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
• Haemophilus influenzae is a bacteria first
described in 1892 during an influenza pandemic
• Important cause of invasive disease causing
pneumonia, meningitis, otitis media, sinusitis,
epiglottitis mainly in children
• It has six serotypes from a to f, type b is most
invasive
Haemophilus Influenzae B (Hib)
Haemophilus Influenzae
4. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
• Hib bacteria live in the
nose and throat area.
• Like measles, Hib
bacteria are passed from
child to child in air
droplets when an
infected child coughs or
sneezes.
Spreads mainly by coughing or sneezing with air droplets
8. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Hib incidence rate
(per 100,000 children
under age 5)
<250
250 - <1000
1000 - <2000
> 2000
hip_incidence_rate
hib_pn_GBD.Hib_incidence_rate_per100000
0.000000 - 299.999000
299.999001 - 999.999000
999.999001 - 1999.999000
1999.999001 - 2837.791538
Estimated 72,000 deaths due to
pneumonia and meningitis per
year in India
Haemophilus Influenzae
Map not to scale
9. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Disease burden due to Hib infection
• Hib is an important cause of pneumonia and meningitis in children.
• An estimated 3 lakh under-5 children die due to pneumonia every year.
– Out of this, 25- 30 % deaths are attributed to Hib infection (estimated
63,000 deaths each year).
• Hib disease is an important cause of bacterial meningitis in children.
– About 50,000 to 60,000 cases of meningitis every year are attributed
to Hib infection.
– out of this, one-third die and another one-third suffer crippling
disabilities such as deafness, paralysis and mental retardation
• Neighboring countries show higher rates of Hib disease which may indicate
under-estimation in India, possibly due to high rates of antibiotic use or
limitations in detection of the pathogen.
10. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Who are at most risk of disease?
• Hib disease is most common in children under five years old
• Children between 4 months and 18 months of age are most at risk
• Children often carry the Hib bacteria without showing any signs or
symptoms, but they still can infect others. Hib bacteria live in the nose and
throat area
• Like measles, Hib bacteria are passed from child to child in air droplets
when an infected child coughs or sneezes
11. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Hib vaccine is highly safe and effective.
Three doses of Hib immunization reduces the
risk of Hib disease by more than 90% which
are mainly pneumonia and meningitis.
Hib vaccine does not protect against diseases
caused by other germs.
Even after full Hib immunization, a child may
still get other types of pneumonia, meningitis
or viral infections, such as the flu.
Protection offered by Hib vaccine
12. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
India : we will use Hib containing pentavalent vaccine
Different types of Hib vaccines
• Monovalent Hib vaccine
• Tetravalent Hib vaccine in combination with DPT (DPT-
Hib)
• Pentavalent Hib vaccine in combination with Hib and
HepB (DPT-HepB-Hib)
• Penta in other combination, Hexa etc
Hib vaccines comes in different formulations:
13. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Pentavalent Vaccine (DPT-HepB-Hib)
Pentavalent
vaccine
protects
against 5
diseases
• Diphtheria
• Pertussis
• Tetanus
• Hepatitis B
• Hib
14. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Open vial policy applicable
Maximum wastage permissible 15%
Pentavalent
Vaccine is Freeze
Sensitive
DO NOT LET IT
FREEZE !!
15. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Pentavalent vaccine is freeze sensitive and should
never be stored at the base of an ice-lined refrigerator
(ILR).
Stored at temperatures: +2 to +8 deg Celsius, in the
basket of an ice-lined refrigerator (ILR) just below the
hepatitis B vaccine and preferably above/with DPT
vaccine.
16. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Age Current immunization schedule
Immunization schedule
(post pentavalent
introduction)
At birth
BCG, OPV (0 dose), hepatitis B (birth
dose)
BCG, OPV (0 dose),
hepatitis B (birth dose)
6 weeks (1 ½
months )
OPV-1, DPT-1, hepatitis B-1 OPV-1, pentavalent-1
10 weeks (2 ½
months )
OPV-2, DPT-2, hepatitis B-2 OPV-2, pentavalent -2
14 weeks (3 ½
months )
OPV-3, DPT-3, hepatitis B-3 OPV-3, pentavalent -3
immunization schedule
17. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Age Current immunization schedule
Immunization schedule
(Post Pentavalent & IPV introduction)
At birth BCG, OPV (0 dose), hepatitis B (birth dose) BCG, OPV (0 dose), hepatitis B (birth dose)
6 weeks (1 ½
months )
OPV-1, DPT-1, hepatitis B-1 OPV-1, pentavalent-1
10 weeks (2 ½
months )
OPV-2, DPT-2, hepatitis B-2 OPV-2, pentavalent -2
14 weeks (3 ½
months )
OPV-3, DPT-3, hepatitis B-3 OPV-3, pentavalent -3 + IPV
9 months Measles first dose, JE-1 (where applicable) Measles first dose, JE-1 (where applicable)
16–24 months
DPT-booster first dose, measles second
dose, OPV booster dose , JE second dose
(where applicable)
DPT-booster first dose, measles second
dose, OPV booster dose , JE second dose
(where applicable)
5–6 years DPT-booster second dose DPT-booster second dose
10 years TT first booster dose TT first booster dose
16 years TT second booster dose TT second booster dose
Immunization Schedule (New)
18. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
DPT Vaccine
10 dose vial
3 injections
at 6,10,14
weeks
44 per vial
HepB Vaccine
10 dose vial
3 injections at
6 ,10,14 weeks
60 per vial
3 injections
instead of 6
at 6,10,14 weeks
1300 per vial
Pentavalent
Vaccine
Pentavalent vaccine is expensive !!
19. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
• Age – a child below 6 weeks of age should not be
given pentavalent vaccine.
• Vaccination history – a child whose vaccination
schedule has been initiated with DPT/hepatitis B
vaccine will continue to receive subsequent doses
of DPT/ hepatitis B and not pentavalent vaccine.
• Severe allergic reactions–history of a severe
reaction to pentavalent vaccine, DPT or Hep B
earlier should not be given another dose.
• Moderate or severe acute illness
in children- refrain vaccination until their condition
improves.
Who should not be vaccinated
with pentavalent vaccine
20. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
What vaccine will be given to a child who has
received at least one dose of pentavalent
vaccine before his/her first birthday?
If a child has received at least
one dose of pentavalent vaccine
before his/her first birthday then
the child should be administered
the due pentavalent doses at a
minimum interval of four weeks,
at the earliest available
opportunity.
21. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Can pentavalent vaccine be given with other
vaccines?
Pentavalent vaccine can safely be given
along with other vaccines such as polio,
BCG, and measles, during the same
immunization visit.
When giving two different immunization
injections, give one in each thigh.
If more then 3 injection give at 1” apart
or three site.
22. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Even after the introduction of pentavalent vaccine, DPT and
hepatitis B will continue in the immunization schedule.
Birth dose of hepatitis B will continue to be administered in institutional
delivery cases and must be provided within 24 hours of birth.
Children will continue to receive DPT boosters at the age of 16–24
months and 5–6 years ( not beyond 7 years) of age.
In case where child has not received any dose of pentavalent vaccine
before his/her first birthday then the child must be given DPT vaccine
doses as per guidelines.
23. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
• The open vial policy is applicable to pentavalent vaccine.
• The amount of buffer stock recommended is generally
25% of the annual requirement.
– Buffer stock is supplied only in the first year of vaccine
introduction.
– It is meant for managing sudden and unexpected shortages.
• Wastage rates
Vaccine
Open Vial
Policy
Maximum
wastage
permissible
Wastage Multiplication factor
Pentavalent vaccine,
OPV, Hepatitis B, DPT, TT
√ 15%.
1.18
Measles and JE vaccine X 25% 1.33
BCG X 50% 2.00
Vaccine Buffer stock and
Wastage rate
24. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Pentavalent Introduction
AD Syringes Stocks
3 injections of Pentavalent Vaccine will replace 6
injections of DPT and hepatitis B
less requirement of AD syringes (0.5 ml) at all levels
As each AD syringe is packed separately, hence,
maximum permissible wastage rate for AD syringes
equal to vaccine doses supplied including wastage
Pentavalent vaccine is a liquid vaccine hence No
requirement of reconstitution syringe
25. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Vaccine Dose Status Action required
HepB
• Prior to penta introduction : 4
doses
• Post penta introduction :
Only hepatitis B birth
• Ensure realistic indenting and re-distribution of Hep
B
• shift Hep B from health facilities which are not
conducting deliveries and not offering hepatitis B
birth dose
• Ensure Hep B availability at all delivery points
DPT
• Prior to penta introduction : 5
doses (three in the first year of
life and two booster doses)
• Post penta introduction :
Only 2 doses (for booster
doses).
• Ensure indenting and re-distribution of DPT
• Ensure realistic indenting
• shift excess stocks of DPT vaccine from cold chain
points
• Ensure that only required stocks are available for
DPT booster doses
Hep B and DPT Vaccine stock positioning
Pre and post pentavalent introduction
Ensure intensive monitoring at all levels for smooth transitioning
& implementation
26. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Important Considerations
– Requires 10% less cold chain space
– Dry storage space requirement reduced
– More Freeze sensitive than DPT and TT
– Cost per dose is 10 times higher than traditional vaccine
Wastage needs to be minimized
Cold Chain Preparedness for
Pentavalent Vaccination
27. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Prototypes/SOPSTracking tools
revised
Immunization portion for
MCP card need based
revision done and
Tracking bags re designed
after field trial.
SOPs / prototypes shared
with states
28. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
The Revised Immunization Portion
in MCP card…
Branded with RI color & logo
Includes Penta, IPV, MR, JE
Records details up to 16 years (NIS)
Counterfoil tracks reasons for missed
doses & ASHA incentives
29. Insightinto Operational Guidelines on Pentavalent Vaccine Introduction
Indicates
Where to write
due date where to
write vaccination
date
Birth dose
6Weeks
10Weeks
14Weeks
9Months
16-24
months
5 -6
yrs
10
yrs
16
yrs
Vit A
9
dose
ASHA
Incentive
Tracking
Missed dose tracking
_______________
Dose missed
Date missed
Reason missed
Next session date
ANM sign
Details of child
mother,
add, ph. no
Routine Immunization
record in MCP card
Routine Immunization
counterfoil
in MCP card
The Revised Immunization Portion in MCP card…
Acute respiratory infections (2 million deaths each year) are the leading infectious cause of death in children 1 mo to 5 years of age. S. pneumo causes approximately 800,000 of those deaths, Hib accounts for almost 400K. Diarrheal diseases are the second leading cause of death with 1.7 million deaths – 500K are estimated to be due to rotavirus. Other leading causes of death include Malaria (853), Measles (395) HIV aids (321)
Meningitis case fatality rates in developing countries >20%. For pneumonia, Hib case fatality rates can be 5-15%.
15- 35% of survivors of meningitis suffer permanent neurologic damage
5
6
7
9
AD syringe (Wastage multiplication factor is 1.11).