A Guide To Introducing: Inactivated Polio Vaccine
A Guide To Introducing: Inactivated Polio Vaccine
A Guide To Introducing: Inactivated Polio Vaccine
Introducing
Inactivated
Polio Vaccine
Based on the Polio Eradication &
Endgame Strategic Plan 2013-2018
WHO Library Cataloguing-in-Publication Data
A guide to introducing Inactivated Poliomyelitis Vaccine based on the Polio Eradication & Endgame Strategic Plan 2013-2018
1.Poliovirus Vaccine, Inactivated. 2.Immunization Programs. 3.National Health Programs. I.World Health Organization.
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1 Introduction 5
Resources 39
Online resources........................................................................................................ 39
Annex 1: IPV introduction plan checklist ............................................................. 40
Annex 2: Frequently asked questions about IPV..................................................... 41
Annex 3: AEFI Reporting Form. . ................................................................................ 42
Annex 4: Job aid on IPV for health workers. . .......................................................... 43
Abbreviations
AFP acute flaccid paralysis
AEFI adverse events following immunization
BCC behaviour change communication
bOPV bivalent oral poliomyelitis vaccine; containing types 1 and 3
CCL cold chain and logistics
cVDPV circulating vaccine-derived poliovirus
cMYP comprehensive multi-year plans for immunization
DTP Diphtheria tetanus pertussis vaccine
EPI Expanded Programme on Immunization
EVM Effective Vaccine Management
GPEI Global Polio Eradication Initiative
ICC Inter-agency Coordinating Committee
IM intramuscular
IPV inactivated poliomyelitis vaccine
MDVP multi-dose vial policy
mOPV monovalent oral poliomyelitis vaccine
NITAG National Immunization Technical Advisory Group
OPV oral poliomyelitis vaccine
PCV pneumococcal conjugate vaccine
SAGE Strategic Advisory Group of Experts on Immunization
SC subcutaneous
SIA supplementary immunization activity
tOPV trivalent oral poliomyelitis vaccine
VAPP vaccine-associated paralytic poliomyelitis
UNICEF United Nations Children’s Fund
VDPV vaccine-derived poliovirus
VVM vaccine vial monitor
WHA World Health Assembly
WHO World Health Organization
WPV wild poliovirus
General guidance about planning for the introduction of a vaccine into a national routine immunization programme
is provided in the document “Principles and considerations for adding a vaccine to a national immunization
programme: from decision to implementation and monitoring” published by the World Health Organization (WHO)
in 2014 and available online1.
›› P rovide up-to-date references on the global policy, technical rationale and strategic issues related to
the introduction of IPV.
›› Inform the policy discussions and planning activities for the introduction of IPV into a national routine
immunization programme.
Section 1 of this guide provides background information on polioviruses, polio vaccines, and the rationale for
the introduction of IPV. Section 2 outlines the decision-making process and WHO recommendations to consider
on schedules and administration of IPV, leading into section 3, which covers planning and operational topics such
as cold chain management, monitoring and evaluation, and communications and training. In the Annexes,
practical and adaptable tools are provided, including a planning checklist, and sample questions and answers
for health workers.
1 http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/
3
1 Introduction
1.1 Background
In May 2012, the World Health Assembly (WHA) declared
the completion of poliovirus eradication to be a
“programmatic emergency for global public health” and
called on the Director General of the World Health
Organization (WHO) to develop a comprehensive polio
endgame strategy.
The Polio Eradication and Endgame Strategic Plan 2013-20181 was endorsed by Member States at the Sixty-sixth
World Health Assembly in May 2013, approving the targets, goals, and timelines to secure a lasting polio-free world.
The Plan seeks to simultaneously eradicate wild poliovirus and eliminate vaccine-derived poliovirus.
The withdrawal of OPV commenced in April 2016 with the globally synchronized “switch” from trivalent OPV (tOPV;
containing types 1, 2, 3) to bivalent OPV (bOPV; containing only types 1 and 3).
Type 2 wild poliovirus was last detected in 1999, and the continued use of tOPV in areas where routine immunization
coverage is inadequate contributes to the emergence of rare circulating vaccine-derived poliovirus (cVDPV) cases.
In preparation for the switch, an updated WHO Position Paper on polio vaccines was published in February
20142. WHO recommended that all countries using OPV only should add at least one dose of IPV to the national
immunization schedule at or after 14 weeks of age.
1
The Polio Eradication and Endgame Strategic Plan 2013-2018 can be found at: http://polioeradication.org/who-we-are/strategy/
2
WHO. Polio vaccines: WHO Position Paper, January 2014. Weekly Epid. Record, 89. (February 2014). Available at: http://www.who.int/wer/2014/wer8909.pdf
5
A revised version of the polio Position Paper was published in March 20163 , replacing the 2014 version. It
reiterates the WHO recommendations and summarizes recent developments in the field. The latest paper
also reflects the global OPV switch as planned for April 2016.
The primary purpose of the IPV dose is to ensure that new birth cohorts have some protection against the type 2
poliovirus, either wild or vaccine-derived, hence mitigating the potential consequences of any re-emergence of
type 2 poliovirus following the switch. Adding at least one IPV dose will also boost immunity against poliovirus
types 1 and 3, and may contribute to hastening their eradication.
IPV can be safely administered with OPV during the same visit and should be given in addition to the 3 or 4 doses
of OPV in the primary series.
Tr a n sm issio n :
Polioviruses are spread by faecal-to-oral and oral-to-oral
transmission. Where sanitation is poor, faecal-to-oral ›› Faecal-oral
transmission predominates, but in most settings, mixed ›› Oral-oral possible
patterns of transmission are likely to occur. If sanitation
and personal hygiene are inadequate, others can be C o m m u n ic a b ilit y:
infected through dirty hands or food and contaminated
›› Most infectious 7-10 days before and after
water. Thus, intestinal immunity is important in order to onset of symptoms
prevent transmission. ›› Virus present in stool for 3-6 weeks
›› Infected persons without symptoms shed virus
No specific anti-viral drugs are available for in the stool and are able to transmit the virus to
poliomyelitis. Treatment consists of supportive, others
symptomatic care during the acute phase.
Infection occurs without symptoms in approximately 72% of cases. In about 24% of cases it causes mild disease
with transitory fever, discomfort, somnolence, headache, nausea, vomiting, constipation, and sore throat, in various
combinations. In approximately 4% of cases, it presents as aseptic meningitis, and on rare occasions (< 1%) it
presents as paralytic poliomyelitis5.
3 WHO. Polio vaccines: WHO Position Paper, March 2016. Weekly Epid. Record, 91. (March 2016). Available at: http://www.who.int/wer/2016/wer9112.pdf
4 Ibid.
5 Sutter RW, Kew OM, Cochi SL, Aylward RB. Poliovirus vaccine - live. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines. 6th ed. Philadelphia: Elsevier; 2013.
›› Today, polio has been eradicated in the regions of the Americas, Europe, South East Asia, and the Western Pacific.
›› The global eradication of wild poliovirus type 2 was declared in September 2015.
›› Polio remains endemic in two countries: Afghanistan and Pakistan.
Vaccines that contain live attenuated viruses, such as oral polio vaccine (OPV), are extremely safe and effective for
immunizing children against polio. On very rare occasions, however, OPV can lead to vaccine-associated paralytic
polio or vaccine-derived poliovirus outbreaks.
6 Platt LR, Estivariz CF, Sutter RW. J Infect Dis. 2014 Nov 1;201 Suppl 1:S380-9
7
table
1. Ty p e s o f p o l i ov irus
Risk factors Low immunization coverage rates, poor sanitation, high population densities.
To stop
Increase immunization coverage rates with OPV
transmission
Type 1: Caused 100% of 2014 cases Until April 2016, the type 2 virus was
Strains Type 2: Eradicated, last seen in 1999 responsible for up to 90% of all cVDPV
Type 3: Last seen in 2012 cases.
Total cases
359 56
in 2014
Total cases
74 32
in 2015⁸
Eradicating polio for good requires eliminating both wild and vaccine-derived polioviruses.
78
7 Reference: http://polioeradication.org/polio-today/polio-now/this-week/circulating-vaccine-derived-poliovirus/
8 Reference: http://polioeradication.org/polio-today/polio-now/this-week/
›› Humoral immunity: presence of antibodies in the blood, which protects the organism by preventing the
virus from invading the nervous system and causing paralysis.
›› Oral mucosal immunity: prevents excretion of the virus in oral secretions and its transmission through
this route.
›› Intestinal mucosal immunity: prevents excretion of the poliovirus in faeces, which means that children
previously vaccinated with OPV coming into contact with this virus are less likely than unvaccinated children
to excrete it in their faeces.
It should be noted that children vaccinated with OPV who have not yet developed intestinal mucosal immunity
to poliovirus can excrete the vaccine virus in faeces, spreading it into the environment, which serves to immunize
others who have not been vaccinated. Due to its low cost and ease of administration by untrained health
workers, OPV has been used by many low and middle income countries where the risk of polio outbreaks has
been the greatest.
Unlike OPV, IPV cannot cause VAPP or cVDPVs. IPV stimulates a good humoral response and is as effective as
OPV in blocking oral transmission. However, IPV on its own it does not induce the same level of intestinal immunity
as OPV, which means that IPV does not prevent wild polio virus from being excreted in faeces and spreading in
the environment.
Polio vaccines generate immune responses to the types of poliovirus they contain. A polio vaccine that contains
only types 1 and 3 polioviruses generates immune responses to only those types (i.e. immunity to one type of
poliovirus does not guarantee immunity to the other two).
9
table
2. Ty p e s o f p o l i o vac c in e
O r a l p o l i o vac c in e I n ac tivate d p ol io
(OPV) vac c in e ( I P V )
Mixture of live, weakened poliovirus
strains.
Trivalent OPV (tOPV): All 3 poliovirus types Mixture of inactivated, killed strains of all
Contains
Bivalent OPV (bOPV): Types 1 and 3 three poliovirus types.
Monovalent OPV (mOPV): Any one
individual type
In response to the weakened virus, the In response to the inactivated virus, the
body produces antibodies in the blood body produces antibodies in the blood.
How it works and gut. Helps stop transmission by Protects the individual, but the virus may
limiting the virus’ ability to replicate in the still replicate in the gut and could spread to
gut and spread to infect others. infect others.
Due to their important but distinct advantages, both OPV and IPV are necessary to eradicate polio.
Because OPV protects both the individual and the community, it has been an essential tool for countries
working to stop wild poliovirus transmission. IPV protects against paralytic polio and cannot cause cVDPVs,
and thus is vital to ending polio.
While wild poliovirus type 2 (WPV2) has been eradicated worldwide and is no longer a naturally occurring threat,
the type 2 component of OPV has caused the majority of vaccine-related cases since 2000. As a result, in this final
phase of global polio eradication, the type 2 component of tOPV presents greater risks than benefits, thus hindering
eradication efforts.
Accordingly, WHO called for the withdrawal of tOPV in April 2016 through a globally synchronized switch to bOPV,
targeting types 1 and 3 viruses.
To help mitigate the risks of the switch from tOPV to bOPV, WHO recommended that all countries currently using
only tOPV in their vaccination programmes introduce at least one dose of IPV into their routine immunization
schedules before the end of 2015 (pending available supply). This is to help address the gap in population immunity
against the type 2 virus following the switch from tOPV to bOPV.
Vaccination with IPV also reduces the risk of sustained transmission. If type 2 poliovirus is reintroduced post-
eradication, it can be more rapidly controlled using monovalent OPV type 2 (or IPV) because the population would
have already received at least one IPV dose and will therefore be primed or have some degree of immunity.
Wh y s h o u l d co u n t r i e s in trod uc e I P V ?
WHO recommends the introduction of at least one dose IPV by the end of 2015 (pending available
supply) for all countries that use only OPV. IPV is a key element of the Polio Eradication and
Endgame Strategic Plan 2013-2018 and the global readiness to manage risks associated with OPV
type 2 withdrawal:
›› To reduce risks: Once tOPV is withdrawn from the global market in April 2016, there will be an increase
in the population susceptible to the type 2 poliovirus. The use of IPV will help to maintain immunity
and prevent the reappearance of the disease in the event of the reintroduction or emergence of this
type of virus.
›› To help maintain immunity to type 2: Once the type 2 component of OPV is withdrawn globally,
there will be a gradual accumulation of infants susceptible to type 2 poliovirus, and IPV will help to
address this gap in immunity.
›› To interrupt transmission in the event of outbreaks: If the use of mOPV type 2 is required to
control a future outbreak, it will be easier to reach the immunity levels needed to stop transmission in a
population previously vaccinated with IPV. Introducing IPV can help to facilitate future outbreak control.
11
table
3. Ti me l i n e l e a d i n g to I P V in trod uc tion
January 2013: The WHO Executive Board approved the Endgame Strategic Plan 2013-2018.
November 2013: SAGE recommended the schedule for at least one dose of IPV
April 2016: Globally coordinated switch from tOPV to bOPV, from 17 April to 1 May
OPV consists of a weakened (attenuated) version of the polio virus, administered orally through two drops, and has
the advantage of immunizing the intestine, where the virus reproduces. OPV is very effective against the wild virus,
but in extremely rare cases can lead to paralysis through VAPP or cVDPV (see Section 1.2, Polio epidemiology).
Even though wild poliovirus type 2 has been declared as eradicated worldwide, vaccine-related type 2 viruses are
responsible for the majority of cVDPV outbreaks and VAPP cases.
As a result, there were more risks than benefits associated with the use of tOPV. Therefore, it was necessary to
replace tOPV with bOPV, which continues to protect against types 1 and 3. Once these two types are eradicated,
bOPV will also be withdrawn and replaced completely with IPV.
The highly synchronized nature of the switch during the “low” polio season was important to reduce the risk of the
re-emergence of type 2 cVDPVs. A globally coordinated switch was therefore the best way for countries to limit the
risk of cVDPV type 2 emergence and spread.
More information on the rationale and timelines for the OPV switch, including
guidance for planning and implementation, is available on a dedicated website:
www.who.int/immunization/diseases/poliomyelitis/
endgame_objective2/oral_polio_vaccine/en/
Strengthening routine
1.6 immunization programmes
Given that IPV will be administered primarily through
routine immunization programmes, it is essential that the
system be sufficiently robust.
High routine immunization coverage establishes adequate population immunity over time to prevent polio
outbreaks, and builds a sustainable platform for the delivery of lifesaving vaccines.
Many activities that are carried out to prepare for, implement, and monitor the introduction of IPV, offer
opportunities to make improvements in routine immunization programmes. Countries have found that new
vaccines tend to perform only as well as the underlying programme, so efforts to make use of the IPV introduction
to reinforce and improve the immunization programme should not be neglected.
Routine immunization strengthening and polio eradication efforts can amplify each other’s impact and together
more effectively achieve disease prevention targets. Strong routine immunization programmes will also help
to sustain the gains already made by polio resources and help ensure that children who are at a greater risk of
contracting polio have access to immunization.
While a strong routine immunization system helps maintain population immunity to prevent outbreaks, vaccination
campaigns will remain important strategies, for example, in reaching hard-to-access populations and responding
to outbreaks. As much as possible, such supplementary campaign activities – and any efforts to add a vaccine to
an immunization programme – should allow for adequate planning in a way that complements and augments the
routine programme.
13
table W h at t r a n s f o r m ativ e in v e stme n ts c an he l p to
4. ach i e v e b e t t e r immun iz ation outc ome s?
The Global Routine Immunization Strategies and Practices (GRISP) document9 calls on national
Governments, global partners and donors to take the following steps to achieving better immunization
outcomes:
Invest in tailored vaccination strategies that will identify the under-vaccinated and the
2.
unvaccinated and provide them with all needed vaccinations regularly.
Invest in a coherent planning cycle, from comprehensive multi-year plans to operational annual
3.
EPI plans to the quarterly monitoring of implementation of these plans.
4. Invest in assuring that sufficient funds reach the operational level of the programme regularly.
Invest in vaccinators and district managers by regularly and systematically building their capacity,
5.
strengthening their performance and providing supportive supervision.
Invest in modernizing vaccine management and supply chains to make sure that each
6.
vaccination session has sufficient amounts of the right and potent vaccines available.
Invest in an information system that identifies and tracks the vaccination status of
7.
everyone targeted.
8. Invest in sustainably expanding the routine vaccination schedules to cover the full life course.
The six building blocks of a health system: aims and desirable attributes
Cov e rage
H e a lt h w o r k f o r ce Re sp on siv e n e ss
fi n a n ci n g
L e a d e r s h i p/
g ov e r n a n ce
15
16 a guide to introducing inactivated polio vaccine
Decision-making at
2 country level
A review of background, evidence and WHO recommendations should also include reference to GPEI’s Polio
Eradication and Endgame Strategic Plan 2013-2018 – endorsed by Member States at the Sixty-sixth session of
the World Health Assembly in May 2013 – as well as the latest WHO Position Paper on polio. Additional guidance
is available on the WHO IVB website (www.who.int/immunization/) and includes the document Principles and
considerations for adding a new vaccine13.
After making a decision, the Inter-agency Coordinating Committee (ICC14) or equivalent should serve to coordinate
partner support and funding for the immunization programme activities.
12
NITAGs should consist of national experts in a broad range of disciplines – such as senior paediatricians, immunization and vaccine experts,
epidemiologists, public health experts, health economists, health system experts and social scientists – who are capable of analyzing the different types
of evidence and issues that should be considered in making an informed decision.
13
Available at: http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/
14
A committee made up of representatives of the Ministry of Health (MOH), WHO, UNICEF and other domestic and external partners to improve
coordination among partners for the support of immunization programmes.
17
WHO recommendations on the
2.2 IPV vaccination schedule
As of February 2014, WHO no longer recommends an OPV-
only vaccination schedule. For all countries using only OPV,
at least one dose of IPV should be added to the national
immunization schedule 15 .
The primary purpose of the IPV dose is to help maintain immunity against type 2 poliovirus during and after the
planned global withdrawal of OPV2 and switch from tOPV to bOPV.
The primary series consisting of 3 OPV doses plus 1 IPV dose can be initiated from the age of 6
weeks with a minimum interval of 4 weeks between the OPV doses.
If one dose of IPV is used, it should be administered at 14 weeks of age or the nearest immunization visit
(when maternal antibodies have diminished and immunogenicity is significantly higher). IPV can be co-
administered with an OPV dose, and should be given in addition to all other scheduled vaccine doses.
For infants starting the routine immunization schedule late (e.g. older than 3 months), the IPV dose should be
administered at the first immunization contact.
table
5. E xa mp l e s o f w he n to ad min iste r I P V
Schedule Ti mi n g o f I P V
6, 10, 14 weeks At 14 weeks, with the third dose of pentavalent/OPV: OPV1, OPV2, OPV3+IPV
2, 3, 4 months At 4 months, with the third dose of pentavalent/OPV: OPV1, OPV2, OPV3+IPV
For countries that experience any delays or interruptions to IPV supply due to the global shortage in 2016 and 2017,
guidance about any potential need to “catch-up” children who missed receiving IPV is under review at the time of
writing. Once available supply is confirmed, WHO and UNICEF will facilitate discussions with countries to help
assist in planning.
WHO recommendations on polio vaccines also include other schedule options such as sequential IPV-OPV and IPV-only. For details please see the WHO
15
Position Paper, March 2016. Weekly Epid. Record, 91. Available at: http://www.who.int/wer/2016/wer9112.pdf
A full dose of IPV (non adjuvanted) can be given as an intramuscular (IM; in the thigh) or subcutaneous (SC)
injection, although IM administration for IPV has been shown to provide equal immunogenicity and have fewer
local reactions than SC. The SC route is a viable alternative for vaccines where this is indicated on the label.
The thigh is the site generally recommended for IM injections. Injection into the deltoid muscle is not
recommended for infants due to inadequate muscle mass17.
IPV can be safely administered to children with immunodeficiencies (e.g. congenital or acquired
immunodeficiency, or sickle cell disease). In fact, because of the elevated risk of VAPP after the use of OPV
in patients with immunodeficiencies, IPV is universally recommended in these children.
IPV should not be administered to infants with known or documented allergy to streptomycin, neomycin, or
polymyxin B, or with a history of an allergic reaction following a previous vaccine injection.
WHO. Polio vaccines: WHO Position Paper, March 2016. Weekly Epid. Record, 91. (March 2016). Available at: http://www.who.int/wer/2016/wer9112.pdf
16
Meeting of the Strategic Advisory Group of Experts on immunization, April 2015: conclusions and recommendations. Weekly Epid. Record, 90. (May 2015).
17
19
Fractional doses of IPV via
2.4 the intradermal route
As an alternative to the intramuscular injection of a full
IPV dose, countries may consider using fractional doses
(one-fifth of the full dose), via the intradermal route.
In the context of an IPV shortage, countries may consider a 2-dose fractional dose schedule, which could ensure
that all eligible infants receive IPV. Such a strategy is dose-sparing and results in better immunogenicity than a
single full dose of IPV.
A schedule of fractional intradermal doses administered at 6 and 14 weeks ensures early and appropriately-timed
protection. The 2 fractional doses should be separated by a minimum interval of 4 weeks. One fractional dose of
IPV may be suitable for outbreak response if supplies are limited.
If considering a two-dose fractional dose schedule for IPV, the following programmatic and operational challenges
should be carefully assessed:
›› The two-dose schedule, which may add time and complexity to existing contacts
›› The procurement of appropriate 0.1ml syringes and devices
›› The need for added training and supervision of health workers to address the demands of intradermal
administration
›› The necessary adjustments to registers and home-based records to support tracking and follow up
›› The communications strategies and messaging to reassure caregivers and communities about the new practice
Further details on the intradermal administration of IPV and a summary of studies to date comparing
seroconversion rates are presented in the WHO Position Paper on polio vaccines published in March 201618. In
addition, to support countries in considering and implementing a fractional dose schedule of IPV, a range of
background papers and adaptable training materials are available on a dedicated web page19.
WHO. Polio vaccines: WHO Position Paper, March 2016. Weekly Epid. Record, 91. (March 2016). Available at: http://www.who.int/wer/2016/wer9112.pdf
18
In 2015, a systematic review of evidence on the safety of administering multiple injectable vaccines during a single
visit (specifically for IPV, PCV and pentavalent vaccines) showed that when given together these vaccines are safe
and generally well tolerated by infants. Data supports co-administration of these vaccines, and no increase in
reactogenicity was found when compared with vaccines injected in separate visits20.
Studies of health worker and caregiver attitudes indicate that both have concerns about infant pain, potential
vaccine side effects, and uncertainty about vaccine effectiveness when multiple vaccines are given. Findings also
demonstrate that health workers should make a positive recommendation to the caregiver and not overestimate
caregiver concerns about multiple injections.
WHO. Meeting of the Strategic Advisory Group of Experts on immunization, April 2015: conclusions and recommendations. Weekly Epid. Record, 90. (May
20
21
When three injections are given, one injection should be
administered in one limb, and two injections in the other
limb, separated sufficiently to differentiate local reactions.
A common acceptable practice is to separate injections in
the same limb by 2.5 cm (approximately 1 inch)21.
Studies and experience have demonstrated that caregiver concerns about multiple injections can
be addressed with effective communication and immunization practices.
21
Weekly Epid. Record, 90. (May 2015). Available at: http://www.who.int/wer/2015/wer9022.pdf
22
Health worker training materials on multiple injections are available: http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/
inactivated_polio_vaccine/implementation/en/
23
In the absence of specified grading of painfulness, healthcare professionals are encouraged to use their practical experience on the painfulness of specific
vaccines to determine accordingly the best sequencing of the injections.
Recommendations for measures that can be taken to reduce pain and anxiety during vaccination, which can
be applied in high, middle and low income countries, are summarized below.
›› Healthcare personnel carrying out vaccination should be calm, collaborative, and well-informed.
They should use neutral words.
›› Proper positioning of the vaccine recipient should be ensured, according to age. Infants and young
children should be held by their caregiver. Older children should be sitting upright.
›› No aspiration (or pulling back of the plunger of a syringe) should be done during intramuscular injections,
as this may increase pain.
›› When multiple vaccines are scheduled to be injected at the same session, they should be given in
order of painfulness, ending with the most painful23.
Further details are available in the Position Paper: Reducing pain at the time of vaccination –
September 2015. Weekly Epid. Record, 90.
Available at: http://www.who.int/wer/2015/wer9039.pdf
23
24 a guide to introducing inactivated polio vaccine
Planning and managing
3 IPV introduction
25
Once the decision to introduce IPV has been made by the national authorities, the first step will be to develop a
plan for IPV introduction. This should be incorporated into the country’s comprehensive multi-year action plan for
the immunization programme.
The plan for IPV introduction should take into account the following:
›› IPV-specific planning – ensuring that the vaccine is licensed, training is scheduled and corresponding
materials available, immunization records and registers updated, and logistics plans prepared.
›› Programme management and coordination – including the formation of a technical and administrative
committee, use of accountability frameworks, data management, evidence-based planning, training and supply
chain management.
›› M icroplanning – including population mapping, harmonization of routine immunization microplans with
those from polio campaigns to enable more complete session planning, vaccine supply management and cold
chain logistics.
›› I mmunization service delivery – including monitoring and supervision of immunization sessions, local
community coverage and vaccine acceptance, availability of health workers, vaccine delivery and other
immunization session logistics.
›› A dvocacy and briefings – including high level advocacy, the engagement of journalists, paediatricians and
local community leaders, and house-hold level outreach.
›› A calculation of the costs of the plan – including the unit cost per activity, the total cost, and the
sources of financing. Fixed costs of activities that form part of the regular programme should be defined to see
whether further investment will be required.
Annex 1 of this document includes a checklist of core components of an IPV introduction plan. The list can be easily
adapted to reflect any country-specific considerations.
Countries planning to introduce another new vaccine and IPV may wish to consider a joint introduction. This option
should be discussed with regional immunization staff, NITAGs and Ministries of Health as soon as possible, in order
to ensure adequate time for planning. Reviews of lessons learned from vaccine introduction experiences to date25
have identified the importance of early planning as a critical factor for success.
Lessons learned from vaccine introduction experiences: opportunities for inactivated poliovirus vaccine (pdf). Available at: http://www.who.int/
25
immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/lessons-learned-vaccine-introduction-ri-strengthening-dec2014_
en.pdf?ua=1
Route of
Intramuscular is preferred. (For more information, see section 2.3.)
administration
WHO recommends at least one dose of IPV with the third dose of DTP and
Immunization
OPV, typically administered at 14 weeks of age (or 4 months, or the nearest
schedule
immunization visit). (For more information, see section 2.2.)
Store between 2°C and 8°C. DO NOT FREEZE. Discard if known or suspected to
have been frozen. The shake test does not work to determine if IPV was frozen.
Storage conditions
IPV is also damaged by accumulated exposure to heat and light (level of heat
exposure can be determined by the VVM).
IPV multi-dose vials may be used for up to 28 days after opening, provided that
Open vial policy
the criteria for the multi-dose vial policy outlined on the next page are fully met.
Co-administration IPV may be safely co-administered with other vaccines. (For more information, see
with other vaccines section 2.4.)
27
Vaccine management
It is essential to handle the vaccines properly from the moment they arrive in country until the moment they
are used. Good vaccine management includes:
›› Sufficient storage volumes
›› Efficient arrival and acceptance procedures
›› Effective stock management
›› Appropriate temperature monitoring
›› Maintaining standards of buildings, storage rooms, equipment and vehicles
›› Vaccine delivery systems, including vaccine handling, transporting people and vaccines
›› Effective use of policies such as the multi-dose vial policy (MDVP) and the use of vaccine vial monitors (VVMs)
Effective vaccine management requires adequately trained staff at all levels from national and subnational
programme managers, district health management teams, cold chain technicians, logisticians, drivers, and health
facility team. These individuals deal with all aspects of vaccine management, cold chain system and logistics.
For vials that can be kept for up to 28 days after opening, it is recommended that national programmes orient
vaccinators, where possible, to record on the vial the day and month when the vial was opened.
Materials for the training of health workers on vaccine handling practices corresponding to the MDVP and VVM are
available for countries and partners to adapt and use as needed28.
26
For a complete list of WHO prequalified vaccines for polio: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/
27
WHO policy on the use of opened multi-dose vaccine vials (2014 Revision). Available at: http://www.who.int/immunization/documents/general/WHO_
IVB_14.07/en/
28
Application of the WHO Multi-Dose Vial Policy for IPV: MDVP and IPV job aid, and modules 4A and 4B. Available at: http://www.who.int/immunization/
diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/implementation/en/
To be sure that the appropriate amount of vaccine is available, vaccine stocks must be checked continuously, and
records kept of all movements of stock in and out of storage areas. Effective planning, management, and storage of
supplies is important for reducing programme costs, preventing stock-outs and high wastage rates, and ensuring
vaccine safety.
Vaccine wastage is the proportion of vaccine that is supplied but never administered due to a number of reasons.
Each country should calculate its wastage rate based on its experience with other vaccines, especially those
packaged in multiple-dose vials.
C a lcu l at i n g t h e n u mb e r of d ose s of I P V n e e d e d
The basic formula for calculating the annual number of IPV doses needed is:
N=
Surviving infants
x target coverage (%)
x number of doses in the schedule
x wastage factor
Wastage rate =
[(doses supplied - doses administered)/doses supplied]
x 100
Wastage factor =
100 / (100-wastage rate)
A proper application of the MDVP can decrease wastage while ensuring safety. Taking advantage of using a 28-day
discard on opened multi-dose vials, the indicative maximum wastage rate of 20% for 10-dose vials, and 15% for
5-dose vials, can be used in forecasting the estimated vaccine needs.
Each level of the supply chain should maintain a 25% buffer (or reserve) stock, which is a quantity of vaccine that can
be used if new supplies are delayed or if there is a sudden increase in demand. Constraints in the global supply of
IPV may mean that initially this level of buffer stock is not possible.
29
3.3 Cold chain considerations
The introduction of any new vaccine offers a good
opportunity to critically review the cold chain and logistics
(CCL) system and to improve its performance.
Countries may conduct an Effective Vaccine Management (EVM)29 assessment and develop a CCL improvement
plan to guide enhancements. For each vaccine storage site, an assessment is needed to ensure that sufficient
capacity is available.
To calculate the net volume for vaccine storage, the following factors should be considered: target
population; number of doses in the immunization schedule; wastage factor; expected reserve, and; storage
volume per dose according to presentation. In order to precisely determine the specific cold chain capacity
needs for the introduction of IPV into the national immunization schedule, programme managers are advised
to use the Excel-based WHO Vaccine Volume Calculator 201231.
30
Once the cold chain storage capacity required for IPV has been calculated, the manager of the immunization
programme should decide if any adjustments are warranted, for example, changes to the frequency of vaccine
deliveries, or additional refrigeration equipment. Those responsible for procuring refrigeration equipment can select
the most appropriate, depending on the capacity and infrastructure of the storage spaces. Any decision should
be taken in the context of other planned vaccine introductions or campaigns that will be implemented over the
coming years.
IPV loses its potency when exposed to temperatures outside the range recommended by the manufacturer. Its
capacity to produce neutralizing antibodies is destroyed by both heat and freezing. The heat impact on vaccines
is cumulative. Proper storage of vaccines and maintenance of the cold chain during storage and distribution are
essential to prevent the loss of potency. Damaged vaccines should be discarded according to current national
guidelines on good practices in injection safety.
Proper management and handling of vaccines requires that they be properly packed and stored. In general, the same
principles that apply to other vaccines also apply to IPV, for example, inventory control systems should ensure that
units with the nearest expiry date are used first in a system known as “first-expired, first-out” (FEFO). The expiry date
and VVM status should always be checked whenever a vial is opened.
Waste management
In preparing for the introduction of IPV, waste management plans should also be updated, to describe the ultimate
destruction of the increased volume of used needles and syringes. Strengthening of the vaccine/healthcare waste
management plan can be noted as an action within the vaccine introduction plan.
As a general guide, vaccinators should place all used needles (without recapping them) and syringes directly in
a safety box immediately after administering the vaccine. The container should be securely closed when full
29
Effective Vaccine Management initiative: http://www.who.int/immunization/programmes_systems/supply_chain/evm/en/
30
Vaccine volume calculator: http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/index4.html
No other waste should be put into the safety boxes. Instead, other waste should be disposed of in bins and collected
along with the safety boxes, or handled according to national guidelines.
Monitoring and evaluation information systems need to be updated to facilitate collection of core indicators
related to IPV introduction. Monitoring and evaluation activities are not unique to IPV and are described in detail
in many other references31, 32.
Monitoring tools
The main recording tools used for immunization that should be adapted to include IPV at the service delivery
level are:
›› Immunization register
›› Tally sheet
›› Immunization card
›› Defaulter tracking system
›› Stock record
›› Integrated monthly report
Evaluation tools
A range of immunization programme evaluation tools are available and may be used to assess the implementation
of IPV. These tools include:
›› EPI reviews
An EPI review is the chief methodology for assessing the progress of a national immunization programme,
identifying challenges and corrective actions, and providing technical recommendations to strengthen the
programme. It is undertaken every 3 to 5 years. Tools to be used for the EPI review should be adapted to suit
local requirements and to include IPV and any other new vaccine that has been added to the programme.
31
Principles and considerations for adding a vaccine to a national immunization programme. Available at: http://www.who.int/immunization/programmes_
systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/
32
Immunization in practice, module 6: Monitoring and surveillance (pdf). Available at: http://www.who.int/immunization/documents/IIP2014Mod6_19may.
pdf
31
›› Post-introduction evaluations (PIEs):
Now that most countries have extensive experience introducing new vaccines, WHO no longer recommends
that a PIE take place 6 to 12 months after the launch. Rather than conduct a stand-alone PIE, it is encouraged
that new vaccine introduction questions be combined with the next EPI review or surveillance review.
Following the introduction of a new vaccine, regular supervision and other ongoing monitoring activities should be
used to assess the impact on the immunization programme and rapidly identify any problems that require action.
›› Coverage surveys
National coverage monitoring is important to validate administrative data that is reported throughout the year
and allow for comparisons of coverage between vaccines and with the coverage achieved by other countries.
Estimates of coverage can be obtained through evaluation surveys using the standard sampling technique for
defined geographical areas. Other survey methods may be employed for larger areas.
The WHO Vaccination Coverage Survey Manual33, updated in 2015, focuses on methods to reduce bias and
improve the accuracy and precision of survey results.
Vaccine-associated adverse events may affect healthy individuals and should be promptly identified to allow
additional investigation and appropriate action to take place. As for all vaccines, AEFIs should be reported according
to current national regulations.
Guidance from the WHO Global Vaccine Safety Initiative34 includes AEFI investigation, the communications
response, a sample AEFI
reporting form35 (also
Ke y R e sourc e
shown in Annex 3), and
other tools and trainings.
Vaccine Safety Events:
managing the
communications response
These resources are
designed to support the
strengthening of national Vaccine safety events: managing the
capacity to detect and communications response. A Guide for
respond to any event in a Ministry of Health, EPI Managers and
clear, factual, and timely Health Promotion Units.
manner.
WHO Regional Office for Europe, 2013.
A Guide for Ministry of
Health EPI Managers and
Health Promotion Units www.euro.who.int/__data/assets/pdf_file/
0007/187171/Vaccine-Safety-Events-managing-the-
communications-response-final.pdf
33
Coverage survey manual: http://www.who.int/immunization/monitoring_surveillance/Vaccination_coverage_cluster_survey_with_annexes.pdf
34
Resources are available through the Global Vaccine Safety Initiative: http://www.who.int/vaccine_safety/initiative/en/
35
AEFI reporting form: http://www.who.int/vaccine_safety/REPORTING_FORM_FOR_ADVERSE_EVENTS_FOLLOWING_IMMUNIZATION.pdf
K e y R e s o u r ce s
To support the strategic planning process for communications and issues/crisis management,
two adaptable guides are available:
www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/implementation/en
33
Communication planning framework
To support the addition of IPV to a national immunization programme, a Communications Planning Guide36 is
available. This guide provides a range of checklists, tools, templates and best practices, to inform effective planning
and implementation of communication activities associated with IPV and any broader efforts to strengthen routine
services. Content and activities can be adapted to local contexts as needed.
Communications planning frameworks typically follow the series of steps shown in the alongside chart
“Communications planning framework”. This may be adapted and used for planning communications activities to
support the introduction of IPV, any other vaccine, or the overall routine immunization programme.
Figure
2. C o mmu n i cat i on s p l an n in g frame work
1 Coord in ation
an d p re paration
5 mo n i to r i n g
a n d e va l uat i o n 2 Commun ic ations
an alysis
4 Cr e at i v e st r ate gy
a n d mat e r i a l
d e v e lo p me n t
3 Strate gic
p l an n in g
an d d e sign
The IPV communications planning guide is available on this web page, under the heading “Communications planning guide”: http://www.who.int/
36
immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/implementation/en/
More details on the overall framework and each phase are available in the IPV Communications Planning Guide.
In addition to developing a communications plan to support the introduction of IPV, countries are also encouraged
to prepare for any unexpected situations that may arise. Created specifically to support IPV, an Issues Management
(or Crisis Communications) Guide37 can be used as a basis to establish a national issues/crisis management plan.
It can be used to help identify an unexpected event, evaluate its potential impact, and have ready in advance an
appropriate communications strategy to minimize potential consequences.
Further guidance on advocacy, communications, and social mobilization activities related to vaccine introductions
and immunization programmes can be found in a number of other resources38, 39.
37
The issues management guide is available under the heading of same name on this page: http://www.who.int/immunization/diseases/poliomyelitis/
endgame_objective2/inactivated_polio_vaccine/implementation/en/
38
Principles and considerations for adding a vaccine to a national immunization programme. Available at: http://www.who.int/immunization/programmes_
systems/policies_strategies/vaccine_intro_resources/nvi_guidelines/en/
39
Immunization in practice, module 7: Partnering with communities (pdf). Available at: http://www.who.int/immunization/documents/IIP2014Mod7_19may.
pdf
35
Training
One of the core success factors for the introduction of a vaccine is comprehensive, high-quality training about the
new vaccine and the disease it prevents. Such training should include all health workers with a role in immunization,
their supervisors and all immunization programme staff. The training should also include refreshing of the skills and
knowledge of important areas of the immunization programme, especially in areas that may have been previously
identified as weak.
If not already available from a recent evaluation, an initial step to plan and design an effective training programme
is to conduct an assessment of the knowledge, attitudes and practices (KAP) of health workers involved in
immunization. This information will highlight areas where refresher training may be needed and inform the
development of a training plan, budget, and the resulting training materials.
›› I PV is a very safe vaccine, whether given alone or in combination with other vaccines. It has been used
for many years in many countries.
›› Given together with OPV, IPV offers the best protection against polio.
›› IPV is generally given with the third dose of a DTP-containing vaccine, such as pentavalent. This enables
the child to be protected as soon as possible.
›› It is safe for a child to receive many vaccines at once, including two polio vaccines. Each vaccine is still
equally effective when given together.
Examples of frequently asked questions (FAQs) to support health workers to respond to caregivers
and communities are available in Annex 2.
When implementing the trainings, the number of levels through which the training is relayed (e.g. cascade training),
should be minimized to maintain the quality of the training content. If cascade training is unavoidable, it should be
supported by the use of videos and materials.
The training for IPV should not be conducted too far in advance of the vaccine introduction to ensure proper
recollection of learning. For frontline health workers, the training should ideally take place two or three weeks prior
to the vaccine launch. It is also important that the training be followed by supportive supervision to ensure that
health workers correctly apply their new skills.
A number of general immunization training resources are also available and include the Immunization in
Practice modules, a series of modules on immunization training for Mid-Level Managers (MLM)42, and a WHO
e-learning course on Vaccine Safety Basics43.
40
The IPV training package includes modules 1-8, a job aid, key messages and frequently asked questions, and review exercises. Available at: http://www.who.
int/immunization/diseases/poliomyelitis/endgame_objective2/inactivated_polio_vaccine/implementation/en/
41
The Mid-level Manager training modules can be found at: http://www.who.int/immunization/documents/training/en/
42
The WHO Vaccine Safety Basics course is available at: http://vaccine-safety-training.org/
37
38 a guide to introducing inactivated polio vaccine
Resources
Online resources
All materials last accessed August 2016.
Principles and considerations for adding a vaccine to a national immunization programme: From decision to
implementation and monitoring. Publication date: April 2014
http://www.who.int/immunization/programmes_systems/policies_strategies/vaccine_intro_resources/nvi_
guidelines/en/
World Health Assembly resolution: Completion of polio eradication a programmatic emergency for global public
health. May 2012. (pdf)
http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_R5-en.pdf
World Health Organization. Immunization, vaccines and biologicals. IPV introduction, OPV withdrawal and routine
immunization strengthening. (website)
http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/en/
WHO papers
Polio vaccines: WHO position paper, March 2016. Weekly Epid. Record, 91. (March 2016)
http://www.who.int/wer/2016/wer9112.pdf
Reducing pain at the time of vaccination: WHO position paper, September 2015. Weekly Epid. Record, 90. (September
2015) http://www.who.int/wer/2015/wer9039.pdf
Administration of multiple injectable vaccines in a single visit. Meeting of the Strategic Advisory Group of Experts
on immunization, April 2015: conclusions and recommendations. Weekly Epid. Record, 90. (May 2015). http://www.
who.int/wer/2015/wer9022.pdf
39
Annex 1
IPV introduction plan checklist
Following is a check list of the core components that should be included in an IPV introduction plan. This may be
adapted depending on country-specific considerations.
Section Ke y c omp on e n ts
❏❏ enefits of introducing IPV
B
❏❏ Summary of the introduction plan activities
❏❏ Key programmatic considerations, e.g. capacity, cold chain, etc.
Executive summary ❏❏ Economic assessments, financial needs and sustainability
(2 pages)
❏❏ Monitoring and evaluation plan and indicators
❏❏ Timeline of activities from preparation to full roll-out
❏❏ Budget summary
What is the benefit IPV provides important additional protection against polio, protecting both your
of IPV? child and children in our community.
How is IPV different IPV and OPV each provide a different kind of immunity, and are needed together
than OPV? to give you child the best protection against polio.
Is IPV safe? Does it have IPV is one of the safest vaccines in humans. After vaccination, there might be a
any side-effects? little bit of redness and the skin may feel tender.
Until polio is eradicated globally, OPV is still the main preventative measure
Why is OPV still against polio. IPV is recommended in addition to OPV and does not replace OPV.
needed? Is OPV safe? IPV and OPV are both safe vaccines, and together provide the best protection
against polio.
I only want my child It is important – and best – for your child to receive both IPV and OPV. Together,
to receive one polio these two vaccines provide safe and strong protection against polio. If your
vaccine, IPV or OPV,
but not both. child only receives one of the vaccines they will not be as well protected.
Giving a child several vaccinations during the same visit allows your child to be
Why does my child immunized as soon as possible. This provides protection during the vulnerable
need three injections
early months of your child’s life. In addition, giving many vaccines at one time
on one visit?
means fewer visits to the health centre.
It is safe for your child to receive three (or more) injections at once. Many
Is it safe to give three countries have immunization schedules where children receive multiple
injections at one visit?
vaccine injections at one visit.
Can multiple injections No. Numerous studies have shown that giving multiple vaccinations at the
of vaccines increase the same visit does not result in a higher rate of adverse events. Each of the
risk of adverse events? vaccines is still equally effective when given together.
41
Annex 3
AEFI Reporting Form
The form shown below is also available on the ‘Tools and methods’ page of the Global Vaccine Safety Initiative web
site: http://www.who.int/vaccine_safety/initiative/en/
1 When to
give IPV OPV
drops
OPV
drops
OPV
drops
1
3
IPV
1
3
14 weeks is the best time to give IPV because it gives the most protection at that time.
IPV should be given at the same time as Oral Polio Vaccine (OPV) drops. IPV is safe to give at 14
weeks even for babies born too early or who get sick often. For infants starting the routine
immunization schedule after 14 weeks, the IPV dose should be given the first time you
see them.
2 How to
give IPV
2
1
90˚
0
IPV
2nd injection
in same thigh
3 Give with
other
vaccines
43
IPV: Inactivated Polio Vaccine
3 things parents and caregivers need to know
1
Vaccines like IPV protect
IPV is babies when they need it most.
very safe It is safe for your child to get 3 or more injections
at one visit.
2
Hold your baby on your lap.
You can Baby’s feet should be between your thighs to help
keep baby still. Hold arms still. You can breastfeed
lessen pain while baby is getting vaccinated.
3
Polio can paralyze your children – but vaccines can
Baby’s protect them from polio.
vaccines are
important In addition to polio, vaccines can protect your
children from other very serious and sometimes
deadly diseases.
25 September 2014