A brief presentation about the needs and the proceedings that lead to change of trivalent to bivalent opv on a single day,and the proposed outcomes of this change.

1. t-opv to b-opv SWITCH
Guide:
Dr. NARAYANA HOLLA
Presentation By:
Dr. AKSHAY.B.K.1.

2. Objectives of the Polio Eradication &
Endgame Strategic Plan 2013-2019
• Detect and interrupt all poliovirus transmission1
• Strengthen immunization systems, introduce
inactivated polio vaccine (IPV) and withdraw oral
polio vaccines (OPV)
2
• Contain poliovirus and certify interruption of
transmission
3
• Plan polio’s legacy4
2
2.

3. Before end
2015
2016
2019-2020
Introduce
• at least one dose of IPV
into routine immunization
Switch
•tOPV to bOPV
Withdraw
• bOPV & routine OPV
use
OBJECTIVE 2: STATES THREE DISTINCT STEPS
3
3.

4. In APRIL 2016, withdraw type 2
The switch refers to the replacement of all tOPV(types 1,2&3) with bOPV (containing types 1 and 3
only) in routine immunization and supplemental immunization activities (SIAs), in every country
around the world within a 2-week timeframe.
Once the switch is made, tOPV will no longer be used anywhere in the world, and
manufacturers will no longer supply tOPV
4
4.

5. Rationale for switching from
trivalent OPV to bivalent OPV
 Since 1999, naturally occurring type 2 wild poliovirus has
not been detected
 The type 2 component of tOPV:
 Causes more than 90% of vaccine-derived polio viruses (VDPVs)
 Causes up to approx. 30% of vaccine-associated paralytic polio (VAPP)
cases
 Interferes with immune response to poliovirus types 1 and 3 in tOPV
Currently, the risks associated with the type 2 component of tOPV
outweigh the benefits
5
5.

6. Type 2 component of tOPV is responsible
for >90% of all circulating vaccine derived
poliovirus (cVDPV) recent years
6
0 1 4 0 0
6
24
71
85
184
55
65 68 65
54
0
0
20
40
60
80
100
120
140
160
180
200
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
cVDPV1
cVDPV2
cVDPV3
6.

7. Global synchronization and planning
All 156 OPV-using countries and territories
must switch within a 2-week switch window
(from 17 April to 1 May)
Globally synchronizing the switch reduces
the risk of re-emergence of type 2 cVDPV or
outbreaks from the use of tOPV
7
7.

8. National Switch Day
Countries will select one day during the 2-week switch
window as their National Switch Day.
On this day, countries will:
 Remove and dispose of tOPV
 Begin use of bOPV
8
National Validation Day
2 weeks after the National Switch Day, countries will schedule a
National Validation Day. All tOPV must be withdrawn by this
date
• All tOPV must be fully disposed of as soon as possible after
the switch day
8.

9. Key dates around the switch
9
May 2015 World Health Assembly endorsement of the
process and tentative timelines
September 2015 National Switch Plans were finalized
October 2015 Strategic Advisory Group of Experts (SAGE)
assessed the epidemiology of persistent type 2
cVDPVs and confirmed the switch date
December 2015 At least 1 dose of IPV was introduced into routine
immunization programmes in all countries
April 2016 The Switch: replace tOPV with bOPV globally.
tOPV should no longer be used anywhere in the
world in routine immunization or SIAs.
May 2016 All tOPV should be disposed of as soon as possible
after the switch. All countries should have
validated the completion of the switch by 15 May.
9.

10. Key dates related to 'switch‘ in INDIA
 April 1st: tOPV would not be available after this date.
 April 11th: bOPV would be available in private market but it is not to be
opened or used before 25th April.
 April 25th: Polio Switch Day, when tOPV would be completely withdrawn
and replaced by bOPV in both routine immunization and polio campaigns.
 9th May: National Validation Day when India would be declared free of
tOPV.
10
10.

11. 11
SWITCH PLANNING FOR INDIA
2 weeks global Switch window
by SAGE
17 th Apr2016 -1st
May2016
W1 W2 W 3 W4
National Switch
Date 25 th
April,16
bOPV distribution
starts 2 weeks before
Only bOPV is used
Switches to bOPV
Recall & Disposal of tOPV
and validation
9th MAY
NATIONAL
VALIDATION DAY
11.

12. Components of a successful switch
12
- Site Visits
- Monitoring
- Process
Monitoring
- Reporting
- Timing
- Storage
- Collection of
tOPV
- Site selection
- Disposal
methods
- Procurement
- Cold chain
plan
bOPV
supply
Training
&
Comms
- Stock
inventories
- Procurement
- Smaller
deliveries
tOPV
supply
ValidationMonitoring
Reducing
excess while
avoiding
stock-outs
Minimizing
time that
tOPV &
bOPV are in
cold chain
together
Ensuring
tOPV is not
used after
the Switch
Making sure
milestones
are met
Ensuring
national
withdrawal
of tOPV
Waste Mgmt
Safely
disposing of
all tOPV
12.

13.  Establishing management structure
 Establishing National Switch Validation Committee
 Conducting situational analysis
 Conducting first tOPV inventory to inform forecasting and procurement
planning
 Drafting national switch plan and communications plan (finalize by end
of Sept 2015)
1.PLAN
(by end of September
2015)
PREPARE IMPLEMENT VALIDATE
13
BASIC STEPS OF SUCCESSFUL
SWITCH
13.

14. National and Regional Switch
Committees
PRIOR TO SWITCH:
National and Regional Switch Management Committees
 Plan, manage, and oversee the implementation of the
switch activities
 Oversee Switch Support Teams who help execute recall and
destruction of tOPV
AFTER THE SWITCH DAY:
National Switch Validation Committee:
 Independent body authorized to validate the switch
 Oversees Switch Monitors
14
14.

15. Switch Support Teams and Switch
Monitors
PRIOR TO SWITCH:
Switch support teams
 Individuals hired or delegated by the national
authorities to carry out preparatory and
implementation activities related to the switch except
validation
AFTER THE SWITCH DAY:
Independent switch monitors
 Individuals hired to validate the withdrawal of tOPV
 Should be independent from the switch planning and
preparation process 15
15.

16.  Updating tOPV procurement plan and inventory
 Planing bOPV procurement and distribution
 Establishing support mechanisms
 Secure budget
 Set up switch support teams
 Finalize communications plan, develop training materials and conduct
briefings of key stakeholders
 Managing logistics (cold chain capacity assessment, waste disposal strategy)
 Developing a monitoring framework
PLAN
2.PREPARE
(Q3 2015-Q1 2016)
IMPLEMENT VALIDATE
16
16.

17. bOPV procurement and distribution
To minimize the time that both bOPV and tOPV have
to be in the cold chain together:
 Plan for bOPV to be delivered 2-3 months prior to the
switch at central level.
 Distribute bOPV to the periphery two weeks prior to the
switch
 Remove all tOPV from the cold chain at all levels on
switch day
17
17.

18. Waste management
National planners should develop and communicate a
tOPV collection and disposal plan for the country
 Disposal plans should be in accordance with national legislation and existing
regulations, where applicable.
18
Co-Incineration Encapsulation Protected Sanitary
Landfill disposal
Functional incinerator
sites that are large
enough (i.e. hospital or
industrial sized) and
able to treat health
care waste by operating
at temperatures
between 900 and
1200°C
Available landfills or
pits where hard
containers (such as
metal drums) in which
vials have been encased
in immobilizing
materials (e.g. cement,
bituminous sand, or
clay) can be disposed of
safely.
Accessible landfill sites
that are fenced off and
inaccessible to the
public and free of
visible illegal recycling
activities
Preferred for both rural
and urban areas
For rural areas only For rural areas only
18.

19. Process Monitoring
National Switch Management Committees will monitor
switch planning and implementation and report to the
WHO and UNICEF country offices on selected, agreed
upon indicators and milestones:
Potential Indicators/Key milestones
 National plan completed
 Budget determined
 OPV procurement plan
completed
 tOPV inventories completed
 Waste management plan
 Vaccine delivered
 Training completed
19
Reporting
• Monthly until Feb 2016 • Weekly from March 2016
19.

20.  Training switch monitors
 Training health workers and logisticians
 Organizing communications and media
events
 Distributing bOPV to all peripheral levels
 Collecting and disposing of tOPV
PLAN PREPARE
3.IMPLEMENT
(2 weeks before switch to
switch day)
VALIDATE
20
20.

21. Training of Health Workers
Emphasize practical implications of the switch:
 Technical rationale for the switch
 When to start using bOPV and stop using tOPV
(National Switch Day)
 How to make best use of storage capacity in the weeks
prior to the switch when both tOPV and bOPV will be
in the cold chain together
 Strategies to ensure bOPV is not used prior to the
switch and tOPV is not used after the switch
21
21.

22. tOPV recall and disposal
On Switch Day, countries will:
• Immediately remove all opened
and unopened tOPV vials from
the cold chain at all levels
• Place tOPV vials in a bag or
container and label it as waste
• Send to disposal facility, or set
aside for collection, as
instructed by the switch
committee
Countries should not keep
recalled tOPV in the cold chain. 22
Date withdrawn from cold chain:_______
Quantity in doses: ___________________
tOPV Recall Form ID (code or name
of department,
municipality and
facility)
Type: Hospital □ Health Center □ Vaccination Post □ Other □
______ Name:
Name of Responsible Staff Title Signature and
Date
Inspection of Facility
Existing tOPV viales
(unopened or opened)
Yes □ No □
Number of vials removed
Sent to final destruction
site
Sí □ No □
Name of final destruction
site
Received at Destruction
Site by:
Name / Title Signature and
Date
Observations:
Two copies: one for the health center and one for
the destruction site22.

23.  Switch monitors to validate at selected sites
 Report to National Switch Validation Committee
 NSVC reviews data and validates the switch
PLAN PREPARE IMPLEMENT
4.VALIDATE
(during 2 weeks post Switch
Day)
23
23.

24. Validating the Switch
For 2 weeks after the Switch Day, independent Switch Monitors will visit
a sample of service points and storage facilities within the country to
confirm facilities are free of tOPV.
Selection strategy: Criteria depends on risk status of country as
determined by GPEI
Reporting: to the National Switch Validation Committee (NSVC) within 2
weeks of the Switch (i.e. by the National Validation Day)
24
24.

25. National Validation
During the two weeks after the National Switch Day, the National
Switch Validation Committee (NSVC) must collate and analyze the
validation data collected by the Switch Monitors.
- The National Switch Management Committee should be notified as soon as
possible of any failures to withdraw tOPV found by switch monitors so
corrective action can be taken
- Once the NSVC concludes that tOPV has been successfully withdrawn from the
country, it should report the switch’s validation to the country’s government
- Additional monitoring needed more than two weeks following the national
switch day can be conducted by National Immunization Program supervisors and
other staff
25.

26. IPV introduction and RI strengthening
 As one of its four major objectives, the POLIO ERADICATION AND END GAME STRATEGIC PLAN calls on countries
to introduce at least 1 dose of inactivated polio vaccine (IPV) into routine immunization schedules,
strengthen routine immunization and withdraw oral polio vaccine (OPV) in a phased manner, starting with
type 2-containing OPV.
The introduction of IPV will help to:
 Reduce risks associated with type 2 polio virus. It will raise population immunity against type 2
poliovirus. A region immunized with IPV would have a lower risk of re-emergence or reintroduction of wild or
vaccine-derived type 2 polio virus.
 Interrupt transmission in the case of outbreaks. Should monovalent OPV type 2 (mOPV type 2) be
needed to control an outbreak, those primed with IPV would be expected to have a stronger immune response,
thus facilitating outbreak control and interruption of polio transmission.
 Hasten polio eradication. IPV will boost immunity against poliovirus types 1 and 3 in children who have
previously received OPV, which could further accelerate the eradication of these two wild viruses.26
26.

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