Oral Cholera Vaccination Guideline- 2016

Epidemiology and Disease Control Division

(EDCD)
Department of Health Services (DoHS)
Teku, Kathmandu

Collaborating Partners:
Rotary club of Nagarjun District 3292, Kathmandu, Nepal
Rotary club of Seoul Southwest, Seoul, South Korea
International Vaccine Institute (IVI), Seoul, South Korea
Group for Technical Assistance (GTA), Kathmandu, Nepal

(Under Rotary global grant record – GG1527228)

 Table of Contents
1.0 INTRODUCTION..............................................................................................................1
1.1 CHOLERA - CAUSATIVE AGENT, RISK FACTORS AND CLINICAL MANIFESTATIONS...........1
1.2 GLOBAL SITUATION.........................................................................................................1
1.3 SITUATION OF CHOLERA IN NEPAL.................................................................................2
1.4 DISEASE CONTROL STRATEGIES......................................................................................3
1.5 ORAL CHOLERA VACCINE................................................................................................3
2.0 ORAL CHOLERA VACCINATION CAMPAIGN....................................................................4
2.1 JUSTIFICATION OF THE CAMPAIGN.................................................................................4
2.2 OBJECTIVES OF CAMPAIGN.............................................................................................4
2.3 TARGET POPULATION.....................................................................................................5
2.4 STRATEGY OF THE CAMPAIGN........................................................................................5
3.0 PLANNING AND COORDINATION OF THE CAMPAIGN.....................................................5
3.1 COORDINATION..............................................................................................................5
3.2 ADVOCACY......................................................................................................................6
3.3 COMMUNICATION AND SOCIAL MOBILIZATION.............................................................7
3.4 MACRO PLAN AT THE NATIONAL LEVEL..........................................................................7
3.5 MICRO PLANNING...........................................................................................................8
3.6 VOCATIONAL TRAINING................................................................................................10
3.7 TRAINING......................................................................................................................11
4.0 ORAL CHOLERA VACCINE - EUVICHOL...........................................................................11
4.1 REQUIREMENTS FOR THE CAMPAIGN...........................................................................12
4.2 VACCINE DISTRIBUTION PLAN.......................................................................................13
4.3 PLANNING FOR WASTE MANAGEMENT........................................................................13
4.4 IMPLEMENTATION OF THE CAMPAIGN.........................................................................13
5.0 ADVERSE EVENT FOLLOWING IMMUNIZATIONS (AEFI)................................................15
5.1 WHAT ARE THE TYPES OF AEFI?....................................................................................15
6.0 DATA MANAGEMENT...................................................................................................17
7.0 MONITORING AND SUPervision...................................................................................17
8.0 POST CAMPAIGN EVAULATION....................................................................................18
8.1. Assessment of feasibility..............................................................................................18
8.2. Assessment of costs.....................................................................................................18
REFERENCES.......................................................................................................................19
ANNEXURES.......................................................................................................................20
Annex I District level micro planning form(s)......................................................................21
1.1 District level micro planning for OCV vaccination campaign.....................................21
1.2 District levellogistic information required for OCV vaccination................................22
1.3 District level requirement of Cold Chain, IEC materials and others..........................22
Annex II...............................................................................................................................23
2.1 Village level micro planning form (s).........................................................................23
2.2 Mapping of the OCV vaccination plan at ward / village level....................................24
2.3 Village level logistic information required for OCV vaccination................................25
2.4 Village level requirement of Cold Chain, IEC materials and others...........................25
Annex III DAILY VACCINE DISTRIBUTION PLAN...................................................................26
Annex IV Tally Sheet...........................................................................................................27
Annex V Vaccination Card...................................................................................................28
Annex VI Reporting form for OCV campaign.......................................................................29
Annex VII Supervision Checklist..........................................................................................30
Annex VIII............................................................................................................................31
Annex IX OCV AE FOLLOWING IMMUNISATION REPORTINGFORM....................................32

List of Tables
Table 1: Distribution of cholera outbreakin Nepal (district wise), 2005-2009..........................2
Table 2: Target population for vaccination campaign...............................................................5

List of Figures
Figure 1: Major Cholera outbreaks over the world (2000-2012)...............................................2
Figure 2: Vaccine Vial Monitor for cold chain.........................................................................12
Figure 3: Steps in opening the vaccine vial before administration.........................................12
1.0 INTRODUCTION
About 1.8–2.8 million people die of diarrhoea every year, representing 3.7% of the 56
million deaths recorded globally. For children under the age of 5, the percentage of deaths
due to diarrhoea reaches 15–19%. In low- and middle-income countries, diarrhoea is the
second killer among communicable diseases after lower respiratory infections, the seventh
when considering all causes of death.[1]

Cholera is an acute diarrhoeal disease caused by ingestion of food or water contaminated

with the bacterium Vibrio cholerae. It remains an important public health problem for many
countries and its short incubation period of two hours to five days, enhances the potentially
explosive pattern of outbreaks.Epidemiological trends indicate that epidemic-prone
diarrhoeal diseases have been rising in recent years. Massive outbreaks of cholera, a disease
representing roughly 4.2% of all epidemic diarrhoea, now affect countries that had been
free of the disease for decades.[2]

1.1 CHOLERA - CAUSATIVE AGENT, RISK FACTORS AND CLINICAL MANIFESTATIONS

It is an enteric disease caused by bacterium named Vibrio cholerae.There are two
serogroups of V. cholerae – O1 and O139 which cause outbreaks. V. cholera O1 causes the
majority of outbreaks. The major route of transmission is by the fecal-oral route (exclusively
by contaminated water or food). Cholera is an extremely virulent disease which affects both
children and adults and can kill within hours. About 75% of people infected with V. cholera
do not develop any symptoms, although the bacteria are present in their faeces for 7–14
days after infection and are shed back into the environment, potentially infecting other
people. Among people who develop symptoms, 80% have mild or moderate symptoms,
while around 20% develop acute watery diarrhoea with severe dehydration. This can lead to
death if untreated.

WHO standard case definition states that cholera should be suspected when:
 In an area where the disease is not known to be present, a patient aged 5 years or
more develops severe dehydration or dies from acute watery diarrhoea.
 In an area where there is a cholera epidemic, a patient aged 5 years or more
develops acute watery diarrhoea, with or without vomiting.

1.2 GLOBAL SITUATION

Since 1800 A.D., cholera has spread through the world in seven pandemics as shown in fig.
1. Man-made and natural disaster can further aggravate the risk of epidemics considerably.
There was huge cholera outbreak following the major earthquake in Haiti. This outbreak
killed more than 10, 000 people and affected millions of Haiti residents. The cholera
outbreak occurred after 9 months following the occurrence of the Earthquake and took
years to control the outbreak effectively.

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 Figure 1: Major Cholera outbreaks over the world (2000-2012)

1.3 SITUATION OF CHOLERA IN NEPAL.

The first scientific report on cholera in Nepal was published in May of 1886 [3]and it is still
one of the most important causes of acute diarrhea in Nepal. There are frequent reports of
cholera in different districts of Nepal (table 1). The largest cholera outbreak reported in
Nepal, with more than 30,000 people affected, was in the Mid-Western Development
Region in 2009. Tragically, more than 100 people lost their life during the outbreak. [4] Recent
outbreaks occurred during the 2014 monsoon in Rautahat, the region adjoining northern
states of India and in Kathmandu valley after the devastating earthquake of 2015. [5- 6]
However, it is generally understood that there is under reporting of cholera because of
inadequate or lack of robust surveillance covering all parts of the country. With the
presence of culture confirmation in 3 out of 5 years, Nepal meets the World Health
Organization (WHO) definition of being endemic for Cholera during both 2005-2009 and
2010-2014 time periods.[3]

Table 1: Distribution of cholera outbreakin Nepal (district wise), 2005-2009

Districts 2005 2006 2007 2008 2009
Accham
Baitadi
Chitwan
Dadeldhura
Dailekh
Dang
Doti
Jajarkot
Kailali
Kalikot
Kathmandu
Lalitpur

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 Districts 2005 2006 2007 2008 2009
Banke
Rautahat
Rukum
Saptari
Sarlahi
Sunsari    
Outbreak cases  

1.4 DISEASE CONTROL STRATEGIES

 Water Sanitation and Hygiene promotion: The provision of clean drinking water,
adequate sanitation, personal and food hygiene remain the mainstays of cholera
prevention and control. In nutshell, a multidisciplinary approach based on prevention,
preparedness and response, along with an efficient surveillance system, is essential for
prevention and mitigation of cholera outbreaks and reducing deaths.

 Oral cholera vaccines: In view of the current availability of Oral Cholera Vaccine (OCV)
that are safe and effective, WHO has issued an updated recommendation (2010) that
states that vaccination should be used as a tool to help prevention and control epidemic
cholera in addition to improvement in Water, Sanitation and Hygiene (WASH) practices
where cholera is endemic as well as in areas at risk of outbreaks.

 Case Management:Up to 80% of people can be treated successfully through prompt

administration of oral rehydration salts (WHO/UNICEF ORS standard sachet). Very
severely dehydrated patients require administration of intravenous fluids. Such patients
also require appropriate antibiotics to diminish the duration of diarrhoea, reduce the
volume of rehydration fluids needed, and shorten the duration of V. cholerae excretion.
With proper treatment, the case fatality rate should remain below 1%. For effective
treatment of cholera cases, there should be adequate health service delivery
preparedness in all health facilities at community level. But, this preparedness is usually
compromised in remote and inaccessible areas following natural disaster or civil unrest.

Once an outbreak is detected, the usual intervention strategy is to reduce deaths by

ensuring prompt access to treatment, and to control the spread of the disease by providing
safe water, proper sanitation and health education for improved hygiene and safe food
handling practices by the community. So, along with WASH intervention, reactive
vaccination with oral cholera vaccine is critical to control the outbreak of cholera.

1.5 ORAL CHOLERA VACCINE

Currently available oral cholera vaccines (OCV) are safe and offer good protection (over
70%) for an acceptable period of time. OCVs have opened up the possibility of preventing
outbreaks among the most vulnerable populations living in high risk areas, where usually
recommended control measures are not sufficient.The use of OCVs should also be
considered reactively to reduce mortality in areas where other interventions cannot be
delivered effectively. The intent to use OCVs is to protect individuals who receive the
vaccine and to limit the burden of disease in the community by reducing transmission.

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2.0 ORAL CHOLERA VACCINATION CAMPAIGN
Cholera continues to a serious public health problem in Nepal with yearly reports of
cholera outbreaks from rural and urban locales, including parts of the country that are
remote and difficult to access, compromised water, sanitation and hygiene condition.
The various stakeholders, including the Ministry of Health, Rotary club of Nagarjun,
UNICEF, GTA were consulted on areas that are at high-risk for cholera in Nepal. Thus,
this oral cholera vaccination campaign was initiated with the mission to provide
immunization in addition to strengthening of current WASH activities and conducting
health education programs for the targeted groups.

2.1 JUSTIFICATION OF THE CAMPAIGN

Banke district has been identified as cholera affected in the past five years and has been
identified as "Hot Spot" for cholera. (IVI unpublished report). Additionally, figures from this
district from 2009 to 2013 provided by the Ministry of Health (MoH, Nepal unpublished
data), identify this district as reporting very high number of acute gastroenteritis cases
continuously almost every year with an outbreak in the year 2011 . This was also highlighted
during the various consultative meetings with the DPHO, Banke and local officials.Banke
district is one of the district with 85% of its 0.49 million population living in the 46 VDCs and
only 15% in its sole municipality —Nepalgunj in the mid-western development region of
Nepal. According to the unpublished report of Ministry of Health (MoH), the literacy rate of
the district is 41.7% with 52% of the households with access to portable water. Households
owning and using improved sanitation facilities at Banke district is only 30% indicating
potential risk for diarrhoeal diseases including cholera. As the availability of OCV doses was
limited, there was a need to prioritize and select the most hard hit areas of the district for
the vaccination campaign. Thus, Sonapur and Udarapur village development committees
(VDCs) and ward number 5 of Nepalgunj municipality of Banke district were selected which
were considered to be at highest risk as reported by the local public health authorities.
Thus, frequent visits to these sites were made by the technical team of GTA and IVI to assess
water and sanitation conditions. It was found that the conditions were sub-optimal.

2.2 OBJECTIVES OF CAMPAIGN

Primary Objectives:
 To identify areas that are at high-risk for cholera.
 To vaccinate target population of about 27000 individuals who are above the age of
one (excluding pregnant women) using the existing public health system.
 To monitor and document Adverse Event following Immunization (AEFI)
 To assess the feasibility of a mass OCV campaign in Nepal.
 To determine cost per OCV dose delivered and compare it with budgeted costs.

Secondary Objectives:
 To educate and mobilize communities to help prevent the spread of acute diarrheal
illnesses including cholera in the targeted areas (e.g., vaccination, hygiene practices)
 To generate data in order to assist the Government of Nepal (GoN) in its decision
making about a nationwide vaccination strategy to combat diarrheal diseases,
particularly cholera.

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  To improve the capacity of local health professionals in project area in controlling
and prevention of acute diarrheal illness including cholera.

2.3 TARGET POPULATION

The total selected population for the targeted OCV campaign is nearly 27,000 residing in VDCs
Sonapur and Udarapur, and ward Number 5 of Nepalgunj municipality of Banke District
(excluding pregnant women and children below the age of 1 year) shown in table 2.The three
selected populations are in the same district and are governed under the same geographic
administrative unit of Mid-western development region of Nepal.

Table 2: Target population for vaccination campaign

VDC/ Total Expected Children Target pop. Excl. Estimated
Municipality Populatio pregnanci <1 exp. Preg.+ child 90%
n es <1 coverage
Sonapur 8856 741 231 7884 7096
Udharapur 12436 1463 361 10612 9551
Ward 5, 9950 230 177 9543 8589
Nepalgunj
Total 31242 2434 769 28039 25236

2.4 STRATEGY OF THE CAMPAIGN

Keeping in mind, the dynamics of the disease and its transmission, integrated and a
comprehensive package of interventions have been adopted for this campaign which
includes strengthening WASH activities at the target sites, dissemination of health education
messages through appropriate media regarding prevention, local capacity building, control
and management of cholera and two dose mass vaccination campaign on a door-to-door
basis.
o Campaign date
• 1st Round: First week of September' 2016.
• 2nd Round: Third week of September' 2016.
o Duration of campaign: 5 days

• Day 1, 2, 3, 4 – House to house based vaccination

• Day 5– Booth based for left out population
o Targeted coverage
• At least 90 % coverage in every target area.

3.0 PLANNING AND COORDINATION OF THE CAMPAIGN

3.1 COORDINATION
National Level.
Nepal has a steering committee for control of enteric diseases under the leadership of
honarary district governor, DoHS, MoH, Nepal. Also, there is a separate Task force for
Cholera Control in Nepal under the leadership of director or EDCD, MoH, Nepal. This
campaign has been approved by the ministry of health and endorsed by the steering
committee.

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6
This committee will have the following responsibilities for the campaign:
 To carve out essential policy and strategies for the successful control and
prevention of cholera.
 To ensure commitment for their support from national and international partner
organizations for the successful conduct of the cholera vaccination campaign.
 To secure necessary resources for the successful conduct of the cholera vaccination
campaign.

District Level
 At the district level, the effective implementation of the cholera vaccination would
be the primary responsibility of DPHO, Banke in close coordination with other key
district level governmental offices like district WASH coordination committee and
local partners engaged in the public health activities.
 To organize the coordination meeting at the district level, to ensure commitment
and secure necessary resources from partner organizations for the successful
conduct of the cholera vaccination at district level.

Village Level
 At the village level, the effective implementation of the cholera vaccination would be
the primary responsibility of health facility In-charge of all the three targeted sites
who will work in close coordination with Village WASH Coordination Committee
(VWASHCC) and other local partners and volunteers.
 To organize the coordination meeting at the village level, to ensure commitment and
secure necessary resources from partner organizations for the successful conduct of
the cholera vaccination at all the targeted sites.

3.2 ADVOCACY
 At Central level: There will central level orientation, training and planning meeting,
where different governmental agencies and international organizations will be invited
for their participation. Risk of cholera, its preventive measures, rationale and strategy of
vaccination should be discussed. The key objective of this meeting will be to coordinate
and advocate at the central level for efficient conduct of the vaccination.

 At District level: District level coordination and advocacy meeting will be held. The key
objective of this meeting will be to coordinate and advocate at the district level. In this
meeting, the key stake holder in the district HQ will be invited and oriented regarding
the vaccination.

 At Village level: VDC level coordination and advocacy meeting will be conducted. The key
objective of this meeting will be to coordinate and advocate at the village level. In this
meeting, the entire key stake holder in the villages will be invited and oriented regarding
the vaccination.

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3.3 COMMUNICATION AND SOCIAL MOBILIZATION
The following culturally appropriate key messages should be disseminated through every
possible medium at personal level or using social media available at local level.
 Health education core messages
 Wash your hands
 Use latrine for defecation
 Use clean water and food
 Key community messages (Annex)
 Inform public how vaccines can complement clean water and hygiene and the
need for two doses for a complete regimen
 Though OCV has been shown to be safe, all community members should know to
return to vaccination or health posts for any adverse events following
immunization.
 Process of key message dissemination:
 Inter personal communication (IPC) through volunteers– FCHVs and other
volunteers disseminate why, when, where and who related to vaccination and
distribute the invitation card.
 Inter personal communication (IPC) through health worker - The local health
workers meet with community leaders, school teachers and mothers’ group and
social workers and other stakeholders on why, who, when and where related to
vaccination.
 Distribution of pamphlets: The pamphlets will be distributed extensively through
volunteers to inform local community about cholera vaccination. These
pamphlets must be distributed to key people in the community. (see annex)
 Distribution of caps: The caps will be distributed to volunteers and local health
workers.
 Use local press: Use the local media before and during the campaign for
spreading the messages of the cholera vaccination campaign, for example by
inviting them in local level coordination meeting. Develop messages carefully to
clear out any misconceptions that people may have about OCV.

Note:
Use the common meeting places for spreading the information about the campaign through
posters (see annex). By choosing the right timing, the message reaches many people at
once. Inform school children through headmasters and teachers about the dates, target
groups and sites of the campaign. Parents will, besides other channels, be informed through
their children.

3.4 MACRO PLAN AT THE NATIONAL LEVEL (SEE ANNEX)

 Obtaining endorsement from policy makers;
 Soliciting high-level political commitment;
 Resource mobilisation;
 Specifying the target population, target area, timelines for the various activities;
 Developing training materials/guideline;
 Providing strategies for Social Mobilization;
 Developing logistics and data tools;
 Organizing training on micro-planning and implementation;

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  Procurement of vaccines and other supplies;
 Distribution of vaccine, supplies and other campaign materials to targeted areas;
 Monitor and supervise activities at district and VDC levels.

3.5 MICRO PLANNING

Micro planning at district and village level is essential for the successful implementation of a
vaccination campaign. A vaccination program consists of 10 essential components (shown
in figure below) of micro- planning. There should be a plan for each of these 10
components which prevents confusion, duplication of work and result in an concerted
effort and output.

 Components of Micro planning

plan

District level orientation and planning meeting (micro-planning):

Period 1 day
Responsibility D(P)HO
Facilitator D(P)HO, Medical officer, EPI supervisor, CCA
Participants: Training agenda Methodology
District  Introduction and objective of the meeting  Presentation /
supervisors, demonstration
health  Cholera – agents, outbreak, global / discussion /
institution in /regional/national status) question and
charges from answer
all selected  Preventive strategies including WASH, session
VDCs Surveillance and Vaccination

 Rationale of cholera vaccination

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 District level orientation and planning meeting (micro-planning):

 Strategy of the vaccination campaign

 Implementation activities

 Vaccine and other logistics demand, storage,

distribution and transportation

 Social mobilizations – its content and activities

 Adverse Event Following Immunization (AEFI)

and its management

 Waste disposal and its management

 Effective supervision and monitoring

 Recording, Reporting and data management

At district Level
 Coordination and advocacy with regional and central authorities
 District level orientation (Annex)
 Review cholera/AGE data in Banke district for the past 3-5 years
 Review training materials for FCHV and other volunteers.
 Identify and mobilize the vaccinating teams, field teams and other volunteers
required for the campaign
 Organizing, conducting and monitoring district and VDC level training
 Receiving and storing vaccines and other supplies
 Support VDC level planning and training activities
 Monitor and supervise implementation at the VDC and ward level

Note: The final district micro plan, which is the compilation of each micro plan prepared by
each VDC, will be submitted to the Regional Health Directorate, Child Health Division and
EDCD.

At the VDC level

 Conduct planning meetings with district and VDC level health institutions and other
stakeholders like school prinicipals, VDC secretary, VWASHCC members etc.
 Ensure that all personnel selected to support the vaccination campaign are
committed.
 Plan and conduct training for vaccinators.
 Develop micro-planning involving all the relevant stakeholders.
 Monitor the pre-campaign, campaign and post campaign in the target areas
 Line list all schools and higher institutes both private and public and estimate the
number of eligible individuals in those schools.

Vaccinator’s training

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Period 1 day
Responsibility Health Institution In charge
Facilitator Health Institution In charge
Participants: Training agenda Methodology
Female Community  Introduction and objective of the
Health Volunteers meeting
(FCHV), other
volunteers  Cholera – agents, outbreak,
global /regional/national status)

 Preventive strategies including

WASH, Surveillance and
Vaccination Presentation / demonstration /
discussion / question and
 Rationale of cholera vaccination answer session
 Strategy of the vaccination
campaign

 Implementation activities

 Vaccine and other logistics

demand, storage, distribution and
transportation

 Social mobilizations – its content

and activities

 Adverse Event Following

Immunization (AEFI) and its
management

 Waste disposal and its

management

 Effective supervision and

monitoring

 Recording, Reporting and data

management

3.6 VOCATIONAL TRAINING

Rotary Nepal will be designing training packages for conducting vocational training and
other educational activities in Nepal after receiving technical support from IVI along with
support from GoN and other stakeholders. It will also seek technical expertise from
Rotarians involved for the vocational training, targeted to MoHP, DHO/DPHO and other
health personnel. The MToT and ToT will be the backbone for the project activities. The
proposed vocational training teams will be representatives from Government of Nepal,
Rotarians and consultant firms. The training will be carried out at different levels i.e. Policy
level, Central level, regional level, district level and community level.

The VTT activities are being conducted in two phase:

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Phase I: Completed: Orientation training for Health care workers in Banke district focusing
on Cholera prevention activities including Oral Cholera Vaccination under the lead of
Epidemiology and Disease Control Division (EDCD) and District Public Health Office, Banke
was conducted from 08th -12th July 2016. Representative from EDCD and Host Rotary club
attended and facilitated the training. The training mainly focuses on vaccination and WASH
activities which is going to be conducted.

Phase II: Preparation ongoing: The second phase VTT activities are planned one week before
the vaccination campaign. For the second phase of VTT activities, training materials have
been planned and prepared. Members of VTT team will travel to the district before the first
round of vaccination campaign and conduct trainings for capacity building focusing
healthcare workers and volunteers and advocacy and educational activities focusing
community in the vaccination area. As Banke does not have a Rotary Club at the moment,
Ex-Rotarians were contacted and requested to help during vocational training as well as
during campaign.

3.7 TRAINING
It is one of the key activities in order to prepare the micro-plan at the district level up to the
ward level. There will be training for the vaccinating team on the rationale of cholera
vaccination, door to door vaccination, health education, AEFI, waste disposal, recording,
reporting etc. (Annex)

4.0 ORAL CHOLERA VACCINE - EUVICHOL

There are two types of safe and effective oral cholera vaccines currently available. Both are
killed vaccines – one is Euvichol and another is Sanchol.Euvichol™ has been pre-qualified by
WHO in 2015 and is registered at Department of Drug Administration (DDA), Nepal which will
be used in this project.
o Vaccine type
Inactivated Oral Cholera Vaccine (Euvichol)
o Vaccine presentation
Euvichol is a single dose vial and is packed in a glass bottle of 1.5 ml per dose with
VVM type 30. Each glass vial occupies 16.8 ccm in volume.
o Vaccine stability
 Cholera vaccine (Euvichol) should be kept and transported at 2-80C, but has been
shown to be stable at ambient temperatures for 14 days at 370C.
 Shelf life of 24 months at 2- 8 degree celsius.
 This vaccine should not be frozen and discard if vaccine has been frozen.
o Vaccination Schedule and administration
The vaccine is given in two doses orallyat interval of at least 2 weeks.Each dose is
1.5ml and it should never be given parentally.
o Adverse Reactions associated with OCV.
 OCV is a safe vaccine given orally.
 Safely given more than 29 million doses.

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 Experience in more than 14 countries.
Well-accepted.
Effective in epidemic and endemic situations.
No serious adverse events have been reported.
If following minor adverse events occurs with oral cholera vaccine use,
immediately report to vaccinator or the nearest health center.
 Acute Gastroenteritis, Diarrhea, Fever, Vomiting, Abdominal pain, Itching, Rash,
Nausea, Weakness, Cough, Vertigo, Dryness of mouth, Oral ulcer (rare), Sore
throat (rare) and yellowing of urine.
 It has been observed that the incidence of adverse events is less after the
second dose as compared to the first.
o Contra indications to use of OCV.
 If acute hypersensitivity occurs in first dose, DO NOT GIVE SECOND DOSE.
 As with other vaccines, immunization with the OCV should be postponed in the
presence of any acute serious illness. However, a minor illness such as mild upper
respiratory tract infection is not a reason to postpone immunization.

4.1 REQUIREMENTS FOR THE CAMPAIGN

o Vaccination Cards: Vaccination cards will be handed out to individuals who receive the
1st dose. Vaccine recipients must present the card again to verify their identity and 1 st
dose date before receiving the 2nd dose two weeks later. Each card will havea unique
identifier (see annex).

o Tally sheet: Age and sex and address of all vaccines will be registered on tally sheets
located by the vaccination team. Eligible individuals who come from places outside the
target area will also be given the vaccine; registration will be on different tally sheets.
(see annex)

o Registration logbook: Registration logbook will be maintained by each vaccination team

and will record all the information written on the vaccination card for both first and
second dose. The unique identifier present in the vaccination card will be reported on
the logbook as well.

o Reporting form: Information from the tally sheets should be reported to the higher
level. At the end of each day, each of thevaccinationteam will fill a summary report by
compiling data from tally sheets and send it to the supervisor.

o Transport: Is needed for:

 transportation of vaccine, cold transportation of vaccine, cold-chain equipment such
as cold boxes, ice packs, vaccine carriers and other supplies (cups, water, water
containers, etc.) from the central to the peripheral levels;
 distribution of social mobilization and monitoring materials;
 transportation of personnel involved in monitoring and supervision of the
vaccination campaign, planning, training and implementation.

o Storage and cold chain equipment

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  From the central storage facility in Kathmandu, the vaccine will be transported
immediately prior to the vaccination campaign to the district capital Nepalgunj in
refrigerating trucks and stored at the regional storage facility in Nepalgunj.
 A 35-vial vaccine package will have a volume of 588 cm3 (14cm x 10.5cm x 4cm). The
volume requirements for storage in cold room or refrigerator to vaccinate 20,000
people (40,000 doses) is: 672L + 15%=772; accordingly, the storage room required
for 54,000 doses is: 907L + 15% = 1,043L. Existing cold chain storage room capacities
are adequate.
 Daily transport from the regional storage facility in Nepalgunj to the health posts in
Udarapur, Sonapur village and ward number 5 of Nepalgunj municipality will be done
during the vaccination days in cold boxes ensuring proper cooling of vaccines to
maintain its integrity.
Note:The above procedures are subject to change, depending on resources available.
However, the safety and integrity of the vaccine will be ensured and assessed prior to
administration.

o IEC materials
Posters, pamphlets, banners containing the health education messages will be designed
and distributed at all the target sites.

4.2 VACCINE DISTRIBUTION PLAN

 The adopted vaccine distribution plan from the district level to the household level
should be known by team supervisors and vaccinators.
 In the distribution of cold boxes, ice packs and other logistics, the preference should
be given to hard to reach and distant areas
 Each vaccination team/site should have one permanent vaccine carrier with at least
four frozen ice packs.
 The ice packs should be changed after 48 hours.

4.3 PLANNING FOR WASTE MANAGEMENT

The proper planning has been planned for appropriate waste collection and disposal at the
beginning of the vaccination campaign. Waste should be sorted out by type:
o Glass: empty OCV vials
o Metal: OCV vial cap
o Rubber: rubber stopper
 All the empty vials collected in a plastic bag must be disposed off in the pit
 The rubber caps and the aluminum cover should also be collected in a separate
plastic bags and disposed off in the pit.

4.4 IMPLEMENTATION OF THE CAMPAIGN

 Vaccination Team: Each vaccination team will consist of three trained volunteers:
 Volunteer 1: responsible for screening for eligibility and filling out the vaccination
card.
 Volunteer 2: vaccinator, responsible for vaccination and checking the full ingestion of
the dose of vaccine
 Volunteer 3: responsible for filling in tally sheets, registration logbook and
communication of health education messages.

14
The health education message will include an overview on cholera as well as detailed
information about the rationale of the campaign, the vaccine, and the importance of a
two-dose schedule.

15
 Vaccine Administration
First dose :
 Checks age of the vaccinee and determine pregnancy status.
 Take out the vaccine vial from the vaccine carrier.
 Check whether the vaccine is frozen or notand also check carefully the Vaccine Vial
Monitor (VVM) status, expiry date and physical status. (fig.2)

Figure 2: Vaccine Vial Monitor for cold chain

 Shake well before use.
 Remove the cap of the vial with clean forceps and give the vaccine for self-
administration for all aged 12 and above. For age less than 12, children need
assistance so they need to be vaccinated in the presence of parents or caretaker.
1. Shake Well 2. Loosen the free aluminum cap with forceps

3. Recap out the aluminum cap with forceps4. Complete removal of the aluminum cap

Figure 3: Steps in opening the vaccine vial before administration.

16
  For the child age less than 5 - ensure mother or care taker makes child cooperative
and administer the vaccine carefully with mother or care taker properly holding the
child.
Note: Ensure that child’s mouth is empty before vaccination e.g. chocolate etc.
 Once vaccine is used, put the used vials into plastic bags while the removed
aluminum foil into another plastic bag.
 Ensure tallying after vaccination and ensures that all clients are properly entered in
the respective age group of the tally sheet.
 Inform vaccinees and mother/ caretaker of children to report to vaccinator/health
workers at nearest health facility for any AEFIs.
 Remind caretaker and individual to come for the second dose.

Administration of second dose:

 The second dose will be administered14 days after the first dose. Protection is
expected 7 to 10 days after the second dose.
 During the second dose, the vaccination teams will also emphasize the continuous
need for other prevention measures like chlorination of water (PIYUSH use),
importance of proper hand washing and advantages of improved sanitation facilities.

Considerations during administration of vaccine:

o Prior to vaccine ingestion, vaccinators will ask each participant if (s)he has fully
understood the information given and was able to ask any question that (s)he may
have about the mass vaccination and whether all his/her questions have been
answered.
o Details on the oral administration of the vaccine will be communicated to
vaccination team members during the training sessions.
o After taking the vaccine, each participant will be asked to stay 20 minutes at the site
for observation. Fasting before or after the vaccination is not required.

Post vaccination
 Dispose the cap and the used vial in two separate color coded bags.
 Return unused vaccine to the district cold room with proper cold chain maintenance
 Collect used and remaining tally sheets and forceps for next day
 Calculate daily coverage and vaccine wastage and report to supervisor
 Review overall performance in daily basis to improve for next day

5.0 ADVERSE EVENT FOLLOWING IMMUNIZATIONS (AEFI)

An adverse event following immunization (AEFI)is defined as a medical incident that takes
place after an immunization, causes concern, and is believed to be caused by immunization.

5.1 WHAT ARE THE TYPES OF AEFI?

AEFI can be classified into 5 types, depending on the suspected cause of the reaction.
1. Vaccine Reactions
2. Programme Error
3. Coincidental

17
 4. Injection Reaction
5. Unknown

Definition and examples of classified AEFI:

Type of AEFI 1.1.1.1 Definition Example
Vaccine reaction An event caused or precipitated by the vaccine Anaphylaxis due to
when given correctly. This is due to the measles vaccine
inherent properties of the vaccine.
Programme Error An event caused by an error in vaccine Bacterial Abscess due to
preparation, handling or administration. un-sterile injection
Coincidental An event that occurs after immunization but is Pneumonia 4 days Oral
not caused by the vaccine. This is due to a Polio Vaccine
chance association administered
Injection Reaction Event from anxiety about, or pain from the Fainting spell in a
injection itself rather than the vaccine teenager after
immunization
Unknown Event’s cause cannot be determined

Oral Cholera vaccine is safe. The rate of serious adverse events following immunization is
quiet less. Most AEFIs are mild and transient including nausea, vomiting, abdominal pain,
fever etc.

Common causes of AEFIs include programmatic errors like not using AD syringes, using
wrong diluents and poor or no training. This is not the case in OCV as it is an oral vaccine.

 SERIOUS ADVERSE EVENTS (SAE):

A Serious Adverse Event means any event that results in:
o death
o is immediately life-threatening
o results in persistent or significant disability/incapacity
o requires inpatient hospitalization or prolongation of existing hospitalization
o a congenital anomaly/birth defect

Severe AEFIs are extremely rare and are defined as events which may result in
hospitalization or death and require treatment with prescription drugs.

 Monitoring and management of AEFI

a. Passive Surveillance
i. During the vaccination campaign, any medical problem following immunization
should report to the FCHVs or health workers. Local health worker should
report to supervisor. If the onset of symptoms is after the last day of
vaccination, they should to go to the nearest health facility
ii. All vaccinee should be informed during immunization session to report near by
health worker or health facility in case of any medical problems after
immunization. All AEFIs are to be recorded and reported on the designated
form (Annex IX).

18
 iii. AEFI surveillance will start on the first day of the first round of the campaign
and continue for two weeks after completion of the second round of
vaccination
b. Designated AEFI focal person (medical officer) will visit area vaccination site for AEFI
monitoring with support of local health care providers
c. Once AEFI reported, health worker will distinguish between serious and non-serious
by above definitions
d. If serious, following steps are required:
i. Fill out designated AEFI form (Annex IX) and report to higher level.
ii. Investigated using AEFI investigation form (Annex IX)
2) Refer severe cases to the hospital and treatment of the patient in designed hospital
3) Detailed investigation of all serious AEFI must be carried out, using the appropriate
form, to determine the cause.
4) Communication with the community to explain the cause of the AEFI and action taken,
or to explain lack of association and thereby dispel rumors and fears.
5) Improvements or correction of service delivery if the AEFI was caused by programmatic
error.

6.0 DATA MANAGEMENT

 All vaccinees are to be provided with vaccination cards
 Tally sheets and register log books will record location, age and sex.
 The details of people from areas other than target sites will be recorded in separate
tally sheet.
 The vaccination team will submit the summarized tally sheets at the end of the day to
the health facility in-charge of the respective area.
 The health facility in - charge will cross check the data and the end of the vaccination
campaign will hand it over to the technical support team of the campaign.

7.0 MONITORING AND SUPervision

 Pre-implementation supervision
o One week prior to implementation, preparedness will again be assessed at all levels
( District, VDC and health facility) and if the target region is not prepared; the
implementation will be postponed until the vaccination sites are prepared.
o Pre -implementation Spot Check (house-to-house visits)

The FCHVs and other volunteers will verify if the community knows about the campaign,
dates, target population a week before the campaign. If there is an indication that social
mobilization efforts are inadequate or ineffective, these efforts must be intensified or
messages should be changed immediately.

 Implementation Phase
During the implementation phase, along with the local supervisors there will a team from
EDCD and from GTA to facilitate the supervision process especially in high-risk and hard-to-
each populations.One local supervisor i.e. health facility in - charge in the three target sites will

19
 be responsible and accountable for ensuring more than 90 % coverage with quality vaccination
in their assigned area.

 Post Implementation -Rapid Convenience survey

After the two rounds of vaccination are complete, the local supervisors in the target
areas will conduct a rapid convenience survey in the difficult and hard to reach areas of
the locality. The will identify missed population and explore the reasons for not receiving
vaccination.

8.0 POST CAMPAIGN EVAULATION

8.1. Assessment of feasibility
To assess the feasibility of a mass vaccination campaign using the existing public health
setting in Nepal, the following will be described and quantified:
a) Timeline and necessities for national vaccine registration
b) Vaccination coverage – first and second round
c) Vaccine wastage rate
d) Number and kind of AEs and SAEs – if any - following immunization.

8.2. Assessment of costs

The cost per OCV dose delivered using the existing health system in Nepal will be
determined and then compared with budgeted costs. Cost items will be categorized into
four groups: vaccine procurement, vaccination program preparation, vaccine
administration, and AEFI.

20
REFERENCES
1. World Health Organization: Oral Cholera Vaccines in mass immunization campaigns.
Guidance for planning and use. WHO 2010.
2. Watson JT, Gayer M, Connolly MA. Epidemics after natural disasters. Emerging Infectious
Diseases, 2007, 13(1) (www.cdc.gov/ncidod/EID / 13/1/1.htm).
3. Gimlette GH (1886) Cholera Epidemic of 1885 in Nepal; With a Short Description of the
Topography and Inhabitants of the Valley. Br Med J 1(1325):963-6
4. Bhandari GP, Dixit SM, Ghimire U, Maskey MK (2009) Outbreak Investigation of Diarrheal
Diseases in Jajarkot.J Nep Health Res Council7(2): 66-8
5. International Society for Infectious Disease June 2014 [accessed 06 July 2016]
http://promedmail.org/direct.php?id=20140629.2573010
6. CIWEC Clinic August 2015 [accessed 06 July 2016]http://ciwec-clinic.com/health-
alerts/cholera-update-august-2015

21
ANNEXURES (Please insert the recent updated annexes and the IEC materials)

22
 Annex I
District level micro planning form(s)

1.1 District level micro planning for OCV vaccination campaign

Target population, vaccinators& other team members, vaccination booth, high risk areas (settlements/camps/special communities) and
supervisor at distict level

Total High risk areas

population (a) EPI target Target population (c No. of Booth
VDC (settlements/camps/special Supervisor
(b) = a – b) vaccinators Location
communities)

10

Tota
l

23
1.2 District levellogistic information required for OCV vaccination
Vaccine Logistics Forms

Zip lock
1st dose 2nd dose Total dose Forceps Tally sheet Reporting form RCS AEFI form
plastic bag

1.3 District level requirement of Cold Chain, IEC materials and others
Cold chain

IEC materials
Vaccine carriers

Permanent Ice packs Banner Posters Pamphlets Invitation letters

Temporary

24
 Annex II
2.1 Village level micro planning form (s)

Name of Village / Health Post:

Target population, vaccinators& other team members, vaccination booth, high risk areas (settlements/camps/special communities) and
supervisor at village level
Total
Target High risk areas
Ward population Under one year Name of Booth
(a) population (c = a (settlements/camps/special Supervisor
no population (b) vaccinators Location
– b) communities)

10

Total

25
2.2 Mapping of the OCV vaccination plan at ward / village level

LEGEND

26
2.3 Village level logistic information required for OCV vaccination
Vaccine Logistics Forms

1st 2nd Total Zip lock

Forceps Tally sheet Reporting form RCS AEFI form
dose dose dose plastic bag

2.4 Village level requirement of Cold Chain, IEC materials and others
Cold chain

IEC materials
Vaccine carriers

Permanent Ice packs Banner Posters Pamphlets Invitation letters

Temporary

27
 Annex III
DAILY VACCINE DISTRIBUTION PLAN

From …………… to ……………………

Division: _____________________ Responsible Staff: _____________________

Mode Mode
Date Total no. returned
Date Total no. released Transportation Transportation

I confirm the above information is correct.

Date: ______________________

Name: ______________________Signature: _____________________

28
 Annex IV
Tally Sheet

29
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3 4 5 1 2 nf3 4 5 1 2 ?if
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6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10
11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15
16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20
21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25
26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30
31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35
36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40
41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45
46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5
6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10 6 7 8 9 10
11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15 11 12 13 14 15
16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20 16 17 18 19 20
21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25 21 22 23 24 25
26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30 26 27 28 29 30
31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35 31 32 33 34 35
36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40 36 37 38 39 40
41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45 41 42 43 44 45
46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50 46 47 48 49 50

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;doM ;doM

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30
31
 Annex V
Vaccination Card

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gfd: ______________________________ pd]/-aif{_:

lhNnf: _____________________________ ufFp÷6f]n: _______________________
j8f g: 3/w'/L;+Vof: ______________________

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32
 Annex VI
Reporting form for OCV campaign
Date:

District / PHC/HP: =============================================== VDC / Ward: M

====================================================

Total Target population ======================================= Total no. of Vaccination booth: ==================================

OCV vaccine
Population information related to Vaccination
(Single dose Vial) Vaccine
waste rate Remark
Total Received (%)
Age wise target Returned
target Total pop. Vaccinated (n / %)
Population (n)
pop (n)
Health Institution
[District / VDC 1 to Achievement (%)
5 to 5 to
level] 5 > 15 1 to > 15
15 15 1 to 5 5 to > 15
yrs yrs 5 yrs yrs Total
yrs yrs yrs 15 yrs yrs
(n) (n) (n) (%)
(n) (n) (%) (%) (%)
(n)

IF you come across any programmatic challenges or if you devised any solution to address those challenges, please write down below:
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Prepared by:………….. Office Stamp Verified by: ………………Signature:……………….

Signature: Date:
Date:
Note:
After the completion of the vaccination campaign, all the health centers should collect all the vaccination reports from all vaccination booths in the wards and
report it compiled to the district (public) health office. Similarly, the district (public) health office should also report the compiled report to Regional health
Directorate, Epidemiology and Diseases Control Division and Child Health Division.

33
 Annex VII
Supervision Checklist
Name of Site: ______ _______ _______ ______ _______
1st site 2nd site 3rd site 4th site 5th site
ye n ye n ye n ye n ye no
s o s o s o s o s
Community participation
People are gathered at the vaccination site
Site Organization
Site is identified by banner
Full vaccination team at site
Sufficient vaccine supply at site
One-way crowd flow is established at site
Vaccinator shakes the vial gently before opening
All the vaccine in the vial is fed
Vaccinator is informing second dose date
Are new tally sheets available and being used?
Cold Chain
Is there functioning cold chain available
(cold box/refrigerator)?
Vaccine are kept in cold box/refrigerator
Ice packs are in cold box
Adequate vaccine and supplies available
Random check vial indicates freezing? (If yes, report immediately to higher level to investigate).

Waste Management
Cap is dropped into waste bag after opening
Vaccine vial is discarded in the waste bag just after empting
Other wastes are collected in separate bag

Supervisors Name_______________________________

Signature______________________________________

Date_________________________________________

Annex VIII

34
 RAPID CONVENIENCE SURVEY (RCS)

DISTRICT:..................... VDC/MUNI:................. WARD NO:................ VILLAGE /TOLE:........................... DATE:..................

NAME & POST OF THE SUPERVISOR:………………………………………

1 year and above

House no: Name of household head Total no. of Oral Cholera Vaccine
household members Taken (2 doses) Taken (single dose) Not taken (Zero dose) If single dose, why? If zero dose, why?
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Reasons for not vaccinated

1 Did not know about the campaign 5 Not in the house during vaccination
2 Heard that the vaccine does not work well 6 Busy in work
3 Heard that the vaccine may cause harm 7 Vaccination center closed
4 Booth too far from the house 8 Others…………..

35
 Annex IX
OCV AE FOLLOWING IMMUNISATION REPORTINGFORM

Date ofreport:
Patient's Name
Patient’s name: Age: M /F
/
> 1 year old:yes/no Pregnant:yes/no Immune compromised:yes/no

District: Village: Ward:

VaccinationSites

Dates ofvaccines first: Second:

Date AEFIstarted: Onsetinterval:

History | How manytimes? | Othercomplaints?

/Complaints: Yes / No | |
NauseaVomi Yes / No | |
ting Yes / No | |
Diarrhoea Yes / No| |
Abdominalp Yes / No|
ain Fever |
Other:
Duration:
Onexamination: Temp: BP: PR: RR:

Otherfindings:

Conclusion:
Name of investigator:
Post:
Signature:
Date:

Outcome:
Recovered: Yes /
Yes / No
Hospitalized: Yes / No
Died: