1. Orientation on the Rotavirus vaccination

2. I. What is rotavirus disease?
Rotavirus disease is a diarrheal disease caused by a virus called rotavirus
The name rotavirus comes from a Latin word “rota” the wheel-like appearance of the virus under the
microscope
Rotavirus is a virus that infects the intestines
Rotavirus is the most common cause of severe
diarrheal disease in infants and young children worldwide
Rotavirus is not the only cause of diarrhea, several other agents may also cause diarrhea
To the facilitator:
Explain to the participants what rotavirus disease is.
Rotavirus is a virus that causes diarrhea (sometimes severe), mostly in babies and young children.
The name rotavirus is derived from the Latin Rota, meaning “wheel,” because the rotavirus has a wheel-like appearance when viewed by a microscope.
Rotavirus infects and damages the cells that line the small intestine and causes gastroenteritis.
WHO estimates that rotavirus is responsible for up to 453,000 diarrheal deaths, mostly infants in developing countries, and over 2 million of admission to hospital per year worldwide. Rotavirus is not the only cause of diarrhea, several other agents may also cause diarrhea.

3. How does rotavirus spread?
Rotavirus infection is highly contagious
Rotavirus spread by fecal-oral route
The primary mode of transmission of rotavirus is the passage of the virus in stool to the mouth of another child
To the facilitator:
Explain to the participants how rotavirus is spread.
Rotavirus is very contagious. The primary mode of transmission is the passage of the virus in the stool of an infected individual to the mouth of another individual (via contact with contaminated hands, surfaces, or objects). This is known as a fecal-oral route of transmission. Transmission usually occurs when an infected child does not wash his or her hands after using the toilet.
Children can spread rotavirus from 2 days before to 10 days after the onset of symptoms.
Rotavirus is very stable and may remain viable in the environment for months if not disinfected. It can survive for days on hard and dry surfaces, and it can live for hours on human hands.

4. What are the the signs and symptoms of rotavirus infection?
Three main symptoms of rotavirus infection:
Fever
Vomiting
Watery diarrhea
Abdominal pain may also occur
Diarrhea usually stops after 3 to 7 days
Young children can become dehydrated, requiring urgent treatment
To the facilitator:
Describe to the participants the signs and symptoms of rotavirus infection.
In young children, rotavirus disease commonly begins with fever and vomiting, followed by diarrhea. The virus damages the cells of the small intestine so that the body cannot absorb water and nutrients.
Children may lose interest in eating and drinking and become dehydrated from loss of fluids.
Vomiting is especially dangerous because it’s difficult to replace fluids in young children who are vomiting frequently.
Diarrhea usually stops after 3 to 7 days, though it sometimes lasts longer, usually the patient then recovers fully. 4

5. How is rotavirus disease diagnosed?
Confirmation of a diarrheal illness such as rotavirus requires laboratory testing
Strains of rotavirus may be further characterized by special testing with enzyme immunoassay or polymerase chain reaction
Such testing is not commonly available or necessary
To the facilitator:
Explain to the participants how rotavirus disease is diagnosed.
The clinical features and stool characteristics of rotavirus diarrhea are nonspecific, and similar illness may be caused by other pathogens.
As a result, confirmation of a diarrheal illness like rotavirus requires laboratory testing.
A sensitive test can be carried out on stool specimens, using a commercial test kit (enzyme immunoassay).
Strains of rotavirus may be further characterized by special testing with enzyme immunoassay or polymerase chain reaction, but such testing is not commonly available or necessary. 5

6. Who is most at risk in the population?
Infants after the age of 3 months
Low to no immunity
Vulnerable to dehydration
Older children if they are immunocompromised
Baby
> 3 months
Risk of disease
Immuno-
compromised Children
Adults
Older people
Population
To the facilitator:
Explain to the participants which population is most at risk.
2 populations are most at risk:
Infants older than 3 months
Older children if they are immunocompromised
The disease is most severe in infants after the age of 3 months at which age they are likely to get their first infection, have no immunity, and are very vulnerable to dehydration.
Older children are also at risk especially if they are immunocompromised.
The first infection will give some immunity, but not complete immunity. Repeat infections tend to be less severe.

7. What can be done to prevent rotavirus and diarrheal disease?
High level of rotavirus morbidity continues to occur in the world
Vaccination
PREVENTION
Good sanitation and hygiene
Improved water quality
Exclusive breastfeeding
To the facilitator:
Explain to the participants how to communicate about prevention methods.
Prevention methods against rotavirus disease include breastfeeding, improvements in nutrition, hygiene, and water quality.
But enhancing nutrition, sanitation and hygiene is not enough to prevent the disease and stop the spread. Currently, vaccination is the only way to prevent severe episodes of rotavirus infection.

8. What can be done to treat rotavirus and diarrheal disease?
TREATMENT
Zinc
Oral rehydration therapy (ORT)
To the facilitator:
Explain to the participants how to communicate about prevention methods.
Treatment against rotavirus disease include zinc and oral rehydration therapy (ORT). ORT consists of a solution of salts and sugars that is taken by mouth. 8

9. Rotavirus Vaccine

10. Is there a vaccine against rotavirus?
Currently there are 2 rotavirus vaccines:
RotaTeqTM
RotarixTM
Main characteristics
Both are highly effective and safe
Both protect against severe forms of rotavirus disease
Both do not protect against diarrhea caused by other agents than rotavirus
To the facilitator
Explain to the participants that there is a vaccine against rotavirus disease.
The best way to protect babies from rotavirus disease is vaccination with rotavirus vaccine.
There are two brands of Rotavirus vaccine: RotaTeqTM and RotarixTM.
Both vaccines are effective and safe. Rotavirus vaccine is very effective against rotavirus disease.
It is important to understand that rotavirus vaccine will not prevent or protect diarrhea or vomiting caused by other germs, but it is very effective at preventing diarrhea and vomiting caused by rotavirus. This means that even after full immunization, a child may still get diarrhea caused by other agents. It is really important that health workers and communities using these vaccines know this fact.

11. What is rotavirus vaccine presentation?
Rotavirus vaccine is a ready-to-use, oral vaccine in a liquid formulation
Specially designed tube for direct oral administration
1 tube = 1 dose
1 tube has 1.5mL liquid
To the facilitator:
Describe to the participants the new rotavirus vaccine presentation.
Rotavirus vaccine is a solution for oral use.
It comes in a tube specially designed for direct oral administration .
1 tube = 1 dose. 1 tube has 1.5mL liquid.
The rotavirus vaccine must be given to babies orally, which means swallowed and not injected. 11

12. Rotavirus vaccine

13. Oral applicator tip cap
Rotavirus vaccine
Oral applicator tip cap
Barrel
Plunger

14. At which temperature must the vaccine be stored?
Rotavirus vaccines should be stored between +2°C to +8°C
To the facilitator:
Explain to the participants at which temperature the vaccine should be stored.
Handling vaccines requires great care. Some vaccines are sensitive to heat and some to freezing.
Careful storage and transport conditions are needed to protect vaccines from becoming ineffective and unusable.
Rotavirus vaccine must be transported and stored at +2°C to +8°C.
It is important to ensure that the vaccine is not frozen.
If vaccines are frozen, they lose their potency and they would not provide adequate protection against the disease. 14

15. Where do you store the vaccine?
The rotavirus vaccine should be stored in a refrigerator
To the facilitator:
Explain to the participants where to store the vaccine.
Good temperature control during the storage and transport of vaccines is critical to ensure their potency and safety. Monitor the temperature of the refrigerator regularly.
As we have mentioned before, rotavirus tubes must be stored between +2°C and +8°C .
Do not put rotavirus vaccine in the freezer.
The vaccine should be administered as soon as possible after being removed from the refrigerator. 15

16. Which vaccine should be stored in front?
Vaccines with early expiration dates should be kept in front to be used first
Further expiry date in back
To the facilitator:
Explain to the participants, how to store the vaccine.
Vaccines with early expiration dates should be kept in front for first use.
Vaccines with the Vaccine Vial Monitor (VVM) at or near stage 2 should be used first. Vaccines with VVM beyond stage 2 should not be used even if the expiration date is valid (more detail in Module 4).
Keep a “use first box” in the refrigerator to put vaccine vials that were taken out of the refrigerator (for fixed or outreach session) and were brought back unused. Vaccines in the “use first box” must be used first in the next session.
Do not open the refrigerator door often and regularly monitor the temperature of the refrigerator.
Closer expiry date in front 16

17. Rotavirus Vaccine targets and schedule

18. POPULATION TARGETS
All 6 weeks up to 15 weeks old infants identified in the list of NHTS for poverty reduction
Nationwide implementation

19. What is the rotavirus vaccine schedule? (1/2)
Rotavirus vaccine is given in a 2-dose schedule at 6 and 10 weeks of age
Rotavirus vaccine can be given at the same time as first and second dose of DTP-HepB-Hib (i.e. Penta1 & Penta2, OPV1 & OPV2)
Maintain an interval of 4 weeks between doses
Rota 1
Rota 2
To the facilitator:
Describe the vaccination schedule to the participants.
Rotavirus vaccine is given in a 2-dose schedule at 6 (for the 1st dose) and 10 weeks of age (for the 2nd dose), preferably.
Rotavirus vaccine doses can be given at the same time as first and second dose of DTP-HepB-Hib (i.e. Penta1 and Penta2). It is better to give Rotavirus vaccine with first and second dose of Pentavalent vaccine rather than second and third dose, because if the child comes late for Penta3, he/she might be too late for getting Rotavirus vaccine.
Note that there should be an interval of at least 4 weeks between the doses. 32
weeks
Birth 6 10 15 19

20. What is the rotavirus vaccine schedule? (2/2)
First dose of vaccine should be given before 15 weeks
Second dose has to be given before 32 weeks
16 weeks is too late for 1st dose and 33 weeks is too late for 2nd dose
Rota 1
To the facilitator:
Explain to the participants the age limits for rotavirus vaccine.
The age limits for rotavirus vaccination are as follows:
The first dose of rotavirus vaccine should be given after 6 weeks of age but before the infant is 15 weeks.
The second and last dose of rotavirus vaccine should be given before the infant is 32 weeks of age.
If an older child comes for vaccination, he/she can get all other vaccines in the schedule but NOT rotavirus vaccine. Rotavirus vaccine schedule is different is some ways from other EPI vaccines.
Rota 2 6
Birth 10 15 32
weeks 20

21. No ‘catch-up’ for rotavirus vaccine
If a child is late for vaccination:
He/she cannot get rotavirus vaccine
He/she can get all other vaccines in the schedule
Older than 32 weeks
 No rotavirus vaccine
Older than 15 weeks
To the facilitator:
Explain to the participants what to do if the child is too old for rotavirus vaccine.
In the past it has been said, “Never miss an opportunity to immunize an infant, even if the infant is late (older) for vaccination.” This is not valid for rotavirus vaccine.
This vaccine cannot be given to children who come late for vaccination and are therefore older.
Infants coming late for vaccination can, however, get other vaccines in the schedule.
 Other vaccines in the schedule

22. How to determine eligibility of infant to receive rotavirus vaccine?
0 doses received
Older than 15 weeks
Make an appointment for second dose of rotavirus vaccine in 4 weeks time, and before child is 32 weeks old.
Explain to the caregiver that the child could not get rotavirus vaccine because he/she is too old.
Doses of RotarixTM vaccine already given?
Give other vaccines as appropriate given the infant's age and schedule the next appointment according to the national immunization schedule.
Between 6 and 15 weeks
Infant's age?
Between 10 and 32 weeks
Older than 32 weeks
Explain to the caregiver that the child has completed his/her rotavirus immunization.
Explain to the caregiver that the child could not get the second dose of rotavirus vaccine because he/she is too old.
1 dose received
Give first dose of RotarixTM
Give second dose of RotarixTM vaccine if first dose was received 4 weeks ago or more
No longer eligible for RotarixTM vaccination
To the facilitator: Describe the flow chart as a tool which can help the Health Worker to determine if an infant is eligible to receive the RotarixTM vaccine. Point out the main criteria to determine the eligibility of an infant to receive the rotavirus vaccine.
Ask participants if they have any questions or concerns.

23. Absolute contraindications
Hypersensitivity after previous administration of rotavirus vaccines
Previous history of intussusception
Administration of RotarixTM should be postponed in subjects suffering from diarrhea or vomiting and in need of rehydration therapy
To the facilitator:
Explain to the participants the absolute contraindications.
Infants suffering from the following should not be vaccinated with rotavirus vaccine.
Hypersensitivity after previous administration of rotavirus vaccines: Do not give second dose of rotavirus vaccine if the infant showed hypersensitivity to first dose
Previous history of intussusception: Do not give rotavirus vaccines if the caretaker informs you that the child has had an episode of intussusception
The administration of RotarixTM should be postponed in subjects suffering from diarrhea or vomiting that requires rehydration therapy
If child has mild diarrhea, vaccinate as usual
Note that mild illness such as an upper respiratory tract infection is not a contraindication.
Mild illness such as an upper respiratory tract infection or mild diarrhea is not a contraindication 23

24. Immunization schedule for infants
Antigen
AGE
At birth
6 W
10W
14W 9M
12M
BCG √
HepB-BD
OPV1
Rota1
Penta1
OPV2
Rota2
Penta2
OPV3
Penta3
AMV1
AMV2

25. Rotavirus Virus Vaccine administration

26. How to check the quality of the vaccine? (1/2)
Before administering the vaccine, you need to check the Vaccine Vial Monitor (VVM)
Stage 1: Vaccine OK
Stage 2: Vaccine OK but use first
Stage 3: Do not use the vaccine
Stage 4: Do not use the vaccine
To the facilitator:
Explain to the participants how to check and interpret the Vaccine Vial Monitor (VVM).
The vaccine vial monitor (VVM) is a round disc of heat-sensitive material placed on a vaccine vial to register cumulative heat exposure.
The inner square is chemically active and changes color irreversibly from light to dark with exposed to heat over time.
By comparing the color of the inner square to the reference color, a health worker can determine whether or not the vaccine has been exposed to heat.
Thanks to the VVM, important decisions about which vaccines to use or to discard are now clear. If the inner square matches or is darker then the outer ring, discard the vaccine. 26

27. How to check the quality of the vaccine? (2/2)
Before administering the vaccine, always check the expiration date on the box
To the facilitator:
Explain to the participants how and where to check the expiration date.
It is important to understand that VVM does not provide information about vaccine potency.
The VVM may be ok (which means the inner square is lighter than the outer circle), but the vaccine may be beyond the expiration date.
So always check the expiration date on the vaccine vial before using it.
The expiration date is mentioned clearly on the cap. 27

28. How to prepare for vaccination? (1/4)
Pull off the oral applicator tip cap
To the facilitator:
Explain to the participants how to prepare the vaccine.
Step 1/4:
Pull off the cap from the tube. Clear the fluid from the upper part of the tube by tapping the tube.
Oral applicator tip cap 28

29. How to position the child for rotavirus vaccination?
The child should be seated in a semi reclining position to take the vaccine orally
To the facilitator:
Explain to the participants how to position the child before administering the vaccine.
The child should be seated in a semi reclining position (i.e. normal feeding position). 29

30. How to position the vaccine?
Open the child’s mouth by gently pressing the cheeks together
Angle the tube towards the inner cheek
To the facilitator:
Explain to the participants how to position the vaccine in the child’s mouth.
Gently squeeze the child's cheeks to open the mouth.
Put the tube towards the inner cheek.
Make every effort to aim the tube containing the vaccine down one side and toward the back of the child's mouth.
Do not put the tube too far back in the mouth. Never place the tube into the center of the mouth to prevent the risk of choking.
NEVER Place the tube into the center of the mouth to prevent risk of choking! 30

31. How to administer the vaccine?
Administer the entire content of the tube by pressing the tube
Squeeze the tube slowly
Make sure the child is swallowing the vaccine to prevent buildup in the mouth
Hold the cheeks together and stroke him/her under the chin to help with swallowing
To the facilitator:
Explain to the participants how to administer the vaccine.
Then, you can administer the entire content of the tube by gently squeezing the tube several times.
Make sure the child is swallowing the vaccine to prevent buildup in the mouth.
Gently hold the cheeks together and stroke her under the chin to help with swallowing.
Afterwards, dispose the rotavirus vaccine tube along with other medical waste.
You can notice that a residual drop may remain in the tip of the tube. 31

32. Can rotavirus vaccine be given at the same time as other childhood vaccines?
Rotavirus vaccine can be administered with any of the following routine childhood vaccines without interfering with their effectiveness:
Diphtheria–tetanus–pertussis vaccine (DTP)
Haemophilus influenzae type b vaccine (Hib)
Pentavalent (DPT-HepB-HiB)
Inactivated polio vaccine (IPV)
Hepatitis B vaccine
Pneumococcal vaccine
Oral polio vaccine (OPV)
Give the OPV first, Rotavirus, then administer other childhood vaccines
To the facilitator:
Explain to the participants that rotavirus vaccines can be given with routine childhood vaccines.
Rotarix™ can be given with any of the following routine childhood vaccines without interfering with their effectiveness, during the same visit.
• Diphtheria–tetanus–pertussis vaccine (DTP)
• Haemophilus influenzae type b vaccine (Hib)
• Inactivated polio vaccine (IPV)
• Hepatitis B vaccine
• Pneumococcal vaccine
Oral polio vaccine
Give the Rotavirus vaccine first, then administer other injectable childhood vaccines. As a general rule its better to give oral vaccines first when the child is still calm and then give injectable vaccines. 32

33. Rotavirus vaccine effectiveness
CONDITION
EFFECTIVENESS
Any rotavirus gastroenteritis
74% - 87%
Severe gastroenteritis
85% - 98%
Both vaccines significantly reduced physician visits for diarrhea,
and reduced rotavirus related hospitalization.

34. Recording and reporting

35. What are the main uses of the immunization card?
Provides the date of birth of the child
Informs health worker and caretaker of:
Vaccines already received and those needed in the future
Next appointment for vaccination
Can help with identifying infants who do return for vaccination on time
Useful to conduct coverage surveys
To the facilitator:
Explain to the participants the main uses of the immunization card.
The immunization card:
Provides the date of birth of the child
Informs the health worker and caretaker of:
The vaccines already received and those needed in the future
The next appointment for vaccination
Can help with tracking infants who do return for vaccination on time
Is useful to conduct coverage surveys

36. How to use the immunization card?
Health worker checks the card, administer the vaccine(s), and writes the date the vaccine(s) were given in the card
To the facilitator:
Explain to the participants how to use the immunization card.
Parents should keep the immunization card in a safe place at home.
Then they need to remember to bring the immunization card back to the health center for each visit.
The health worker must check the card to determine eligibility and fill it out after the child’s vaccination, providing details of vaccines given and the date for the next visit.
Then, the parents should take the immunization card back home and keep in a safe place.

37. How to record vaccination on the card?
Immunization cards are being updated to include boxes for indicating first and second rotavirus vaccine doses immunization card
= 1st dose of rotavirus vaccine
= 2nd dose of rotavirus vaccine
To the facilitator:
Explain to the participants how to record the vaccination.
Each time a vaccine is administered, health workers should complete the vaccination card outlining which vaccines have been given.
Health workers should also note the date of the next appointment on the vaccination card and remind the caretaker to return on that date with the card.
Caretakers should be reminded to bring the immunization card at each visit.
Note that the immunization card is being updated to include the rotavirus vaccine doses, and the generic abbreviation for the rotavirus vaccine is "Rota". Health workers should use this abbreviation when recording the vaccine they administered.

38. How to record the vaccination on the target client list ?
On the “REMARKS” column, draw 2 columns and write “ROTA1” in the 1st drawn column and “ROTA2” in the 2nd drawn column
Indicate the date Rota vaccine was administered
Put an asterisk (*) in the space before the registration number/date of the infant
An asterisk indicates member of NHTS family
Tally sheets, stock management forms, and monthly reporting forms are also being updated to include the new rotavirus vaccine
To the facilitator:
Explain to the participants how to record the immunization on the tally sheet.
Tally sheets have been updated to reflect the inclusion of rotavirus vaccine in the national immunization program.
Health workers should keep a tally of each vaccine dose given.
At the end of an immunization session, count the tally sheet. This will provide the total number of immunizations given with each vaccine by dose.
If you have old tally sheets, include a lines for Rota1 and Rota2.

39. How to record rotavirus vaccine on the monthly report?
Report Rota1 and Rota2 doses given each month, along with other vaccine doses
To the facilitator:
Explain to the participants how to record the immunization on the monthly report.
Reporting forms have been updated to reflect the inclusion of rotavirus vaccine in the national immunization program.
Report Rota1 and Rota2 doses given each month, along with other vaccine doses.
Use tally sheets to prepare monthly reports to send to supervisors.
If you have the old reporting forms, add lines to report Rota1 and Rota2 doses given.

40. How safe is the vaccine?
Rotavirus vaccines are safe and do not cause any serious adverse events
Irritability and loss of appetite are very common side effects of rotavirus vaccine
Rotavirus vaccine may be given with other vaccines in the infant Expanded Program on Immunization (EPI) schedule without interfering with their effectiveness
To the facilitator:
Explain to the participants that the new rotavirus vaccine is safe.
Current rotavirus vaccines are generally well tolerated. They do not appear to cause many serious adverse events.
Irritability and loss of appetite are very common side effects of rotavirus vaccine, other effects are mentioned below.
Side effects include:
Very common(1/10): Irritability, loss of appetite
Common(1/100, <1/10): Fever, fatigue, diarrhea, vomiting, flatulence, abdominal pain, regurgitation of food
Any adverse events and other problems related to the vaccines should be reported through the existing AEFI Reporting System established by the National Immunization Program (more details in Module 6).
Rotavirus vaccine can be given safely with other vaccines. 40

41. What is an AEFI?
At the end AEFI = Adverse event following immunization
A medical incident
Takes place after an immunization
Causes concern
Is believed to be caused by immunization
AEFI can be categorized into
Vaccine reaction
Programme error
Coincidental
Injection reaction
Unknown
To the facilitator:
Explain to the participants the adverse event following immunization of rotavirus vaccine.
An adverse event following immunization (AEFI) is a medical incident that takes place after an immunization, causes concern, and is believed to be caused by the immunization. The safety profile of the rotavirus vaccines currently available is good. Most infants who get the rotavirus vaccine do not experience any side effects.
Intussusception has been associated with Rotavirus vaccine and can result in severe illness or death.

42. What about Intussusception (IS)? (1/2)
IS is a rare type of bowel obstruction that occurs when one portion of the bowel slides into an immediately adjacent segment (also known as telescoping or prolapse).
Symptoms of IS include stomach pain with severe crying (which may be brief); several episodes of vomiting; blood in the stool; weakness, or irritability.
The increased risk appears to occur mainly in the first days following the first dose of rotavirus vaccine
To the facilitator:
Explain to the participants what intussusception (IS) is, its symptoms, and link with rotavirus vaccine.
IS is a rare type of bowel obstruction that occurs when one portion of the bowel slides into an immediately adjacent segment (also known as telescoping or prolapse).
Symptoms of IS include stomach pain with severe crying (which may be brief); several episodes of vomiting; blood in the stool; weakness, or irritability.
With the old Rotavirus vaccine called the RotashieldTM vaccine, studies suggested that the Rotavirus vaccine may be associated with a slight increased risk of IS in infants after they receive the vaccine, during the first week, especially. 42

43. What about Intussusception (IS)? (2/2)
In the past, the first rotavirus vaccines (RotashieldTM) caused IS, a serious but very rare bowel obstruction
With the new rotavirus vaccines, there seems to be a very small increased risk of IS in infants following rotavirus vaccination
The increased risk appears to occur mainly in the first days following the first dose of rotavirus vaccine
To the facilitator:
Explain to the participants what intussusception (IS) is, its symptoms, and link with rotavirus vaccine.
IS is a rare type of bowel obstruction that occurs when one portion of the bowel slides into an immediately adjacent segment (also known as telescoping or prolapse).
Symptoms of IS include stomach pain with severe crying (which may be brief); several episodes of vomiting; blood in the stool; weakness, or irritability.
With the old Rotavirus vaccine called the RotashieldTM vaccine, studies suggested that the Rotavirus vaccine may be associated with a slight increased risk of IS in infants after they receive the vaccine, during the first week, especially. 43

44. Risk of IS against risk of rotavirus infection
Whether the new rotavirus vaccine affects the overall incidence of IS has not yet been established
The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children!
To the facilitator:
Explain to the participants what intussusception (IS) is, its symptoms, and link to rotavirus vaccine.
Whether the new rotavirus affects the overall incidence of IS has not yet been established.
The rotavirus vaccine offers tremendous benefits by protecting infants and children from rotavirus disease. Rotavirus is the most common cause of severe diarrhea among infants and young children. According to the U.S. Centers for Disease Control and Prevention, the risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children. Hence, rotavirus vaccine is strongly recommended to prevent rotavirus disease in infants and young children.

45. How to report an AEFI? (2/2)
AEFI report should contain
Client information
Immunization event(s) description
Adverse event(s) description
Relevant medical and treatment
history
Associated event(s)
Reporter details
To the facilitator:
Explain to the participants what information should be included in an AEFI report.
An AEFI report should contain:
Client – unique identifier, date of birth and gender
Immunization event(s) – province where given, date, all vaccines given including name, manufacturer, lot number, administration site and route, as well as the number in series of vaccine doses if relevant
Adverse event(s) – description, including time of first onset following immunization, duration, health care utilization, treatment and outcome
Relevant medical and treatment history – underlying disease, known allergies, prior AEFI, concomitant medication
Associated event(s) – acute illness, injury, exposure to environmental toxins
Reporter details

46. How to report a AEFI? (1/2)
Report the identified AEFI through existing AEFI reporting systems established by NEC/RESU
To the facilitator:
Explain to the participants what should be done for adverse events following immunization (AEFIs).
Similar to all other vaccines, rotavirus vaccine needs to be monitored for safety and adverse events following immunization.
Health workers should ask parents to immediately report any reaction that may be related to the vaccine. Report the AEFI through the existing AEFI reporting systems established by national immunization programs. Health workers should report AEFI to the upper level of the health system. The National Authorities will then decide if further investigation is required.
Suspected signs or symptoms
Communit/yprovince/city, and regional levels
National
authorities 46

47. How to communicate with caretakers?
Be respectful
Use simple words and avoid technical terms
Listen to caretaker's concerns
Make sure the caretaker has understood your key messages
To the facilitator:
Explain to the participants how to communicate with parents.
To effectively communicate with caretakers, health workers must first understand the concerns of parents regarding immunization and understand factors that can lead to misinformation about the safety and effectiveness of vaccines. Healthcare workers should establish an open, friendly dialogue with vaccine-hesitant parents at an early stage and provide clear answers to their questions and provide accurate information about vaccination.
In a few words, the health worker should :
Be respectful: smile often, be friendly
Use simple words to make sure the caretaker understands your key messages: look directly at caretakers and try to judge by their body language if they have understood your messages. Reword and simplify if needed.
Listen to caretaker's concerns: do not get angry or irritated when caretakers ask questions or raise concerns.
Ongoing dialogue may successfully reassure vaccine-hesitant parents that immunization is the best and safest option for their child.

48. What is “triple A” communication
with parents?
Advice
on what is
given
Alert
on side effects and how to respond
Arrange
for when
to return
To the facilitator:
Describe to the participants what the concept of triple A communication with parents.
Triple A is a mnemonic system/memory trigger that allows health workers to remember the three ways of communicating with parents: A A A as Advice, Alert, and Arrange.
Advice: Health workers should advise parents on what is given: the name of the vaccine(s), the diseases prevented, etc.
Alert: Health workers should alert parents of the potential side effects after immunization and how to respond.
Arrange: Health workers should arrange with parents the next appointment for administering the subsequent doses to complete the schedule.

49. Advice: How to inform about the disease?
Rotavirus causes severe diarrhea, vomiting, and fever leading to rapid dehydration
Rotavirus is found everywhere
Almost every child in the world will suffer from at least one infection by the time he or she is three years old
Rotavirus is not the only cause of diarrhea, but it is one of the most serious
Rotavirus infection spreads very quickly
To the facilitator:
Explain to the participants how to inform about rotavirus disease.
Key messages for caretakers include:
Rotavirus is a virus that causes diarrhea, sometimes severe, mostly in babies and young children. It is often accompanied by vomiting and fever and can lead to dehydration.
Rotavirus is not the only cause of diarrhea, but it is one of the most serious. Before a vaccine was available, rotavirus was responsible for the death of as many as 600,000 children each year (worldwide). Almost every child in the world will suffer from at least one infection by the time he or she is three years old.
The primary mode of transmission of rotavirus is the passage of the virus in stool to the mouth of another child. This is known as a fecal-oral route of transmission. Children and adults can transmit the virus also when they forget to wash their hands before eating or after using the toilet or after cleaning the child. Rotavirus can live for hours on hands and days on surfaces and objects such as toys.
Touching a surface that has been contaminated with rotavirus and then touching the mouth area can result in infection. Children can also pass rotavirus to family members and other people with whom they have close contact.

50. What can be done to treat rotavirus diarrhea?
TREATMENT
Zinc
Oral rehydration therapy
To the facilitator:
Explain to the participants how to communicate about prevention methods.
Treatment against rotavirus disease include zinc and oral rehydration therapy (ORT). ORT consists of a solution of salts and sugars that is taken by mouth. 50

51. What can be done to prevent rotavirus diarrhea?
Vaccination as part of a comprehensive approach to diarrheal disease control offers the best hope for protecting children from rotavirus
Vaccination
PREVENTION
Good sanitation and hygiene
Improved water quality
Exclusive breastfeeding
To the facilitator:
Explain to the participants how to communicate about prevention methods.
Prevention methods against rotavirus disease include breastfeeding, improvements in nutrition, hygiene, and water quality.
But enhancing nutrition, sanitation and hygiene is not enough to prevent the disease and stop the spread. Currently, vaccination is the only way to prevent severe episodes of rotavirus infection. 51

52. Advice: What is the new rotavirus vaccine?
Millions of children have received rotavirus vaccine in the last 8 years and the vaccine is considered very safe and effective
This vaccine will be given at the same time as pentavalent vaccine, therefore no extra visit is required for this vaccine
Rotavirus vaccine will not prevent diarrhea or vomiting caused by other germs, but it is very good at preventing diarrhea and vomiting caused by rotavirus.
To the facilitator:
Explain to the participants what the new rotavirus vaccine is.
Vaccination offers the best hope for preventing severe rotavirus disease and the deadly dehydrating diarrhoea that it causes. Rotavirus is so contagious and resilient that typical interventions that stop many bacteria and parasites that cause diarrhoea—such as improved hygiene and sanitation— do not adequately prevent the transmission of rotavirus. This is illus­trated by the fact that virtually everyone in the world is infected by rotavirus disease by age five years, despite differences in sanitation between countries. Rotavirus disease cannot be treated with antibiotics or other drugs, and nearly every child in the world is at risk of rotavirus infection, regardless of hygiene practices or access to clean water.
A vaccine has been administered to many infants and is safe. This is an oral vaccine that is given along with pentavalent vaccine so no extra visit is required. Your child can still get diarrhea due to other means therefore methods to prevent diarrhea should always be applied.

53. Advice: Rotavirus vaccine schedule?
Getting vaccinated on time is important
2 doses of rotavirus vaccine
First dose between 6 weeks and 15 weeks
Second dose between 10 weeks and 32 weeks
Interval of 4 weeks between the 2 doses
Rota 1
To the facilitator:
Explain to the participants how to vaccinate your child against rotavirus.
Explain to the caretakers that it is important to get vaccinated on time. If the infant is brought late for vaccination, he/she will not get rotavirus vaccine.
Rotavirus vaccine is given orally in 2 doses at ages 6 and 10 weeks. Children should be vaccinated with the first dose of rotavirus by 15 weeks and the last dose by 32 weeks. There should be an interval of at least 4 weeks between the 2 doses.
Rota 2 6
Birth 10 15 32
weeks

54. Alert: How to respond to side effects?
Infants may be more irritable. Some infants may also experience loss of appetite, fever, fatigue, diarrhea, and vomiting
After immunization, if your infant has fever (>39˚C), give paracetamol
If your infant shows unusual signs- persistent crying, vomiting, blood in bowel motion take him/her directly to the hospital
To the facilitator:
Explain to the participants how to respond to side effects.
Current rotavirus vaccines are generally well tolerated.
Irritability and loss of appetite are very common side effects of rotavirus vaccine.
If the child has fever (>39˚C), paracetamol may be given
Some studies have shown a small increase in cases of intussusception within a week after the first dose of rotavirus vaccine. Intussusception is a type of bowel blockage that is treated in a hospital. In some cases surgery might be required. There are bouts of crying, a pale looking baby who pulls his or her legs up, progressing to persistent crying, vomiting and sometimes blood in the bowel motion. In most cases in babies the cause is unknown and there is no link to rotavirus vaccine.
If the child shows any unusual symptoms, take him/her directly to the hospital or contact the health worker who administered the vaccine.
Parents have to understand that the risk of the side effects after rotavirus vaccination is much lower than the risk of severe
rotavirus disease in unvaccinated children.

55. Arrange: When to return?
Make an appointment for the next dose of rotavirus vaccine and other vaccines according to the immunization schedule
Wait at least 4 weeks before next appointment and make sure the child is less than 32 weeks old
Ensure that there is a session on the attributed date
i.e., no public holiday, weekend, or other event
Write the date of the next visit on the immunization card
Remind the caretaker to come on the specified date and to bring the card
To the facilitator:
Explain to the participants when to return for the second dose.
Make an appointment for the next dose of rotavirus vaccine and other vaccines according to the immunization schedule.
Make sure a minimum interval of 4 weeks is maintained but before the child is 32 weeks of age.
Ensure that there is a session on the given date (no public holiday, weekend, etc.).
Write the date of the next visit on the immunization card and remind the caretaker to come on the specified date and to bring the card.

56. How to track infants for the first dose of rotavirus vaccine?
It is critical to ensure that all infants get the first dose of rotavirus vaccine by 15 weeks of age
Identify newborns
Review the birth registry or other records for newborns
Use volunteers/CHTs to inform about new births
Inform parents of vaccination sessions
Use volunteers/CHTs to follow up with newborns that are due for rotavirus vaccination
To the facilitator:
Explain to the participants how to track infants for first dose of rotavirus vaccine.
If infants are not given first dose to rotavirus vaccine on time, they miss the opportunity of being vaccinated with Rotavirus vaccine.
Unlike other vaccines that can even be started late, rotavirus vaccination has to start on time.
This should be communicated to parents and the community at large.
Use volunteers to inform and motivate parents of newborns to bring their children for vaccination on time.
Parents of infants who are due for vaccination, but have not yet come to the health center, should be reminded and followed up with.

57. How to track infants for the second dose of rotavirus vaccine?
Ensure that all children get the last dose of rotavirus vaccine before 32 weeks of age
Follow up with infants who have received the first dose and have not come back for the second dose
Reminder cards or immunization registries could be used follow up with defaulters
Use volunteers/CHTs to follow up with families of infants who will soon become ineligible for rotavirus vaccine
To the facilitator:
Explain to the participants how to track infants for the second dose of rotavirus vaccine.
A copy of the infant immunization card may be kept in the month the infant is supposed to return for second dose of rotavirus vaccine.
For example, if an infant receives pentavalent vaccine and rotavirus vaccine in January, place a copy of the card in the February section. Every month, review the reminder cards and follow up with those who did not attend when due.
Involve community volunteers to bring children who are eligible for the second dose.
Also explain to the volunteers why it is important to bring children back for a second dose of rotavirus vaccine before they are 32 weeks old.
Year: 2012

58. How to monitor uptake of rotavirus vaccine?
Use a monitoring chart to track the number of infants who received first and second doses of rotavirus vaccine
To the facilitator:
Explain to the participants how to monitor uptake of rotavirus vaccine.
Use a monitoring chart to track the number of infants who received first and second doses of rotavirus vaccine.
If the gap between Rota1 and Rota2 is large, this means that several children received the first dose but not the second. Therefore follow-up systems (mentioned in previous slide) need to be strengthened.
If there is big gap between the monthly target and infants getting Rota1, this means that newborns need to be followed up with more regularly.

59. Key messages
Fill in the immunization card once the vaccines have been administered to the infant
The child immunization card, tally sheet, and monthly report are being updated to include rotavirus vaccine doses
It is very important that all infants receive their first dose of rotavirus vaccine between 6 and 15 weeks
Follow up with infants to ensure they receive the second dose of Rotavirus vaccine by 32 weeks of age
To the facilitator:
Explain to the participants that this is the main information to keep in mind.

60. Key messages The current safety profile of rotavirus vaccines is good
Many infants who get the rotavirus vaccine do not experience any side effects
The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children
AEFIs should be reported through the existing AEFI reporting systems/forms
Reassure the caretaker- Admit uncertainty, investigate fully, and keep the community informed
To the facilitator:
Explain to the participants that this is the main information to keep in mind.

61. Key messages (1/4)
Triple A communication - Be respectful - Listen to caretaker's concerns
Use simple phrases and avoid technical terms to make sure the caretaker understands your key messages
Ongoing dialogue may successfully reassure vaccine- hesitant parents that immunization is the best and safest option for their child
To the facilitator:
Explain to the participants that this is the main information to keep in mind. 61

62. Key messages (2/4) Rotavirus infection is highly contagious
Vaccination is the only way to prevent the severe episodes of rotavirus infection
A child immunized with rotavirus vaccine can still get diarrhea from other agents
Follow all steps to prevent and control diarrhea
To the facilitator:
Explain to the participants that this is the main information to give to the caretakers.

63. Key messages (3/4) On-time vaccination is very important
If children come late they will get other vaccines but will lose out on getting the important rotavirus vaccine
Current rotavirus vaccines are generally well tolerated
Parents have to understand that the risk of side effects after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children
If your child shows any serious symptoms such as blood in the stool, take him/her immediately to the nearest hospital
Keep the immunization card safe and remember to bring it next time
To the facilitator:
Explain to the participants that this is the main information to give to the caretakers. 63

64. Key messages (4/4)
A coordinated approach that combines rotavirus vaccines with other prevention and treatment methods should be practiced to reduce death and illness from diarrhea, such as:
Rotavirus and measles vaccination
Promotion of exclusive breastfeeding and Vitamin A supplementation
Promotion of hand washing with soap
Improved water supply including treatment and safe storage of household water
Community-wide sanitation promotion
Fluid replacement (ORT)
Zinc treatment
To the facilitator:
Explain to the participants that this is the main information to give to the caretakers. 64

65. for your attention! Thank you To the facilitator:
This is the end of the training, thank you for your attention!
A Pocket Guide of the training is available. This Pocket Guide is intended to remind you of key information in routine practice.

66. ADDITIONAL SLIDES

68. What should you do in this scenario?
The parents of a child provide you with an old immunization card. The rotavirus vaccine is not included in this card.
How should you record the vaccination given?
To the facilitator:
Read the situation and question to the participants.
This question will test if participants understand what to do in the event that the Immunization card is not updated (i.e. rotavirus rows are not included on the immunization card).
Response:
If the parents of the infant provide you with an old immunization card, the health workers may add the rotavirus vaccination data by hand to the old card. Write Rota1 and Rota2 and the dates when the doses were given. Or replace card with the new one transferring all the data from the old card. 68

69. What should you do in this scenario?
A child's vaccination card shows that he/she received the first dose of rotavirus vaccine and pentavalent vaccine at 10 weeks of age.
The child is now 35 weeks of age.
What vaccines should you give to this child?
To the facilitator:
Read the situation and question to participants.
The question will test if participants understand that the second dose of vaccine cannot be given after 32 weeks. Other vaccines can be given as appropriate.
Response:
The child will not get rotavirus vaccine as the second dose of rotavirus vaccine cannot be given after 32 weeks.
Explain to the caretaker that the second dose of Rotavirus vaccine cannot be given, as the child came late for vaccination.
Give the second dose of pentavalent vaccine
Make an appointment for the next doses according to the immunization schedule 69

70. What should you do in this scenario?
A child's immunization card shows that he/she is now 17 weeks old and has only received BCG and OPV 1 vaccines.
What should you do?
To the facilitator:
Read the situation and question to participants.
The question will test if participants understand that the first of rotavirus vaccine cannot be given after 15 weeks of age. Other vaccines can be given as appropriate.
Response:
The child will not get rotavirus vaccine. The first dose of rotavirus vaccine cannot be given after 15 weeks
Explain to the caretaker that rotavirus vaccine cannot be given, as the child came late for vaccination
Give the first dose of pentavalent vaccine and other vaccines according to national schedule
Make an appointment for the next doses according to the schedule
Explain to the caretaker the importance of coming for vaccination on time and completing the immunization schedule 70

71. What should you do in this scenario?
A child's immunization card shows that he/she is now 13 weeks old and has only received BCG, OPV 1,
Penta 1 vaccines.
What should you do?
To the facilitator:
Read the situation and question to participants.
The question will test if participants understand that the first of rotavirus vaccine can be given until 15 weeks of age. Other vaccines can be given as appropriate.
Response:
The child will get rotavirus vaccine. The first dose of rotavirus vaccine can be given
Give the second dose of pentavalent vaccine and other vaccines according to national schedule
Make an appointment for the next dose of Rotavirus vaccine and other vaccines according to the schedule
Explain to the caretaker the importance of coming for vaccination on time and completing the immunization schedule 71

72. What should you do in this scenario?
A caretaker brings a child to the health center for the first time and comes without any written documentation.
The caretaker does not remember the exact date of birth (DOB) of the infant.
What are some possible ways of determining DOB?
To the facilitator:
Read the situation and question to participants.
The question will test if participants understand the different ways to determine the DOB of a child.
See response on next slide. 72

73. What should you do? The refrigerator stops functioning.
To the facilitator:
Read the slide.
The question will test if participants understand what to do if the refridgerator stops functioning.
Answer:
Find another refrigerator or cold room to store vaccines (be sure that the temperature is maintained between +2°C and + 8°C).
If another refrigerator is unavailable, line ice packs or cold packs in cold box(es) or vaccine carrier(s) then put vaccines in the box(es) (Be careful not to put rotavirus vaccines or other freeze-sensitive vaccines near frozen ice packs, as it may affect vaccine potency).
Inform supervisor immediately. 73

74. What should you do in this scenario?
A caretaker comes to the health center without an immunization card.
The caretaker says the child is 20 weeks old and is not sure if a first dose of rotavirus vaccine was administered.
What should you do?
To the facilitator:
Read the situation and question to participants.
The question will test if participants know what to do if immunization card is unavailable to determine whether the first dose of Rotavirus vaccine was given.
See response on next slide. 74

75. What should you do in this scenario?
The vaccine vial monitor shows that the inner square is lighter than
the ring (=  stage 2).
What should you do?
To the facilitator:
Read the situation and question to the participants.
This question will test if participants understand what to do if the vaccine vial monitor shows that the inner square is still lighter than the ring.
Response:
Use these vaccines first, as their VVM has already started to change. 75

76. What should you do in this scenario?
While opening the RotarixTM tube to administer the vaccine, the tip seal is accidentally pushed into the tube solution.
What should you do?
To the facilitator:
Read the situation and question to the participants.
This question will test if participants understands what to do in case the tip seal is accidentally pushed into the tube.
Response:
In the event that the tip seal is accidentally pushed into the tube, discard the vaccine tube and use another tube to vaccinate the child.
This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine. 76

77. What should you do in this scenario?
The child is 6 weeks old. You give him/her OPV, rotavirus and pentavalent vaccines.
In which order should you give the vaccines?
To the facilitator:
Read the situation and question to the participants.
This question will test if participants understand when to administer the vaccine.
Response:
First vaccine in the following order
OPV, Rotavirus vaccine, then injectable vaccines. It is to be give oral vaccines while the child is still calm, before giving injectable vaccines. 77

78. What to do when exact DOB is unknown?
Possible ways of determining the DOB
Question the caretaker to see if he/she can recall the child's birth based on a cultural, religious or national/local event
Look for DOB record in other documents kept in the health center or other local registries
Antenatal Care record
Birth registry
Look for development indicators
If the child is able to sit unsupported and reaches out with one hand, he/she is probably too old to get rotavirus vaccination
To the facilitator:
Explain to the participants how to determine age when DOB is unknown.
An infant’s date of birth (DOB) is needed to determine eligibility for the first dose of rotavirus vaccine. The following methods may be used:
Question the caretaker to see if he/she can recall the child's birth based on a cultural, religious or national/local event
Look for DOB record in other documents kept in the health center or other local registries (ANC record, birth registry)
Look for development indicators (e.g. if the child is able to sit unsupported and reaches out with one hand, he/she is probably too old to get rotavirus vaccination) 78

79. What to do when immunization card is missing?
Possible ways of determining when the child received the first dose:
Look for a record within the health center like Target Client List (TCL), Family Health Record, ITR
Try to contact another health center if the child has moved recently to get his/her record
Show the caretaker the rotavirus tube and ask if he/she can remember if such a tube was used to orally administer a large amount of liquid during the child’s last immunization visit
To the facilitator:
Explain to the participants what to do when the immunization card is missing.
Possible ways of determining when the child received the first dose:
Look for a record within the health center like immunization registry
Try to contact another health center if the child has moved recently to get his/her record
Show the caretaker the rotavirus tube and ask if he/she can remember if such a device was used to orally administer a large amount of liquid during the child’s last immunization visit
If none of the above is successful, don't give Rotavirus vaccine. 79

80. Key messages
On-time vaccination is very important for rotavirus vaccine
First dose of rotavirus should be given at 6 weeks of age
Children older than 15 weeks are not eligible to receive the first dose of rotavirus vaccine
Second dose should be given at 10 weeks of age
Children older than 32 weeks are not eligible to receive the second dose of rotavirus vaccine
“Never miss an opportunity to immunize an infant, even if the infant is late (older) for vaccination” is NOT valid for rotavirus vaccine
To the facilitator:
Explain to the participants that these messages are the main information to keep in mind.