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Rotavirus vaccines in routine immunization

Pocket Guide

Training for rotavirus vaccine introduction 2/26

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Foreword

Countries are introducing the rotavirus vaccine. To ensure that this introduction is done in a safe way, the World Health Organization (WHO), through its Department of Immunization, Vaccines and Biologicals (IVB), developed a training package on rotavirus vaccine introduction for developing countries.

The training package is composed of seven modules. It is targeted at staff working in health facilities at district level such as medical officers, nurses, and medical assistants, as well as Expanded Program on Immunization (EPI) staff/vaccinators.

This Pocket Guide is a hands-on practical document that is part of the original learning material for the rotavirus vaccine introduction training. Its main purpose is to remind health staff of key information in the workplace.

The Pocket Guide is structured by topic. Each topic is described with short descriptions, illustrations, and key messages. The Pocket Guide provides a framework for users and is to be adapted to local conditions.

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Table of Contents

Introduction to rotavirus disease...............................................................................................6

Rotavirus vaccine......................................................................................................................7

Rotavirus vaccine storage.........................................................................................................8

Vaccine eligibility.......................................................................................................................9

Special situations....................................................................................................................13

Vaccine contraindications.......................................................................................................14

Vaccine preparation................................................................................................................15

Vaccine recording...................................................................................................................17

Tracking infants for rotavirus vaccine.....................................................................................18

Intussusception.......................................................................................................................19

Monitoring AEFIs....................................................................................................................20

Communicating with caretakers..............................................................................................21

Advice on what is given..........................................................................................................22

Communicating about side effects and how to respond.........................................................23

Arranging for a return visit.......................................................................................................24

Annex 1- Poster on how to open the tube..............................................................................25

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Introduction to rotavirus disease

Rotavirus disease is a diarrheal disease caused by a virus called rotavirus. Rotavirus is the most common cause of severe diarrheal disease in infants and young children worldwide.

In young children, rotavirus disease commonly begins with fever and vomiting, followed by diarrhea.

Rotavirus clinical symptoms

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 is difficult to replace fluids in young children who are vomiting frequently.

Rotavirus is very contagious, and spreads easily from children who are already infected to other children and sometimes adults. Large amounts of rotavirus are excreted in the stool of infected persons and the virus can be easily spread via contaminated hands and objects, such as toys. This is known as a fecal-oral route of transmission. Rotavirus is not the only cause of diarrhea, several other agents may also cause diarrhea.

Rotavirus transmission

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Rotavirus vaccine

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. Our country is introducing the RotarixTM vaccine.

It is s 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 when children are fully immunized against rotavirus, they may still get diarrhea caused by other agents.

As stated above, rotavirus vaccine is very effective against rotavirus disease. Studies show the vaccine to be highly effective (85%-98%) against severe rotavirus disease and very effective against rotavirus disease of any severity through the first rotavirus season after vaccination. The chances that children need to be hospitalized for rotavirus disease are also greatly decreased (96%) by the vaccine.

Rotavirus vaccine is a solution for oral use.

It comes in a tube specially designed for direct oral administration.

1vial = 1 dose. 1 tube has 1.5mL liquid

The rotavirus vaccine must be given to babies orally, which means swallowed and not injected.

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Rotavirus vaccine storage

The rotavirus vaccine should be stored in a refrigerator. Do not put rotavirus vaccine in the freezer. If the vaccines are frozen, they lose their potency and no longer provide protection against the disease.

Vaccines with early expiration dates should be kept in the front of the refrigerator for first use. Keep a “use first box” containing vaccines with a Vaccine Vial Monitor (VVM) at stage 2 (and nearing stage 2) and vaccines that were taken out of the refrigerator and were brought back unused. Vaccines in the “use first box” must be used first in the next session.

Good temperature control during the storage and transport of vaccines is critical to ensure the potency and safety of vaccines. Rotavirus vaccines must be stored between +2°C and +8°C.

Do not open the refrigerator door often. Regularly monitor the temperature of the refrigerator.

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Vaccine eligibility

On-time vaccination is very important for rotavirus immunization. Rotavirus vaccine is given in a 2-dose schedule:

- First dose at 6 weeks of age- Second/last dose at 10 weeks of age

Remember that:- 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 first dose and 33 weeks is too late for second dose- There should be an interval of 4 weeks between the doses.

Rotavirus vaccine can be given at the same time as first and second dos of DTP-HepB-Hib (i.e. Penta1 and Penta2).

Rota 2

6 15 32

weeks

Rota 1

Rota 1

Rota 2

6Birth 10 15 32

weeks

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10Birth


Rotavirus vaccine schedule

To determine the eligibility of an infant you have to know:- The age of the infant- If he/she already received the first dose or not

For each case, the flowchart helps you to determine if the infant is eligible and what to do after vaccination (or not).

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0 doses received

Older than 15 weeks

Make an appointment for second dose of RotarixTM 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.

Between 6 and 15 weeks

Infant's age?

Give first dose of RotarixTM

No longer eligible for RotarixTM vaccination

Give other vaccines as appropriate to the infant's

according to the national

Doses of Rotavirus


“Never miss an opportunity to immunize an infant, even if the infant is late (older) for vaccination” is not valid for rotavirus vaccine:

- Children older than 15 weeks are not eligible to receive the first dose of rotavirus vaccine.

- Children older than 32 weeks are not eligible to receive the second dose of rotavirus vaccine.

Infant's age?

Older than 32 weeks

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 second dose of RotarixTM vaccine if first

dose was received 4 weeks ago or more

No longer eligible for RotarixTM vaccination

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Explain to the caregiver that the child has completed his/her

rotavirus immunization.

Between 10 and 32 weeks

age and schedule the next appointment

immunization schedule.

vaccine already given?


Special situations

Determining age when DOB unknownThere are possible ways of determining the DOB for first rotavirus vaccination:

- 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)

Determining when the child received the first doseWhen the immunization card is missing, there are possible ways of determining when the child received the first dose:

- Look for a record within the health center such as the 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

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Vaccine contraindications

Contraindications- Hypersensitivity after previous administration of rotavirus vaccines- Previous history of intussusception- Administration of rotavirus vaccine should be postponed in subjects suffering from diarrhea or vomiting and in need of rehydration therapy

Note that mild illness such as an upper respiratory tract infection is not a contraindication.

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Vaccine preparation

Before preparing rotavirus vaccineBefore administering the vaccine, you need to verify and interpret the Vaccine Vial Monitor (VVM) and always check the expiration date marked on the tube cap.

Prepare for vaccination

Step 1: Pull off the cap from the tube. Clear the fluid from the upper part of the tube by tapping the tube.

Step 2: Turn the cap upside-down and place the cap vertically onto the tip seal. Insert the tip seal into the small hole in the top of the cap.

Step 3: Twist the cap in the direction of the arrow (clockwise) to remove the tip seal. Do not snap off tip seal: It may fall into tube.

Step 4: Ensure that a hole clearly appears at the top of the tube and the detached tip seal is inside the top of the cap. It is very important to note that the vaccine must be discarded if the tip seal falls into the tube.

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Administer the vaccine

The child should be seated in a semi reclining position (i.e. normal feeding position) to take the vaccine orally. Before administration of the vaccine, make a final visual inspection to ensure that the tip has not fallen inside the tube

Step 1: Open the mouth of the child by gently pressing the cheeks.

Step 2: 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.

Step 3: Administer the vaccine slowly by pressing the tube. Prevent spitting by administering the vaccine in small portions slowly.

Step 4: Make sure the child is swallowing the vaccine. Hold the cheeks together and stroke him/her under the chin to help with swallowing. A replacement dose maybe given if the child spits

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part of the vaccine.

Vaccine recording

Immunization card

Immunization card’ use

Each time a vaccine is administered, complete the vaccination card outlining which vaccines have been given.You should also note the date of the next appointment on the immunization card and remind the caretaker to return on that date with the card.Parents should be reminded to bring the immunization card at each visit.

Note that the immunization card has been updated to include the rotavirus vaccine doses, and the generic abbreviation for rotavirus vaccine is "Rota." Use this abbreviation when recording the vaccine being administered.

Tally sheetTally sheets have been updated to reflect the inclusion of rotavirus vaccine in the national immunization program. Keep a tally of each vaccine dose given. At the end of an immunization session, count the tally sheets to identify the total number of vaccinations given (for each dose). If you have old tally sheets, include a line for Rota1 and Rota2.

Monthly reportReporting 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. If you have old reporting forms, add lines to report Rota1 and Rota2.

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Use tally sheets to prepare monthly reports to send to supervisors. .

Tracking infants for rotavirus vaccine

Track for the first dose of rotavirus vaccineIf infants are not given first dose to rotavirus vaccine on time, they miss the opportunity of being vaccinated and remain unprotected. 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.

Track for the second dose of rotavirus vaccineA copy of the immunization card may be filed under the month the infant should return for a 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 the second dose of rotavirus vaccine before 32 weeks.

Monitor uptake of rotavirus vaccineUse a monitoring chart to track the number of infants who received the first and second dose 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. Thus, follow-up systems need to be strengthened.

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A big gap between monthly targets and infants getting Rota1 means newborns need to be followed up with regularly.

Intussusception

Intussusception (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.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.

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Monitoring AEFIs

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.

The safety profile of currently available rotavirus vaccines is good. Most infants who get the rotavirus vaccine do not experience any side effects.

Report adverse eventsHealth agents, who administer the vaccine, should ask the parents to immediately report any reaction that may be related to the vaccine. Report the identified AEFI through the existing AEFI reporting systems established by national immunization programs. Other problems related to the vaccines, such as administering the vaccines to infants who should not be vaccinated, or errors in vaccine administration, should also be reported.

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

Important: Reassure the caretaker – Admit uncertainty, investigate fully, and keep the community informed

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Communicating with caretakers

Triple A communicationThere are three ways of communicating with parents: - Advice: Provide advice to parents on what is given: the name of the vaccine, the disease

to prevent, etc.- Alert: Alert parents of side effects after immunization and how to respond to them- Arrange: Arrange with parents the next appointment for administering the second dose

of the vaccine

To effectively communicate with caretakers, you must first understand the concerns of parents regarding immunization and understand factors that can lead to misinformation about the safety and effectiveness of vaccines.

You should establish an open, friendly dialogue with vaccine-hesitant parents at an early stage and provide clear answers to their questions and accurate information about vaccination.

In sum, you 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.

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Advice on what is given

Inform about rotavirus disease- 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. 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.

Communicate about diarrhea prevention methodsPrevention methods against rotavirus disease include breastfeeding, improvements in nutrition, hygiene, and water quality, and ORL/zinc (treatment); they can reduce diarrheal disease and child mortality where diarrheal disease is a serious burden. But enhancing 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.

Communicate about the new rotavirus vaccineMillions of children have received rotavirus vaccine in the last 8 years and the vaccine is considered very safe and effective.The rotavirus vaccine must be given to babies orally, which means swallowed and not injected. This vaccine is given at the same time as pentavalent vaccine, therefore no extra visit is required for this vaccine. Your child can still get diarrhea due to other agents.

Explain to the caretakers that it is important to get vaccinated on time. If the infant is brought in late for vaccination, he/she may 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.

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Communicating about side effects and how to respond

Current rotavirus vaccines are generally well tolerated.

Following vaccination, children may be more irritable and have loss of appetite. Some children may also experience fever, fatigue, diarrhea, and vomiting

- If the child has a fever (>39˚C), caretakers can give him/her paracetamol

- If the child shows any unusual symptoms, caretakers should take him/her directly to the hospital

Parents have to understand that the risk of the side effects after rotavirus vaccination are much lower than the risk of severe rotavirus disease in unvaccinated children.

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Arranging for a return visit

Make an appointment for the next dose of rotavirus vaccine and other vaccines according to the immunization schedule.

Ensure that a minimum gap 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.

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Annex 1- Poster on how to open the tube

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Special thanks to the Agence de Médecine Préventive (AMP) for its input in the instructional design of the training package to enhance the concepts and enrich the understanding and learning experience.

© World Health Organization 2012

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