1. Module 4 Rotavirus vaccine administration
Training for rotavirus vaccine introduction
Module 4
Rotavirus vaccine administration

2. Learning objectives
At the end of the module, the participant will be able to:
Identify the necessary steps to assure good vaccine quality
Describe the method to administer the vaccine
Describe special considerations for outreach
Duration
45’

3. Key issues 1 2 3 4 How to check the quality of the vaccine?
How to prepare for vaccination? 2
How to administer the vaccine? 3
To the facilitator:
Explain to the participants the key issues raised in this module.
You have infants to vaccinate, what are you going to do first?
We will provide you with answers to the following questions:
How to check the quality of the vaccine?
How to prepare for vaccination?
How to administer the vaccine?
What to do if infant spits part of the vaccine out?
What to do if the infant spits part of the vaccine out? 4

4. How to check the quality of the RotaSiilTM vaccine? (1/2)
Before administering the RotaSiilTM vaccine, always check the Vaccine Vial Monitor (VVM) on the vial cap
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 cap (not the diluent), in the case of RotaSiil™, 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.
If a vaccine vials is found to be at any of the discard points, the vaccine should not be used and the supervisor should be informed. 4

5. How to check the quality of the RotaSiilTM vaccine? (2/2)
Before administering the RotaSiilTM vaccine, always check the expiration date on the vial’s label
It is possible that the expiry date of the diluent differs from that of the vaccine. Make sure to use the earliest expiring diluent first.
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, or the diluent, may be beyond the expiration date.
So always check the expiration date on the vaccine and the diluent vials before using them.
The expiration dates are mentioned clearly on the labels.
N.B. The diluent may have a different (longer) expiry date than the vaccine: make sure to use the earliest expiring diluent first. 5

6. What should you do in this scenario?
The vaccine vial monitor shows that the inner square is lighter than the ring, but it is already darker than the initial color.
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. 6

7. How to prepare for vaccination with the single dose RotaSiilTM presentation? (1/4)
The single dose RotaSiilTM presentation contains 4 elements:
Single dose vaccine vial
Diluent (only for use with this vaccine)
3 ml oral syringe (not to be injected)
Adapter 1 2 3 4
To the facilitator:
Explain to the participants how to prepare the vaccine.
First, identify the different components that are present in the single-dose presentation RotaSiilTM package:
Vaccine vial
Diluent vial. N.B. This diluent must only be used with this RotaSiilTM vaccine. It must never be used to reconstitute other freeze-dried vaccines.
3 ml oral syringe
Adapter

8. How to prepare for vaccination with the single dose RotaSiilTM presentation? (2/4)
Snap off the top of the vaccine vial
Snap off the top of the diluent vial
Push transfer adapter onto diluent vial
Hold adapter by its body
Avoid touching the tip
Connect disposable syringe to transfer adapter 1 2 3 4
To the facilitator:
Explain to the participants, how to prepare the vaccine.
Snap off the flip off seal of the diluent vial.
Connect disposable syringe to the transfer adapter, holding the adapter by its body, avoid touching the tip of the adapter or its spike. Fix the adapter from the wider end by piercing the rubber cap of the diluent.

9. How to prepare for vaccination with the single dose RotaSiilTM presentation? (3/4)
Pull the plunger back and aspirate ml of diluent into the syringe
Remove the assembly (syringe and adapter) from the diluent vial
Connect assembly with the vaccine vial containing the freeze-dried powder
Transfer the contents of the syringe into the vial, ensuring the syringe has been emptied 5 6 7 8
To the facilitator:
Explain to the participants, how to prepare the vaccine.
Pull the plunger back and withdraw 2.5 ml of reconstituted vaccine back into the syringe.
Remove the assembly (syringe and adapter) from the diluent vial by separating the syringe containing vaccine, ensuring that the adapter remains with the vial.
Connect the assembly with the vaccine vial containing the freeze-dried powder vaccine.
Transfer the contents of the syringe into the vial, ensuring the syringe has been emptied

10. How to prepare for vaccination with the single dose RotaSiilTM presentation? (4/4)
Pull the plunger back and withdraw the reconstituted vaccine back into the syringe
Remove the oral syringe from the transfer adapter carefully
Administer the oral vaccine slowly into the inside cheek of the infant (infant should be seated in reclining position)
Dispose of the syringe and adapter with other non-sharp immunization waste
DO NOT INJECT 9 5 10 6 7 8 11
To the facilitator:
Explain to the participants, how to prepare the vaccine.
Invert the vial and pull the plunger back and withdraw the reconstituted vaccine back into the syringe.
Remove the syringe from the transfer adapter carefully to avoid spillage of the vaccine
Administer the oral vaccine slowly into the inside cheek of the infant making sure that the infant is swallowing the vaccine. (Infant should be seated in reclining position.)
The oral syringes and adapters can be safely disposed with other non-sharp immunization waste (e.g. vials, plastics, etc.).
DO NOT INJECT

11. Can rotavirus vaccine (RotaSiil™) be given at the same time as other childhood vaccines?
RotaSiil™, as well as other rotavirus vaccines, 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)
Inactivated polio vaccine (IPV)
Hepatitis B vaccine
Pneumococcal vaccine
Oral polio vaccine (OPV)
Give the rotavirus (and OPV) vaccine first, then administer other injectable childhood vaccines
To the facilitator:
Explain to the participants that rotavirus vaccines can be given with routine childhood vaccines.
RotaSiil™ 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 OPV and Rotavirus (RotaSiil™) oral vaccines first, then administer other injectable childhood vaccines. As a general rule its better to give oral vaccines first when the infant is still calm and then give injectable vaccines.
Additionally, as the OPV vaccine has a bitter taste, but is of a smaller quantity than the RotaSiil vaccine (0.1 ml versus 2.5 ml), administer the bitter (OPV) vaccine first, then give the infant the sweeter tasting vaccine (RotaSiil) second to take the bitter taste away. 11

12. What should you do in this scenario?
The infant 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:
Administer the vaccines in the following order:
Give the OPV and Rotavirus (RotaSiil™) oral vaccines first, then administer the injectable childhood vaccines.
As a general rule it is better to give oral vaccines while the infant is still calm and then give the injectable vaccines.
Additionally, as the OPV vaccine has a bitter taste, but is of a smaller quantity than the RotaSiil vaccine (0.1 ml versus 2.5 ml), administer the bitter (OPV) vaccine first, then give the infant the sweeter tasting vaccine (RotaSiil™) second to take the bitter taste away. 12

13. How to position the infant for rotavirus vaccination?
The infant should be seated in a semi reclining position to take the vaccine orally
To the facilitator:
Explain to the participants how to position the infant before administering the vaccine.
The infant should be seated in a semi reclining position (i.e. normal feeding position). 13

14. How to position the vaccine?
Open the infant’s mouth by gently pressing the cheeks together
Angle the syringe at a 45°angle
Slowly depress the plunger of the syringe, stopping to allow the infant to swallow
Administer 2.5 ml into the inner cheek of the infant
To the facilitator:
Explain to the participants how to position the vaccine in the infant’s mouth.
As you would do for the oral polio vaccine (OPV)
Gently squeeze the infant’s cheeks to open the mouth.
Angle the syringe at a 45°angle into the inner cheek of the infant.
SLOWLY depress the plunger of the syringe, stopping to allow the infant to swallow.
Administer 2.5 ml into the mouth of the infant. 14

15. What should you do in this scenario?
Is the infant in the right position to be vaccinated?
To the facilitator:
Read the situation and question to the participants.
This question will test if participants understand the correct position the infant must be in for rotavirus vaccination.
Response:
Yes. The infant should be seated in a semi reclining position (i.e. normal feeding position). 15

16. What to do if the infant spits out part of the rotavirus vaccine (RotaSiilTM)?
A dose of rotavirus vaccine (RotaSiil™) is larger than a dose of oral polio vaccine
RotaSiil™ = 2.5 ml; Polio = 0.1 ml (2 drops)
To prevent spitting
Open the infant’s mouth by gently pressing the cheeks together
Angle the syringe at a 45o angle to the inner cheek of the infant
Slowly depress the plunger of the syringe, stopping to allow the infant to swallow
A replacement dose is not needed if an incomplete dose is administered for any reason
e.g. infant spits or regurgitates the vaccine
To the facilitator:
Explain to the participants how to manage with partial vaccination.
The rotavirus vaccine dose quantity is larger than that of oral polio vaccine (RotaSiil™ =2.5 ml, OPV= 0.1 ml (2 drops)) and in some cases infants may find it a bit difficult take the full dose all at once. However, countries that have been using this vaccine have not reported many cases of spitting.
Spitting can be prevented if the health workers prepare for the administration correctly, spend enough time administering the vaccine slowly to the infant and encouraging the infant to swallow.
How to prevent spitting:
Open the infant’s mouth by gently pressing the cheeks together
Angle the syringe at a 45°angle to the inner cheek of the infant
Slowly depress the plunger of the syringe, stopping to allow the infant to swallow
A replacement dose is not needed if an incomplete dose is administered for any reason, e.g. infant spits or regurgitates the vaccine 16

17. How many vials to take for outreach?
Rotavirus vaccines can be given at the same time as other vaccines in the routine programme
For outreach take the same number of doses of rotavirus (RotaSiil™) vaccine as for OPV
Unopened rotavirus vials brought back from outreach should be immediately kept in the refrigerator for use in the next session, provided that the VVM and expiry date have not passed the discard point and date
To the facilitator:
Explain to the participants how many vials to take.
Rotavirus vaccine can be given at the same time as pentavalent vaccine (DTP-HepB-Hib), PCV, OPV or any other vaccine in the routine programme.
A simple method to calculate the number of vials that need to be taken, is to take same amount of single doses of OPV and Rotavirus (RotaSiil™). They both have a 3 dose schedule and are given at weeks.
OPV comes in 10 or 20 dose vials, and Rotavirus (RotaSiil™) in 1 or 2 dose vials.
As an example, in a country using 20 dose OPV vials and single dose Rotavirus (RotaSiil™) vials, you would need to take 20 vials of Rotavirus (RotaSiil™) for each OPV vial.
Unopened rotavirus vials brought back from outreach should be immediately kept in the refrigerator for use in the next session, provided that the VVM and expiry date have not passed the discard point and date

18. Key messages
Check and interpret vaccine vial monitor and check expiration date on the vial before giving the rotavirus vaccine (RotaSiilTM)
Prepare for administration, reconstituting the vaccine correctly
Give the oral vaccines - OPV and RotaSiilTM - first, then administer the injectable vaccines
Give OPV before RotaSiil™ so the “sweeter” vaccine (RotaSiil™) takes away the taste of the “bitter” OPV vaccine
RotaSiil™ vaccine dose quantity is larger than that of OPV (2.5 ml vs. 0.1 ml). To make sure that infants take the full dose at once:
Seat the infant in a semi-reclining position, open the infant’s mouth by gently pressing the cheeks together and angle the syringe at a 45o angle, administer the vaccine slowly into the inner cheek of the infant
If the infant spits out some or all of the vaccine, the dose does not need to be given again during that visit
To the facilitator:
Explain to the participants that this is the main information to keep in mind. 18

19. End of module for your attention! Thank you To the facilitator:
This is the end of the module.
You have been introduced to “Rotavirus vaccine administration” module.
The following module is titled “Recording and monitoring uptake of rotavirus vaccine”.
Thank you for your attention!