1. Training for rotavirus vaccine introduction
World Health Organization
10 August, 2019
Training for rotavirus vaccine introduction
Module 2
Rotavirus vaccine attributes and storage conditions

2. Learning objectives
At the end of the module, the participant will be able to:
Describe the main attributes of RotarixTM vaccine
Describe storage conditions of RotarixTM vaccine
Duration
15’

3. Key issues 1 2 3 4 What is rotavirus vaccine presentation?
How safe is rotavirus vaccine? 2
At which temperature should the vaccine be stored? 3
To the facilitator:
Explain to the participants the key issues raised in this module.
This module will explain how to store the vaccine.
We will provide you with answers to the following questions:
What is rotavirus vaccine presentation?
How safe is rotavirus vaccine?
At which temperature should the vaccine be stored?
Where should the vaccine be stored?
Where should the vaccine be stored? 4

4. What is rotavirus vaccine (RotarixTM) presentation?
RotarixTM vaccine is a ready-to-use, oral vaccine in a liquid formulation
It comes in 1 (1.5 ml) dose tubes specially designed 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.
RotarixTM 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 infants orally, which means swallowed and not injected.
A squeezable
plastic tube 4

5. How safe is the vaccine?
RotarixTM vaccine is safe and does NOT cause any serious adverse events
Irritability and loss of appetite are very common side effects of RotarixTM rotavirus vaccine
RotarixTM vaccine may be given with other vaccines in the infant Expanded Programme 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 RotarixTM vaccine, other effects are mentioned below.
RotarixTM side effects include:
Very common(1/10): Irritability, loss of appetite
Common(1/100, <1/10): Fever, fatigue, diarrhoea, 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 Programme (more details in Module 6).
RotarixTM vaccine can be given safely with other vaccines. 5

6. At what temperature must the vaccine be stored?
RotarixTM vaccine should be stored between +2°C to +8°C
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.
RotarixTM 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 will not provide adequate protection against the disease.
It is critical to ensure that the storage conditions comply with this. 6

7. Where do you store the vaccine?
The rotavirus vaccine (RotarixTM) 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, RotarixTM tubes must be stored between +2°C and +8°C .
Do not put RotarixTM vaccine in the freezer.
The vaccine should be administered as soon as possible after being removed from the refrigerator. 7

8. Which vaccine should be stored in front?
Vaccines with early expiration dates should be kept in front to be used first
Later expiry date in back
Earlier expiry date in front
“Use first” box for vaccines brought back unused from fixed or outreach sessions
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 discard point should be used first. Vaccines with VVM beyond discard point 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. 8

9. 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. 9

10. Key messages
RotarixTM vaccine is an oral vaccine in liquid formulation
RotarixTM comes in a single-dose squeezable 1.5 ml plastic tube
Irritability and loss of appetite are very common side effects of rotavirus vaccine
Store vaccines between +2°C to +8°C
Vaccines with early expiration dates and VVM at discard point (or nearing discard point) should be kept in front of the refrigerator to be used first
Do not open the refrigerator door often
Regularly monitor the temperature of the refrigerator
To the facilitator:
Explain to the participants that these are the important things to keep in mind.

11. 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 attributes and storage conditions”.
The following module is titled “Rotavirus vaccine eligibility”.
Thank you for your attention!