1. Training for rotavirus vaccine introduction
World Health Organization
24 April, 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 rotavirus vaccine
Describe storage conditions of rotavirus 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 (RotavacTM) presentation?
Rotavac™ vaccine is a ready-to- use, oral vaccine in liquid formulation
It comes in 5 (2.5 ml) or (5 ml) dose vials with dropper
Dosage:
1 dose = 0.5ml = 5 drops
To the facilitator:
Describe to the participants the new rotavirus vaccine presentation.
Rotavac™ vaccine is a liquid solution for oral use.
It comes in a vial and with the use the dropper provided, it is designed for direct oral administration.
5 (containing 2.5ml) or 10 (containing 5ml) dose vials.
1 dose = 0.5ml = 5 drops
The rotavirus vaccine (Rotavac™) must be given to infants orally, which means swallowed and not injected.
Note that VVM is on the cap, indicating that open vial should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first (More details in Module 4 – Administration-) 4

5. How safe is the vaccine?
Rotavac™ vaccine is safe and does NOT cause any serious adverse events
Fever and diarrhoea are very common side effects of Rotavac™ rotavirus vaccine
Rotavac™ 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.
Fever and diarrhoea are very common side effects of Rotavac™ vaccine, other effects are mentioned below.
Rotavac™ side effects include:
Very common(1/10): fever, diarrhoea, cough
Common(1/100, <1/10): vomiting, irritability, crying and rash
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).
Rotavirus vaccine can be given safely with other vaccines. 5

6. At what temperature must the vaccine be stored?
Rotavac™ vaccine should be stored at -20oC at levels where walk-in freezers or deep freezers are available
RotavacTM can be stored between +2oC to +8oC at any time during its shelf-life until the expiry or discard point of the vaccine vial monitor (VVM)
Once thawed, the shelf life of RotavacTM is 6 months
Rotavac™ can be subjected to 6 freeze-thaw cycles
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.
Rotavac™ vaccine must be transported and stored at -20°C, where walk-in freezers or deep freezers are available - this is frozen.
It can be stored between +2°C to +8°C at any time during its shelf-life until the expiry or discard point of the VVM found in the vial’s cap.
RotavacTM’s shelf life at -20oC is 60 months, once thawed, its shelf life reduces to 6 months.
Rotavac™ can be subjected to 6 freeze-thaw cycles, without loosing its potency or safety characteristics.
It is critical to ensure that the storage conditions comply with this. 6

7. Where do you store the vaccine?
At levels where they are available, Rotavac™ should be stored in walk-in freezers or deep freezers
At the peripheral level, where there are no negative storage facilities, Rotavac™ should be stored in ILRs at same level as BCG or OPV vaccines
Transport of Rotavac™
To storage points: cold boxes with conditioned ice-packs
To session sites: vaccine carriers with conditioned ice packs*
* The appropriate water pack strategy should be guided by national policy and practice
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 freezer and refrigerator regularly.
As we have mentioned before, Rotavac™ vials must be stored at -20°C at storage points and +2 to +8°C at service delivery points.
Transport of the vaccine with cold boxes or vaccine carriers should be done with conditioned ice packs or the following the national policy and routine practice. 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 freeze-sensitive vaccines near frozen ice packs, as it may affect vaccine potency).
Inform supervisor immediately. 9

10. Key messages Rotavac™ vaccine is an oral vaccine in liquid formulation
Rotavac™ comes in 5 and 10 dose vials with a dropper
1 dose is 5 drops (0.5 ml)
Fever and diarrhoea are very common side effects of Rotavac™ vaccine
Store vaccine at -20°C where freezers are available, and between °C to +8 °C at service delivery points
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 freezer and 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 “Rotavac™ rotavirus vaccine attributes and storage conditions”.
The following module is titled “Rotavirus vaccine eligibility”.
Thank you for your attention!