1. Training for rotavirus vaccine introduction
World Health Organization
15 September, 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 RotaSiilTM vaccine
Describe storage conditions of RotaSiilTM 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 the rotavirus vaccine (RotaSiilTM) presentation?
RotaSiil™ vaccine is a lyophilized vaccine which is reconstituted into a liquid solution for oral administration
It comes in 1 (2.5 ml) or 2 (5 ml) dose vials
Dosage:
1 dose = 2.5 ml
To the facilitator:
Describe to the participants the new rotavirus vaccine presentation.
RotaSiil™ vaccine is a lyophilized vaccine which is reconstituted into a liquid solution for oral use.
It comes in a 1 (2.5 ml) or 2 (5 ml) dose vials.
1 dose = 2.5 ml
The rotavirus vaccine (RotaSiilTM) must be given to infants orally, which means swallowed and not injected.
Note that the 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. What is contained in the RotaSiilTM single dose package?
RotaSiil™ package contains:
A vial of freeze-dried vaccine
A diluent vial (only for use with RotaSiilTM vaccine)
One 3 ml oral syringe
An adapter
To the facilitator:
Describe to the participants the new rotavirus vaccine presentation.
RotaSiil™ package contains:
A vial of freeze-dried vaccine.
A vial of diluent for reconstitution of the vaccine. N.B. This diluent must only be used with this RotaSiil vaccine. It must never be used to reconstitute other freeze-dried vaccines.
One 3 ml oral syringe for reconstitution and administration.
An adapter – to facilitate reconstitution. 5

6. How safe is the vaccine?
RotaSiil™ vaccine is safe and does NOT cause any serious adverse events
Fever and diarrhoea are very common side effects of RotaSiil™ rotavirus vaccine
RotaSiil™ 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 RotaSiil™ vaccine, other effects are mentioned below.
RotaSiil™ 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).
RotaSiil™ vaccine can be given safely with other vaccines. 6

7. At what temperature must the vaccine be stored?
RotaSiil™ vaccine should be stored between +2oC to +8oC
Care should be taken that neither the vaccine nor the diluent are frozen
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.
RotaSiil™ vaccine must be transported and stored between +2°C to +8°C.
It is important to ensure that neither the vaccine nor the diluent are frozen.
If vaccines and/or diluent are frozen, they lose their potency and will be provide adequate protection against the disease.
It is critical to ensure that the storage conditions comply with this. 7

8. Where do you store the vaccine?
The rotavirus vaccine (RotaSiilTM) should be stored in a refrigerator
The RotaSiilTM-specific diluent should be stored as for MR and BCG vaccines
The RotaSiilTM oral syringes and adapters should be stored in a cool, dry place e.g. with polio droppers
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, RotaSiil™ vials must be stored between +2 to +8°C.
Do not put RotaSiil™, nor the diluent, in the freezer.
The vaccine should be administered as soon as possible after being removed from the refrigerator.
N.B. RotaSiilTM vials, diluent, oral syringes and adapters are not bundled. The vaccine will be transported with cold chain transport, the diluent in its own boxes and the syringes and adapters will be transported as dry transport.
Healthcare Workers should store the diluent the same was they do with MR and BCG vaccines, i.e. if they keep other diluents in dry storage, they should do the same. If they keep them in fridges, then they should follow same practice, as long as there is sufficient capacity in the fridge.
Healthcare Workers should stroe the oral syringes and adapters in a cool, dry place, e.g. with the polio droppers. 8

9. 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. 9

10. 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 refrigerator 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 conditioned 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. 10

11. Key messages RotaSiil™ is an oral vaccine in liquid formulation
RotaSiil™ comes in 1 and 2 dose vials
1 dose is 2.5 ml
Fever and diarrhoea are very common side effects of RotaSiil™ vaccine
Store vaccines between +2oC to +8oC
Store diluent with MR and BCG diluent – either dry storage or fridge
Store oral syringes and adapters in a cool, dry place – with polio droppers
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.

12. End of module for your attention! Thank you To the facilitator:
This is the end of the module.
You have been introduced to “RotaSiil™ rotavirus vaccine attributes and storage conditions”.
The following module is titled “Rotavirus vaccine eligibility”.
Thank you for your attention!