Training for rotavirus vaccine introduction World Health Organization 28 March, 2017 Training for rotavirus vaccine introduction Module 2 Rotavirus vaccine attributes and storage conditions

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

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

What is rotavirus vaccine presentation? Rotavirus vaccine is a ready-to-use, oral vaccine in a liquid formulation Specially designed tube for direct oral administration 1 tube = 1 dose 1 tube has 2 mL liquid A squeezable plastic tube To the facilitator: Describe to the participants the new rotavirus vaccine presentation. Rotavirus 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 2mL liquid. The rotavirus vaccine must be given to babies orally, which means swallowed and not injected. 4

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

At which temperature must the vaccine be stored? Rotavirus vaccines should be stored between +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. Rotavirus 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 would not provide adequate protection against the disease. 6

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

Which vaccine should be stored in front? Vaccines with early expiration dates should be kept in front to be used first Further expiry date in back Closer expiry date in front 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. 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

Handling RotaTeqTM with No VVM In the absence of a VVM, it is impossible to know if vaccines have been exposed to high temperatures (above 8 degrees) and for how long and how many times  It is extremely important that cold chain conditions are strictly maintained and closely monitored from vaccine receipt to vaccine administration. Temperatures should be recorded twice daily on a monitoring chart and corrective action taken immediately if there is a cold chain failure.

Handling RotaTeqTM with No VVM: Outreach Careful micro-planning is needed so that the appropriate numbers of rotavirus tubes are placed in the vaccine carrier; this will minimize unnecessary wastage at the end of the session. Discard unopened vaccine RotaTeq tubes at the end of outreach or mobile sessions if there is no assurance that the cold chain was maintained.

Handling RotaTeqTM with No VVM: Outreach To avoid wastage, careful planning for outreach and mobile sessions is needed: Keep a due list that has names of all children needing Rotavirus vaccine Put the RotaTeq vaccine in the vaccine carrier based on the number of children expected to get the vaccine Keep vaccine carrier in a cool place away from Sun Keep the RotaTeq vaccine inside the vaccine carrier until you are ready to give the vaccine

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 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 in cold box(es) or vaccine carrier(s) then put vaccines in the cold box(es) (Be careful not to put rotavirus vaccines or other freeze-sensitive vaccines near frozen ice packs, as it may affect vaccine potency). If another refrigerator is unavailable, discard unopened RotaTeq tubes if the vaccine is exposed to temperatures between 9- 25 Celsius for more than 24 consecutive hours or if the ambient temperature is more than 25 degrees. Inform supervisor immediately. 12

Key messages Rotavirus vaccine is an oral vaccine has a liquid formulation Vaccine comes in a squeezable plastic tube RotaTeq vaccine comes without a VVM and therefore proper planning and handling in essential Store vaccines between +2°C to +8°C Vaccines with early expiration dates should be kept in front of the refrigerator to be used first Regularly monitor the temperature of the refrigerator Do not open the refrigerator door often To the facilitator: Explain to the participants that these are the important things to keep in mind.

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!