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

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’

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

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

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

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

How to prepare for vaccination with the two dose RotaSiilTM presentation? (1/7) The two dose RotaSiilTM presentation contains 4 elements: Two dose vaccine vial Diluent (only for use with this vaccine) Two 6 ml oral syringes 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 two-dose presentation RotaSiilTM package: Two-dose 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. Two 6 ml oral syringes – one for reconstitution and administering the first dose, and the second one to administer the second dose Adapter

How to prepare for vaccination with the two dose RotaSiilTM presentation? (2/7) 1 2 1 Snap off the top of the diluent vial Insert vial adapter onto diluent vial Draw back plunger of 6 ml oral syringe to half-way mark (3 ml) Connect syringe to adapter and push air from syringe into diluent vial 3 4 To the facilitator: Explain to the participants, how to prepare the vaccine. Hold the adapter by its body – avoid touching the tip or the spike. Snap off the top of the diluent vial and insert vial adapter onto diluent vial. Draw back plunger of 6 ml oral syringe to half-way mark (3 ml). Connect syringe tip to adapter and push air from syringe into diluent vial (this creates overpressure in the vial). N.B. Follow reconstitution steps closely – failure to do so may compromise reconstitution and administration.

How to prepare for vaccination with the two dose RotaSiilTM presentation? (3/7) Invert vial, allow diluent to flow into syringe. Draw back plunger to 5 ml mark to extract residual diluent Remove syringe and vial adapter combination from diluent vial, taking care not to touch tip of adapter Snap off the top of the vaccine vial and insert syringe and vial adapter combination into vaccine vial - Push plunger to its limit to empty vial 5 5b 6 7 To the facilitator: Explain to the participants, how to prepare the vaccine. Invert vial and allow diluent to flow into syringe. Draw back plunger (to 5 ml mark) to extract any residual diluent. Remove syringe and vial adapter combination from diluent vial, taking care not to touch tip of adapter. Snap off the flip off seal of the vaccine vial and insert syringe and vial adapter combination into vaccine vial. (The contents of the syringe will be drawn into the vaccine vial – push the plunger of the syringe to its limit to ensure the entire contents of the syringe are transferred to the vial.)

How to prepare for vaccination with the two dose RotaSiilTM presentation? (4/7) Check reconstitution is complete – solution is clear Disconnect syringe, draw back plunger to 1 ml mark Connect syringe to vial adapter fitted to vial and push air into vial Invert vial and allow reconstituted vaccine to flow into syringe 8 5 9 6 7 8 11 10 To the facilitator: Explain to the participants, how to prepare the vaccine. Visually check reconstitution is complete and solution is clear. Use within 4 hours or at the end of the immunization session, whichever comes first. Disconnect the syringe, draw back the plunger to approximately the 1 ml mark. Connect the syringe tip to the vial adapter fitted to the vial and push air from the syringe into the vial (this creates an overpressure within the vial). Invert the vial and allow the reconstituted vaccine to flow into the syringe. N.B. Follow reconstitution steps closely – failure to do so may compromise reconstitution and administration.

How to prepare for vaccination with the two dose RotaSiilTM presentation? (5/7) 13 Draw 2.5 ml of reconstituted vaccine Remove only the syringe (leave adapter in place, taking care not to touch tip of adapter) and administer first dose to the infant – slowly and into inner cheek Dispose of the syringe after administration with other non-sharp immunization waste DO NOT INJECT 12 5 6 7 8 13b To the facilitator: Explain to the participants, how to prepare the vaccine. Draw out 2.5 ml (one dose) of the reconstituted vaccine slowly. CAUTION: DO NOT DRAW MORE THAN 2.5 ml. Remove only the syringe, leaving the vial adapter in place. Administer the first dose of the vaccine to the infant. Administration should be slow with the nozzle pointed towards the inside cheek of the infant. Discard the syringe after administration. The oral syringe can be safely disposed with other non-sharp immunization waste (e.g. vials, plastics, etc.). DO NOT INJECT

How to prepare for vaccination with the two dose RotaSiilTM presentation? (6/7) For the SECOND dose Take a fresh 6 ml oral syringe, connect it to the vial adapter on the vaccine vial Leave fresh syringe connected to vial adapter to avoid contamination Repeat steps of drawing 2.5 ml into syringe Disconnect syringe from adapter and administer second dose of the vial to the second infant Discard all components with other non-sharp immunization waste DO NOT INJECT 5 15 6 16 7 8 18 17 To the facilitator: Explain to the participants, how to prepare the vaccine. For the 2nd dose: Take a fresh 6 ml oral syringe, connect it to the vial adapter on the vaccine vial. If there is a gap between the administration of the first and second dose of the vaccine, leave the fresh syringe connected to vial adapter to avoid contamination. When the infant is ready to be vaccinated, repeat the steps of drawing 2.5 ml into the syringe from the vial adapter. Disconnect syringe from adapter and administer second dose of the vial to the second infant Discard all components. The oral syringes and adapters can be safely disposed with other non-sharp immunization waste (e.g. vials, plastics, etc.). 18b

How to prepare for vaccination with the two dose RotaSiilTM presentation? (7/7) Unlike the OPV vaccine, the two dose RotaSiilTM vaccine should be used within 6 hours of opening, or until the end of the vaccination session If there are no infants to be vaccinated with the second dose of the RotaSiilTM vaccine, discard the vaccine 15 16 7 8 To the facilitator: Explain to the participants, how to prepare the vaccine. Unlike the OPV vaccine, the two dose RotaSiilTM vaccine should only remain for 6 hours, or until the end of the vaccination session – whichever comes first If there are no more infants to vaccinate immediately with the second dose of the RotaSiilTM vaccine, the vaccine should only remain for 6 hours or until the end of the vaccination session, whichever comes first. After which, the vaccine should be discarded in the usual way.

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. 14

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. 15

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). 16

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. 17

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). 18

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 19

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 Opened vials should be discarded after 6 hours of opening or at the end of session, and must not be used in next session 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 6-10-14 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 2 dose Rotavirus (RotaSiil™) vials, you would need to take 10 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. Opened vials should be discarded after 6 hours of opening or at the end of session, and must not be used in next session.

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 and in the case of the 2 dose presentation, ensuring to change syringes between infants 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. 21

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!