Chapter 3- HepB-BD- Vaccine Logistic managment.pptx

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1. Chapter 3: Hepatitis B Birth Dose Vaccine Logistics Management August 2025 Addis Ababa, Ethiopia 22 August 2025 1

2. Outline 22 August 2025 2 Learning objectives Type, Characteristics and presentation of the vaccine HepB BD vaccine and supply stock management HepB BD vaccine Storage and Handling Vaccine Distribution Summary

3. Learning objectives At the end of the module, you will be able to: Describe Type and characteristics of the HepB BD vaccine Manage HepB BD vaccine and supply stock Estimate vaccine needs Monitor temperature of vaccine refrigerator Take steps to handle suspected frozen vaccines 22 August 2025 3

4. There are two type of HepB BD vaccine: Recombinant or genetically engineered vaccine Plasma- derived vaccines Formulation: Monovalent formulation vaccine In combination formulation E.g Pentavalent Note: Only a monovalent vaccine can be used for the birth dose Combination vaccines that include HepB BD vaccine MUST NOT BE USED to give the birth dose of HepB BD vaccine because DTP and Hib vaccines should not be administered at birth 22 August 2025 4 Type of HepB BD Vaccine

5. HepBvaccines are manufactured in various presentations, including multi- dose vials single- dose vials, compact pre- filled auto- disable syringes (cPAD), and emerging technologies such as micro- array patches (MAP). Type of HepB BD Vaccine Cont… Multi- Dose Vial (10 dose or 20 Dose) Each vial contains multiple doses, typically 10 or 20 doses for HepB BD birth dose Ideal for use in larger health facilities with more frequent births Single Dose Vial Each vial contains one pre- measured dose of the Hepatitis B vaccine Ideal for use in smaller populations with low delivery volumes Compact pre- filled auto- disabled syringe (cPAD) Single- use syringes prefilled with HepB BD vaccine, designed for safe and efficient administration. Ideal for non- medical trained vaccinators Micro- array patch (MAP) MAPs consist of thousands of tiny projections that can be coated with or contain vaccine. They are pressed and held to skin for a few minutes, then removed and vaccine remains in the skin. This format will not be available for 5- 10 years. 22 August 2025 5

6. Characteristics and Presentation of the HepB- BD vaccine 22 August 2025 6 Type of vaccine Recombinant DNA or plasma- derived Number of doses 1 (one) dose Schedule Highly recommended Immediately after birth within 24 hrs. It can be given after and until 2 weeks, but the effectiveness will be lower. Adverse Reactions Mild: soreness at the injection site, irritability, and fever Contraindications Anaphylactic reactions to previous dose. However, new born will not have received a previous dose. Thus, there are no true contraindication to birth dose Special precautions Use only monovalent Hep B birth dose vaccine for the birth dose Dose Dosage 0.5ml Injection site Intramuscular injection anterolateral aspect of the thigh. Storage Store between 2°C–8°C.(Do not freeze) Presentation 10 doses/vial, liquid VVM Type VVM 30 Packed volume per dose 2.109 cm3/dose (Serum Inst. of India), 2.86 cm3 (LG Chem.)

7. HepB BD Vaccine s Supply Stock Management Forecasting In order to maintain adequate stock and provide the immunization service accurate forecasting/estimation is crucial. Exercise The forecast for 2018 E.C is being prepared for ABC Health Center. The total population served under catchment is 30,000 and Live birth proportion estimated to be 3.47% of the total population. Expected coverage for the year is 100% and estimated HepB BD wastage was 10%. What is the total number vaccine doses, injection syringe and safety box required for the budget year (2018)? Vaccine need = Target population X Planned Coverage X Number of dose in schedule X Wastage factor 22 August 2025 7

8. Vaccine Storage and Handling 22 August 2025 8

9. Vaccine Storage and Handling… Handling the Cold Boxes and Vaccine Carriers: Condition the ice packs: Shake until you can hear water moving inside Place them in the vaccine carrier along with Fridge Tag. Do not put HepB BD vaccine in direct contact with ice packs Put the foam pad on top and carefully close the lid. The temperature of vaccines stored in a vaccine carrier or cold box should be closely monitored, and the water packs should be replaced at least every 24 hours . 22 August 2025 9

10. Temperature Monitoring According to WHO recommendation HepB BD vaccine should be kept between +2 ° C and +8 ° C. Before administering the vaccine, you need to check the Vaccine Vial Monitor (VVM) on the vaccine vial 22 August 2025 10

11. What to do in case of Suspected Frozen Vaccine If freezing is suspected, the shake test should be conducted, particularly if the following conditions are observed: Low temperature alarm on the continuous temperature recorder Refrigerator temperature below 0⁰C Vaccine vial in contact with frozen ice packs Cross (X) on the Freeze Tag If the shake test shows that freezing has occurred, remove all vaccines from the same batch, note the quantity concerned and discard all affected vaccines. Complete and submit appropriate f orms to indicate vaccines and supplies loss. 22 August 2025 11

12. How to perform a shake test?1/3 22 August 2025 12

13. How to perform a shake test? (2/3) 22 August 2025 13

14. Examples of shake test vial results (3/3) FROZEN VIAL (control) TEST VIALS Not frozen test vial USE THIS VACCINE If the test vial sediments slower than the frozen vial, it was not frozen and is safe to use. Frozen test vial DO NOT USE THIS VACCINE If sedimentation is similar in both vials, or the test vial sediments faster than the frozen vial, vaccines in that batch should be discarded. Nearly transparent Thick sediment 22 August 2025 14

15. MULTI- DOSE VIAL POLICY (MDVP) FOR HepB BD VACCINE 22 August 2025 15 In Health Facilities, opened multi- dose vials of HepB BD vaccine may be kept and used for up to four weeks (28 days) if all the following conditions are met: The expiry date has not passed; The Vaccine Vial Monitor (VVM) has not reached the discard point; The vial has been kept at recommended temperatures (between 2 ° C– 8 ° C); The part of the vaccine vial where the needle is inserted to withdraw doses has not been submerged under water. An aseptic technique has been used to withdraw all doses. In outreach sessions, opened multi- dose vials of HepB BD vaccine may be kept and used for up to four weeks (28 days) if: all the above conditions for reuse of multi- dose vials in fixed health facilities are met. Opened vials should be clearly labeled and should be kept in visible area

16. Vaccine and Dry Supplies Distribution EPSS Center EPSS Hubs Woredas/HFs Vaccine Requisition Form (VRF) will be is used to place Orders. The VRF should be submitted based on agreed VRF submission schedule. Quarterly Monthly 22 August 2025 16

17. Summary 22 August 2025 17 Vaccine used for HepB- BD is monovalent, liquid, and will contain 10 doses in each vial. The estimate of vaccine and supplies needed is calculated using a method based on the target population. The vaccine must be stored between +2⁰C and +8⁰C and must Never be Frozen . If freezing is suspected, the SHAKE TEST should be conducted. Opened multi- dose vials of HepB BD vaccine may be kept and used for up to four weeks (28 days) if all MDVP conditions are meet

18. Thank You! 22 August 2025 18