Essential Training Package for HPV Vaccine Introduction

Module 2

HPV vaccine attributes and storage conditions GardasilTM Learning objectives

⚫ At the end of the module, you will have learned to: - Describe HPV vaccine characteristics (GardasilTM) - Discuss the presentation of HPV vaccine - Apply vaccine cold chain requirements

⚫ Duration – 25’

2 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Key issues

TM, 1 What is HPV vaccine, Gardasil presentation?

2 How effective is the vaccine?

3 How safe is the vaccine?

4 At which temperature should the vaccine be stored?

5 Where in the refrigerator should HPV vaccines be stored?

3 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 What is the presentation of GardasilTM?

⚫ GardasilTM (or SilgardTM) is available in a liquid formulation: ➢ as a single dose vial ➢ intramuscular injection

⚫ 1 vial has 0.5mL suspension

⚫ Each vial contains a Vaccine Vial Monitor (VVM)

⚫ Vaccine vials are available in pack sizes of 1, 10, and 100

4 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Is GardasilTM effective?

⚫ GardasilTM is a quadrivalent vaccine to prevent from: – Infection due to HPV types 16 & 18 that cause the majority of cervical cancers – Infection due to HPV types 6 & 11 that are responsible for genital warts

⚫ High efficacy of GardasilTM against persistent infection with HPV types has been demonstrated in females

⚫ There is no evidence of waning immunity

5 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Is GardasilTM safe?

⚫ GardasilTM is well-tolerated with no major safety concerns ⚫ Injection site reactions such as redness, pain and swelling can occur ⚫ Mild adverse events include fever, dizziness and nausea ⚫ Syncope can occur after any medical procedure and is not uncommon in adolescents following receipt of a vaccine. ⚫ It is recommended that adolescents be seated during HPV vaccine administration and observed for 15 minutes afterwards

6 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 HPV vaccine storage conditions

⚫ HPV vaccines should be stored between +2oC and +8oC

⚫ HPV vaccine is freeze sensitive

⚫ HPV vaccine is light sensitive

7 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Temperature sensitivity of vaccines

Heat OPV sensitivity Most Rotavirus sensitive MMR Measles Rotavirus Penta- valent Vaccine formulation BCG Pneumo PS-PCV Vaccines to the Freeze dried left of the line HPV Liquid, no adjuvant are not damaged by freezing Liquid, with alum adjuvant

HepB Least sensitive Least Most sensitive Freeze sensitivity sensitive

8 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Where to place HPV vaccine in the refrigerator?

9 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Which vaccine vials should be stored in front?

⚫ Vaccine vials with early expiration dates and vials with VVM that has started to change color should be kept in front to be used first

Further expiry date in back

Closer expiry date in front

10 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Cold boxes and vaccine carriers

11 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 Key messages

⚫ GardasilTM vaccine is safe and effective

⚫ GardasilTM is available as a single dose vial (0.5mL) in a liquid formulation with VVM

⚫ HPV vaccine is freeze sensitive and light sensitive – HPV vaccine must be stored at +2oC to +8oC – HPV vaccine should be stored in their original package

⚫ When using icepacks in cold boxes and vaccine carriers, they should be conditioned to reduce the risk of vaccine freezing

12 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 End of module

Thank you for your attention!

13 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014 References

⚫ HPV vaccine introduction into national immunization programmes: Information for programme managers and health workers. WHO 2014

⚫ Gardasil/SilgardTM package inserts. Merck & Co, Inc. 2009

14 | HPV vaccine attributes and storage conditions, Module 2 GardasilTM | June 2014