1. World Health Organization
28 February, 2019
Essential Training Package for HPV Vaccine Introduction
Module 2
HPV vaccine attributes and storage conditions
GardasilTM

2. 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’

3. Key issues 1 2 3 4 5 What is HPV vaccine, GardasilTM, presentation?
How effective is the vaccine? 2
How safe is the vaccine? 3
At which temperature should the vaccine be stored? 4
Explain to the participants the key issues raised in this module:
What is GardasilTM, presentation?
How effective is the vaccine?
How safe is the vaccine?
At which temperature should the vaccine be stored?
Where in the refrigerator should HPV vaccines be stored?
Where in the refrigerator should HPV vaccines be stored? 5

4. 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
Gardasil vaccine is available as a single dose vial in a liquid formulation for intramuscular injection
Each vial contains 0.5 ml suspension
Each vial contains a vaccine vial monitor (VVM) to indicate cumulative exposure to heat
Vaccine vials are available in pack 1, 10, and 100 4

5. 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
Data from several large clinical trials of HPV vaccine have demonstrated very high efficacy of GardasilTM against persistent infection with HPV types in females aged years who had not been exposed to the HPV types targeted by the vaccine prior to the vaccination
GardasilTM is a quadrivalent vaccine that protects from HPV infection types 16 & 18 that cause most of the cervical cancers worldwide as well as HPV infection types 6 & 11 responsible for benign anogenital warts & recurrent respiratory papillomatosis
There is no evidence of waning immunity 9 years after vaccination in females who were vaccinated as part of the clinical trials conducted in the early 2000’s.

6. 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
Safety studies of HPV vaccine were conducted in thousands of women around the world prior to licensure. Results of the studies demonstrated that vaccines were well tolerated with no major safety concerns for either vaccine.
Post licensure, millions of girls have received the HPV vaccine. The most common adverse events reported in vaccinated girls have involved injection site reactions such as pain and swelling
Other mild adverse events reported following HPV vaccination included fever, dizziness and nausea
Syncope (fainting) has also been reported after HPV vaccine administration. Syncope can occur after any medical procedure and is not uncommon in adolescents following receipt of a vaccine (see following modules).
It is recommended that adolescents be seated during HPV vaccine administration and observed for 15 minutes afterwards 6

7. HPV vaccine storage conditions
HPV vaccines should be stored between +2oC and +8oC
HPV vaccine is freeze sensitive
HPV vaccine is light sensitive
Handling vaccines requires great care. Careful storage and transport conditions are needed to protect vaccines from becoming ineffective and unusable.
HPV vaccine must be transported and stored at +2°C to +8°C
HPV vaccine is sensitive to temperatures lower than 0°C and loses efficacy if frozen
It is sensitive to light and should be stored in the original package in order to protect from light 7

8. Temperature sensitivity of vaccines
Freeze dried
Liquid, no adjuvant
Liquid, with alum
adjuvant
Vaccine formulation
Rotavirus
HPV
Pneumo
PS-PCV
Measles
OPV
BCG
HepB
Penta- valent
Least sensitive
Most sensitive
Vaccines to the left of the line are not damaged by freezing
Most sensitive
Heat sensitivity
Freeze sensitivity
MMR
This slide shows the overall temperature sensitivity of common vaccines. Each bubble represents the overall or “representative” heat/freeze sensitivity for a type of vaccine.
As you can see from this slide, HPV is one of the most freeze sensitive vaccines, along with HepB and PCV and Pentavalent vaccines.
If freezing is suspected, perform shake test.

9. Where to place HPV vaccine in the refrigerator?
Good temperature control during the storage and transport of vaccines is critical to ensure their potency and safety.
As we have mentioned before, HPV vaccines must be refrigerated at+2°C to +8°C. The vaccine should be administered as soon as possible after being removed from the refrigerator
HPV vaccine should not be placed in or near the freezer portion of the refrigerator nor directly on a frozen ice pack. Keep the HPV vaccine away from all cold air vents
If the refrigerator is a side opening model, no vaccine should be stored in the door as the temperature is more likely to fluctuate when opening and closing the refrigerator
The temperature inside the refrigerator should be monitored regularly 9

10. 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
Vaccines vials with early expiration dates should be kept in front for first use
Vaccine vials with the Vaccine Vial Monitor (VVM) that has started to change color (i.e. inner square getting darker) should be used first
Vaccine vials with VVM reaching discard point should not be used even if the expiration date is valid.
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 10

11. Cold boxes and vaccine carriers
If transport of vaccine is required, only conditioned ice packs should be used to maintain a cold chain at +2°C to +8°C .
Frozen icepacks should be kept at room temperature for 5-10 or more minutes until the ice inside can be heard to move when shaken before placing the vaccines in them. This is called “conditioning” the ice packs and prevents the vaccine from freezing when it is placed near the packs
HPV vaccine is sensitive to light and should be stored in the original boxes until ready to use

12. 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
GardasilTM or SilgardTM is available as a single dose vial (0.5mL) in a liquid formulation for intramuscular injection
Each vial contains a VVM
GardasilTM is very safe and effective against diseases caused by HPV types 16 and 18
Store vaccines at +2°C to +8°C and administer as soon as possible after being removed from the refrigerator
HPV vaccines are sensitive to temperatures lower than 0°C and lose efficacy if frozen
HPV vaccines are sensitive to light and should be stored in the original packaging in order to protect from light
When using icepacks in cold boxes and vaccine carriers, they should be conditioned well to reduce the risk of vaccine freezing

13. End of module for your attention! Thank you
This is the end of the module, thank you for your attention!

14. References
HPV vaccine introduction into national immunization programmes: Information for programme managers and health workers. WHO 2013
Gardasil/SilgardTM package inserts. Merck & Co, Inc. 2009