Temperature Sensitivity of Vaccines...Speaker’s notes\爀嘀愀挀挀椀渀攀猀愀爀攀氀椀猀琀攀搀椀渀愀氀瀀栀愀戀攀琀椀挀愀氀漀爀搀攀爀眀椀琀栀椀渀

$Page 1: Temperature Sensitivity of Vaccines...Speaker’s notes\爀嘀愀挀挀椀渀攀猀愀爀攀氀椀猀琀攀搀椀渀愀氀瀀栀愀戀攀琀椀挀愀氀漀爀搀攀爀眀椀琀栀椀渀$
Temperature Sensitivity of Vaccines

March 2014

Rubella

Typhoid PS

JE live

Temperature sensitivity of vaccines

Freeze dried

Liquid, no adjuvant

Liquid, with alum adjuvant

Vaccine formulation

Rotavirus Rotavirus

HPV

Pneumo PS-PCV

JE inactivated

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

Rabies

Yellow fever

MenA PS-PCV*

Hib

Least sensitive

Most sensitive

Vaccines to the left of the line are not damaged by freezing

Most sensitive

Least sensitive

Heat sensitivity

Freeze sensitivity

HepA

Influenza inactivated IPV

MMR

Varicella- zoster virus

DTaP Hexa- valent

MenC PS-PCV

*The diluent for MenA PS-PCV contains alum adjuvant and is freeze sensitive.

Cholera inactivated

Not sensitive

Presenter

Presentation Notes

Speaker’s notes This slide shows stability of all vaccines that have been reviewed. Each bubble represents the overall or “representative” heat/freeze sensitivity for that type of vaccine. Individual vaccines of the same type but from different manufacturers can have different stabilities and, therefore, may also have different VVMs. Notes and caveats: While the stability data for liquid rotavirus vaccines demonstrate resistance to freezing, the temperature handling recommendations in the vaccine product insert should be followed. Inactivated cholera vaccines: There is not much information on inactivated cholera vaccine stability. The package inserts for Shanchol and Dukoral state “do not freeze” and Shanchol should be “discarded if frozen,” but there is no information on the relative freeze sensitivity compared with other vaccines. So, they have been grouped with other freeze-sensitive, non-adjuvanted vaccines. The only guidance regarding heat stability is that Shanchol has a VVM 14. On this basis, inactivated cholera vaccines have been grouped with other VVM 14 vaccines. Inactivated flu vaccines include whole inactivated flu vaccines, inactivated split flu vaccines, and purified influenza protein (from inactivated virus) vaccines. JE inactivated refers to JE-vax from Sanofi, not the “new” adjuvanted, liquid-inactivated JE vaccine (Ixiaro) from Intercell. Not included: Live typhoid or live attenuated flu are not included as there are not enough data for any of these to allow reliable plotting. Meningococcal and pneumococcal polysaccharide vaccines (not conjugated) are not included, as there are PS-protein vaccines (PS-PCVs) as alternatives. The vaccines are animated to appear in four phases. Group 1: “Traditional EPI” vaccines (11 bubbles)—OPV, measles, rubella, MMR, BCG, DTwP, pentavalent, Hib (both freeze dried and liquid), T/DT/dT, Hep B. Group 2: “Newer” vaccines (4 bubbles)—Pneumococcal, rotavirus (both freeze dried and liquid), HPV. Group 3: “Regionally specific” vaccines (7 bubbles)—JE (both live and inactivated), cholera (inactivated), typhoid (PS), Men A, rabies, yellow fever. Group 4: “Middle-/Upper-income” vaccines (7 bubbles)—Varicella, influenza (inactivated), IPV, DTaP, hexavalent, Men C, Hep A.

Heat sensitivity Vaccine

Most sensitive Oral poliovirus Varicella-zoster virus

Influenza (inactivated, split)

Inactivated poliovirus Japanese encephalitis (live) Measles, mumps, rubella

Cholera (inactivated) DTaP DTwP DTaP-hepatitis B-Hib-IPV (hexavalent) DTwP-hepatitis B-Hib (pentavalent) Hib (liquid) Measles Rotavirus (liquid and freeze dried) Rubella Yellow fever

Bacillus Calmette-Guérin Human papillomavirus Japanese encephalitis (inactivated) T, DT, dT

Least sensitive Hepatitis A Hepatitis B Hib (freeze dried) Meningitis A (polysaccharide-protein conjugate) Meningitis C (polysaccharide-protein conjugate) Pneumococcal (polysaccharide-protein conjugate) Rabies Typhoid PS

Vaccine sensitivity to heat

All freeze-dried vaccines become much more heat sensitive after they are reconstituted.

Note: Bolded vaccines are freeze dried.

Use vaccine vial monitors to monitor heat exposure.

Presenter

Presentation Notes

Speaker’s notes Vaccines are listed in alphabetical order within each grouping. Groupings follow VVM usage (if applicable) and stability data from graph.

Freeze sensitivity Vaccine Most sensitive Least sensitive

DTaP DTaP-hepatitis B-Hib-IPV (hexavalent) DTwP DTwP-hepatitis B-Hib (pentavalent) Hepatitis A Hepatitis B Human papillomavirus Meningitis C (polysaccharide-protein conjugate) Pneumococcal (polysaccharide-protein conjugate) T, DT, dT

Cholera (inactivated) Influenza (inactivated, split) Hib (liquid) Inactivated poliovirus Typhoid PS Rotavirus (liquid)*

These vaccines are not damaged by freezing.

Meningitis A (polysaccharide-protein conjugate)† Yellow fever

Bacillus Calmette-Guérin Hib (freeze dried) Japanese encephalitis (live and inactivated) Measles Measles, mumps, rubella Oral poliovirus Rabies Rotavirus Rubella Varicella-zoster virus

Vaccine sensitivity to freezing

Cautions: Never expose these

vaccines to zero or subzero temperatures.

Avoid the use of ice for transport.

Note: Bolded vaccines are freeze dried.

* While the stability data for liquid rotavirus vaccines demonstrate some resistance to freezing, the temperature handling recommendations in the vaccine product insert should be followed. † The diluent for MenA PS-PCV contains alum adjuvant and is freeze-sensitive.

Presenter

Presentation Notes

Speaker’s notes Vaccines are listed in alphabetical order within each grouping. The most sensitive vaccines are generally alum adjuvanted. The next group is freeze sensitive but not adjuvanted. Men A and yellow fever vaccines can be exposed to freezing temperatures. The least-sensitive group has data to show these are resistant to multiple cycles of freezing/thawing.

Abbreviations

Information sources 1. PATH, Working in Tandem. Summary of Vaccine Stability Data. Seattle: PATH; 2012. Available at:

http://www.path.org/publications/detail.php?i=1696. 2. World Health Organization. Temperature Sensitivity of Vaccines. Geneva: WHO; 2006. Available at:

http://www.path.org/vaccineresources/files/Temp_sensitivity_WHO.pdf.

Acknowledgments These slides have been adapted from an original slide set produced by Julie Milstien and John Lloyd at the Technet 2006 consultation.

BCG: bacillus Calmette-Guérin IPV: inactivated poliovirus vaccine

DTaP: diphtheria, tetanus, acellular pertussis JE: Japanese encephalitis

DTwP diphtheria, tetanus, whole-cell pertussis Men A: meningitis A

HepA: hepatitis A Men C: meningitis C

HepB: hepatitis B MMR: measles, mumps, rubella

Hexavalent DTaP-hepatitis B-Hib-IPV OPV: oral polio vaccine

Hib: Haemophilus influenzae type b Pentavalent DTwP-hepatitis B-Hib

HPV: human papillomavirus Pneumo: pneumococcal

Influenza: influenza (inactivated, split vaccine) PS: polysaccharide

PS-PCV: PS-protein conjugate vaccine

T, DT, dT: tetanus, diphtheria tetanus, diphtheria (low-dose) tetanus

Presenter

Presentation Notes

Speaker’s notes Both information sources list the primary references used for stability data.

Extra slides for adaptation

Rubella

Typhoid PS

JE live


Rotavirus Rotavirus

HPV

Pneumo PS-PCV

JE inactivated

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

Rabies

Yellow fever

MenA PS-PCV*

Hib

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity

HepA


MMR


DTaP Hexa- valent

MenC PS-PCV

Freeze dried

Liquid, no adjuvant


Vaccine formulation


Cholera inactivated

Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes This version of the slide has no animations or groupings. Each bubble represents the overall or “representative” heat/freeze sensitivity for that type of vaccine. Individual vaccines of the same type, but from different manufacturers, can have different stabilities and therefore may have different VVMs. Notes and caveats: While the stability data for liquid rotavirus vaccines demonstrate some resistance to freezing, the temperature handling recommendations in the vaccine product insert should be followed. Inactivated cholera vaccines: There is not much information on inactivated cholera vaccine stability. The package inserts for Shanchol and Dukoral state “do not freeze” and Shanchol should be “discarded if frozen,” but there is no information on the relative freeze sensitivity compared with other vaccines. So, they have been grouped with other freeze-sensitive, non-adjuvanted vaccines. The only guidance regarding heat stability is that Shanchol has a VVM 14. On this basis, inactivated cholera vaccines have been grouped with other VVM 14 vaccines. Inactivated flu vaccines include whole inactivated flu vaccines, inactivated split flu vaccines, and purified influenza protein (from inactivated virus) vaccines. JE inactivated refers to JE-vax from Sanofi, not the “new” adjuvanted, liquid-inactivated JE vaccine (Ixiaro) from Intercell. Not included: Live typhoid, or live attenuated flu are not included as there are not enough data for any of these to allow reliable plotting. Meningococcal or pneumococcal polysaccharide vaccines (not conjugated) are not included, as there are PS-PCVs as alternatives.


Freeze dried

Liquid, no adjuvant


Vaccine formulation

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity

Hib

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

MMR

“Traditional” EPI vaccines

Rubella

Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes Group 1: “Traditional EPI” vaccines (11 bubbles)—OPV, measles, rubella, MMR, BCG, DTwP, pentavalent, Hib (both freeze dried and liquid), T/DT/dT, Hep B.


Rotavirus Rotavirus

HPV

Pneumo PS-PCV

Freeze dried

Liquid, no adjuvant


Vaccine formulation

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity

Hib

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

MMR

“Traditional” EPI and newer vaccines

Rubella

Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes Group 1: “Traditional EPI” vaccines (11 bubbles)—OPV, measles, rubella, MMR, BCG, DTwP, pentavalent, Hib (both freeze dried and liquid), T/DT/dT, Hep B. Group 2: “Newer” vaccines (4 bubbles)—Pneumococcal, rotavirus (both freeze dried and liquid), HPV.


Typhoid PS

JE live

Rabies

Yellow fever

MenA PS-PCV*

JE inactivated

Freeze dried

Liquid, no adjuvant


Vaccine formulation

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity “Traditional” EPI and regionally specific vaccines

Hib

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

MMR

Rubella


Cholera inactivated

Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes Group 1: “Traditional EPI” vaccines (11 bubbles)—OPV, measles, rubella, MMR, BCG, DTwP, pentavalent, Hib (both freeze dried and liquid), T/DT/dT, Hep B. Group 3: “Regionally specific” vaccines (7 bubbles)—JE (both live and inactivated), typhoid, Men A, rabies, yellow fever, cholera (inactivated).


Rotavirus

Rotavirus

HPV

Pneumo PS-PCV

Freeze dried

Liquid, no adjuvant


Vaccine formulation

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity

Hib

Measles

OPV

BCG

Hib

HepB

DTwP Penta- valent

T, DT, dT

MMR

HepA



DTaP Hexa- valent

MenC PS-PCV

“Traditional” EPI, newer and middle-/

upper-income country vaccines

Rubella

Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes Three groupings, not animated. Group 1: “Traditional EPI” vaccines (11 bubbles)—OPV, measles, rubella, MMR, BCG, DTwP, pentavalent, Hib (both freeze dried and liquid), T/DT/dT, Hep B. Group 2: “Newer” vaccines (4 bubbles)—Pneumo (PS-PCV), rotavirus (both freeze dried and liquid), HPV. Group 4: “Middle-/Upper-income country” vaccines (7 bubbles)—Varicella, influenza, IPV, DTaP, hexavalent, Men C, Hep A.


Freeze dried

Liquid, no adjuvant


Vaccine formulation

Least sensitive


Most sensitive

Least sensitive

Heat sensitivity

HepA


DTaP Hexa- valent

MenC PS-PCV

Middle-/upper- income country vaccines


Not sensitive

Freeze sensitivity

Most sensitive

Presenter

Presentation Notes

Speaker’s notes Group 4: “Middle-/Upper-income country” vaccines (7 bubbles)—Varicella, influenza (inactivated), IPV, DTaP, hexavalent, Men C, Hep A.

Documents

Temperature Sensitivity of Vaccines...Speaker’s notes\爀嘀愀挀挀椀渀攀猀 愀爀攀 氀椀猀琀攀搀 椀渀 愀氀瀀栀愀戀攀琀椀挀愀氀 漀爀搀攀爀 眀椀琀栀椀渀

Temperature Sensitivity of Vaccines...Speaker’s notes\爀嘀愀挀挀椀渀攀猀愀爀攀氀椀猀琀攀搀椀渀愀氀瀀栀愀戀攀琀椀挀愀氀漀爀搀攀爀眀椀琀栀椀渀