Australian Immunisation Handbook, 8th Edition - Vaccine Stability at different temperatures (1) (2) 2 page pdf

Vaccine (3) (4)

< 0ºC

2ºC to 8ºC

22ºC to 25ºC

35ºC to 37ºC

over 37 ºC

BCG (freeze-dried or  lyophilised vaccine) (3) (4)

Can be stored at up to –20ºC.

 

Do not expose to light (ultraviolet and/or fluorescent).

Safe storage for 12 months.

 

Do not expose to light (ultraviolet and/or fluorescent).

Diluent – do not freeze (5) Store between 2ºC and 8ºC.

Stability varies. Some BCG vaccine may lose 25% to 40% of original potency after 2 months.

 

Do not expose to light (ultraviolet and/or fluorescent).

Loses potency rapidly.

 

Do not expose to light (ultraviolet and/or fluorescent)

Rapid loss of potency. Up to 73% loss of  potency after 3 days.

 

Do not expose to light (UV and/or fluorescent)

BCG (Reconstituted with diluent) (3) (4)

DO NOT FREEZE.

Very unstable.

 

Protect from all forms of light (inactivates vaccine).

 

Keep at between 2ºC and 8ºC when vial is not being used. Discard all unused vaccine at the end of the vaccination session (8 hours).

Very unstable.

 

Protect from all forms of light (inactivates vaccine).

 

Keep between 2ºC and 8ºC when vial is not being used.

Very unstable.

 

Protect from all forms of light (inactivates vaccine).

 

Keep between 2ºC and 8ºC when vial is not being used.

Very unstable.

 

Protect from all forms of light (inactivates vaccine).

 

Keep between 2ºC and 8ºC when vial is not being used.

Diphtheria, tetanus and/or acellular pertussis- containing vaccines Includes DTPa, DTPa- hepB, DTPa-Hib, DTPa-IPV, DTPa- hepB-IPV, DTPa-IPV- Hib, DTPa-IPV/Hib, DTPa-hepB-IPV-Hib, dTpa, DT (CDT),  dT(ADT).

DO NOT FREEZE.

Vaccines loses significant potency when stored at –5ºC to –10ºC.

 

NB: Some vaccines may still remain as a liquid at 0ºC. As little as 24 hours at 0ºC or 25ºC may cause antigens to fall from suspension and be very difficult to resuspend. Freezing point of tetanus is between –5ºC to –10ºC. The  freezing point of pertussis is  not known.

 

Discard if exposed to temperatures of 0ºC or below.

Safe to store at 2ºC to 8ºC for 24 months in spite of continuous slow decrease in potency of the pertussis component.

The DT components are stable for 4,  possibly 6 months; the limiting factors are some of the  other components.

 

Some vaccines containing pertussis are stable for only 2 weeks at this temperature.

The DT components are stable for weeks  but the stability of  the other components vary  with different  vaccines.

 

Some vaccines containing pertussis lose 50% of potency after one week.

DT components: stable for 2 weeks at 45ºC but much less at higher  temperatures.

 

The other components are (where known) very unstable at  high temperatures.

Freeze dried (lyophilised) monovalent PRP-T  Hib vaccine

Freeze-dried or lyophilised vaccine PRP-T can be frozen.

Diluent – do not freeze (5) Store between 2ºC and 8ºC.

Not available.

Not available.

Not available.

Reconstituted monovalent PRP-T Hib vaccine

Reconstituted vaccine must NOT be frozen.

Store all components of the vaccine between 2ºC and 8ºC.

Not available.

Not available.

Not available.

Other Hib-containing vaccines (PRP-OMP, HbOC, Hib (PRP-OMP)-hep B

 

DO NOT FREEZE.

 The precise freezing point is not established. Manufacturers state freezing temperature of HbOC is –1.0ºC. Discard if exposed to temperature of 0ºC or below.

Store between 2ºC and 8ºC.

 

Stable for at least 24 months when stored at 25ºC.

 

 

Not available.

 

Not available.

 

Monovalent hepatitis

A vaccine

 

DO NOT FREEZE.

 Discard if vaccine has been

exposed to temperature of 0ºC

or below.

Store between 2ºC to 8ºC for many months (up to 36 months for some brands).

 

Stable for 15

months.

 

Stable for 15

months.

 

Not available.

 

Monovalent hepatitis

B vaccine

 

DO NOT FREEZE.

Freezing point of hepatitis B

vaccine is – 0.5ºC and vaccine

is destroyed at this temperature.

 

Discard if exposed to

temperature of 0ºC or below.

Retains satisfactory potency for 2 years.

 

Retains satisfactory

potency for 30 days.

 

Stable for 1 week.

 

Stable for 3 days.

 

Inactivated

poliomyelitis vaccine (IPV)

DO NOT FREEZE.

Discard if exposed to

temperature of 0ºC or below.

Store for up to 2 years between 2ºC to 8ºC.

 

Loses significant

potency after 20

days.

Destroyed after 20 days.

 

Not available.

 

Influenza vaccine

 

 

DO NOT FREEZE.

Discard if exposed to

temperatures of 0ºC or below.

Store between 2ºC to 8ºC

 

 

Not available.

 

Not available.

 

Not available.

 

Measles-mumps-

rubella (MMR)

(freeze-dried or

lyophilised vaccine) (4)

May be stored in freezer at 0ºC

or below.

 

Protect from light, which may

inactivate virus.

Safe storage for 2 years at 2ºC to 8ºC.

 

Diluent – do not freeze. (5)

Store between 2ºC & 8ºC.

Retains satisfactory

potency for 1 month.

 

Retains

satisfactory

potency for at

least 1 week.

50% loss of

potency after 2 to

3 days at 41ºC:

80% loss of

potency after 1

day at 54ºC.

Reconstituted measles-

mumps-rubella

(MMR) (3) (4)

 

DO NOT FREEZE.

 

Protect from light.

 

 

Can be stored between 2ºC to 8ºC. Protect from light, which may inactivate the vaccine virus.

 

Should be used in one vaccination session (8 hours) if kept cool and protected from sunlight. If not, discard after 1 hour.

Unstable: 50% loss of potency after 1 hour, 70% loss after 3 hours.

 

Protect from light.

 

 

Very unstable:

titre may be below acceptable level

after 2 to 7 hours.

 

Protect from light.

Inactivation

within 1 hour.

 

 

Meningococcal C

conjugate vaccine

(MenCCV) NeisVac-C

Meningitec (freeze-dried or lyophilised vaccine)

DO NOT FREEZE.

 

Discard if exposed to

temperatures of 0ºC or below.

 

 

Store in refrigerator between 2 and 8ºC. Shelf life 18 months at this temperature.

 

Not available.

 

 

Not available.

 

Not available.

 

 

Meningococcal C

conjugate vaccine

(MenCCV)

Menjugate

 

 

DO NOT FREEZE.

 

Discard if exposed to

temperatures of 0ºC or below.

 

 

Store between 2 and 8ºC. Shelf life is 24 months at this temperature.

Reconstituted vaccine must be used immediately.

 

Diluent – do not freeze (5)

Store between 2 to 8ºC.

Not available.

 

 

Not available.

 

Not available.

 

Oral poliomyelitis

vaccine (OPV) opened vials (3) (4)

 

May be stored for up to 2 years

at around –20ºC. The freeze-

thaw-refreeze cycle can occur

until the vial is empty.

 

Can be stored at 2ºC to 8ºC between use as long as the expiry date has not passed, and the vaccine has not been taken out of the health centre (eg outreach immunisation setting).

Stable for at least 1 week at 20ºC to

25ºC.

  

Not available.

 

 

Remains potent

for 24 hours.

 

Pneumococcal

conjugate vaccine

(7vPCV)

DO NOT FREEZE.

Discard if exposed to

temperature of 0ºC or below.

Store between 2ºC and 8ºC.

Not available.

 

Not available.

 

Not available.

 

Pneumococcal

polysaccharide

vaccine, 23-valent

(23vPPV)

DO NOT FREEZE.

 

Discard if exposed to

temperature of 0ºC or below.

Store between 2ºC and 8ºC.

 

Not available.

 

Not available.

 

Not available.

 

 

Varicella-zoster

vaccine:

Varivax Refrigerated,

Varilrix (freeze-dried or lyophilised vaccine) (3) (4)

May be stored in frost-free

freezer at an average

temperature of –15ºC or colder.

 

Maintains potency for 24

months (Varilrix) or 18 months

(Varivax Refrigerated).

 

Protect from light.

Prior to reconstitution,

varicella-zoster vaccine retains potency when stored between 2ºC to 8ºC for up to 2 years (Varilrix) or 18 months (Varivax Refrigerated).

 

Diluent – do not freeze (5)

Store between 2ºC & 8ºC.

Not available.

 

Not available.

 

Not available.

 

Reconstituted varicella

-zoster vaccine:

Varilrix and

Varivax Refrigerated

(3) (4)

 

DO NOT FREEZE.

 

Protect from light.

 

Administer immediately after reconstitution to minimise loss of potency. Discard if reconstituted vaccine is not used within 90 minutes (Varilrix) or within 30 mins (Varivax Refrigerated).

 

Diluent – do not freeze (5)

Store between 2ºC & 8ºC.

Not available.

 

Not available.

 

Not available.

 

 

 

(1) For thermostability information on other vaccines not listed in this Table, refer to the specific chapter in this Handbook.

(2) The information in this Table is in many cases not consistent with the Australian product information documents. However, this Table provide guidelines based on the WHO (1998) Thermostability of Vaccines, WHO/GPV/98.07.

(3) The vaccines that are most unstable at room temperature are OPV and reconstituted MMR, varicella-zoster and BCG vaccines.

(4) OPV and reconstituted MMR, varicella-zoster and BCG vaccines must be protected from exposure to light.

(5) DO NOT FREEZE DILUENT AS THIS MAY CAUSE UNDETECTABLE CRACKS IN THE AMPOULE LEADING TO CONTAMINATION.

Australian Immunisation Handbook, 8th Edition (September 2003) – pages 40 - 42