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Australian Immunisation Handbook, 8th Edition - Vaccine
Stability at different temperatures (1) (2) 2 page pdf |
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Vaccine (3) (4) |
< 0ºC |
2ºC to 8ºC |
22ºC to 25ºC |
35ºC to 37ºC |
over 37 ºC |
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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) |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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