General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 117

7. Storage and Handling of Immunobiologics

Updates

Most of the 2011 language was removed because this content is now codified and 

continually updated in the CDC’s Vaccine Storage and Handling Toolkit, available at 

www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. This content included 

Storage Units, Monitoring Storage Temperature, Vaccine Inventory, and Vaccine 

Transport.

General Principles

Failure to adhere to recommended specifications for storage and handling of 

immunobiologics can reduce or destroy their potency, resulting in inadequate or no 

immune response in the recipient 

(www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html). Recommendations in the 

product package inserts, including methods for reconstitution of the vaccine, should be 

followed carefully. Maintenance of vaccine quality is the shared responsibility of all 

handlers of vaccines from the time a vaccine is manufactured until administration. All 

vaccines should be inspected on delivery and monitored during storage to ensure that the 

recommended storage temperatures are maintained. Vaccines should continue to be 

stored at recommended temperatures immediately upon receipt until use. Inadequate 

vaccine storage also can result in significant costs to replace vaccine inventory 

(www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html).

Storage Temperature

Vaccines licensed for refrigerator storage should be stored at 2°C-8°C (36°F-46°F). Liquid 

vaccines containing an aluminum adjuvant permanently lose potency when exposed to 

freezing temperatures. Non-live vaccines that are stored in a liquid state (i.e., nonlyophilized [freeze-dried]) but that do not contain aluminum adjuvants should also 

generally be kept at refrigerator temperature, although whether or not they lose potency 

when frozen is not known. 
General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 118

Non-live lyophilized vaccines generally do not need to be frozen, but lyophilized varicellacontaining vaccines that are recommended to be stored frozen lose potency when exposed 

to higher temperatures because the viruses degrade more quickly at storage temperatures 

that are warmer than recommended (Table 7-1). These varicella-containing vaccines also 

can be prone to losses in sterility if kept too cold, due to increased gas permeability of the 

rubber vaccine vial (observed with use of dry ice at temperatures below -50°C or -58°F 

[personal communication, manufacturer]).

Expiration Dates and Windows

All vaccines have an expiration date determined by the manufacturer that must be 

observed. Providers should record the vaccine expiration dates and lot numbers on a stock 

or inventory record for each vaccine vial when a shipment is received. When vaccines are 

removed from storage, clinicians and other health-care providers should note whether an 

expiration window exists for vaccine stored at room temperature or at an intermediate 

temperature. For example, single-component varicella vaccine that is stored frozen must 

be discarded after 72 hours of storage at refrigerator temperature. Vaccine transport 

between the storage site and the administration clinic is discouraged unless the cold chain 

is maintained, and vaccine transport by the patient is particularly discouraged. An 

expiration window also applies to vaccines that have been reconstituted. For example, 

after reconstitution, MMR vaccine should be kept at refrigerator temperature and must be 

administered within 8 hours. Doses of expired vaccines that are administered 

inadvertently generally should not be counted as valid and should be repeated. Non-live 

vaccines should generally be repeated as soon as possible. Recombinant zoster vaccine 

(RZV) should be administered 28 days after the invalid dose, to reduce the burden of 

adverse reactions which occurs with this vaccine. Live vaccines should be repeated after a 

28-day interval from the invalid dose to reduce the risk for interference from interferon on 

the subsequent doses. For rotavirus vaccines, the repeat dose should be administered after 

a 28-day interval from the invalid dose or at the maximum age for the vaccine dose 

(whichever is earlier). Additional information about expiration dates is available at

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html. 
General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 119

Response to Out-of-Range Temperature Reading

An out-of-range temperature reading should prompt immediate action. A plan should be 

developed ahead of time to address various types of emergencies that might require 

removal of vaccine from the original storage unit. Transfer of vaccines to a predesignated 

alternative emergency storage site might be necessary if a temperature problem cannot be 

resolved immediately (e.g., plugging in an unplugged unit or closing a door that has been 

left open). It is critical to avoid freezing vaccine during transport (improperly packing 

vaccine with ice can damage vaccines). Vaccine should be marked “do not use” and moved 

to the alternate site after verifying that the alternate unit is at the proper temperature. 

Determinations of vaccine viability in practice include consideration of both time and 

magnitude of temperature excursions and should be made in consultation with state/local 

public health departments or the vaccine manufacturer, as one or both of these groups 

may have additional information based on a broad international perspective. Damage to 

the immunogenicity of a vaccine exposed to temperatures outside of the recommended 

range might not be apparent visually. As a general rule, vaccines that have been stored at 

inappropriate temperatures should not be administered unless public health authorities or 

the manufacturer determine it is safe and effective to do so. If such vaccines already have 

been administered, vaccine exposed to inappropriate temperatures that is inadvertently 

administered should generally be repeated. Non-live vaccines should generally be repeated 

as soon as possible. Recombinant zoster vaccine (RZV) is neither live nor inactivated: the 

repeat dose of RZV should be administered 28 days after the invalid dose, to reduce the 

burden of adverse reactions which occurs with this vaccine. Live vaccines should be 

repeated after a 28-day interval from the invalid dose to reduce the risk for interference 

from interferon on the subsequent doses. For rotavirus vaccines, the repeat dose should be 

administered after a 28-day interval from the invalid dose or at the maximum age for the 

vaccine dose (whichever is earlier). Clinicians should consult promptly with state or local 

health departments in these situations. Consultation with CDC is available when 

necessary.
General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 120

TABLE 7-1. Vaccine storage temperature recommendations

Nonlyophilized, aluminum-adjuvanted vaccines

Vaccines Vaccine storage 

temperature

Diluent storage temperature

Diphtheria-tetanuscontaining vaccines 

(DT, Td) or pertussiscontaining vaccines 

(DTaP, Tdap)

2°C-8°C (36°F-46°F)

Do not freeze

No diluent(a)

HepA and HepB 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

MenB(b) 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

PCV13 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

PCV15 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

PCV20 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

HPV(b) 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

Nonlyophilized, nonaluminum-adjuvanted vaccines

Vaccines Vaccine storage 

temperature

Diluent storage temperature

PRP-OMP Hib 2°C-8°C (36°F-46°F) No diluent

IPV(b) 2°C-8°C (36°F-46°F) No diluent

MenACWY(b),(c) 2°C-8°C (36°F-46°F) No diluent

PPSV 2°C-8°C (36°F-46°F) No diluent

IIV(b) 2°C-8°C (36°F-46°F) No diluent

RZV(b) 2°C-8°C (36°F-46°F)

Do not freeze

2°C-8°C (36°F-46°F)

Do not freeze
General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 121

Lyophilized (non-varicella) vaccines

Vaccines Vaccine storage 

temperature

Diluent storage temperature

PRP-T Hib(b) 2°C-8°C (36°F-46°F) (d) 2°C-8°C (35°F-46°F) Do not freeze

MMR(b) -50°C-8°C (-58°F46°F) (d)2°C-25°C (35°F-77°F)

Can be refrigerated or stored at 

room temperature

DEN4CYD 2°C-8°C (36°F-46°F) 

Do not freeze

2°C-8°C (36°F-46 °F) Do not freeze

Varicella-containing vaccines

Vaccines Vaccine storage 

temperature

Diluent storage temperature

MMRV(b) -50°C to -15°C (-58°F5°F)2°C-25°C (35°F-77°F)

Can be refrigerated or stored at 

room temperature

Varicella(b) -50°C to -15°C (-58°F5°F)2°C-25°C (35°F-77°F)

Can be refrigerated or stored at 

room temperature

Noninjectable vaccines

Vaccines Vaccine storage 

temperature

Diluent storage temperature

RV5 vaccine(b) 2°C-8°C (36°F-46°F)

Do not freeze

No diluent

RV1 vaccine(b) 2°C-8°C (36°F-46°F)

Do not freeze

The diluent may be stored at a 

controlled room temperature 20°C25°C (68°F-77°F).

Do not freeze

LAIV(b) 2°C-8°C (36°F-46°F) No diluent

Abbreviations: DEN4CYD = dengue vaccine; DT = diphtheria and tetanus toxoids; DTaP = diphtheria and 

tetanus toxoids and acellular pertussis; HepA = hepatitis A; HepB = hepatitis B; Hib = Haemophilus influenzae 

type b; HPV = human papillomavirus; IIV = inactivated influenza vaccine; IPV = inactivated poliovirus; LAIV = 

live, attenuated influenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MenB = Serogroup 

B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, and varicella; 

MPSV4 q adri alent
General Best Practice Guidelines for Immunization: Storage and Handling of Immunobiologics 122

REFERENCES

1. Kroger A, Atkinson W, Pickering L. General immunization practices. In: 

Plotkin S, Orenstein W, Offit P, eds. Vaccines. 6th ed. China: Elsevier 

Saunders; 2013:88-111.

2. CDC. Guidelines for maintaining and managing the vaccine cold chain.

MMWR Morb Mortal Wkly Rep. 2003;52(42):1023-1025.

meningococcal polysaccharide vaccine; PCV13 = pneumococcal conjugate vaccine; PPSV23= pneumococcal 

polysaccharide vaccine; PRP-OMP = polyribosylribitol phosphate-meningococcal outer membrane protein 

conjugate; PRP-T = polyribosylribitol phosphate polysaccharide conjugated to a tetanus toxoid; PRP-T Hib = 

polyribosylphosphate tetanus-toxoid conjugate Hib vaccine; PRP-T Hib-MenCY = polyribosylphosphate-tetanustoxoid Hib vaccine with a bivalent Meningococcal vaccine; RV = rotavirus; RV1 = live, attenuated monovalent 

rotavirus vaccine; RV5 = live, reassortment pentavalent rotavirus vaccine; Td = tetanus and diphtheria toxoids; 

Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.

Sources: (1,2).

(a) DTaP-Daptacel is sometimes used as a diluent for ActHib.

(b) Protect from light.

(c) There are 2 meningococcal conjugate vaccines; Menactra is nonlyophilized, and Menveo is lyophilized. Both 

powder and diluent should be stored at 35°F-46°F.

(d) The lyophilized pellet may be stored at freezer temperature; the reconstituted vaccine should be stored at 

refrigerator temperature.