This document is not a formal publication of the World Health Organization (WHO), and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced and translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes. The views expressed in documents by named authors are solely the responsibility of those authors. ADT accelerated degradation test BC benzethonium chloride BCG bacille Calmette-Guérin (vaccine) CO 2 carbon dioxide CP culturable particle D 2 O heavy water DEV duck embryo vaccine DNA deoxyribonucleic acid DT diptheria-tetanus vaccine DTP diphtheria-tetanus-pertussis vaccine EPI Expanded Programme on Immunization (WHO) HB hepatitis B HbsAg hepatitis B surface antigen HDCV human diploid cell vaccine IPV inactivated polio vaccine IU/ml international units per millilitre JE Japanese encephalitis MgCL 2 magnesium chloride MMR measles, mumps, rubella (vaccine) OPV oral polio vaccine PDEV purified duck embryo vaccine PFU plaque-forming unit PHK primary Syrian hamster kidney cell culture PVRV vero cell line vaccine TT tetanus toxoid VVM vaccine vial monitor 5 WHO/GPV/98.07 Every year the immunization services in developing countries prevent about 490 000 children from becoming paralysed by poliomyelitis. Over three million deaths are similarly prevented from measles, neonatal tetanus and pertussis (51). These achievements are partly attributable to the training of staff in the proper storage and transport of vaccines and partly to improvements in the cold chain. However, vaccines are still not being stored and transported properly in many areas. Questions are often raised as to what should be done with stocks of vaccines that have been exposed for varying periods to elevated temperatures. There is no simple and cheap method that can be used in the field to assess whether a vaccine exposed to ambient temperature has retained at least the minimum required potency, although the vaccine vial monitors (VVMs) now provided with oral poliomyelitis vaccine (OPV) can indicate the level of heat exposure of individual vials. Vaccine potency can be determined only by costly laboratory assays, the results of which are often delayed for several months. Only a large number of doses can justify sending a vaccine for retesting (from 2000 doses for poliomyelitis and measles vaccines, to 200 000 doses for diphtheria-tetanus-pertussis (DTP) vaccine) (45). A knowledge of a vaccine's stability, especially of the rate of decline in potency at a given temperature, can be helpful in determining storage requirements. The present document …

https://www.pphsn.net/Outbreak/Thermostablilty_of_Vaccines.pdf

Thermostability of vaccines

An estimated 400,000 deaths occur annually from neonatal tetanus (NT). In 1989 WHO adopted the goal of eliminating NT as a public health problem worldwide. To achieve this, and to control non-neonatal tetanus (non-NT), WHO recommends that newborns be passively protected at birth by the antepartum administration of at least two doses of tetanus toxoid (TT) to their mothers and that all children subsequently receive at least three doses of diphtheria-tetanus-pertussis (DTP) vaccine. For this strategy to be effective, the TT used must be immunogenic. Potential factors that may affect TT immunogenicity need to be evaluated if NT is to be eliminated and if non-NT is to be controlled. Although data are conflicting, concurrent malarial infection may decrease the immune response to TT; however, malarial chemoprophylaxis may enhance the immune response. Malnutrition does not appear to affect immunogenicity; nevertheless, one study suggests that vitamin A deficiency is associated with an impaired immune response. Although it has been postulated that placental transfer of tetanus antibody is impaired in African women, a survey of the published literature suggests that this is not the case. Freezing TT has been shown to decrease its potency, but its impact on immunogenicity needs more evaluation.

Factors affecting the immunogenicity and potency of tetanus toxoid: implications for the elimination of neonatal and non-neonatal tetanus as public health problems.

The effects of different inactivating agents on the potency, toxicity and stability of pertussis vaccine.

Immobilisation of vaccines onto micro-crystals for enhanced thermal stability.

Effects of elevated temperatures on the opacity and toxicity of pertussis vaccines manufactured with different inactivating agents.

The requirements for vaccines demand that they be safe and efficacious. The recommended storage temperature for vaccines is 2-8 degrees C, but their conditions of storage and transportation in the developing countries may frequently be far from ideal. This had led to the present study in which several vaccines have been stored at ambient temperature (+24 degrees C) and at +37 degrees C and their antigenic stabilities examined. Under these adverse conditions, typhoid, cholera and the components of DPT vaccines either in final containers or in bulk form have been shown to be stable for extended periods of time.

The stability of bacterial vaccines at elevated temperatures.

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The stability of bacterial vaccines at elevated temperatures.