Frequent exposure to suboptimal temperatures in vaccine cold-chain system in India: results of temperature monitoring in 10 states

Murhekar, Manoj; Dutta, Srihari; Kapoor, Ambujam Nair; Bitragunta, Sailaja; Dodum, Raja; Ghosh, Pramit; Swamy, Karumanagounder Kolanda; Mukhopadhyay, Kalyanranjan; Ningombam, Somorjit Singh; Parmar, K. P.; Ravishankar, Devegowda; Singh, Balraj; Singh, Varsha; Sisodiya, Rajesh; Subramanian, Ramaratnam; Takum, Tana

doi:10.2471/blt.13.119974

Cited by 81 publications

(48 citation statements)

References 14 publications

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“…31 However, it is very difficult to maintain the temperature at the vaccine stores and during cold chain transit, particularly in developing countries, resulting in large amount of vaccine being wasted. 32 For example, in India, with largest Universal Immunization Program (UIP) in the world, vaccines spend at least nine months from manufacturer to recipients, 33 putting huge burden on cold chain which has issues of space, quality and maintenance at all levels. 34-36 Since cold chain is the most important component to ensure the quality of vaccine, developing a heat stable vaccine that could be transported and stored outside cold chain for extended period of time is the high priority for healthcare sector.…”

Section: Discussionmentioning

confidence: 99%

Rational design of heat stable lyophilized rotavirus vaccine formulations

Madhu

Sikriwal

Sharma

et al. 2018

Human Vaccines & Immunotherapeutics

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To develop a safe and efficacious heat-stable rotavirus vaccine, new lyophilized formulations were developed using rotavirus serotypes constituting RotaTeq®. A series of formulation compositions, differing in buffering agents, bulking agents, cryoprotectants, amino acids and divalent cations, were screened for their ability to provide stability to rotavirus serotypes during lyophilization and when stored under elevated temperatures for extended periods. Lead formulations and lyophilization cycles were further optimized. Stability profiles of thus optimized formulations showed their ability to retain the potency of rotavirus for > 36 months at 5°C, 20 months at 37°C, and 7 months at 45°C. The heat-stable lyophilized rotavirus formulations developed met the all critical quality attributes for appearance, heat-stability during storage, moisture content as well as pH, viability and stability after reconstitution and has great potential to be used as vaccine candidates for improving access in low-income countries.

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Section: Discussionmentioning

confidence: 99%

Rational design of heat stable lyophilized rotavirus vaccine formulations

Madhu

Sikriwal

Sharma

et al. 2018

Human Vaccines & Immunotherapeutics

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“…The new global recommendations aim to minimize exposure to accidental freezing, which is in fact the main threat to the potency of immunobiological agents, compromising its effectiveness (21,(27)(28) . Among these indications is the ice/gel coils setting that precedes the packaging of immunobiological agents in thermal boxes.…”

Section: Setting Of Recyclable Ice Coilsmentioning

confidence: 99%

“…Among these indications is the ice/gel coils setting that precedes the packaging of immunobiological agents in thermal boxes. Freezing risk increases if the ice/gel coils are not properly set up as demonstrated in a study in India that identified that two-thirds of the vaccine vials showed evidence of freezing (27) . The presence of ice coils below 0 °C is one of the main factors for exposure of immunobiological agents to freezing temperatures (18,23) .…”

Section: Setting Of Recyclable Ice Coilsmentioning

confidence: 99%

Collective construction of bundle for immunobiological agents conservation best practices

Oliveira

Castro

et al. 2019

Rev. Bras. Enferm.

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Objective: to construct collectively with nursing professionals bundle for best practices of cold chain maintenance of immunobiological agents conservation at the local level. Method: a qualitative research of convergent care type. Bundle construction was guided by the Evidence-Based Practice criterion. Data collection was carried out from October to December 2016, through five workshops, with the participation of 21 professionals from 7 vaccination rooms of a municipality of Minas Gerais State. The framework developed by Morse and Field was adopted for data analysis. Results: through bundle, care is taken regarding refrigeration equipment temperature monitoring, contingency plan performance, recyclable ice coil setting and chamber use as refrigeration equipment. Final considerations: the chosen interventions began to guide the practice and promote a care based on safety and quality.

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“…Vaccine cold chain studies also suggest exposure to extreme temperatures occurring in developing countries [95]. Vaccine vial temperature monitors (used for the oral polio vaccine) are not always reliable at high temperatures [96].…”

Section: Blood-borne Diseasesmentioning

confidence: 99%

The potential impact of climate change and ultraviolet radiation on vaccine-preventable infectious diseases and immunization service delivery system

Guo¹,

Naish

Tong

2014

Expert Review of Vaccines

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Climate change and solar ultraviolet radiation may affect vaccine-preventable infectious diseases (VPID), the human immune response process and the immunization service delivery system. We systematically reviewed the scientific literature and identified 37 relevant publications. Our study shows that climate variability and ultraviolet radiation may potentially affect VPID and the immunization delivery system through modulating vector reproduction and vaccination effectiveness, possibly influencing human immune response systems to the vaccination, and disturbing immunization service delivery. Further research is needed to determine these affects on climate-sensitive VPID and on human immune response to common vaccines. Such research will facilitate the development and delivery of optimal vaccination programs for target populations, to meet the goal of disease control and elimination.

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Frequent exposure to suboptimal temperatures in vaccine cold-chain system in India: results of temperature monitoring in 10 states

Cited by 81 publications

References 14 publications

Rational design of heat stable lyophilized rotavirus vaccine formulations

Rational design of heat stable lyophilized rotavirus vaccine formulations

Collective construction of bundle for immunobiological agents conservation best practices

The potential impact of climate change and ultraviolet radiation on vaccine-preventable infectious diseases and immunization service delivery system

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