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Vaccine Vial Monitors (VVM) are used to estimate if a vaccine has been exposed to excessive hot temperatures. This endpoint measurement is useful in determining if a vaccine is safe to be administered to a patient, but it does not pinpoint where in the cold chain a vaccine was exposed to excessive heat. With the expansion and technological advancement of cold chain equipment temperature monitoring, it is now possible to remotely estimate VVM status as a vaccine moves through the cold chain. In the present study, we examine the application of the mathematical principles backing VVMs on real, continuous, temperature monitoring data in Africa. Results suggest that exposure to short bursts of hot temperature or long power outages may still allow for safe distribution of affected vaccines. The remaining VVM life calculation could improve managerial visibility into cold chain equipment performance allowing for better data-driven planning and maintenance decisions.

Vacine cold chain assessments conducted in various parts of the world indicate that maintaining equipment at the temperature range recommended by the World Health Organization (WHO) is not always observed. It has been also the case that staff rather prioritize protecting vaccine from heat damage, thus often exposing vaccines to freezing temperatures. As a result, inadvertent freezing of vaccines is a largely overlooked problem all over the world. In a recent systematic review, comparison of the occurrence of freezing temperatures during storage and transport were found to be a global problem occurring both in the resource-rich as well as the resource-limited settings. A vaccine cold chain temperature monitoring study was conducted using standard WHO study protocol with the objective to document potential problems and to identify appropriate control measures. Multiple temperature monitoring devices were used in the study to evaluate user friendliness of these devices and staff attitudes towards them. In general, majority of the time, temperatures were kept between recommended temperature range of 2–8 °C. Temperature variation got wider when products moved from 3PL Laboratory to service points. The wider variation is found at the service points. High temperature excursions were observed or short periods of time while exposures to freezing temperatures were more both higher in number and duration, however, shake test with these vaccines indicated no freeze damage. 91% of staff believed that they did not have the necessary tools to detect if a vaccine had been damaged by a temperature excursion outside the 2–8 °C range, and all staff believed that inclusion of such devices (e.g. vaccine vial monitor) in the system would improve cold chain operations as they have became aware of problematic areas through this study.

ObjectivesTo assess the effectiveness of training workshops for knowledge enhancement of program managers prior to rotavirus vaccine (RVV) introduction in the routine immunization program.MethodThe study was conducted among the participants attending two training workshops for the introduction of RVV; a state workshop in Pune and a regional workshop in Guwahati. The participants who attended the workshops and participated in both the pre and post-test - 53 for Guwahati and 59 for Pune. Data was collected in real-time via pre-post-test.ResultsIn both workshops, a comparison of pre-test and post-test scores of all questions taken together showed a significant increase in the knowledge level of the participants (pConclusionsA pre-planned and well-designed knowledge assessment tool can be used to understand the impact of training workshops in enhancing the knowledge and practical skills of the participants prior to the introduction of a new vaccine.

Vaccine vial monitor (VVM) stands out amongst all the temperature monitoring devices and tools, as the only one that has shaped the course of vaccine management practices as well as the vaccine cold chain. Some critical vaccine management approaches that are practiced today, such as multi-dose vial policy, and controlled temperature chain have only been made possible with the help of VVM, and others such as rotating stocks and dispatches have been made more effective. Using the Albania immunization programme as a case, this paper reviews the vaccine management practices from the VVM perspective.

Vaccine vial monitor (VVM) is now commonly used for vaccines that are included in the National Immunization Schedule in India. It helps to indicate the viability of the vaccine and of the proper functioning of the cold chain. This is useful as it prevents health personnel from administering damaged vaccine. Studies have shown a lack of awareness of health workers regarding the use and interpretation of a VVM. The current study, undertaken among the caregivers of children who were immunized, showed that this lack of information about the VVM also exists among the caregivers. This deficiency in knowledge, both in the health workers and the caregivers, can affect the health of the child and needs urgent attention.

Background: Vaccine cold-chain distribution system must be monitored to guarantee the vaccine quality. Improper vaccine distribution system can cause damage and loss of efficacy. Therefore, the Indonesian government released some regulations to manage the vaccine cold-chain system, including the Good Distribution Practices for Pharmaceutical Products (Cara Distribusi Obat yang Baik/CDOB) in 2012 and Regulation of the Minister of Health Number 42 in 2013 (PMK 42/2013). Objective: The purpose of this study was to evaluate the implementation of the vaccine distribution system in primary healthcare (PHCs). Methods: A survey was conducted in 30 PHCs in the Special Region of Yogyakarta. Data were collected by observing the vaccine distribution system in PHCs using checklists developed based on CDOB 2012 and PMK 42/2013. Results: The study showed that the personnel in 24 PHCs (80%) checked the condition of the temperature monitoring device and Vaccine Vial Monitor (VVM) while receiving the vaccines. Furthermore, all PHCs (100%) had both cool packs and vaccine carriers, whereas those having cold packs were only 2 (7%). First expired - first out (FEFO) and first in - first out (FIFO) systems were implemented in 30 (100%) and 28 (93%) PHCs, respectively. Conclusion: The results indicated that most of the PHCs in Yogyakarta Special Region had implemented a good vaccine distribution system, yet they still need improvement especially in vaccine recording procedures.

Introduction: The potency of vaccines depends on maintaining the cold chain, that is, a prescribed temperature range during distribution from manufacture to use. The paramedical staff of any hospital plays a pivotal role in cold chain maintenance. Hence, the study aims to assess knowledge and practice of cold chain maintenance of vaccines by paramedical staff. Materials and Methods: A cross-sectional questionnaire-based study was conducted among paramedical staff in a tertiary health care of western Maharashtra, from June 15, 2019, to August 30, 2019. The data were collected using interview schedule. Results:A total of 115 paramedics were enrolled. The final data analysis was done on 91 respondents. Participants' knowledge about maintenance of refrigerators with respect to place of vaccine storage (54; 59.34%), temperature recording in a day (54; 59.34%), and preferable place of deep freezer (62; 68.13%) was satisfactory. A total of 42 (46.15%) participants had knowledge about shake test; however, only 38 (41.75%) participants knew about demonstration of shake test, suggesting that awareness about testing the frozen vaccine was poor among paramedical staff. Full form and use of vaccine vial monitor (VVM) in participants were satisfactory, being 70 (76.92%) and 59 (64.83%), respectively. Participant's knowledge about correct site and route of administration of vaccines were satisfactory. Conclusion: The study demonstrates the gap in knowledge in cold chain maintenance of the paramedical workers. Regular training may be conducted for the paramedical workers to improve their understanding of the cold chain management.

The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries. Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems.

Highlights • The first field use of MenAfriVac's new label allowed the vaccine to be kept at up to 40 °C for up to 4 days. • 155,000 people were vaccinated using the CTC approach in the Meningitis A campaign in northern Benin in 2012. • 98.7% of supervisors and 100% of vaccinators would prefer to conduct their next campaign using CTC. • They saw CTC benefits as: more people vaccinated, no need to return to health centre every night, reduced logistic burden. • Taking advantage of the flexibility offered by CTC opens the door for the implementation of new immunization strategies., Background In October 2012, the Meningococcal A conjugate vaccine MenAfriVac was granted a label variation to allow for its use in a controlled temperature chain (CTC), at temperatures of up to 40 °C for not more than four days. This paper describes the first field use of MenAfriVac in a CTC during a campaign in Benin, December 2012, and assesses the feasibility and acceptability of the practice. Methods We implemented CTC in one selected district, Banikoara (target population of 147,207; 1–29 years of age), across 14 health facilities and 150 villages. We monitored the CTC practice using temperature indicators and daily monitoring sheets. At the end of the campaign we conducted a face-to-face survey to assess vaccinators’ and supervisors’ experience with CTC. Findings A mix of strategies were implemented in the field to maximize the benefits from CTC practice, depending on the distance from health centre to populations and the availability of a functioning refrigerator in the health centre. Coverage across Banikoara was 105.7%. Over the course of the campaign only nine out of approx. 15,000 vials were discarded due to surpassing the 4 day CTC limit and no vial was discarded because of exposure to a temperature higher than 40 °C or due to the Vaccine Vial Monitor (VVM) reaching its endpoint. Overall confidence and perceived usefulness of the CTC approach were very high among vaccinators and supervisors. Interpretation Vaccinators and supervisors see clear benefits from the CTC approach in low income settings, especially in hard-to-reach areas or where cold chain is weak. Taking advantage of the flexibility offered by CTC opens the door for the implementation of new immunization strategies to ensure all those at risk are protected.

Introduction The vaccine vial monitor (VVM) registers cumulative heat exposure on vaccines over time. As low- and lower-middle-income countries transition beyond support from the Global Alliance for Vaccines and Immunization (Gavi), they will assume full responsibility for vaccine financing and procurement. It is unclear to what extent countries transitioning out of Gavi support will continue to include VVMs on their vaccines. This paper aims to systematically review evidence on VVM availability and use in low- and middle-income countries to document factors behind global access to and country demand for VVMs. Such results could help identify actions needed to ensure continued use of VVMs in countries that transition out of Gavi support. Methods We performed a systematic review of electronic databases, reference lists, and grey literature in English and French languages with publication dates from 2005 onwards. The studies included were analyzed for the following outcomes: (1) availability and deployment of VVM-labeled vaccines; (2) VVM practices and perceptions in the immunization system; (3) vaccine introduction and decision-making processes; (4) Gavi graduation and vaccine program sustainability. Results The study found that VVM availability and use was affected by multiple sourcing of vaccines and the extent to which VVM was included in the vaccine specification in the tendering documents when procuring vaccines. Knowledge about VVM and its impact on the EPI program was found to be high among health workers as well as decision-makers. However, the study also found that weak capacity in key national institutions such as NRA and NPA might impact on demand for VVM. As countries take decisions regarding the adoption of new vaccines, factors such as disease burden and vaccine price may assume greater importance than vaccine characteristics and presentation. Finally, the study found that countries rely largely on the advice and recommendations from technical partners such as WHO and PAHO. Conclusion The study concludes that global access to and country demand for VVM are dependent on policy statements and recommendations about VVM by key policy institutions such as WHO and UNICEF. The study also concludes that despite Gavi-eligible countries having access to VVM-labeled vaccines, inclusion is often below 100%. Weak institutional capacity in key national agencies such as NRA and NPA seems to be a contributing factor, while other factors include the procurement of clear national policies on the inclusion of VVM on vaccines, along with the capacity to enforce the policy. Finally, the study concludes that knowledge about VVM and its impact on vaccine program efficiency, safety, and cost is critical for transitioning countries’ continuous demand for VVM.

We conducted the first systematic documentation of using oral polio vaccine (OPV) out of the cold chain during national immunization day (NID) campaigns in Mali. Using a crossover intervention design, vaccinators compared the transport of OPV in vaccine carriers with or without ice packs. Vaccine integrity was assured through monitoring vaccine vial monitor (VVM) status. Despite ambient temperatures up to 40 degrees C, none of the VVMs on any of the vials used (n=956) reached their discard point. Over 90% of vaccinators and supervisors preferred conducting NIDs without ice packs. In addition, using OPV out of the cold chain reduced vaccine wastage resulting from melting ice packs causing labels to detach from the vial.

Administration of a birth dose of hepatitis B vaccine (HepB vaccine) to neonates is recommended to prevent mother-to-infant transmission and chronic infection with the hepatitis B virus (HBV). Although manufacturers recommend HepB vaccine distribution and storage at 2-8 degrees C, recognition of the heat stability of hepatitis B surface antigen stimulated research into its use after storage at, or exposure to, ambient or high temperatures. Storage of HepB vaccine at ambient temperatures would enable birth dosing for neonates delivered at home in remote areas or at health posts lacking refrigeration. This article reviews the current evidence on the thermostability of HepB vaccine when stored outside the cold chain (OCC). The reports reviewed show that the vaccines studied were safe and effective whether stored cold or OCC. Field and laboratory data also verifies the retained potency of the vaccine after exposure to heat. The attachment of a highly stable variety of a vaccine vial monitor (measuring cumulative exposure to heat) on many HepB vaccines strongly supports policies allowing their storage OCC, when this will benefit birth dose coverage. We recommend that this strategy be introduced to improve birth dose coverage, especially in rural and remote areas. Concurrent monitoring and evaluation should be undertaken to affirm the safe implementation of this strategy, and assess its cost, feasibility and effect on reducing HBV infection rates. Meanwhile, release of manufacturer data verifying the potency of currently available HepB vaccines after exposure to heat will increase confidence in the use of vaccine vial monitors as a managerial tool during storage of HepB vaccine OCC.

We have conducted a study to analyze monitoring of the cold chain of 674 OPV field samples collected at four different levels of vaccine distribution viz., immunization clinics, district stores, hospitals and Primary Health Centers (PHC) from states of Uttar Pradesh, Madhya Pradesh, and Delhi. The study design included: collection and scoring of vaccine vial monitor (VVM) status of the samples and testing for total oral polio virus concentration (TOPV) by standard WHO protocol. Ten samples each were exposed to 25 degrees C and 37 degrees C, and 10 samples as controls were kept at -20 degrees C. VVM were scored daily till they attained grade 4 and each sample was subsequently subjected to potency testing for individual polio serotypes 1, 2 and 3, and TOPV. Of the 674 samples tested it was observed that: samples from immunization clinics and district stores had an acceptable VVM score of grade 1 and 2; however the probable risk that a sub potent vaccine could have been administered was 2.15%. In 2.5% samples received from district stores vaccine had a VVM score of grade 3 (i.e., discard point), although vaccine when tested was found to be potent (i.e., leading to the vaccine wastage). With exposure to higher temperatures, VVM changed score to grade 2 and 3 when the vaccine was kept at 25 degrees C/37 degrees C, and the titres of individual serotypes 1, 2 and 3 and TOPV were beyond the acceptable limits. Important observations at the different levels of vaccine distribution network and correlation of VVM and potency status of OPV are discussed in the paper which will be of help to the EPI program managers at different transit levels.

Background: There has been a re-emergence of Yellow Fever (YF) disease across Africa and in South America since the 1980s. According to WHO estimate, 508 million people in 32 countries are at risk because of their location in the rainforest region, the habitat of the vector mosquito.Intense YF virus circulation occurred in West Africa in 2008 and 2009 with outbreaks reported from Burkina Faso, Cameroon, Central African Republic, Chad, Congo, Cote d’Ivoire, Guinea, Liberia and Sierra Leone. Between January 2010 and March 2011, outbreaks of YF were reported to the WHO by Cameroon, Cote d’Ivoire, Democratic Republic of Congo, Sierra Leone, Senegal and Uganda. Most recent outbreaks in Africa were reported simultaneously in Ghanaand Cameroun on the 3rd of February, 2012.This study investigates a possible correlation between vaccine manufacture, cold chain handling and vaccine potency/ stability as a risk factor in the repeated outbreak of yellow fever in the face of increased immunisation coverage in Nigeria and West Africa by extension. Methods: Samples of Stamaril®, a yellow fever vaccine collected from different open market sources were subjected to potency test by measuring their immunogenicity indicators.Their embryo infectivity dose and mice LD50 as well as their pyrogenicity were determined. Results: Results showed that 42% of the vaccines tested were not suitable for use even though the vaccine vial monitor certifies they are fit for use. Conclusion: A large proportion of YF vaccines sold in open markets in Eastern Nigeria may be compromised in terms of potency. Vaccine vial monitors only are not entirely reliable as indicators of vaccine potency or usability.

Background: Mamta Divas is a fixed day, fixed site, preventive, and promotive health-care service center for mother and child population. Growth health checkup, immunization, primary treatment, referral, and counseling services are provided by FHW (Female Health Worker), ANM (Auxiliary Nurse Midwife) and AWW (Anganwadi Worker). Objective: To study the reproductive and child health services during Mamta days among the beneficiaries of health-care facility centers. Materials and Methods: It was a cross-sectional study conducted in 20 urban health centers of Surat Corporation Area from July 2012 to June 2013 by using pretested, semi-structured questionnaire for the assessment of maternal and child health services during the Mamta days. Result: In all sites it was noted that vaccine vial monitor of vials was in stage I or II, freeze-sensitive vaccines were in liquid form, vaccines have readable label, all vaccines were within expiry date, and all providers knew which vaccine cannot be reused. Information about follow-up date was provided in 94.59% session sites, followed by family planning advice in 67.57%, and nutrition advice in 60.81%. Breast-feeding assessment and examination were not done by them. Abdominal palpation was not performed in 88.52% of session sites because of lack of privacy as separate rooms and curtains were unavailable. Conclusion: Maternal and child health services were not provided satisfactorily in many session sites, therefore, training and retraining of health workers is required for better outcome.

Background\ud \ud Diarrhoea is an important cause of death in the developing world, and rotavirus is the single most important cause of diarrhoea associated mortality. Two vaccines (Rotarix and RotaTeq) are available to prevent rotavirus disease. This analysis was undertaken to aid the decision in Kenya as to which vaccine to choose when introducing rotavirus vaccination.\ud \ud Methods\ud \ud Cost-effectiveness modelling, using national and sentinel surveillance data, and an impact assessment on the cold chain.\ud \ud Results\ud \ud The median estimated incidence of rotavirus disease in Kenya was 3015 outpatient visits, 279 hospitalisations and 65 deaths per 100,000 children under five years of age per year. Cumulated over the first five years of life vaccination was predicted to prevent 34% of the outpatient visits, 31% of the hospitalizations and 42% of the deaths. The estimated prevented costs accumulated over five years totalled US$1,782,761 (direct and indirect costs) with an associated 48,585 DALYs. From a societal perspective Rotarix had a cost-effectiveness ratio of US$142 per DALY (US$5 for the full course of two doses) and RotaTeq US$288 per DALY ($10.5 for the full course of three doses). RotaTeq will have a bigger impact on the cold chain compared to Rotarix.\ud \ud Conclusion\ud \ud Vaccination against rotavirus disease is cost-effective for Kenya irrespective of the vaccine. Of the two vaccines Rotarix was the preferred choice due to a better cost-effectiveness ratio, the presence of a vaccine vial monitor, the requirement of fewer doses and less storage space, and proven thermo-stability.

Introduction The potency of oral polio vaccine (OPV), a heat-labile vaccine, is preserved by the cold chain. The Vaccine Vial Monitor, a heat-sensitive label, is critical to the monitoring and maintenance of the cold chain. This study was conducted to evaluate the relationship between the adequacy of cold chain infrastructure and the proper use of Vaccine Vial Monitor in a rural district of India. Methods Forty-six health centers in a rural district were included in our evaluation of the cold chain equipment and the Vaccine Vial Monitors. Cold chain equipment and vaccine vials within each health center were evaluated for adherence to WHO cold chain maintenance protocols and the Vaccine Vial Monitor stage, respectively. Results Among the 46 health centers, Vaccine Vial Monitor stage I was found at 58% of the health centers, 33% of the health centers reported stage II and 9% reported a stage III, indicating weaknesses in the cold chain mechanism Conclusion Cold chain for the OPV was not adequately maintained at primary and sub-health centers in this rural district. Well maintained ice packs and vaccine carriers will help ensure delivery and availability of a safe and potent vaccine to children in rural areas of India.

India was certified polio free on 27 March 2014. Supplementary immunization activities, in the form of national immunization days, is one of the core strategies for eradication, where oral polio vaccine is administered to children aged under 5 years throughout the country. Oral polio vaccine is heat sensitive and requires maintenance of a stringent cold chain. Therefore, vaccine carriers with ice packs are used in the Pulse Polio Immunization (PPI) programme. This study assessed whether the cold chain is maintained during National Immunization Day in Beed district. A cross-sectional study was conducted at six randomly selected booths, one each from six primary health centres in Georai block of Beed district in Maharashtra. Electronic data loggers, configured to measure half-hourly temperatures, were kept in vaccine carriers throughout the day of PPI. The vaccine carrier temperature was below 8 °C at all six booths; minimum temperature recorded was -9.5 °C, while the maximum was 4.5 °C. The vaccine vial monitor did not reach discard point in any booth. A vaccine carrier with four ice packs very effectively maintains the cold chain required for oral polio vaccine.

Cool water packs are a useful alternative to ice packs for preventing unintentional freezing of vaccines during outreach in some situations. Current guidelines recommend the use of a separate refrigerator for cooling water packs from ambient temperatures to prevent possible heat degradation of adjacent vaccine vials. To investigate whether this additional equipment is necessary, we measured the temperatures that vaccine vials were exposed to when warm water packs were placed next to vials in a refrigerator. We then calculated the effect of repeated vial exposure to those temperatures on vaccine vial monitor status to estimate the impact to the vaccine. Vials were tested in a variety of configurations, varying the number and locations of vials and water packs in the refrigerator. The calculated average percentage life lost during a month of repeated warming ranged from 20.0% to 30.3% for a category 2 (least stable) vaccine vial monitor and from 3.8% to 6.0% for a category 7 (moderate stability) vaccine vial monitor, compared to 17.0% for category 2 vaccine vial monitors and 3.1% for category 7 vaccine vial monitors at a constant 5 °C. The number of vials, number of water packs, and locations of each impacted vial warming and therefore percentage life lost, but the vaccine vial monitor category had a higher impact on the average percentage life lost than any of the other parameters. The results suggest that damage to vaccines from repeated warming over the course of a month is not certain and that cooling water packs in a refrigerator where vaccines are being stored may be a useful practice if safe procedures are established.