|BRIEF RESEARCH ARTICLE
|Year : 2019 | Volume
| Issue : 2 | Page : 139-142
Temperature integrity and exposure to freezing temperature during vaccine transfer under the universal immunization program in Three States of India
Manoja Kumar Das1, Narendra Kumar Arora2, Thomas Mathew3, Bhadresh Vyas4, Monica Sindhu5, Abhishek Yadav5
1 Director Projects, The INCLEN Trust International, New Delhi, India
2 Executive Director, The INCLEN Trust International, New Delhi, India
3 Principal and Professor, Department of Community Medicine, Government Medical College, Thiruvananthapuram, Kerala, India
4 Professor, Department of Pediatrics, M P Shah Medical College, Jamnagar, Gujarat, India
5 Assistant Research Officer, The INCLEN Trust International, New Delhi, India
|Date of Web Publication||18-Jun-2019|
Manoja Kumar Das
The INCLEN Trust International, F1/5, Okhla Industrial Area, Phase 1, New Delhi - 110 020
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Temperature excursion and exposure to sub-zero temperatures may reduce the potency of the freeze-sensitive vaccines. This study assessed temperature during vaccine transfers at various levels under the Universal Immunization Program. This cross-sectional study undertaken in 21 districts of three states of India – Bihar (n = 8), Kerala (n = 8), and Gujarat (n = 5). We documented temperature inside the cold boxes and vaccine carriers using LogTag-Trix8 data loggers. In total, 110 vaccine transportation episodes were observed; 55 inter-facility transfers and 55 outreach sessions. Sizable proportions of inter-facility (9% to 35%) and outreach vaccine transfers (18%) were exposed to sub-zero temperature. The proportions of exposure to temperature to >8°C were in the range of 0.8%–11.3% for inter-facility transfers and 2.3% for outreach sessions. The vaccines were exposed to freezing temperatures for significant durations during transportation across the cold chain. Rigorous monitoring of temperature integrity is essential to ensure the delivery of potent vaccines and to avoid vaccine failure.
Keywords: Cold chain, temperature excursion, vaccine freezing, vaccine transportation
|How to cite this article:|
Das MK, Arora NK, Mathew T, Vyas B, Sindhu M, Yadav A. Temperature integrity and exposure to freezing temperature during vaccine transfer under the universal immunization program in Three States of India. Indian J Public Health 2019;63:139-42
|How to cite this URL:|
Das MK, Arora NK, Mathew T, Vyas B, Sindhu M, Yadav A. Temperature integrity and exposure to freezing temperature during vaccine transfer under the universal immunization program in Three States of India. Indian J Public Health [serial online] 2019 [cited 2021 Sep 21];63:139-42. Available from: https://www.ijph.in/text.asp?2019/63/2/139/260592
Vaccination is one of the most powerful public health interventions for reducing the childhood morbidity and mortality and control/elimination/eradication several diseases. Optimal temperature integrity throughout is essential for vaccine potency. On exposure to temperatures outside of the recommended narrow range, vaccines lose potency faster. While the exposure to heat is bad for almost all vaccines, exposure to freezing are equally damaging for the freeze-sensitive vaccines such as diphtheria-pertussis-tetanus, tetanus toxoid, haemophilus influenzae-b (Hib), and inactivated poliovirus making them inactive. On exposure to freezing temperatures, the adjuvants in these vaccines clump together, which adversely affect the immunogenic potency.
Under Universal Immunization Program (UIP) in India, the cold chain is comprised of 26,388 cold chain points, including 4 government medical supply depots, 53 state stores, 110 divisional stores, 666 district stores, and 25,555 subdistrict stores at community health centers (CHCs) and primary health centers (PHCs). Usually, the vaccines are supplied by manufacturers to state or division stores. Within the state, the vaccines supply follows a cascade system: state to division or district stores; division to district stores; district to subdistrict stores (CHCs and PHCs); and sometimes CHCs to PHCs. These transfers between different stores use cold boxes (large or small size) with icepacks. From the CHCs and PHCs, the vaccines are supplied to the immunization sessions at the facilities, subcenters and outreach sessions using vaccine carriers. The vaccines are to be stored and transported at 2°C–8°C temperature across the cold chain.
A review (2007–2014) reported that vaccines were exposed to freezing temperatures during storage (29.7%), transportation (28.1%), and outreach (14.1%) in low- and middle-income countries. A study reported exposure of vaccine to sub-zero temperatures for 18.1% of the time during transportation in India. In this context, this study was undertaken to assess the temperature integrity during vaccine transportation between stores and to the outreach sessions in India.
This cross-sectional study was conducted in three states of India: Bihar, Gujarat, and Kerala during 2013–2014 as part of the cold chain assessment. The states were purposively selected considering the status of immunization coverage (lowest, moderate, and best, respectively) in India and also three different governance levels. In each state, one-third of the districts were covered randomly, 13 out of 38 in Bihar, 9 out of 26 in Gujarat, and 5 out of 14 in Kerala. The temperature documentation for vaccine transfers was feasible in 21 districts including eight in Bihar (Muzaffarpur, West Champaran, Kaimur, Nawada, Aurangabad, Gopalganj, Jamui, and Buxar), eight in Gujarat (Baroda, Sabarkantha, Panchmahal, Bharuch, Surat, Banaskantha, Junagarh, and Kutch), and five in Kerala (Thrissur, Kollam, Kasaragod, Kottayam and Wayanad). In these 21 districts, there were 1054 cold chain stores (Bihar - 108, Gujarat - 594, and Kerala - 352). In addition, there were 17 division/state stores in these states. Transfers from state to division store (n = 2) were only documented in Bihar. In Gujarat and Kerala, the manufacturer supplied the vaccines to division stores. Seventeen transfers (Bihar - 7, Gujarat - 5, and Kerala - 5) from division stores to districts stores were documented. Twenty-eight vaccine transfers (Bihar - 13, Gujarat – 9, and Kerala - 6; 1–2 per district) from district to subdistrict stores were observed. We also observed vaccine transfers between subdistrict stores, from CHCs to PHCs in Gujarat and Kerala. The vaccine transfers were done usually at monthly interval to the cold chain stores. The outreach sessions were held weekly. In total, we documented temperature integrity for 110 vaccine transfer episodes; 55 inter-facility transfers and 55 outreach sessions (2–4 per district) during the study observation. Administrative permissions were obtained from the national and state health authorities. The findings were shared with national and state health authorities in due course.
We used LogTag-Trix8 data loggers (range −40°C to +85°C; precision ± 0.5°C) to record the temperatures (LogTag Recorders, Auckland, New Zealand). The data logger battery and memory could record 8000 readings continuously. The data logger was programmed to record the temperature every 15 min. The research staff pressed the start button immediately before placing the data logger inside the cold box or vaccine carrier along with the first batch vaccines. At removal, the research staff removed the data logger with the last batch of vaccines and stopped the recording. A data collection tool documented information about facilities, cold box or vaccine carrier, icepacks, ID of the data logger used, and start and end times. The readings from the data loggers were downloaded using the software provided with the data logger and exported into excel, which contained date/time stamp for each temperature recording.
Descriptive statistics measures were calculated using Microsoft Excel and STATA version 12. The exposure of vaccines to temperatures <0°C, ≥0°C to <2°C, ≥2°C to ≤8°C, and >8°C as proportions of the observation period were estimated.
The sample size for the temperature documentation was based on the feasibility of documentation within the observation period. According to the temperature excursion to sub-zero temperature (18%–28%), 1747 observations (436.75 h; each observation at 15 min interval) would have been adequate to document temperature deviation in the tune of 18% with relative 10% variation with a confidence level of 95% and power of 80%., According to post hoc power analysis done using the pooled temperature excursion observed as 20% (to sub-zero temperature - 14.4%, above 8°C–6.2%, and pooled 20.6%) with relative 10% variation, 1535 observations (383.75 h; each observation at 15-min interval) of recording was needed for a confidence level of 95% and power of 80%.
The description of vaccine transfers between different levels of stores, distance traveled and time taken for the transfers were summarized in [Table 1].
Temperatures for total 478 h (1912 observations) during vaccine transfers between different level stores and outreach sessions were recorded. The vaccines were exposed to sub-zero (<0°C) for 62 h (15%; 95% confidence interval [CI]: 14%–15.2%), ≥0°C to <2°C for 138.5 h (33.5%; 95% CI: 32.2%–33.8%), ≥2°C to <8°C for 189.25 h (45.8%; 95% CI: 45.5%–46.1%), and >8°C for 23.5 h (5.7%; 95% CI: 5.5%–5.8%). As shown in [Table 2], exposure to sub-zero temperatures was frequent during vaccine transfers between subdistrict stores such as CHCs to PHCs (35%), district to subdistrict stores (8.9%), and division to district stores (10.2%).
|Table 2: The pattern of temperature maintenance during the vaccine transfers|
Click here to view
This study documented exposure of vaccines to sub-zero temperature frequently and for considerable periods than to higher temperature (>8°C) during transfer between the vaccine stores and to outreach sessions. While the proportions of exposure to sub-zero temperature were 9%–10% for transfers from division and district stores, it was 35% for transfers between subdistrict stores. The proportions of exposure to freezing temperature were equivalent to the exposure for temperature >8°C for transfers from division and district stores, but much higher for transfers between subdistrict stores. The overall proportion exposure to sub-zero temperature was much higher than for >8°C (18% vs. 2.3%, respectively).
Another study from India reported temperature excursion to <0°C and >8°C for 18.1% and 7.3% of the observation period for 103 vaccine transfers. For the outreach sessions, 5% were exposed to sub-zero temperature.
In Bolivia, during routine shipments, the DTP-HB-Hib vaccines were exposed to freezing temperatures for 2%–50% of transit periods, compared to 1.3% for exposure to >8°C. A review (1985–2006) summarized exposure of vaccines to sub-zero temperature in 35.3% and 16.7% of shipments in developing and developed countries, respectively. A recent review (2007–2014) summarized that vaccines were exposed to sub-zero temperature in 19.3% and 38% of shipments in developing and developed countries, respectively. During outreach vaccine transfers the exposure to sub-zero temperature was around 18% of shipment tenure. Another report from rural India documented exposure of oral polio vaccines (OPV) to sub-zero temperature kept in vaccine carriers in five of the six PHC areas for 30–240 min. Although the observation was for OPV, the similar exposure is expected for the freeze-sensitive vaccines. These exposures are putting the vaccines, especially the freeze-sensitive vaccines at risk for freezing and losing potency. Vaccination with the frozen less potent vaccines may lead to vaccine failure and suboptimal population immunity, as observed for hepatitis B and pertussis., According to the national effective vaccine management assessment in India (2013), adequate knowledge and use of shake test were observed for only 19%–38% of cold chain handlers. A study from Assam reported poor practice of shake test by vaccinators (91.3% demonstration failure).
This study documented frequent and considerable exposure of vaccines to sub-zero temperatures during transportation. The infrequent conduct and inadequate knowledge of shake test by cold chain handlers and vaccinators further the chance of using frozen vaccines with lower potency.
Our study has certain limitations. Temperatures during the transport of vaccines were only monitored with the data loggers and shake test for vaccines were not documented. The impact of temperature excursion on immunogenicity or potency of vaccines was not documented.
This study indicates that vaccines are being exposed to freezing temperatures during transportation across the cold chain in all three states. The proportion of exposure to freezing temperature is substantial during transportation, 9%–35% between vaccine stores and 18% for outreach sessions. As the new and costlier freeze-sensitive vaccines are added to the UIP basket, freeze prevention shall become important to ensure vaccine potency, avoid vaccine failure, and maintain population immunity. Thus, along with the temperature integrity monitoring at the cold chain points, attention for monitoring of temperature maintenance during vaccine transfers and appropriate orientation of the cold chain handlers are also necessary. More rigorous and comprehensive studies across the cold chain in different geographic and climatic conditions are needed, including laboratory linked studies to improve understanding of vaccine potency alteration with temperature excursion in program settings.
We are grateful to Immunization Division, Government of India, Departments of Health and Family Welfare, Kerala, Gujarat and Bihar for providing the opportunity to undertake this project in the respective states. We highly appreciate the support from the health functionaries and health administration of the districts in the three states for implementing the project activities.
Financial support and sponsorship
This project was funded by the Bill and Melinda Gates Foundation (grant number OPP1041395).
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]
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