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How to ensure we can track and trace global use of COVID-19 vaccines?

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... The validation report details are related to the installation's quality (IQ), operational quality (OQ), and performance quality (PQ). This invention includes vaccinations within established norms and complies with WHO requirements for packaging to bear the standard GS1 barcode (Jarrett et al. 2020;Vander Stichele et al. 2021) Some vials were not stable in one position, making label reading and verification more difficult. The initial step between label verification and labeling is a manual adjustment to ensure that the vial can be precisely read (Jarrett et al. 2020). ...
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COVID-19 has spread worldwide, and several governments, including Indonesia, are actively vaccinating. However, numerous factors may contribute to decreased vaccination administration, including hesitation, a lack of information, and demographic considerations. Therefore, this review provides insights on maximizing vaccine distribution and raising community awareness about COVID-19 vaccination in rural regions with difficulty in transportation access, a lack of health care workers, and limited vaccine storage facilities. It was discovered that numerous potential methods, such as the Internet of Things (IoT), bio-tracking and bio-detect, P-median, and Vehicle Routing Problem (VRP), can monitor vaccination delivery in rural parts of Indonesia. The correct vaccine distribution system can monitor situations during distribution by combining IoT technology with bio-tracking and bio-detect in airborne transportation. Besides enhancing vaccine distribution technologies, healthcare professionals play a critical role in maintaining vaccine quality and improving community awareness of diseases. In particular, as a healthcare professional, a pharmacist has an essential role in ensuring the quality of the vaccine until it is administered to the patient and improving patients’ awareness of COVID-19 and the vaccinations. Pharmacists can collaborate with other healthcare professionals to educate the community to identify important information related to wrong perceptions about COVID-19 and vaccinations.
... The global community has repeatedly highlighted the need for better data to track progress and ensure accountability of global initiatives such as the Global Strategy for Women's, Children's and Adolescents' Health, Universal Health Coverage, and the Sustainable Development Goals [4][5][6][7][8][9]. The COVID-19 pandemic has illustrated that well-functioning health information systems and high-quality data are crucial to prevention, provision of care, and the successful rollout of new vaccines [10]. ...
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Analyzing immunization coverage data is crucial to guide decision-making in national immunization programs and monitor global initiatives such as the Immunization Agenda 2030. We aimed to assess the quality of reported child immunization coverage data for 194 countries over 20 years. We analyzed child immunization coverage as reported to the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) between 2000-2019 by all WHO Member States for Bacillus Calmette-Gué rin (BCG) vaccine birth dose, first and third doses of diphtheria-tetanus-pertussis-containing vaccine (DTP1, DTP3), and first dose of measles-containing vaccine (MCV1). We assessed completeness, consistency, integrity, and congruence and assigned data quality flags in case anomalies were detected. Generalized linear mixed-effects models were used to estimate the probability of flags worldwide and for different country groups over time. The probability of data quality flags was 18.2% globally (95% confidence interval [CI] 14.8-22.3). The lowest probability was seen in SouthEast Asia (6.3%, 3.3-11.8, p = 0.002), the highest in the Americas (29.7%, 22.7-37.9, p < 0.001). The probability of data quality flags declined by 5.1% per year globally (3.2-7.0, p < 0.001). The steepest decline was seen in Africa (-9.6%,-13.0 to-5.8, p < 0.001), followed by Europe (-5.4%,-9.2 to-1.6, p = 0.0055), and the Americas (-4.9%,-9.2 to-0.6, p = 0.026). Most country groups showed a statistically significant decline, and none had a statistically significant increase. Over the past two decades, the quality of global immunization coverage data appears to have improved. However, progress has not been universal. The results highlight the need for joint efforts so that all countries collect, report, and use high-quality data for action in immunization.
... Undoubtedly, INN would contribute immensely to identifying COVID-19 vaccines, especially altered versions and the use of combinations. However, it is recognised that for a full track and trace system, additional measures such as barcoding that captures batch number and expiry data, access to manufacturers' traceability data, and the mandatory recording of immunization acts, would be required [33]. Various projects are ongoing to digitise identifiers for substances and products and all refer to INN, including INN information. ...
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International Nonproprietary Names (INN) are assigned by the World Health Organization (WHO) to pharmaceutical substances to ensure global recognition by a unique name. INN facilitate safe prescribing through naming consistency, efficient communication and exchange of information, transnational access and pharmacovigilance of medicinal products. Traditional vaccines such as inactivated or live-attenuated vaccines have not been assigned INN and provision of a general name falls within the scope of the WHO Expert Committee on Biological Standardization (ECBS). However, novel vaccines that contain well-defined active ingredients such as nucleic acids or recombinant proteins fulfil the criteria to be assigned INN. In the current environment where multiple SARS-CoV-2 vaccines are being developed to combat the COVID-19 pandemic and with virus variants emerging, assigning INN to well-defined vaccine substances will strengthen pharmacovigilance and ultimately enhance the safety of vaccine recipients. This article examines the background to INN for vaccines and explains the applicability and value of assigning INN to novel well-defined vaccines.
... Different vaccines will have different event profiles, requiring careful tracking of product detail and lot numbers. 24 Vaccine registries, which may provide such information locally, may not be linked to healthcare databases. The possibility that individuals will receive different vaccines for the two doses (eg, AstraZeneca for first dose and Pfizer for second dose) will make it more difficult to identify which vaccine may have caused an adverse event. ...
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Traceability systems play an important role in the digital transformation of the supply chain. This chapter examines the principal issues on the what, why, and how of achieving digital supply chain traceability in relation to data and technology. We consider the overlapping definitions of visibility, traceability, tracking, tracing, and transparency. We highlight factors driving the need to achieve higher levels of traceability, including regulatory demands, business incentives, and customer concerns and preferences. The emergence of global standards related to traceability is noted. The types of information required to successfully track and trace products in a digital supply chain are explained, as well as the technologies applied to collect, follow, and share information, including radio frequency identification, Internet of Things, and blockchain. The challenges around cybersecurity, standards, data quality, integrating new technologies, and potentially competing interests among stakeholders are discussed. We examine the traceability of wood products, which are important globally and raise significant sustainability challenges. The case illustrates how technical solutions can be incorporated into the traceability system to respond to the needs and challenges of stakeholders. Further research is needed on the technical, policy, and business strategy solutions to address common data and technology challenges for effective traceability systems.
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Introduction: The Latin American Society of Pediatric Infectious Diseases (SLIPE by its Spanish acronyms) is working to understand the current situation, gaps, and opportunities for traceability of the quality vaccination process in Latin America and the Caribbean. Areas covered: On September 24th and 25th, a Latin American forum of experts in immunization programs was held through the Zoom platform; the topics discussed included: computerized systems for recording immunizations, vaccination programs traceability, challenges, and information systems for the integrated management of vaccination. Expert opinion: Latin American countries have transitioned from having a nominal registration system to a nominal tracking system, with many of them not migrating their platforms to new technologies; therefore, the low-quality data, fragmented databases, and slow information traffic present a challenge that must be taken on.
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The counterfeiting of vaccines is an increasing problem globally with the safety of persons vaccinated, the trust in vaccines generally and the associated reputation of vaccine manufacturers and regulatory agencies at risk. This risk is especially critical with the on-going development of COVID-19 vaccines. The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced. In this context of traceability, the global immunization community has recently set the barcoding of the primary packaging of vaccines, specifically vaccine vials and pre-filled syringes, as a top priority. Emerging vaccine manufacturers are already engaged in investigating ways to incorporate barcoding in their labelling and packaging using GS1 international standards. A specific pilot taking place in Indonesia by the national vaccine manufacturer, Bio Farma, shows the innovation of barcoding on primary packaging already underway with a relatively modest level of investment and success at this stage. This article highlights the efforts of industry and governments on the value of traceability and introduction to 2D barcodes. Access to financial resources and support from the international immunization community would accelerate such innovations leading to enhanced security of the vaccine supply chain.
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Background: Two-dimensional (2D) barcoding has the potential to enhance documentation of vaccine encounters at the point of care. However, this is currently limited to environments equipped with dedicated barcode scanners and compatible record systems. Mobile devices may present a cost-effective alternative to leverage 2D vaccine vial barcodes and improve vaccine product-specific information residing in digital health records. Objective: Mobile devices have the potential to capture product-specific information from 2D vaccine vial barcodes. We sought to examine the feasibility, performance, and potential limitations of scanning 2D barcodes on vaccine vials using 4 different mobile phones. Methods: A unique barcode scanning app was developed for Android and iOS operating systems. The impact of 4 variables on the scan success rate, data accuracy, and time to scan were examined: barcode size, curvature, fading, and ambient lighting conditions. Two experimenters performed 4 trials 10 times each, amounting to a total of 2160 barcode scan attempts. Results: Of the 1832 successful scans performed in this evaluation, zero produced incorrect data. Five-millimeter barcodes were the slowest to scan, although only by 0.5 seconds on average. Barcodes with up to 50% fading had a 100% success rate, but success rate deteriorated beyond 60% fading. Curved barcodes took longer to scan compared with flat, but success rate deterioration was only observed at a vial diameter of 10 mm. Light conditions did not affect success rate or scan time between 500 lux and 20 lux. Conditions below 20 lux impeded the device's ability to scan successfully. Variability in scan time was observed across devices in all trials performed. Conclusions: 2D vaccine barcoding is possible using mobile devices and is successful under the majority of conditions examined. Manufacturers utilizing 2D barcodes should take into consideration the impact of factors that limit scan success rates. Future studies should evaluate the effect of mobile barcoding on workflow and vaccine administrator acceptance.
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Mass vaccination is a crucial public health intervention during outbreaks or pandemics for which vaccines are available. The US government has sponsored the development of medical countermeasures, including vaccines, for public health emergencies; however, federally supported programs, including the Public Health and Emergency Preparedness program and Cities Readiness Initiative, have historically emphasized antibiotic pill dispensing over mass vaccination. While mass vaccination and pill dispensing programs share similarities, they also have fundamental differences that require dedicated preparedness efforts to address. To date, only a limited number of public assessments of local mass vaccination operational capabilities have been conducted. To fill this gap, we interviewed 37 public health and preparedness officials representing 33 jurisdictions across the United States. We aimed to characterize their existing mass vaccination operational capacities and identify challenges and lessons learned in order to support the efforts of other jurisdictions to improve mass vaccination preparedness. We found that most jurisdictions were not capable of or had not planned for rapidly vaccinating their populations within a short period of time (eg, 1 to 2 weeks). Many also noted that their focus on pill dispensing was driven largely by federal funding requirements and that preparedness efforts for mass vaccination were often self-motivated. Barriers to implementing rapid mass vaccination operations included insufficient personnel qualified to administer vaccinations, increased patient load compared to pill-dispensing modalities, logistical challenges to maintaining cold chain, and operational challenges addressing high-risk populations, including children, pregnant women, and non-English-speaking populations. Considering the expected availability of a severe acute respiratory syndrome coronavirus 2 vaccine for distribution and dispensing to the public, our findings highlight critical considerations for planning possible future mass vaccination events, including during the novel coronavirus disease 2019 pandemic.
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Evolution of the current infrastructure for surveillance of vaccine safety will be essential to meet our commitments to the public in the deployment of a vaccine (or vaccines) to COVID-19. The incorporation of concepts and tools within the fields of data science and systems immunology can be used to propel vaccine safety monitoring into the twenty-first century. Rebecca Chandler from the Uppsala Monitoring Centre discusses how the COVID-19 pandemic could be the catalyst that propels vaccine safety surveillance into the twenty-first century.
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Background and objective: Accurately recording vaccine lot number, expiration date, and product identifiers, in patient records is an important step in improving supply chain management and patient safety in the event of a recall. These data are being encoded on two-dimensional (2D) barcodes on most vaccine vials and syringes. Using electronic vaccine administration records, we evaluated the accuracy of lot number and expiration date entered using 2D barcode scanning compared to traditional manual or drop-down list entry methods. Methods: We analyzed 128,573 electronic records of vaccines administered at 32 facilities. We compared the accuracy of records entered using 2D barcode scanning with those entered using traditional methods using chi-square tests and multilevel logistic regression. Results: When 2D barcodes were scanned, lot number data accuracy was 1.8 percentage points higher (94.3-96.1%, P<0.001) and expiration date data accuracy was 11 percentage points higher (84.8-95.8%, P<0.001) compared with traditional methods. In multivariate analysis, lot number was more likely to be accurate (aOR=1.75; 99% CI, 1.57-1.96) as was expiration date (aOR=2.39; 99% CI, 2.12-2.68). When controlling for scanning and other factors, manufacturer, month vaccine was administered, and vaccine type were associated with variation in accuracy for both lot number and expiration date. Conclusion: Two-dimensional barcode scanning shows promise for improving data accuracy of vaccine lot number and expiration date records. Adapting systems to further integrate with 2D barcoding could help increase adoption of 2D barcode scanning technology.