The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring

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.     

Intradermal delivery of vaccines: potential benefits and current challenges

Delivery of vaccine antigens to the dermis and/or epidermis of human skin (i.e. intradermal delivery) might be more efficient than injection into the muscle or subcutaneous tissue, thereby reducing the volumes of antigen. This is known as dose-sparing and has been demonstrated in clinical trials with some, but not all, vaccines. Dose-sparing could be beneficial to immunization programmes by potentially reducing the costs of purchase, distribution and storage of vaccines; increasing vaccine availability and effectiveness. The data obtained with intradermal delivery of some vaccines are encouraging and warrant further study and development; however significant gaps in knowledge and operational challenges such as reformulation, optimizing vaccine presentation and development of novel devices to aid intradermal vaccine delivery need to be addressed. Modelling of the costs and potential savings resulting from intradermal delivery should be done to provide realistic expectations of the potential benefits and to support cases for investment. Implementation and uptake of intradermal vaccine delivery requires further research and development, which depends upon collaboration between multiple stakeholders in the field of vaccination.     

Intradermal delivery for vaccine dose sparing: Overview of current issues

There is a wide range of methods and technologies aimed at improving human vaccine products and the way they are delivered. Some of these have the potential to increase vaccine effectiveness in specific populations and may furthermore help to increase vaccine access, reduce costs, and ease the logistical burdens of immunization programs, especially in low-resource settings. One strategy under evaluation is the use of intradermal (ID) delivery of vaccines, which has been shown to result in dose sparing with some vaccines. Novel ID delivery devices could enable needle-free and therefore safer and more reliable ID administration than current ID injection methods, facilitating ID delivery and dose sparing with existing or new vaccines. There are promising clinical data with some vaccines that highlight the potential of reduced-dose immunization via the ID route. And more studies are under way. However, a number of clinical and technical research as well as operational challenges exist, including establishing the optimal doses for different vaccines, reformulating to adjust antigen concentration or add preservatives, matching vaccine vial volume to session size, working with vaccine manufacturers to achieve regulatory clearance for ID delivery, and developing ID delivery devices suitable for the varying scenarios of use of different vaccines. These will need to be addressed before the benefits of ID delivery and the impact of novel ID delivery technologies on human health are fully realized.     

Vaccines,inspiring innovation in health

This report covers the topics of pandemics, epidemics and partnerships, including regulatory convergence initiatives, new technologies and novel vaccines, discussed by leading public and private sector stakeholders at the 18th Annual General Meeting (AGM) of the Developing Countries Vaccine Manufacturers’ Network (DCVMN). Contributions of Gavi and the vaccine industry from emerging countries to the growing global vaccine market, by improving the supply base from manufacturers in developing countries and contributing to 58% of doses, were highlighted. The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI) and others reported on new strategies to ensure speedy progress in preclinical and clinical development of innovative vaccines for future MERS, Zika or other outbreak response. Priorities for vaccine stockpiling, to assure readiness during emergencies and to prevent outbreaks due to re-emerging diseases such as yellow fever, cholera and poliomyelitis, were outlined. The role of partnerships in improving global vaccine access, procurement and immunization coverage, and shared concerns were reviewed. The World Health Organization (WHO) and other international collaborating partners provided updates on the Product, Price and Procurement database, the prequalification of vaccines, the control of neglected tropical diseases, particularly the new rabies elimination initiative, and regulatory convergence proposals to accelerate vaccine registration in developing countries. Updates on supply chain innovations and novel vaccine platforms were presented. The discussions enabled members and partners to reflect on efficiency of research & development, supply chain tools and trends in packaging technologies improving delivery of existing vaccines, and allowing a deeper understanding of the current public-health objectives, industry financing, and global policies, required to ensure optimal investments, alignment and stability of vaccine supply in developing countries.     

Estimating the costs of the vaccine supply chain and service delivery for selected districts in Kenya and Tanzania

Having data on the costs of the immunization system can provide decision-makers with information to benchmark the costs when evaluating the impact of new technologies or programmatic innovations. This paper estimated the supply chain and immunization service delivery costs and cost per dose in selected districts in Kenya and Tanzania. We also present operational data describing the supply chain and service delivery points (SDPs).To estimate the supply chain costs, we collected resource-use data for the cold chain, distribution system, and health worker time and per diems paid. We also estimated the service delivery costs, which included the time cost of health workers to provide immunization services, and per diems and transport costs for outreach sessions. Data on the annual quantities of vaccines distributed to each facility, and the occurrence and duration of stockouts were collected from stock registers. These data were collected from the national store, 2 regional and 4 district stores, and 12 SDPs in each country for 2012. Cost per dose for the supply chain and immunization service delivery were estimated.The average annual costs per dose at the SDPs were $0.34 (standard deviation (s.d.) $0.18) for Kenya when including only the vaccine supply chain costs, and $1.33 (s.d. $0.82) when including immunization service delivery costs. In Tanzania, these costs were $0.67 (s.d. $0.35) and $2.82 (s.d. $1.64), respectively. Both countries experienced vaccine stockouts in 2012, bacillus Calmette-Guérin vaccine being more likely to be stocked out in Kenya, and oral poliovirus vaccine in Tanzania. When stockouts happened, they usually lasted for at least one month.Tanzania made investments in 2011 in preparation for planned vaccine introductions, and their supply chain cost per dose is expected to decline with the new vaccine introductions. Immunization service delivery costs are a significant portion of the total costs at the SDPs.     

The origins of the vaccine cold chain and a glimpse of the future

International efforts to eradicate smallpox in the 1960s and 1970s provided the foundation for efforts to expand immunization programmes, including work to develop immunization supply chains. The need to create a reliable system to keep vaccines cold during the lengthy journey from the manufacturer to the point of use, even in remote areas, was a crucial concern during the early days of the Expanded Programme on Immunization. The vaccine cold chain was deliberately separated from other medical distribution systems to assure timely access to and control of vaccines and injection materials. The story of the early development of the vaccine cold chain shows how a number of challenges were overcome with technological and human resource solutions. For example, the lack of methods to monitor exposure of vaccines to heat during transport and storage led to many innovations, including temperature-sensitive vaccine vial monitors and better methods to record and communicate temperatures in vaccine stores. The need for appropriate equipment to store and transport vaccines in tropical developing countries led to innovations in refrigeration equipment as well as the introduction and widespread adoption of novel high performance vaccine cold-boxes and carriers. New technologies also helped to make injection safer. Underlying this work on technologies and equipment was a major effort to develop the human resources required to manage and implement the immunization supply chain. This included creating foundational policies and a management infrastructure; providing training for managers, health workers, technicians, and others. The vaccine cold chain has contributed to one of the world’s public health success stories and provides three priority lessons for future: the vaccine supply chain needs to be integrated with other public health supplies, re-designed for efficiency and effectiveness and work is needed in the longer term to eliminate the need for refrigeration in the supply chain.     

An opportunity to incentivize innovation to increase vaccine safety in the United States by improving vaccine delivery using vaccine patches

Vaccines represent cost-effective and safe interventions that provide substantial health and economic benefits to individuals and populations. The US vaccine enterprise that supports all aspects of immunization continues to encourage innovation. Despite some limited historical recommendations to create a fund to support investments in vaccine safety, and recent legislation that supports innovation for new vaccines (the 21st Century Cures Act, Public Law 114–255), to date the US lacks financial incentives to fund innovation in vaccine delivery technologies. Building on separate reviews of the US Vaccine Injury Compensation Program (VICP) and the state of development of vaccine patches as an innovative vaccine delivery platform, we suggest an opportunity to allocate some VICP Trust Fund resources to prevent future VICP claims by creating a new incentives fund to support translational studies for improving vaccine delivery technologies. We identify shoulder injury related to vaccine administration (SIRVA) as a test case.     

Evaluating the value proposition for improving vaccine thermostability to increase vaccine impact in low and middle-income countries

The need to keep vaccines cold in the face of high ambient temperatures and unreliable access to electricity is a challenge that limits vaccine coverage in low and middle-income countries (LMICs). Greater vaccine thermostability is generally touted as the obvious solution. Despite conventional wisdom, comprehensive analysis of the value proposition for increasing vaccine thermostability has been lacking. Further, while significant investments have been made in increasing vaccine thermostability in recent years, no vaccine products have been commercialized as a result. We analyzed the value proposition for increasing vaccine thermostability, grounding the analysis in specific vaccine use cases (e.g., use in routine immunization [RI] programs, or in campaigns) and in the broader context of cold chain technology and country level supply chain system design. The results were often surprising. For example, cold chain costs actually represent a relatively small fraction of total vaccine delivery system costs. Further, there are critical, vaccine use case-specific temporal thresholds that need to be overcome for significant benefits to be reaped from increasing vaccine thermostability. We present a number of recommendations deriving from this analysis that suggest a rational path toward unlocking the value (maximizing coverage, minimizing total system costs) of increased vaccine thermostability, including: (1) the full range of thermostability of existing vaccines should be defined and included in their labels; (2) for new vaccines, thermostability goals should be addressed up-front at the level of the target product profile; (3) improving cold chain infrastructure and supply chain system design is likely to have the largest impact on total system costs and coverage in the short term—and will influence the degree of thermostability required in the future; (4) in the long term, there remains value in monitoring the emergence of disruptive technologies that could remove the entire RI portfolio out of the cold chain.     

Strategies for vaccine-product innovation: Creating an enabling environment for product development to uptake in low- and middle-income countries

Vaccine-product innovations that address barriers to immunization are urgently needed to achieve equitable vaccine coverage, as articulated in the new Immunization Agenda 2030 and the Gavi 5.0 strategy. In 2020, the Vaccine Innovation Prioritisation Strategy (VIPS) prioritized three innovations, namely microarray patches (MAPs), heat-stable and controlled-temperature chain (CTC) enabled liquid vaccine formulations and barcodes on primary packaging. These innovations were prioritized based on the priority immunization barriers that they may help overcome in resource constrained contexts, as well as by considering their potential impact on health, coverage and equity, safety, economic costs and their technical readiness and commercial feasibility. VIPS is now working to accelerate the development and lay the foundation for future uptake of the three priority vaccine-product innovations, with the long term-goal to ensure equitable vaccine coverage and increased impact of vaccines in low- and middle- income countries.To inform our strategic planning, we analyzed four commercially available vaccine product-innovations and conducted interviews with individuals from 17 immunization organizations, and/or independent immunization experts. The findings are synthesized into an ‘innovation conundrum’ that describes the challenges encountered in developing vaccine-product innovations and a vaccine-product innovation ‘theory of change’, which highlights actions that should be undertaken in parallel to product development to incentivize sustainable investment and prepare the pathway for uptake and impact.     

Technologies that make administration of vaccines safer

There is an ever-expanding technology that is aimed at making the administration of vaccines safer. Conventional ways of administering vaccines are being upgraded, modified or replaced by a wide variety of innovations. The paradigm of liquid vaccines, needles and syringes is slow to change, but already developments are occurring that will change for ever the way vaccines are administered and will improve the safety record of immunization. The oral route of vaccine administration has generally been thought of as safe, but until now only the polio vaccine has been widely used in this way. The conventional method of vaccine administration is by injection. Many ingenious devices have become available that now make injecting safer. Inventors are now looking imaginatively to alternative routes and technologies for delivering vaccines. Vaccines are generally manufactured to extremely high standards and rarely are shown to be the cause of safety issues. People remain the weakest safety link is vaccine administration. Technologies that bypasses the ability of man to make bad decisions or to behave incorrectly are of tremendous value. The vaccine world is in the middle of a radical re-think about how vaccines might best be administered. The presentation of the vaccine can be altered to fit new technologies such as powder jet guns, or skin patches. Even the conventional needle and syringe have evolved to much safer versions, and are set to continue this evolution. All this means even safer vaccines and their delivery.     

Gram-positive and Gram-negative bacteria as carrier systems for DNA vaccines

Vaccination by intradermal or intramuscular injection of eukaryotic antigen expression vectors (so-called DNA vaccines) elicits strong cellular and humoral immune responses. A novel approach employs attenuated mutant strains of Gram-positive and Gram-negative intracellular bacteria as carriers for the delivery of DNA vaccines. This strategy allows the administration of the DNA vaccines via mucosal surfaces and a direct delivery of the plasmid DNA to professional antigen presenting cells (APC), such as macrophages and dendritic cells (DC). In this work, we have found that several Gram-negative bacteria are capable of delivering plasmid vectors to human DC. In addition, we tested the suitability of the Gram-positive bacterium Listeria monocytogenes as a vaccine carrier for the immunization of fish.     

Vaccine innovation prioritisation strategy: Findings from three country-stakeholder consultations on vaccine product innovations

As part of the Vaccine Innovation Prioritisation Strategy (VIPS), three immunization-stakeholder consultations were conducted between September 2018 and February 2020 to ensure that countries’ needs drove the prioritization of vaccine product innovations.All consultations targeted respondents with immunization program experience. They included: (1) an online survey to identify immunization implementation barriers and desired vaccine attributes in three use settings, (2) an online survey to identify and evaluate the most important immunization challenges for ten exemplar vaccines, and (3) in-depth interviews to better understand the perceived programmatic benefits and challenges that could be addressed by nine innovations and to rank the innovations that could best address current challenges.The first consultation included responses from 442 participants in 61 countries, representing 89% of the 496 respondents who correctly completed at least one section of the online survey. For facility-based settings, missed opportunities for vaccination due to reluctance to open multidose vaccine vials was the barrier most frequently selected by respondents. In community-based (outreach) and campaign settings, limited access to immunization services due to geographic barriers was most frequently selected. Multidose presentations with preservative or single-dose presentations were most frequently selected as desired vaccine attributes for facility-based settings while improved thermostability was most frequently selected for outreach and campaign settings. The second online survey was completed by 220 respondents in 54 countries. For the exemplar vaccines, vaccine ineffectiveness or wastage due to heat or freeze exposure and missed opportunities due to multidose vial presentations were identified as the greatest vaccine-specific challenges. In-depth interviews with 84 respondents in six countries ranked microarray patches, dual-chamber delivery devices, and heat-stable/controlled temperature chain qualified liquid vaccines as the three innovations that could have the greatest impact in helping address current immunization program challenges.These findings informed the VIPS prioritization and provided broader application to designing immunization interventions to better meet country needs.     

Dual-chamber injection device for measles-rubella vaccine: The potential impact of introducing varying sizes of the devices in 3 countries

IntroductionBy pairing diluent with vaccines, dual-chamber vaccine injection devices simplify the process of reconstituting vaccines before administration and thus decrease associated open vial wastage and adverse events. However, since these devices are larger than current vaccine vials for lyophilized vaccines, manufacturers need guidance as to how the size of these devices may affect vaccine distribution and delivery.MethodsUsing HERMES-generated immunization supply chain models of Benin, Bihar (India), and Mozambique, we replace the routine 10-dose measles-rubella (MR) lyophilized vaccine with single-dose MR dual-chamber injection devices, ranging the volume-per-dose (5.2–26 cm³) and price-per-dose ($0.70, $1.40).ResultsAt a volume-per-dose of 5.2 cm³, a dual-chamber injection device results in similar vaccine availability, decreased open vial wastage (OVW), and similar total cost per dose administered as compared to baseline in moderately constrained supply chains. Between volumes of 7.5 cm³ and 26 cm³, these devices lead to a reduction in vaccine availability between 1% and 14% due to increases in cold chain storage utilization between 1% and 7% and increases in average peak transport utilization between 2% and 44%. At the highest volume-per-dose, 26 cm³, vaccine availability decreases between 9% and 14%. The total costs per dose administered varied between each scenario, as decreases in vaccine procurement costs were coupled with decreases in doses administered. However, introduction of a dual-chamber injection device only resulted in improved total cost per dose administered for Benin and Mozambique (at 5.2 cm³ and $0.70-per-dose) when the total number of doses administered changed <1% from baseline.ConclusionIn 3 different country supply chains, a single-dose MR dual-chamber injection device would need to be no larger than 5.2 cm³ to not significantly impair the flow of other vaccines.     

Devices for intradermal vaccination

New insights in vaccine development, the need for safe, economic and efficient vaccine administration and the increasing mechanistic knowledge of immune responses induced by targeting the intradermal layers of the skin have all driven the engineering of devices for intradermal vaccination. In this review we highlight different delivery devices that make the epidermal and dermal layers of the skin accessible for vaccine administration. Depending on the device the desired vaccine can be applied either as a liquid formulation or as solid, powdered vaccine particles. The process of intradermal injection employs micron-sized needles that are inserted 1.5 mm perpendicularly into the skin, and which inject approximately 100-200 μl of a liquid vaccine formulation into the dermal skin layers. Tattoo devices, on the other hand, can be used to deliver liquid vaccine formulations into the dermal layer of the skin by the use of oscillating needles. Microneedle arrays are made of vaccine-coated solid microneedles or biodegradable microneedles. These are inserted into the dermal layers of the skin where either the vaccine coating is dissolved, or the microneedle itself dissolves in place. Jet-injectors operate by generating a high pressured stream, which flushes the liquid vaccine formulation into the deeper skin layers. Delivery devices using liquid vaccine formulations are advantageous, as established vaccine formulations can be used as provided without the need for reformulation. However, approaches that deliver vaccines in a solid form may also prove to be promising. One such method is the ballistic approach, in which solid vaccine particles or vaccine-coated gold particles are accelerated towards the skin by needle-free devices, so that the particles are deposited in the epidermal and dermal layers of the skin. These various delivery devices are explored in this review with regard to their delivery mechanism and ease of handling, their efficacy in clinical trials and their suitability for practical use.     

Funding gap for immunization across 94 low- and middle-income countries

Novel vaccine development and production has given rise to a growing number of vaccines that can prevent disease and save lives. In order to realize these health benefits, it is essential to ensure adequate immunization financing to enable equitable access to vaccines for people in all communities. This analysis estimates the full immunization program costs, projected available financing, and resulting funding gap for 94 low- and middle-income countries over five years (2016–2020). Vaccine program financing by country governments, Gavi, and other development partners was forecasted for vaccine, supply chain, and service delivery, based on an analysis of comprehensive multi-year plans together with a series of scenario and sensitivity analyses.Findings indicate that delivery of full vaccination programs across 94 countries would result in a total funding gap of $7.6 billion (95% uncertainty range: $4.6–$11.8 billion) over 2016–2020, with the bulk (98%) of the resources required for routine immunization programs. More than half (65%) of the resources to meet this funding gap are required for service delivery at $5.0 billion ($2.7–$8.4 billion) with an additional $1.1 billion ($0.9–$2.7 billion) needed for vaccines and $1.5 billion ($1.1–$2.0 billion) for supply chain. When viewed as a percentage of total projected costs, the funding gap represents 66% of projected supply chain costs, 30% of service delivery costs, and 9% of vaccine costs. On average, this funding gap corresponds to 0.2% of general government expenditures and 2.3% of government health expenditures.These results suggest greater need for country and donor resource mobilization and funding allocation for immunizations. Both service delivery and supply chain are important areas for further resource mobilization. Further research on the impact of advances in service delivery technology and reductions in vaccine prices beyond this decade would be important for efficient investment decisions for immunization.     

Vaccines for a healthy future: 21st DCVMN Annual General Meeting 2020 report

The Developing Countries Vaccine Manufacturers' Network held its 21st Annual General Meeting virtually in November 2020 given the COVID-19 pandemic. Vaccine manufacturing experts, leaders from local and global public health organizations and multilateral organizations, through diverse presentations, questions and answers, focused on the pandemic and the response of vaccine manufacturers where many are engaged in research and development and production agreements. The pandemic is expanding rapidly which makes the global availability and equitable access to safe and effective COVID-19 vaccines critical. Strategies put in place include the establishment of the Access to COVID-19 Tools Accelerator (ACT-A) within which the COVAX facility aims to distribute 2 billion COVID-19 vaccine doses by the end of 2021, with procurement mechanisms already being established. At the same time, regulatory authorities have emergency use authorizations aimed at the rapid approval of safe and effective vaccines, with a push for harmonization in regulatory approaches being advocated. The Meeting was also apprised of other innovations being developed for vaccines including multi-array patches for easier vaccine application, increased heat stability for mitigating cold chain and storage challenges, the barcoding of primary packaging for enhancing vaccine traceability, and gathering data for decision-making. Over time, these innovations will facilitate the widespread availability and equitable access of vaccines including those addressing epidemics and pandemics. In addition, a number of manufacturers described technologies they have for accelerating vaccine manufacturing and supply globally.Overall, there was agreement that manufacturers from developing countries play a critical role in the global research, development and supply of vaccines for a healthy future, with increasing collaboration and partnering between them a growing strength.     

Modular vaccine packaging increases packing efficiency

BackgroundWithin a typical vaccine supply chain, vaccines are packaged into individual cylindrical vials (each containing one or more doses) that are bundled together in rectangular “inner packs” for transport via even larger groupings such as cold boxes and vaccine carriers. The variability of vaccine inner pack and vial size may hinder efficient vaccine distribution because it constrains packing of cold boxes and vaccine carriers to quantities that are often inappropriate or suboptimal in the context of country-specific vaccination guidelines.MethodsWe developed in Microsoft Excel (Microsoft Corp., Redmond, WA) a spreadsheet model that evaluated the impact of different packing schemes for the Benin routine regimen plus the introduction of the Rotarix vaccine. Specifically, we used the model to compare the current packing scheme to that of a proposed modular packing scheme.ResultsConventional packing of a Dometic RCW25 that aims to maximize fully-immunized children (FICs) results in 123 FICs and a packing efficiency of 81.93% compared to a maximum of 155 FICs and 94.1% efficiency for an alternative modular packaging system.ConclusionsOur analysis suggests that modular packaging systems could offer significant advantages over conventional vaccine packaging systems with respect to space efficiency and potential FICs, when they are stored in standard vaccine carrying devices. This allows for more vaccines to be stored within the same volume while also simplifying the procedures used by field workers to pack storage devices. Ultimately, modular packaging systems could be a simple way to help increase vaccine coverage worldwide.     

Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats

Despite limitations of glass packaging for vaccines, the industry has been slow to implement alternative formats. Polymer containers may address many of these limitations, such as breakage and delamination. However, the ability of polymer containers to achieve cost of goods sold (COGS) and total cost of delivery (TCOD) competitive with that of glass containers is unclear, especially for cost-sensitive low- and lower-middle-income countries.COGS and TCOD models for oral and parenteral vaccine packaging formats were developed based on information from subject matter experts, published literature, and Kenya’s comprehensive multiyear plan for immunization. Rotavirus and inactivated poliovirus vaccines (IPV) were used as representative examples of oral and parenteral vaccines, respectively. Packaging technologies evaluated included glass vials, blow-fill-seal (BFS) containers, preformed polymer containers, and compact prefilled auto-disable (CPAD) devices in both BFS and preformed formats.For oral vaccine packaging, BFS multi-monodose (MMD) ampoules were the least expensive format, with a COGS of $0.12 per dose. In comparison, oral single-dose glass vials had a COGS of $0.40. BFS MMD ampoules had the lowest TCOD of oral vaccine containers at $1.19 per dose delivered, and ten-dose glass vials had a TCOD of $1.61 per dose delivered. For parenteral vaccines, the lowest COGS was achieved with ten-dose glass vials at $0.22 per dose. In contrast, preformed CPAD devices had the highest COGS at $0.60 per dose. Ten-dose glass vials achieved the lowest TCOD of the parenteral vaccine formats at $1.56 per dose delivered. Of the polymer containers for parenteral vaccines, BFS MMD ampoules achieved the lowest TCOD at $1.89 per dose delivered, whereas preformed CPAD devices remained the most expensive format, at $2.25 per dose delivered.Given their potential to address the limitations of glass and reduce COGS and TCOD, polymer containers deserve further consideration as alternative approaches for vaccine packaging.     

Ensuring vaccine safety in immunization programmes--a WHO perspective

Ever since vaccines were firstly used against smallpox, adverse events following immunization have been reported. As immunization programmes expand to reach even the most remote communities in the poorest countries, it is likely that many more events will be temporally linked with vaccine administration. Furthermore, the profound shift in the general public and media interest in adverse events may lead to undue concerns and allegations which may ultimately jeopardize immunization programmes world-wide. While the health professional has understood this issue for some time, the public and the media have now also become all too aware of the significance of vaccine-related adverse events. The familiar vaccines, well-tested over decades, have not changed--but the perception regarding their safety has shifted. Claims outrageous or reasonable are being made against both the old and the newly-introduced vaccines. At the same time, the immunological and genetic revolution of the last decade may well bring to our notice some hypothetical risks that need to be addressed at pre-clinical level. WHO has been at the leading edge to guarantee vaccine safety for the last 30 years and will continue to do so. The Organization's plans for the next decade and beyond include the Safe Injection Global Network (SIGN), the development and introduction of safer technologies, and the prevention, early detection and management of AEFIs. The new technologies include needle-containing injection devices such as the autodisable syringe, as well as mucosal and transcutaneous immunization. Training will continue to be at the centre of WHO's efforts, limiting human error to a minimum. Mechanisms have been set in place to detect and respond to new and unforeseen events occurring. Above all, there is a willingness to respond to new climates and new technologies so that the Organization is in the best position to ensure safe immunization for all the world's children.     

Outsourcing vaccine logistics to the private sector: The evidence and lessons learned from the Western Cape Province in South-Africa

With few exceptions, immunization supply chains in developing countries continue to face chronic difficulties in providing uninterrupted availability of potent vaccines up to service delivery levels, and in the most efficient manner possible. As these countries struggle to keep pace with an ever growing number of vaccines, more and more Ministries of Health are considering options of engaging the private sector to manage vaccine storage, handling and distribution on their behalf. Despite this emerging trend, there is limited evidence on the benefits or challenges of this option to improve public supply chain performance for national immunization programmes. To bridge this knowledge gap, this study aims to shed light on the value proposition of outsourcing by documenting the specific experience of the Western Cape Province of South Africa. The methodology for this review rested on conducting two key supply chain assessments which allowed juxtaposing the performance of the government managed segments of the vaccine supply chain against those managed by the private sector. In particular, measures of effective vaccine management best practice and temperature control in the cold chain were analysed. In addition, the costs of engaging the private sector were analysed to get a better understanding of the economics underpinning outsourcing vaccine logistics. The results from this analysis confirmed some of the theoretical benefits of outsourcing to the private sector. Yet, if the experience in the Western Cape can be deemed a successful one, there are several policy and practice implications that developing countries should be mindful of when considering engaging the private sector. While outsourcing can help improve the performance of the vaccine supply chain, it has the potential to do the reverse if done incorrectly. The findings and lessons learnt from the Western Cape experience can serve as a step towards understanding the role of the private sector in immunization supply chain and logistics systems for developing countries.