Managing Risks to Good Governance: Key for Keeping COVID-19 Vaccination on Track
Patricio V. Marquez and Betty Hanan
COVID-19 vaccines and vaccination are critical to reduce the risk of infection and death from COVID-19 disease, and hence for global economic recovery, including normalization of social interactions and travel. As we are witnessing across countries, the deployment of the vaccines is requiring unprecedented efforts in terms of population coverage. Despite the availability of considerable quantities of vaccines on hand, many countries, including developed countries, are facing major challenges to deploy vaccines at scale.
There are also risks of corruption, fraud, abuse, and misuse throughout the vaccine procurement, deployment, and administration processes. The design of vaccination programs must include monitoring of these risks and provisions for action when they are identified, resolving them to ensure that the vaccination programs reliably achieve their objectives.
There are several potential risks in rolling out a COVID-19 vaccination program that merit attention. Some key risks are:
Risks in policy decision-making and planning. Elites, the private sector, and other stakeholders may try to influence government decision-making concerning vaccine policy and deployment. Government officials may seek or be offered payoffs and bribes from a company with a stake in the provision of vaccines. Individuals with close ties to the pharmaceutical industry may also be involved in the decision-making process regarding vaccine purchases and deployment. There is also a substantial social risk of inequity in access to vaccines due to either political pressures to provide vaccines to groups that are not prioritized due to need or vulnerability, or that target groups could be misaligned because of available vaccines. This includes possible exclusion of population groups based on gender, race, ethnicity, refugee status, religion, or other characteristics. Decision making related to the allocation of vaccines to priority groups is also vulnerable to abuse of power (e.g., conflicts of interest, nepotism). Indeed, the “V.I.P. immunization” for the powerful and their friends and family members have rattled some South America countries such as Argentina, Ecuador, and Peru, as the wave of scandals have exposed how the powerful and well-connected jumped the line to get vaccines early. Public dismay, in turn, is turning into anger and adds to the lack of trust in government action.
Risks in emergency funding. The large inflows of funding that are being disbursed quickly during the pandemic for the purchase of vaccines and vaccination activities may be vulnerable to corruption and fraud if appropriate due diligence criteria are not in place. Monitoring and reporting on the use of funds are also challenging in a health crisis (e.g., due to lockdowns and virtual working arrangements). The potential for misuse of these funds requires different approaches to the fiduciary functions of monitoring and supervision.
Risks in vaccine procurement. The key procurement risks associated with vaccines concerns the: (i) complexity of the vaccine market given the significant market power enjoyed by vaccine manufacturers; (ii) inability of the market to supply sufficient quantities of vaccines to meet the demand; (iii) limited market access due to advance orders by developed countries; (iv) weak bargaining position, especially of developing countries; and (v) delays in triggering emergency procurement procedures thereby delaying procurement and contract implementation, including payments. Fraud can also be found throughout the procurement cycle and is often accompanied by theft, diversion, favoritism or conflict of interest, and corruption/bribery to facilitate the fraud. During the pre-bidding phase, fraud risks include, inter alia: (i) buying favorable policy decisions or privileged access, (ii) misrepresenting the demand for a product or service, (iii) circumventing tender procedures, and (iv) tailoring tender documents to favor a particular bidder. During the bidding phase, there is the risk of government officials soliciting/receiving bribes or kickbacks from suppliers or turning a blind eye to risks of collusion among bidders themselves. Oversight of to prevent such corruption may be circumvented in the interest of speed and rapid impact. For programs funded by international organizations, risks of corruption and fraud in connection with the negotiation and implementation of direct contracts with manufacturers or third-party suppliers cannot be discounted. Lastly, in the post-bidding phase, contracts may be subject to false invoicing or changed for non-legitimate reasons. Vaccines may not be delivered per the signed contracts. In this context, the use of trustworthy procurement agents is critical.
Risks of procuring and using substandard and falsified vaccines. Counterfeit medicines are a public health threat. With the urgent global demand for vaccines, there is a risk of substandard and falsified vaccines entering the market. Criminal groups may be active in the manufacturing of and trafficking in substandard or falsified vaccines, particularly when supplies are limited in the early stages of vaccine production and deployment. This risk is compounded if quality assurance measures are compromised during the emergency response, leading to adverse health outcomes for the population and an erosion of public trust in the safety and efficacy of a vaccine.
Risks throughout the vaccine deployment process. There are risks and challenges in the COVID-19-vaccine and vaccination rollout, including cold-chain logistics and storage-management challenges, strained labor capacities or diversion of workers from other critical roles, wastage at points of care, and IT challenges (e.g., lack of or limited vaccine-tracking systems and immunization information systems, which are essential for allocating, distributing, recording, and monitoring the deployment of vaccines). While mistakes ensuing from weak capacity might not be considered misuse in and of themselves, the deliberate concealment or misrepresentation of events would fall into the category of misuse. For example, vaccines may be stolen from the public supply chain during the transportation process and diverted to favor certain individuals or sold in informal markets or kept for personal use. Vaccine supplies are also at risk once they reach the hospital or a public health facility administering the vaccinations, if there are not strict and reliable oversight measures in place. Public health facility staff may steal vaccines for resale in the informal market, for use in their own private practices and/or to vaccinate own families and friends. This risk is particularly pronounced when supplies are limited and demand is high, as is the case during the COVID-19 pandemic.
Vaccine hesitancy risks. In some countries and among some population groups, particularly among minorities, vaccine hesitancy continues to be high. In the case of new COVID-19 vaccines, this risk is further accentuated by their rapid development and emergency use approval. Typically, the development of new vaccines requires years of research and testing before being deployed. In the case of the new COVID-19 vaccines, scientists have been racing to produce a safe and effective vaccine in record time. In a historical feat, the development and trials of some of the vaccines have taken less than a year. Also, anti-vaccine information about COVID-19 vaccines is being aggressively promoted via social media, including false claims attributing deaths and miscarriages caused by COVID-19 vaccines.
Facility level risks. Some potential risks at this level include: (i) underdosing (reducing the injection volume or adding more diluent to generate extra doses for fraudulent use); (ii) replacing one vaccine brand with another which is deemed to be less desirable by the population (if a facility administers more than one vaccine); (iii) replacing the vaccine with a non-vaccine product (e.g., injecting people with saline); and (iv) demanding and exchanging vaccination for non-monetary gains (including sexual favors). Issuance of fake vaccination certificates may also occur.
Risks of expired and unused vaccines. Ensuring no doses are left on the table due to misuse and/or expiration is critical. Each COVID-19 vaccine has a unique set of requirements for packing, storage, preparation, and administration. Several of these vaccines, such as the Pfizer-BioNTech vaccine, require complex ultra-cold chain and cold storage that are time- and temperature-sensitive. Pfizer, Moderna, Johnson & Johnson, and AstraZeneca vaccines can be used for only about six hours after reconstitution, after which they need to be discarded.
Risks of potential adverse effects of vaccines. Before a vaccine is marketed, its safety and efficacy exposure are limited to its use in clinical trials. Generally, clinical trials cover a limited number of patients with strict inclusion criteria, often excluding special patient groups like those with co-morbid conditions, children, elderly, and pregnant women. Hence, they do not reflect the experience in bigger populations and in different geographical regions. People from different geographical regions differ from one another with respect to genetics, food habits, life style, and clinical practices. This makes it obligatory to maintain a continuous vigil on the application of COVID-19 vaccines during the post-marketing period to identify and assess any reported adverse effects related to their administration. Where vaccines are recalled or paused for further distribution, as has happened with both the AstraZeneca and Johnson & Johnson vaccines, or are suspected to be defective or counterfeit, a transparent management response and a clear communication strategy are essential to identify the issues and inform all stakeholders to avoid accidental dispatch or use, as well as to prevent compounding vaccine hesitancy among some population groups.
How to manage these risks?
Risk management encompasses processes through which program management identifies, analyzes, and, where necessary, responds appropriately to risks that might adversely affect program implementation and its main objective—to vaccinate people, helping reduce risk of COVID-19 disease and associated deaths. We elaborate on key risk management processes below.
Sanctionable practices and other requirements. Cases of “corruption and fraud,” as well as “collusion,” “coercion” and “obstruction” are legally sanctionable practices included in anti-corruption frameworks (e.g., the anti-corruption strategy the World Bank Group adopted in September 1997). Theft is not part of the defined terms “corruption” or “fraud,” nor is it a separate sanctionable practice under anti-corruption framework. Similarly, counterfeiting/trafficking in substandard vaccines is misconduct but is not directly sanctionable under sanctions regimes. There are also cases of “misuse”, that do not necessarily represent “corruption and fraud”. For example, there are cases of misuse in vaccine reception, storage, handling, and stock management, or non-observance of cold supply chain requirements, and others. Close supervision of program implementation should support identification and management of the risks of misuse.
Vaccine allocation prioritization. To avoid risks associated with the vaccine allocation process in the context of limited supply of vaccines, vaccination programs need to be structured to ensure that those most socially and medically vulnerable and disadvantaged are able to get timely access to vaccines. Moreover, measures are needed to prevent that the COVID-19 crisis and the response put the vulnerable at risk of even further stigmatization or abuse and harassment, including risks of sexual exploitation for accessing vaccines. Vaccination programs need to include careful review of vaccine allocation and prioritization plans, together with measures to ensure that those that may be disadvantaged or vulnerable have access to vaccines in accordance with the stated prioritization plan. Given the limited availability of vaccines, consensus exists in countries to first target heath workers, other essential workers, and the most vulnerable populations, which will include a mix of the elderly, people with co-morbidities, and people in high-population density location such as slums and refugee camps. All targeting criteria and implementation plans will need to be reflected in the country’s national vaccination plan, which, will need to be updated periodically as countries learn from their own and others’ experience. Also, publicizing detailed vaccination information by facility on a regular basis (e.g., daily or weekly) would be important to hold individual facilities accountable, along with citizen monitoring/oversight. The potential for insecure situations or conflict arising due to the high demand for and limited supply of COVID-19 vaccines will moreover require active preparation with stakeholders to ensure the safety of the vaccinators, facilities, equipment, and vaccines.
Traceability mechanisms to prevent corruption and address counterfeit vaccines. Digital technology has the potential to scale up COVID-19 responses and recovery. Expanding the use of digital technology for vaccine tracing will benefit not just the short-term efforts, but the wider goal of improving health system resilience. Doing so well will require a concomitant focus on identifying context-specific technologies that can be rapidly deployed in environments where digital connectivity and skills are lacking. Linking digital technology for COVID-19 response to the country’s wider health information system and protecting data privacy and consent for use should be a priority. In the context of COVID-19 vaccination programs, the use of a digital registry for pre-registration, prioritization, and scheduling can help reduce corruption and misuse. For example, two methods to improve traceability could be the use of Quick Response Codes (QR codes, a type of matrix barcode that contains data for a locator, identifier, or tracker that points to a website or application), and bar codes (machine-readable optical label that contains information about the item) on the packaging of vaccines and related supplies. QR codes can provide rapid access to important vaccine information and help receive and track critical information on products released to national markets. Barcodes can also help monitor the movements of vaccines, which can enable countries to track the vaccines at arrival and distribution points. It is recommended that vaccination programs or in-country logistics managers use this functionality, likely enabled by barcode scanners or through scanners in mobile phones. This information, once scanned, should be shared to a central repository that can verify if the vaccine is in its expected destination. Similarly, a clear protocol/standard operating procedure for vaccination sites is helpful to minimize the misuse or the perception of such in case of “no shows” of registered people and resulting in surplus vials being administered. Another important point to consider is the potential replacement of one vaccine brand with another which is deemed to be less desirable by the population (if a facility administers more than one vaccine). To reduce this risk, it would be desirable that vaccination sites only carry one type of vaccine. Lastly, control mechanisms must be put in place at vaccination sites to prevent other types of risks: (i) replacing vaccines with a non-vaccine product, e.g., injecting people with saline, and (ii) issuance of fake vaccination certificates.
Vaccine safety monitoring. After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. Adverse events can also be monitored through electronic health records and claims-based systems in the health system or in cases where vaccination sites do not have access to electronic health records, “paper-based” records must be in place. If an unexpected adverse event is seen, experts quickly study it further to assess whether it is a true safety concern. Experts then decide whether changes are needed in vaccine recommendations. This monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.
Strategic risk communication. Large-scale communication efforts, including behavior change interventions associated with vaccination programs and addressing vaccine hesitancy as well as efforts to foster trust in the system, need to be built into the program design with adequate budget and appropriate expertise. A point that matters most and that requires utmost attention and careful navigation is how national authorities and teams communicate clearly information that is anchored in good-quality data on vaccine safety and side effects to vaccine-hesitant populations who do not trust governments in the first place.
Use of Third-Party Monitoring (TPM). This mechanism is important to mitigate some of the above risks. A TPM arrangement, for example, could be established to monitor the COVID-19 vaccine supply chain management from technical, environmental, and social safeguards perspectives, including, among others: (i) storage, stock, and temperature maintenance across the supply chain; (ii) service delivery at vaccination sites; (iii) eligibility of vaccine recipients; and (iv) capturing client perspectives and feedback, working in partnership with other international partners. Civil society organizations and faith-based organizations could also be included as part of TPM arrangements. The World Bank Group, for example, has taken steps to institutionalize citizen engagement across all our programs because it can improve the delivery and quality of public services; enhance the management of public finances; and bring greater transparency, accountability, and social inclusion.
What to do when corruption, fraud, abuse, or misuse have been discovered?
Good governance of COVID-19 vaccination programs requires that managers, teams, and other stakeholders exercise effective control over the vaccination program, using a combination of information and management control procedures, to achieve the maximum achievable vaccination throughput regardless of public demand for vaccination.
Corruption, fraud, abuse, and misuse events risk may not only compromise population’s access to safe and effective COVID-19 vaccines, but undermine public confidence in vaccines and the vaccination program.
Accountability, oversight, and transparency are, therefore, essential for vaccination programs’ credibility. The timely and effective application of standard policies and procedures in instances of corruption, fraud, abuse, or misuse, taking into account the severity of the allegations or the event and country context, is a critical managerial action (e.g., adoption of contractual remedies such as suspension or cancellation, or the threat thereof). These events merit discussion with and involvement of partners, funding agencies, and stakeholders, to ensure a common understanding of and support for courses of action.
The development of specific communication plans for coordinating, communicating, and sharing information about allegations or events is of great importance as well. This requires that program teams: (i) obtain as much information as possible about the events; (ii) analyze the situation, e.g., what is the potential level of impact on trust in vaccines and the vaccination program; and (iii) shape the communications’ response according to conclusions. Prompt communication of any corrective actions deemed necessary will help increase public confidence by demonstrating compliance of program activities with laws, regulations, contracts, strategies, and policies.