By Manasi Gajjalapurna
As COVID-19 has spread across every single country on our planet, governments around the world are initiating vaccine distribution and monitoring, and setting comprehensive standards in order to avoid major roadblocks along the way.
Many of the challenges with current vaccine distribution lie in 4 main areas — logistics, health outcomes, user-centric impact, and communication. Each of these challenges plays an immense role in the spread of disease, individual behavior, society, economy, and data privacy alike.
Through logistical planning, a diverse range of populations and countries of differing economic, racial/ethnic, and cultural backgrounds, as well as varying age groups requires careful consideration in order to ensure equitable vaccine distribution.
Due to the current circumstances and severity with which the COVID-19 pandemic has brought, the past several months have ushered in an unparalleled period of rapid vaccine research, development, and production.
The efforts of the COVAX Initiative have contributed to the success of the Pfizer vaccine, which must be administered in 2 doses 21 days apart, and clinical trials have proved it to be 95% effective at preventing laboratory-confirmed COVID-19 illness in individuals without evidence of previous infection.
However, there is currently no seamless framework for vaccine allocation, distribution, and administration.
We are only just beginning to assess the effectiveness of a vaccine and its long-term effects on health outcomes. The incredible speed of vaccine development cannot stand alone; it must be supplemented with long-term monitoring of vaccinated individuals in order to further understand the characteristics and/or consequences of vaccination.
Furthermore, there are several challenges surrounding consumer privacy and individual behavior; from vaccine hesitancy, accurate information sharing, and individual data privacy.
There is a large gap in the communication of vaccine information between governments, companies, and the general public. In our current era of misinformation and politicization of science, clear and transparent communication is the key to achieving widespread vaccination.
The complexity of planning the production, allocation, distribution, administration, and monitoring of hundreds of millions of COVID-19 vaccinations poses a broad range of challenges.
In order for logistical and equitable distribution, vaccine production, prioritization, distribution, equity, and record-keeping must be taken into account.
Production: Demand for COVID-19 vaccines internationally outstrips current supply chains. In the US, the COVID-19 vaccine might not be widely available to the general public until the middle of 2021.
Prioritization: Most COVID-19 vaccine rollout plans suggest that healthcare workers should be the first to receive the vaccine, yet organizations including the National Academy of Health, the WHO, and others have developed their own distribution guidelines. While a CDC framework for vaccine distribution exists, it is limited due to its ambiguity and is dependent on factors including efficiency rates and length of vaccine immunity in different regions.
Distribution: The Pfizer Vaccine, among others, must be stored at sub-zero temperatures during both transport and storage. In developing countries, storage facilities may lack vaccine-qualified refrigerators, which could greatly affect the efficacy and storage life of vaccines. Furthermore, there is no proper data monitoring framework in order to track and evaluate the transport and storage conditions of vaccines distributed widely across many countries, meaning that it may be difficult to ensure that a shipment of vaccines has been properly stored throughout transit.
Equity: Equitable distribution of the vaccine is an enormous challenge, as economic and racial disparities can be exacerbated by inappropriate or unequal eligibility criteria for vaccine distribution. Internationally, wealthier and more influential nations might also have increased access to limited vaccine doses.
Record Keeping: Following vaccine administration, obtaining and maintaining secure and thorough immunization records for patients will pose several challenges. These records are imperative in understanding which segments of the population have been vaccinated to guide distribution as well as public health policy while being used to monitor long-term efficacy, duration of immunity, long term side-effects, and compliance to the two-dose regime required by the Pfizer vaccine.
Consequences of Unaddressed Logistical Challenges
A lack of an effective digital framework to monitor vaccine allocation, distribution, and storage could result in inefficient vaccination. Vaccines that are lost and incorrectly transported are wasted, and inadequate monitoring systems can hinder investigative procedures into vaccine distribution or storage errors. This allows for supply chain problems to persist longer than necessary while resulting in higher economic costs.
There can be long-term negative impacts on individuals due to inadequate logistical preparation for vaccine distribution. Individuals of certain regions will be less likely to receive a vaccine, and an individual unable to receive one in their area may choose to travel elsewhere for vaccination, which poses them at a higher risk to receive the disease.
The consequences for individual behavior could be more widely observed in societal behaviors, such as more widespread mistrust in the government and regulations. Disparities in vaccine distribution also have the potential to further widen socioeconomic divides between races and classes.
If a country does not carefully monitor the total pipeline of vaccine distribution, there may be opportunities for theft and counterfeit vaccine delivery. Privacy concerns can also arise as private information, including health records, will be collected for some individuals receiving a vaccine, and a framework must be in place to safeguard against improper usage or access of personal data.
Therefore, it is crucial that systems are put in place to coordinate and monitor the distribution and administration of COVID-19 vaccines. Vaccine distribution must be coordinated across a variety of private and public sectors including governments, manufacturers, and transport agencies. Systems must also be in place to target errors quickly and steps must be taken to ensure a transparent methodology that enables the public to directly observe that there are no unintended biases in vaccine distribution.
Simple technology such as the barcoding of individual vaccines can help address problems that may arise along the vaccine supply chain and may be useful in monitoring long-term safety and effectiveness.
Through the deployment of the vaccine, the limited amount of data and previous knowledge of similar vaccine platforms provides insight into some of the potential challenges with the potential reactogenicity of mRNA vaccines, potential issues with multiple-dose regimens, and HIV susceptibility for adenoviral vector vaccines:
mRNA vaccines: mRNA vaccines are ideal for rapid vaccine development and previous clinical trials have examined their efficacy with promising results. While trials with the Moderna and Pfizer vaccines demonstrate greater than 90% efficacy and no serious side effects, these results only represent a small number of patients.
Adenoviral Vector Vaccines: Another relatively new technology for vaccine development involves the usage of adenoviral vectors, which contain genetic coding sequences for COVID-19 antigens. There are very few vaccines using this technology, yet Johnson & Johnson and AstraZeneca have both taken this route. The primary challenge with this technology lies in the host immunity to the viral vector, and if trials do not account for immunization prevalence in certain populations, these vaccines might be drastically less effective.
Duration of Immunity: Currently, there is no set duration of immunity that we know of. Clinical trials have demonstrated short-term safety. but we have very minimal knowledge of any long-term effects other than our estimations which tell us cannot guarantee any more than around 12 months of immunity.
Efficacy of Immunity: Trials for both the Pfizer and Moderna vaccines have reported over 90% efficacy. although the potential for lower effectiveness must be addressed, and the potential for immunity may wane over time must be addressed.
Vaccination of Special Populations: There is still concern over the immediate and long-term efficacy of vaccine immunity in specific populations such as seniors, children, and immunocompromised individuals. While there have been a substantial amount of these populations enrolled in clinical trials, it is still unknown if long-term vaccine efficacy differs in patients of different age groups or poses a medical risk for individuals with certain conditions.
Consequences from Lack of Attention to Health Outcomes
While the consequences of ineffective or short-lasting vaccines will be evident, these issues are made more complicated but the potential for varied effects among different population groups.
Vaccine efficacy and reactogenicity are among the most critical determinants of individual willingness to obtain a COVID-19 vaccine. Additionally, the duration of immunity conferred by COVID-19 vaccines must be communicated to individuals to help inform their decision-making behavior. While the CDC and several public health officials have suggested that mask-wearing and social distancing will still be needed to optimally combat disease spread even after vaccine distribution, it is likely that vaccinated individuals will be less willing to adhere to these guidelines.
Differences in vaccine efficacy among diverse populations would result in imbalanced prevalences of disease spread and transmission in various regions of the country and the world. Misinformation and a lack of transparency regarding the relative efficacy, side effects, and length of immunity for COVID-19 vaccines might initiate unnecessary fear, rumors, and concern.
A uniform system for both top-down and participatory monitoring of health outcomes for vaccinated individuals can address the concerns of the safety and efficacy of rapidly developed vaccinations. It is imperative that we create a framework to prioritize individual privacy while also gathering enough information to analyze the effects of a COVID-19 vaccine across multiple demographic groups.
In addition to high-level issues regarding the logistics of high-volume vaccine distribution and the effectiveness of new vaccine candidates, it is crucial to consider various issues that are directly pertinent to individual behavior.
Trust in the System: In each country, there are extremely different levels of willingness to take the COVID-19 vaccine, and governments will need to contend with the challenge of raising these numbers in order to widely distribute vaccines. There must be an understanding of which demographics, economic classes, education levels, and geographic locations contain individuals least likely to seek vaccination. Gaining user trust relies on a combination of transparency and clear, effective planning from governments.
Follow-Up Tracking and Multi-Dose Reminders: The Pfizer vaccine, among most other candidates, require two-dose vaccination schedules. The importance of developing systems to record individuals who have received one or two doses of the vaccine and to remind individuals to receive a second booster of the same vaccine type will be of utmost importance.
Data Privacy: The CDC offers various high-level software tools to assist state and local governments including the Vaccine Tracking System (VTrckS) and PANVAX. Other digital products have also been developed by Palantir Technologies Inc., Salesforce, the Maryland Department of Health, Accenture, and SAP in order to address various challenges in vaccine distribution and administration. While these tools could be utilized for identifying and allocating vaccines to high-priority populations, several of these companies have neither disclosed what collected private health information might be used for nor whether any privacy safeguards have been set in place to protect an individual’s name, race, location, travel history, and past health record.
Vaccine Incentivization and Motivation: Primary deterrents for vaccine reluctance are concerns over side effects and low efficacy rates. Governments will need to work to motivate these individuals towards vaccination while grappling with ethical concerns regarding individuals’ right to refuse vaccination.
Consequences of Lack of Attention Towards User-Centric Issues
Left unaddressed, user-centric issues can result in population-level trends in mistrust and low rates of vaccination. Vaccination frameworks must be designed with user behavior in mind lest societal norms outweigh scientific and government guidelines.
Data privacy breaches can result in large-scale fraud and economic loss when instigated by malfeasant parties or result in losses via lawsuits when the result of improper precautionary measures.
Technologies seeking to address issues in vaccine distribution pipelines must take thorough measures to protect user data and privacy, such as individuals’ consent for collecting sensitive information before disclosing their identity. To obfuscate the sensitive personal information, one could guarantee privacy using cryptographic techniques such as hashing, private set intersection, secret sharing, and fully homomorphic encryption.
These tools must be transparent, enabling a user to understand the use of their data. Digital solutions can be more effective and secure than the use of traditional paper methods for user engagement and follow-up reminders.
The public must be fully aware of both the importance of vaccination, as well as the fact that vaccines are only a part of the continued public health framework of social distancing and mask-wearing that must be put in place to overcome COVID-19.
Political Communication: Political leaders who downplay the pandemic or disregard the opinions of health care experts and scientists in an attempt to manufacture good news to the public can stifle a nation’s trajectory towards recovery. A lack of consistent messaging across a country’s top executive and scientific officials creates ideal conditions for the spread of false information and mistrust.
Coordination in Vaccine Distribution: Thorough distribution of a vaccine in both developed and developing nations will require varying levels of coordination between multiple levels of government, private companies, and nonprofit organizations. Within developed countries, the collaboration between national health authorities and authorities at the state, district, and county levels will be required to assess vaccination needs and plan the distribution of vaccines accordingly.
Miscommunication and Trust: Especially in the United States, there is a large divide in the acceptance of vaccines, taking into account long-standing anti-vaxxer sentiment and newly raised COVID-19-specific concerns leading to the reluctance of a COVID-19 vaccine. Systemic biases and discrimination present in medicine have also impacted communication surrounding COVID-19 vaccine distribution.
Misinformation Shared on Social Media: Rumors regarding cures for COVID-19 have led to death and hospitalizations, and have also prompted individuals to be less concerned about mask-wearing and social distancing.
Consequences of Lack of Proper Communication
Intentional and unintentional miscommunication has the power to sway individual and societal understandings of vaccine efficacy and safety.
Miscommunication can reduce vaccination rates and adherence to public health policies, thereby resulting in higher disease prevalence and spread.
Improper or inadequate communication by the government can have dramatic implications for an individual’s likelihood to adhere to precautionary measures in the pandemic. Misinformation that downplays or underestimates the severity of COVID-19 can de-incentivize people from seeking vaccines. Skepticism, doubt, and mistrust can cause individuals to actively reject vaccines, further compounding beliefs that the COVID-19 pandemic is “fake news.”
If governments are not explicit about vaccination procedures, it is possible for bad actors to provide disingenuous information in order to perform fraudulent acts or other malicious actions. For instance, if long-term monitoring is introduced for vaccinated individuals, false apps or websites as were observed in the setting of contact tracing might appear in attempts to steal user information.
Technological advances have the potential to greatly augment effective communication efforts during COVID-19 vaccine distribution. Large social network companies are in positions to take bigger steps to eliminate the spread of misleading information through their platforms. Social media platforms also are uniquely situated to disseminate accurate educational information concerning vaccine development and distribution. It is also critical that governments have intense security built around their technological solutions to prevent unwanted influence from bad actors.
The initial step in overcoming the multitude of challenges associated with vaccination is the proper identification of each potential issue and understanding its consequences on the spread of disease, individual behavior, societal impact, economic impact, and data security. While this list does not address every single challenge likely to be faced over the next several months, these key factors must be taken into account in order to ensure equitable vaccine distribution.
Many of these challenges have still been unaddressed by current vaccination strategies and guidelines and while no easy solutions exist, it is crucial that governments, organizations, academics, and individuals begin to develop the frameworks and approaches necessary to prevail over these challenges and ensure the equitable and effective distribution of COVID-19 vaccines.
About the PathCheck Foundation
PathCheck Foundation, a generously funded 501(c)(3) non-profit spin-off from MIT, is developing decentralized pandemic response solutions using an open-source, open standard interoperable model. PathCheck is committed to sustained innovation in the middle of rapidly changing protocols, APIs, and epidemiological research in the pandemic response. Previously, PathCheck has delivered Google/Apple Exposure Notification-based full-featured apps in 5 US states/territories and multiple nations. The PathCheck Foundation has now developed a new privacy-preserving approach to vaccine rollout and distribution, utilizing a vaccination app and physical cards. Follow updates at https://pathcheck.org/en/blog