12 Oct 4 key challenges to a COVID vaccine management solution
by Dr. Suman De
In April, a survey found that over 90 percent of respondents were at least somewhat concerned about pharmaceutical supply chain disruptions due to COVID-19, with less than 10 percent saying they were not concerned. And those stats are not without good reason. The novel coronavirus poses new and disruptive challenges for public health agencies to undertake a large-scale immunization program (probably the first of its kind) that must be met with creative solutions and best strategies. Unfortunately, most current vaccine management systems are legacy, ill-prepared to administer the long-awaited COVID-19 vaccine once it becomes widely available. Riddled with outdated processes, unscalable technology, and poor integration setups, vaccine providers are in for a wake-up call.
As the world eagerly anticipates the advent of a successful COVID-19 vaccine, systems everywhere will need to be prepared to administer it—and this is no small task. Since the world is larger and more connected than it ever has been, and a pandemic of this magnitude has not hit the worldwide population since influenza in 1918, there are naturally going to be some bigger challenges than before. Hence, to ensure timely and equitable access to the new vaccines essential to preventing and containing the old and any new outbreaks, the public health care delivery system must reconfigure its systems and make additional efforts to strengthen the overall immunization infrastructure.
In this article, we’ll take a look at four primary areas of concern as providers, scientists, epidemiologists, public health officials, and government policymakers evaluate current vaccine management systems in a new light: scale, unknown factors, logistics, and program administration.
First and foremost is the sheer size of the COVID-19 outbreak and the ensuing vaccination process to be comprehensive and equitable. A vaccination program of this size has never been done before because the worldwide population has never been this large before, nor has there been an outbreak this large.
To give you an idea, let’s compare the coverage requirements of the flu vaccine with COVID-19: the flu vaccine can be done successfully with about 40–50 percent coverage. But with COVID-19, the country will require approximately 100+ Million doses more than typical flu season, and at least 70 percent coverage to reach an acceptable herd immunity level. That’s well over a majority of the entire population (roughly targeting 2.4 million people each day across the country for the first dose only), leaving little room for error.
Even after surmounting the demand versus supply challenges, vaccinating such a vast cohort in an aggressive manner (safely immunizing as many people as possible, as quickly as possible) and simultaneously running the existing vaccine-preventable disease programs will require the jurisdiction to adopt a highly scalable, novel, and innovative vaccine management technology solution.
The existing vaccine management systems (though they can manage for flu vaccination) are not really designed to handle the scale that the COVID vaccination program demands. Hence, trying these systems for effective COVID vaccination delivery by integrating with many new providers and their systems and additional different channels is likely to face massive breakdowns.
Because of the urgency and novelty behind the COVID-19 vaccine, there will still be many unknowns when the vaccine is approved for global rollout. As a first of its kind drug with testing and trials being conducted at a fast pace, it may not wholly represent every socio-economic, behavioral, and demographic factor or medical condition of the citizens receiving the vaccine. It will be challenging to know what variables have been taken into account and what effects to expect in different population groups. Due to these uncertainties and limited information (indications and contraindications) being readily available, there will be several areas vaccine administrators will have to be ready to react to that they haven’t necessarily had to address in the past with other routine vaccinations:
Potential adverse reactions: Everyone who receives the COVID-19 vaccine must be monitored for possible side effects. Additionally, response and follow-up data must be gathered and sent to the state and CDC to ensure there are no larger adverse events associated or to analyze the new drug’s safety and success rates. There will be an institutional demand to understand what vaccine products or batches are problematic, their effects, the reaction types (local, systemic to anaphylactic and their extent of aggravations and casualties), wrong vaccine sources, incorrect ages, incorrect routes, health condition contraindicated, etc. Large amounts of adverse reactions will also pressure local providers and public health departments to provide continuous monitoring, adequate case management, and clinical aid.
Anti-vaccination resistance: Misinformation, fear of the unknown, stigma, and politicized public opinions may lead to extensive selections of the population refusing and resisting vaccination, slowing down the charge to reach 70 percent coverage and threatening the ultimate success of the vaccine program. It will also be challenging to mobilize population groups who have long been in various states of quarantine or isolation. Advocacy and awareness campaigns will be critical more than any preexisting vaccination.
Ineffective batches: Recalls and defective batches are a fact of pharmaceutical administration. We know that. But what is unknown is how to respond to weak or ineffective batches of this new, novel vaccine, which clinics and vaccinators have no prior experience with. Clinics need to be prepared to safely and securely handle these unsuitable batches. This includes follow-up with anyone already given an ineffective dosage, proper waste disposal, and stringent data logs.
There’s also a whole host of logistical challenges we know vaccine management will encounter regardless of how and how much of the vaccine is received: What does the supply chain look like? Will all the points of dispensing have the vaccine storage capability? Will they be able to comply with the required ultra-cold chain requirements? Will the efficacy be maintained on the shelf or in the freezer? What preparation is needed to administer the vaccine? How much time does it take to prepare? Does the facility have space to house the vaccine and clinical administration while still maintaining social distancing and crowd control requirements? What compliance and regulations will local organizations demand? How much supply can they hold, and how fast can they reorder? What happens when the supply chain is disrupted and how any unexpected bottleneck in logistics will affect the integrity of the entire program delivery?
It can get very complicated very quickly. The workflow of delivery, storage, cold chain maintenance, preparation, reconstitution, and, eventually, administration of a single vaccine dose is far more involved than many citizens may realize. Clinics and providers need to be equipped with a complete end-to-end program, providing visibility into the supply chain at every stage so potential inventory and cold chain problems can be forecasted and resolved well in advance. Governing jurisdictions also need to better prepare for maintaining those distribution channels at optimal efficiency.
Due to social distancing measures and state regulations, the COVID-19 vaccine can not be performed as a walk-in. Although walk-ins are in many ways easier on the general public and often lead to higher immunization rates, the COVID-19 outbreak is incredibly unique and fraught with uncertainties, eliminating the option of a walk-in distribution strategy.
COVID-19 vaccine recipients will need to be proven eligible (and, in the beginning, high priority based on age, occupation, and preexisting conditions), their appointment scheduled, follow-ups, reminders, and their individual supplies prepared before arriving on-site and point of service health screening being done to immediately rule out any presence of COVID. This reduces the time of possible exposure and minimizes the risk of contact between staff and vaccine recipients.
Additionally, vaccine administration will require a vast degree of partner technology and system l integration never done or fully leveraged before. From locally run departments of public health, mass vaccination clinics, private-sector contract immunizers, school vaccination camps, college health clinics, and healthcare providers to pharmacy chains, nursing homes, long-term care facilities, and even occupational health clinics will all become a part of the delivery ecosystem and will necessitate information exchange and collaboration.
Most current systems will only allow vaccine administrators to do some fragmented jobs. This falls in line with the standard, historical guidelines, but it will fall short of the new CDC mandates for COVID-19 vaccination. Requirements will include capturing and processing new data, submitting reports within 24 hours to manage adverse reactions and order management. Providers will have to document and report daily on how much of the drug has been used, wasted, spoiled, and the forecasted demand for supply. All these make the COVID vaccine administration a new challenge for jurisdictions and especially when the pandemic still continues.
In the current context of the crisis triggered by the novel coronavirus, the mass immunization of the population through effective and safe vaccination is recognized as a new public health priority and challenge. Hence, to ensure the world gets the vaccine for the right people and with the right administrative and therapeutic support will require a higher degree of program visibility, system scalability, integration, and collaboration between historically fragmented and siloed organizations.
The Infosys/Simplus vaccine management solution has been designed with these challenges and concerns in mind. Prepared to scale and flexible to adapt to ever-changing conditions, the IVM is a best-in-class solution for comprehensive, dependable vaccine administration.
Dr. De is Infosys Public Services’ Head for Government Healthcare Solutions. In this capacity, he is responsible for the ideation and development of next-generation solutions for public health agencies. He has vast experience in the public health domain, and his previous work experience ranges from involvement with Govt. of India’s National pulse polio immunization program in collaboration with the World Health Organization and various other public health projects conducted by international organizations like UNICEF, Indian Public Health Association, etc. He has been recognized as a subject matter expert (SME) in healthcare for his contribution to the industry through thought leadership, point of views, articles, workshops, running webinars, and speaking sessions, among others. Dr. De is a graduate in medicine from India and holds a Masters in Healthcare Administration from a premier business school in India. He is the recipient of several awards of excellence in recognition of his work for the healthcare industry.