Health care leaders faced many unforeseen challenges in 2020. Organizational processes were upended overnight, with strict safety practices defining the way forward. Meanwhile, federal, state and local regulations shifted daily, putting even more pressure on decision makers.
The newest logistical challenge for health care administrators is the distribution of the COVID-19 vaccine throughout their hospital or health system. Not only must they work through the supply chain process, but they must also champion the efficacy and safety of the vaccine itself.
Overview of COVID-19 Vaccine
It’s important to level set on what was a highly accelerated COVID-19 vaccine development process by understanding that similar vaccines were already being studied. According to the New England Journal of Medicine (NEJM), once the global Coalition for Epidemic Preparedness Innovation (CEPI) became aware that this was a novel coronavirus, they were able to identify possible vaccine partners.
While it can take decades to bring a vaccine to market, the advance work that was being done on MERS and SARS-CoV-2 allowed for the process to be advanced rapidly. It may seem that these new MRNA (messenger RNA) vaccines have been rushed through to approval, but the reality is that they have been in development, in some form, for years.
Stages of COIVD-19 Vaccine Development
National Geographic reports that 150 different coronavirus vaccines are currently being studied in countries across the globe. The World Health Organization is also part of the development process, helping to coordinate efforts. The goal? Two billion doses by late 2021.
It’s an aggressive timeline when you consider each of the steps that must be part of any vaccine trial and approval. Johnson & Johnson, through their Janssen Pharmaceutica subsidiary, is working on a single-dose vaccine and communicates these five stages of development on its website:
- Preclinical Stage
At the outset, researchers look at how a vaccine will work in terms of immune response and protection against the virus.
- Phase 1/2a and 2b
For COVID-19, Johnson & Johnson combined what would normally be two phases (1 and 2) into one stage. Small human trials were conducted to determine the safety of the vaccine, as well as the dosing strategy.
- Phase 3
Phase 3 ramps up the clinical trial, recruiting tens of thousands of additional volunteers to support vaccine development. Half are injected with the COVID-19 vaccine and the other half receive a placebo.
- Regulatory Approval
Once Phase 3 proves successful, researchers can apply for approval to the U.S. Food and Drug Administration (FDA) and similar international bodies. The safety and efficacy of the vaccine are reviewed, along with the ability of the company to manufacture a consistent quality product at scale.
- Phase 4
Phase 4 encompasses ongoing oversight by the FDA and other regulatory agencies to safeguard production by visiting manufacturing facilities and testing the vaccine product for quality assurance
COVID-19 Vaccine Distribution
While the single-dose Johnson & Johnson vaccine is still in Phase 3 development, two-dose vaccines from Pfizer and Moderna are already being distributed to health care facilities and some retail pharmacy providers. Hospitals and health systems are receiving deliveries based on their ability to safely store the vaccine in either deep freeze and/or traditional freezers. The challenge now is three-fold: securing the vaccine, determining who is eligible to get the vaccine first (and next), and tracking the progress.
Security
According to The Hill, worries about a potential black market for vaccines have grown over time, posing a real threat to the greater population. United States law enforcement has warned against “criminal syndicates” that seek to acquire the vaccine for profit. Interpol has also alerted its 194 member countries against potential vaccine theft.
Health care leaders are doing whatever it takes to secure their supply. Facilities are deploying security cameras in sensitive areas, hiring guards to watch over vaccine storage sites, and using auditors to keep track of distribution by dose.
Eligibility
Most hospitals and health systems are rolling out distribution plans that prioritize doctors and nurses. Some are scheduling personnel via email based on their unit and exposure risk, others are using complex algorithms to decide who should be first in line.
Fortune magazine interviewed vaccine initiative leadership at the Mayo Clinic, learning that the organization developed a grid of tasks and units. This grid helps to determine who is at the greatest risk of contracting COVID-19 to give them priority, including non-clinical workers who have patient contact. As a multifacility health system, the Mayo Clinic must also factor in sporadic vaccine shipments at different locations. Leaders expect several “waves” of vaccine distribution over the months ahead.
Tracking
How much vaccine did we get? Who gets the vaccine first? Who gets it next? Who already got it? When do they need their second dose? Which vaccine did they get for the first dose? What have the side effects been?
There is an enormous amount of data to input and track regarding vaccine distribution. That’s why Microsoft and its partners have been working on technology solutions that can make vaccine management easier. These solutions use scalable and cloud-based applications to help health care administrators get real-time visibility into what is happening within their organization, while also supporting the reporting requirements of local, state and federal authorities.
The Challenge of a Lifetime
No health care executive ever trained or planned for how COVID-19 would challenge their organization, their knowledge or their wherewithal. All were forced to think on their feet, collaborate more widely and learn by trial and error.
The next generation of administrators will learn differently, studying the virus and the vaccines in real time as outcomes and implications emerge over the next few years. You can be among them with an executive MHA online from the USC Sol Price School of Public Policy. Find out more today.
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