With two COVID-19 vaccines developed by Pfizer and Moderna on track to be approved for emergency use authorization (EUA) in the U.S. by the Food and Drug Administration (FDA), the next big hurdle remains: How will the vaccine reach those that need it the most?
“The delivery of hundreds of millions of vaccine doses, is a logistics challenge that’s unprecedented,” said Eric Chetwynd, general manager of healthcare at Everbridge. “Although promising, distribution is being introduced at a time when COVID-19 cases are increasing, and healthcare systems are managing surge capacity. Many health systems are looking to plans implemented during H1N1 to guide them.”
As U.S. officials await approval, distribution of the Pfizer/BioNTech COVID-19 vaccine is already underway in the U.K. following their announcement of authorization from The Medicines & Healthcare Products Regulatory Agency.
Like the U.K., the U.S. has also preordered Pfizer/BioNTech’s vaccine (100 million doses). In the U.K., the MHRA has recommended that healthcare workers and residents of long-term facilities receive the vaccine first and similarly, an advisory group to the U.S. Centers for Disease Control (CDC) has provided the same guidance. Upon approval, the U.S. will initially release 6.4 million doses of the Pfizer vaccine as they await authorization of the Moderna vaccine.
With the EUA decision by the FDA, infectious disease experts estimate that the vaccine will likely be available in the U.S. at the start of the new year with plans to prioritize distribution to healthcare and essential workers and our most vulnerable populations nationwide. Distribution to the general population could be as early as April.
Given that there will initially be a restricted vaccine supply, the CDC provides guidance in their COVID-19 Vaccination Program Interim Playbook, prioritizing distribution among the following populations:
Healthcare personnel
People 65 years of age and older (including those living in LTCFs)
Adults with high-risk medical conditions who possess risk factors for severe COVID-19 illness]
Non-healthcare essential workers
According to the CDC, there are about 21 million healthcare workers, including people who work in hospitals, long-term care facilities, home healthcare, pharmacies, emergency medical services as well as in public health and about 3 million older Americans living in skilled nursing or long-term care facilities.
Roll-out to Front-line Healthcare Workers
Even if all goes according to the federal government’s plan for rolling out a coronavirus vaccine, many hospitals will initially receive just a fraction of the doses they’ll need to cover their health care staff.
“During the initial phase of distribution, due to limited supplies hospitals won’t be able to vaccinate every staff member at the same time,” said Chetwynd.
“Hospitals will need to stratify distribution based on a combination of risk factors including staff health conditions and direct care responsibilities.”
Each of the vaccines currently on track for EAU approval by the FDA require two doses distributed over multiple weeks and given that each vaccine is different, they are not interchangeable. To add to the complexity, some of the vaccines require extremely low-temperature storage. For example, Pfizer’s vaccine requires storage at ultra-low temperatures (-94 Fahrenheit). While Moderna’s vaccine can live in a standard refrigerator for 30 days, once thawed, providers must administer the vaccine within 12 hours — or toss it out. Proper freezers, handling, and storage of the vaccine will be necessary to ensure the effectiveness of the vaccine.
“Each vaccine tray contains about 5,000 doses with an estimated cost of a single tray at $100K,” said Chetwynd. “Hospitals are also required to distribute the first tray before receiving additional trays. Losing a tray would be costly and could severely impact dose availability for staff.”
Technology: How Hospitals Can Prepare
In response, hospitals will need new ultra-low temperature freezers and monitoring systems to ensure the vaccines stay at the appropriate temperature.
“A strong surveillance and response system will help hospitals protect, monitor, track and automate the distribution of vaccines as they become available,” said Chetwynd.
Most facilities may need to update technology to track and report vaccine distribution, ensure the second dose is delivered in a timely manner and report adverse reactions, as required by the CDC. Reporting adverse reactions will help determine whether the reaction was related to a particular vaccine batch or if there were other contributors including mishandling or improper storage of the vaccine. This data will need to be shared with health authorities and made publicly available.
“Technology solutions can help automate the process by offering wellness checks to monitor for adverse effects and the option for patients and staff to check-in through a polling feature to verify when they’ve taken the appropriate doses or if there experiencing adverse reactions” said Chetwynd. “A data driven system that can track, monitor and report every step – from distribution, patient and staff receipt of both doses, follow-up care and the effectiveness of the vaccine, will provide a clear picture of any gaps that need to be closed.”
Roll-out to Long-term Care Facilities
As cases rise among our most vulnerable populations, the urgency for the initial phase of vaccine distribution is only increasing. According to the COVID Tracking Project, 40 percent of the nation’s COVID-19 deaths originated within long-term care facilities (LTCF). To address this, as part of Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) are partnering with CVS and Walgreens to administer COVID-19 vaccines on-site to residents and staff of LTCF nationwide free of charge. This is critical given that many long-term facilities may not have the capacity to store the vaccines or adequate staffing to administer vaccines on-site.
Having health care workers visit the facility to administer the vaccine will be key as it may be difficult for some LTCF residents to travel to an off-site vaccination site. Measures to ensure those visiting have received a COVID-19 test and are following proper infection control protocols must be in place to mitigate risks.
The measures that are being taken now by hospitals and long-term facilities, will set the stage for the next phase of vaccine distribution to the general population. A strong communication strategy for providing updates and new information on what to expect, why vaccine is important and continued provider outreach will further help hospitals and long-term care facilities coordinate with health authorities to adapt and respond to this unfolding situation.
“Although each public health crisis will always have different nuances, insights gained from COVID-19 will help shape the way we prepare and respond in the future,” said Chetwynd.
Nearly everyone agrees that life won’t return to normal anywhere until a COVID-19 vaccine is widely available, but experts are working on ways to achieve something that approaches normalcy given the limitations of epidemiological technology.
As many U.S. states prepare for limited reopening of some nonessential services in the coming weeks, people are looking for inspiration to areas of the world that are further along the recovery curve. They are finding no easy answers.
Experts note that the goal of a restart effort isn’t to shut down transmissions entirely but to limit the reinfection rate to a ratio of less than one-to-one. In other words, if each infected person infects less than one other person, the incidence of the disease will go into a natural decline. With this goal in mind, a limited restart is possible if sufficient testing is available.
Theme park lovers will be closely watching the experience of the Walt Disney World resort in Shanghai, whichhas partially reopened with restrictions that include temperature screens for every visitor, mandatory face masks, and the need to present a QR code using a government-mandated mobile app that verifies park-goers as healthy. Because it’s unlikely that government mandates will work in the U.S., entertainment venues here will probably need to impose their own verification procedures.
Companies that are reopening in the U.S. are routinely requiring workers to wear surgical masks and checking temperatures at the door. They’re bringing in extra cleaning crews and many are changing floor plans to minimize the need for people to interact directly with each other as well as opening additional entrances and exits and staggering shifts.
Volkswagen has compiled a list of 100 changes it’s making before opening factories this week, including a requirement that workers not pass materials to each other by hand and that they line up single-file six feet apart to enter factory gates.
On a more macro level, researchers are developing statistical models that may be used to determine the conditions under which offices, restaurants, and entertainment venues can return to partial operations using testing only or without testing at all.
Two Microsoft researchers applied exhaustive statistical analysis to determine the optimal testing scenario for flattening the curve. Using lessons from South Korea and Taiwan, they propose that a strategy that uses precision contact tracing and targeted testing could effectively contain the outbreak with as little as 5 million tests per day across the U.S. and a total cost of $30 billion.
Amore pessimistic study from Harvard’s Harvard’s Edmond J. Safra Center for Ethics estimates that the U.S. will need to administer 20 million tests per day by Midsummer to safely lift lockdowns. Just over 4.1 million tests have been administered to date in total.
The Microsoft researchers also model an imprecise tracing approach in which those who are infected report their own location history and also track the location history of others to determine if there is an intersection that requires testing. While this technique would catch about 90% of all transmissions, it would cost $500 billion or more, the researchers estimate. Although that number is staggering, it “compares to estimated costs of more than even the worst-case estimate for each month of continued uniform lockdown,” they note.
Researchers at Israel’s Weizmann Institute of Science haveoutlined a minimal-testing scenario in which the population would be divided into two sets of households and people could work or visit entertainment facilities four out of every 14 days. This would bring the spread of the disease down to manageable levels without requiring large-scale testing, they argue. While the economic impact would still be significant, it would be less serious than under the current full lockdown.
Bottom line: For now there appears to be no shortcut to fully normal.
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Last week, former Deputy Director of FEMA, Richard Serino, joined us to share his thoughts and experiences on how to prepare for an epidemic/pandemic as a public health official. As the 2018 flu season is already well underway, he focused much of his presentation on influenza preparedness, citing previous flu pandemics as well as discussing this year’s flu season and how government officials across departments can all pitch in to help keep the public healthy. During his presentation, Richard broke down his method for epidemic/pandemic preparedness into 10 manageable steps. In this blog, we’ll dive into his insights into the first step: leadership. If you’re interested in hearing all 10 of Richard’s steps for epidemic/pandemic preparedness, you can watch a replay of the entire webinar here. Richard took a look at the role public health officials take in terms of leading the fight against disease outbreak, and he came up with the following best practices:
Regardless of what type of organization you are a part of, make sure to encourage staff to stay home if they are sick.
When addressing the public about a potential outbreak, ensure that you are transparent and honest with your communications. Inform them of everything you know and don’t be afraid to admit that there may be things you do not know yet, but you are working towards finding answers.
Giving action items, such as coughing into your elbow instead of your hand, helps the public feel a sense of control over the situation and reduces panic.
Remind the public that your knowledge of the situation will change as it continues to unfold. Known information may change and ‘unknowns’ may get answered as an outbreak progresses.
Provide clear policies, but be transparent about changes. Public health policies should be in place, but may need to change as an outbreak progresses. If a policy needs to be amended, be clear as to why the change is necessary or beneficial.
Have a trusted, local expert provide communications. People are more likely to follow directions if they are provided by someone they recognize or trust as an expert in public health.
Before any outbreak ever occurs, ensure that local officials in all departments already have a good relationship with public health officials so cross-department communication is easy and trusted.
All members of a public health department should coordinate on what information they are broadcasting. Additionally, information should flows sideways to other departments so they can also provide the same message if asked (i.e. fire department, police department, etc). Leaders in other departments will also have other conduits for sharing information such as neighborhood watch programs, faith organizations, etc.