Yesterday morning, the CNBC Co-Anchor of “Squawk on the Street,” Jim Cramer said something that all Americans reeling from the pain of Covid-19 suspect. In an interview with Operation Warp Speed’s Chief Science Advisor, Dr. Moncef Slaoui, Cramer challenged the depiction of the administration’s “plan” for an organized distribution and delivery of Covid-19 vaccine(s) and described the current situation as pure chaos with a huge gap in planning. It was a much-needed challenge to the current superficial US Government’s CDC description of vaccine implementation with all of its missing details. Below is an excerpt of Cramer’s most telling words and his direct assessment should give pause to any American holding positive expectations for a smooth vaccine distribution.
Cramer’s Critical Words:
No one knows what’s going to happen. You think CVS knows what’s going to happen? You go to your CVS in two weeks and they’re going to say ‘listen, when we get the plan, we are ready to roll.’ I have done the homework on this, sir. You are not ready, and it’s not just that you don’t have enough vaccines, it’s just because no one has a plan down there.
Succinctly, the immediate takeaway is that nothing will be accomplished without clear instructions, and given the Trump Administration’s checkered history with any Covid-19 operations, that might be asking too much. That leaves us with the needed planning to be done by the forthcoming Biden administration, which stresses the need for immediate cooperation between the current task force and the incoming administration’s COVID task force (Which is currently not even legal!).
Simply put, as current general planning statements describe, it is of no use to declare that pharmacies will be among the vaccine distribution sites when the pharmacies are ignorant of what that entails today, tomorrow, and especially three months from now. If every community is to have a pharmacy distribution site, enlisting other companies in addition to CVS will be necessary, and for some communities, privately owned pharmacies will be needed. Even then, people in rural and/or under-served urban areas will need transportation to the distribution sites. So just declaring that a particular pharmacy chain or all pharmacies will be the distribution points is insufficient. And how will these private enterprises be compensated for use of their facilities and staffs? As we have painfully learned, declaring preparedness does not make it so. What follows are many of the essentials needing incorporation into a national plan. And as with any chain, it is only as strong as its weakest link.
As the headlines all say, the Pfizer COVID-19 vaccine will be reviewed by the Food and Drug Administration FDA Advisory Committee on December 10th, prior to granting them an Emergency Use Authorization (EUA). And this is encouraging, but developing a safe and effective vaccine is just the beginning of the challenge. Getting the vaccine to thousands of locations in the U.S. so it can be injected into arms of all willing Americans is a daunting project.
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The vaccine delivery and administration initiatives are Herculean and complex undertakings. It will require multiple simultaneous and sequential activities, all of which must be synchronized. Failure or delay at any step of the process will compromise the success of the entire operation on which millions of lives depend.
The following is an analysis of the challenges faced from manufacture to injection to monitoring. Each aspect of the project is separated into categories of logistics, defense, and social. Many steps of the process offer financial opportunities for those willing to look beyond investment in vaccine developers. Those with foresight, will recognize the risks and opportunities each challenge affords.
Once a vaccine is proven to be safe and effective, it must be manufactured in quantities sufficient to meet national and international demand. No single vaccine is likely to satisfy global or even U.S. requirements. Multiple vaccines will be derived from similar or complementary technologies to meet the demand, thereby further complicating a complex process. Each will face similar development and approval requirements, but each will present unique challenges in manufacturing, distribution, administration, and monitoring.
Since the Pfizer and even the Moderna vaccines each require two doses, hundreds of millions of disposable items will be needed to vaccinate the U.S. population alone. Liquid vaccines are most often packaged in sterile, 10-dose bottles fitted with a specialized cap to allow multiple needle punctures for vaccine withdrawal. At the sites where the vaccines are administered, each injection will require needles, syringes and swabs, and every worker will need gloves, masks, and gowns for personal protection.
Once manufactured and packaged, the vaccine must be stored in controlled climate containers to preserve potency. The Pfizer vaccine must be maintained at -90º Fahrenheit, while the Moderna vaccine can be stored in laboratory refrigerators. Unimaginable quantities of dry ice or, preferably, specialized freezers and transportable containers will be needed. Neither of which is currently available in sufficient quantity.
Distribution is the next challenge. The current plan calls for the military for to perform the initial phase of distribution. Each delivery team will need to be trained on the handling and safety requirements for transporting these vaccines. The safely stored vaccine must be transported to warehouses in each state and then to the state designated Points of Distribution (PODs) under the specified rigorous cold storage conditions. This will require deployment of specially equipped airplanes and trucks that are able to maintain the temperature requirements; these are also in short supply.
Security is a pervasive concern. At each step in this process, there will be need for securing the vaccine from threats both domestic and foreign. This is discussed in greater detail below in the defense against threats section.
Each state is charged with developing a plan for distribution and administration of the vaccine. Because initial supplies will be limited, this includes assigning citizens to categories of priority for vaccination. Most states will assign highest priority to first-responders, followed by those at special risk, followed by the public at large. Because there is no national plan, there will be at least 50 separate distribution protocols to coordinate, and each state will need to identify and contract for PODs.
State and local governments will be pressed to provide the people and secure funding to implement vaccine administration. It will do no good if a POD has vaccine and supplies but lacks the appropriate staff and equipment for its administration. Each POD will require clinical, clerical, and security services. It is unclear how the staff will be recruited, hired, and trained or who will be the designated employer for their services.
Before any patient arrives for vaccination, there must be a system of identification and scheduling. Each state must determine how to identify those eligible in each priority category. It is unclear how individuals will register for vaccination, what information will be collected to assign tier placement, and how that information will be validated. Since there will not be enough vaccine to treat all of those in the first tier, some form of lottery will likely be employed. (For example, New Jersey estimates that 500,000 people would be in the first tier for receiving vaccination. The first tranche of vaccine is expected to be 86,000 doses, which will be enough to vaccinate only 43,000.)
Because both the Pfizer and the Moderna vaccines require two doses, administered at different intervals, and since the vaccine from one manufacturer cannot be mixed with vaccine from another manufacturer, it will be necessary to schedule all vaccinated patients for two vaccination appointments of the correct vaccine. Implementing this whole process will require computers at each POD, with newly created sophisticated, and specialized software. The equipment must be portable and secure. The data must be collected in real-time, not only to track that an individual received both doses but to gather long-term efficacy and safety information.
Security will involve more than protecting the vaccine supply from theft. Each POD will need security officers to protect the staff and patients from harm or abuse as well as to provide traffic and crowd control.
It is unclear whether a waiver of liability for adverse events resulting from the vaccine will be necessary or legally defensible and each site will need liability insurance to cover slips, falls, or other accidents.
Defense Against Threats and Error Reduction
It is important to prepare for interference in the vaccination implementation process. A lifesaving commodity in short supply is certain to attract hijackers, black marketeers, and purveyors of mock or adulterated vaccine. The military will provide the initial shield during the transportation and distribution phase. It is unclear if they will be asked to maintain a presence at the various POD sites. There will be those opposed to the vaccination initiative. Their rights to express their opinions must be preserved but disruption must be prevented. Will security personnel carry arms, and if so, what will the requirements be for use of force?
In addition to physical threats, safeguards must be in place to protect the security of the information both for data preservation and privacy maintenance. It is unclear how much personal data will be collected from each patient. Some people may be reluctant to be forthcoming about risk factors such as genetic illnesses or chronic diseases out of fear of repercussions at work or from their insurance carriers.
Whenever humans are involved, human errors occur. There must be a concerted effort to reduce these errors. Once thawed, the vaccine begins to lose its potency. One estimate for the Pfizer vaccine potency is 5 hours after thawing. There will be tremendous pressure to administer the vaccine to as many willing people as quickly as possible. To that end, staff may feel overwhelmed. That is when errors occur. Either due to fatigue or distraction or both, needles may not be changed between doses, contaminating the subsequent doses. The incidence of staff needle-sticks increases. If left out too long, the vaccine loses its potency so, even if administered, it will provide no beneficial effect. All these errors can be reduced with adequate staffing and training. There may be urgency, but it must not be translated into carelessness.
Not even considering the massive secure database requirements, this vaccine administration initiative will only be effective through clear, coherent, and consistent messaging about safety and effectiveness. With multiple vaccines likely to be available at any one time, confusion will be avoided only with public education. Because it will take months to years before one vaccine proves to be superior to the others, citizens need to be willing to take the one that is the most readily available at the time and avoid trying to travel to another state for a different vaccine.
In addition to the reluctance to disclose personal medical information for fear of repercussions, there may be religious or cultural resistance to being vaccinated. Again, transparency, education, and dialog are the best tools available to deal with that situation.
By definition, any complex activity that takes place on a national scale and requires military-like precision carries an element of danger. If anticipated, much of the danger can be ameliorated or avoided. It is also likely that no matter how thorough the planning is, there will be unexpected events once the project is initiated, therefore, flexibility and adaptability also will be important requirements for efficient and effective nationwide distribution of a Covid-19 vaccine.
In the end the lives and well-being of all Americans is being placed on the development, manufacture, delivery and administration of vaccines to control Covid-19. This effort must be conducted in a carefully planned and professionally implemented manner and as Jim Cramer pointed out, there are no plans, hence rather than a predictably reliable roll-out, chaos should be expected. We all remember the hackneyed but true adage – If you fail to plan, you plan to fail.