HOW TO DISTRIBUTE HOPE

Hope is the pillar that hold up the world. ~ Pliny the Elder  

Was I surprised when American voters cancelled #45’s next “season” at 1600 Pennsylvania Ave? No; the 75 million majority of us weren’t surprised; we were thankful and thrilled. But true to form, he certainly was surprised; saying in his mediocre Barnum-style, “How could they? I’m the greatest.”

But how could he not be surprised with his team of sub-single-A leaguers, led by the indomitably pathetic Rudi Giuliani preaching Lawn and Order at the Four Seasons Total Landscaping back parking lot. Coach Rudi later continued talking gibberish to judges in several states.

These vacuous pranks confirmed my belief that the president’s high-exposure maneuvers to reverse the election via 30 or so zombie lawsuits scattered among seven states have no legal purpose – as judges have substantiated. No, #45’s legal actions, and the media’s fawning coverage, have everything to do with keeping his base upset at the voters’ results and, most importantly, keep them contributing to his campaign slush fund. They’re purely political anti-democratic bleats of the worst kind, with Rudi as co-bleater-in-chief.

Rudi expounding on their vacuous victory at Total Landscaping.

The president’s infantile post-election anger antics echo his long-standing disregard for a key issue that if resolved can restore the physical (and mental) health of the public: how are we going to distribute hope?

The hope I’m referring to is the vaccines that hopefully will be soon available on an “emergency use” basis to mitigate the coronavirus’ onslaught that has now claimed over 268,000 US lives.

This issue encompasses the last of the three “basic questions” that any economic system must address: for whom will the scarce output, here coronavirus vaccine, be distributed? The first two questions are: what will be produced and how will it be produced.

Regarding the “how” question, the federal government decided in late April to initiate Operation Warp Speed (OWS) that has provided substantial public funding – about $10 billion – to accelerate the vaccine’s development and production. Even deceitful, fiscally-recalcitrant Repubs were in favor of providing this government support to the vaccine-developers.

The demand for a covid vaccine will far exceed the available production for the foreseeable future. There are seven major vaccine developers in the US, shown in the table below, five of which have received OWS funding.

Because of the sizeable public funding, the federal government has priority to order significant dosages of these vaccines should their Phase 3 efficacy trials prove the vaccines’ effectiveness to the CDC and FDA. Currently there are 13 vaccines in Phase 3 trials. The government has pre-ordered these OWS vaccines, and also has options to purchase more dosages in the future.

US Covid Vaccine Developers 

Vaccine Developer	Vaccine Type	Required Doses Per-Person	Doses Pre-Ordered+ (Trillions)
AstraZeneca/Oxford*	Viral vector	2	2.40
Johnson & Johnson*	Viral vector	1	0.10
Merck/IAVI*	Viral vector	2	NA
Moderna*	mRNA	2	0.10
Novavax	Inactivated	2	1.30
Pfizer/BioNTech	mRNA	2	0.53
Sanofi/GSK*	rDNA	2	0.73

Sourcist, CD FSources: Economist, CDC, FDA. *Received OWS funds. +Ordered plus options.

The covid-19 vaccine rush has been on since January, when the coronavirus’ genome was first provided by Chinese scientists, less than a month after the first reported case in Wuhan. As noted in the media, the development of these vaccines has been at light-speed, compared to any previous ones. Vaccine development time has been reduced because of a series of important biological and institutional progressions, including vastly improved virological knowledge, accelerated clinical development and more efficient regulatory processes.

The world’s first vaccine was administered by Edward Jenner in 1796 to combat smallpox. Dr. Jenner practiced medicine where he grew up in Berkeley, England. He inoculated an eight-year-old local boy with his pioneering cowpox vaccine. Dr. Jenner’s vaccine successfully prevented the boy from succumbing to smallpox.

It wasn’t until 44 years later (1840) that the British government provided the smallpox vaccine – originally devised by Dr. Jenner – free of charge to the British public. After killing possibly 900 million people over the ages, and thanks to the success of vaccination, the World Health Organization WHO declared smallpox totally eradicated in 1980. Smallpox is the only infectious human disease to date to be completely eliminated.

The 1918-20 Spanish Flu produced many of the 675,000 American fatalities by causing pneumonia in its victims. The flu (and its accompanying pneumonia) was nicknamed the captain of death. The first pneumococcal vaccine was licensed in 1977, after more than 60 years of on and off efforts.

More recently, other diseases’ vaccines have similarly taken quite some time to develop and be utilized. The Salk polio vaccine took nearly 30 years. The Diphtheria/Tetanus/Pertussis (DTaP) vaccine took 20 years. The mumps vaccine was more quickly developed in just four years, relying on medical understanding established during WWII. The FDA approved the mumps vaccine in 1967, and recommended it for general public use a decade later in 1977. The MMR vaccine is routinely administered to protect children and adults from mumps, measles, and rubella.

None of these prior vaccines have faced the challenges that now befall the covid-19 vaccine and its distribution.

Both the need and scope of the tasks surrounding this vaccine distinguish it. In theory, each of the 7.7 billion people now alive on Earth need the vaccine. Let me simplify by focusing only on each of the 330.6 million folks now in the US. We need the vaccine yesterday. This scope and need, as well as development and production realities, creates the inevitable shortage of the covid vaccine, which in turn requires a necessary prioritization for whom receives the vaccine when.

Every public authority has performed “word songs” about this prioritization, in an attempt to sweet-talk the vaccine shortages. They initially sound melodically pleasing, but turn out to be off key. Why? Because their lyrics provide negligible substance. For example, no public official has used the term “vaccine rationing.” It is never sung in their word songs. Rationing sounds negative and presumes a production shortage.

Dr. Francis Collins, director of the National Institutes of Health, referred to the process of establishing priorities more realistically. He spoke last summer at the kickoff meeting of a committee of experts helping to plan the country’s vaccination efforts, “There will be many people who feel that they should have been at the top of the list, and not everybody can be.”

The president’s words have always sung a fantasy, no matter what he’s talking about. Regarding the vaccine, he said in September the government could start distributing a coronavirus vaccine as early as October or right after the November 3^rd election. A reality reminder: both dates have come and gone without any vaccines being shot into the public’s arms. His viral word songs have nothing to do with real life, yet too many people somehow believe them.

Other prominent public experts like Dr. Anthony Fauci of the CDC have also crooned songs, although not nearly as exaggerated as #45. Dr. Fauci said in September that the covid-19 vaccine might be ready by the end of 2020, but he warned that availability will not be widespread at first. Dr. Robert Redfield, the director of the CDC, mouthed an aria before Congress in September saying he expects vaccinations to begin in November or December, but in limited quantities with those most in need getting the first doses, such as health-care workers and the elderly. With some luck, he and Dr. Fauci may be right about December.

It’s December 1. None of the US vaccines shown in the above table have completed their Phase 3 trials. But on November 20 Pfizer/BioNTech applied to the FDA for an “emergency-use” authorization for their vaccine. Ten days later, Moderna also applied to the FDA for an emergency-use approval. Interestingly, Moderna has never before fabricated a vaccine for the market.

These two companies estimated they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by January assuming quick FDA authorization and no unexpected delays. Prior estimates by the government as well as the companies of year-end vaccine production were much higher.

Operation Warp Speed set an initial target of producing 300 million doses this year. Now we’re all hoping for just 15% of that idealistic objective. Manufacturing biologic materials like vaccines always is challenging and often erratic.

Pfizer/BioNTech and Moderna hope to meet such eased production levels, but recognize even 45 million doses is by no means not a sure thing. Rapid upscaling of vaccine assembly is a complex often temperamental process that relies on many inputs and continuously precise management 24/7.

When produced, 45 million doses basically would be provided just to highest-priority healthcare personnel. Vaccine production will continue to expand throughout the winter and spring, as more firms gain FDA approval. These firms, and others, expect they can each produce one billion dosages by the end of 2021. Let’s hope so.

Thus, believing that each and every one of the 331 million American will be vaccinated by next June, as Dr. Redfield stated in September, is very doubtful. In other words, keep wearing your masks for a long time to come.

Drs. Redfield and Fauci are certainly correct that there will be a shortage of vaccine. It will be rationed for quite some time to impatient, awaiting arms. The CDC has developed an Interim Plan for providing the vaccine’s short-supply to all of us. It has identified four generic “populations of focus for initial Covid-19 vaccination”:

1.       Healthcare personnel;

2.       Non-healthcare essential workers;

3.       Adults with high-risk medical conditions; and

4.       People 65 years of age and older, including those living in long-term care facilities.

It’s worth remembering that the CDC itself will not be making any final judgements about the sequence of who will receive the vaccines. The CDC’s Advisory Committee on Immunization Practices (Committee) has been considering these implicit prioritizations. The ultimate distribution decisions will be made by Biden administration staff at the White House, HHS, FDA as well as the CDC.

President-elect Biden already has formed a special transition Coronavirus Team (CTeam) dedicated to coordinating the coronavirus response for the post-January 20th government. The Team will be co-chaired by David Kessler, former FDA Commissioner, former Surgeon General Vivek Murthy and Marcella Nunez-Smith, an associate professor of medicine and epidemiology at the Yale School of Medicine.

The government’s decisions about vaccine dispersal will rest heavily on exactly how each of these population cohorts will be defined. I expect several of these definitions will be hotly disputed because various people’s health will be directly affected amid vaccine shortages.

The CDCs Interim Plan purposefully makes no statement about the ordering of these four groups’ access to the vaccines, but the arrangement of each group’s listing likely reflects the expected sequencing of availability, with healthcare personnel getting the vaccines first.

The first CDC category, presumably highest-priority, is healthcare personnel. Healthcare personnel already have been included in each of the 13 vaccines’ large-scale Phase 3 test samples. It’s very unlikely that there will be any major disputes about first providing vaccines to healthcare personnel. But no one knows; should epidemiologists be incorporated in this category? They (and their models) are prominent prognosticators of the pandemic. But epidemiologists are not usually considered healthcare professionals. Time will tell. The CDC Interim Plan identifies healthcare personnel as paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.

How many people can be classified as healthcare personnel? The Department of Labor categorizes people employed into 22 “detailed occupations” (and a myriad of more detailed occupations) including healthcare practitioners and related technical occupations. I made several adjustments to the DOL healthcare personal categorization. For example, I did not include veterinarians or dieticians.

My healthcare personnel totals 16.6 million workers, which is 9.8% of our workforce. Healthcare personnel consist of doctors, nurses, pharmacists, EMTs, health technologists and home healthcare providers among others. That is a whole bunch of people’s arms to vaccinate ASAP.

But let’s be clear about the trials and tribulations for counting how many folks are in each of the four CDC’s “populations of focus.” Depending on one’s persuasion and purpose, you can pick within a wide range of numbers for Healthcare Personnel, the presumed highest-priority group. Their numbers have increased almost exponentially in various public statements. Here are several other estimates of healthcare personnel, beyond mine, that show the impressive numeric “spread”:

1.       12 million (M) from a recent Washington Post story about healthcare and essential workers.

2.       Over 18M people, according to the CDC.

3.       20.5M from the Census, although this number includes social assistance workers.

The CDC’s second group, non-healthcare essential workers, is far more nebulous and open to debate. “Essential” has never been tightly defined. This band of folks could include essential folks like: police, firefighters, primary/secondary school teachers, airline pilots/mechanics (airlifting the vaccines hither and yon), funeral arrangers & morticians, power plant operators, public transit drivers and grocery store clerks. Employed persons in just these eight professions totals 10.9 million workers. Many more “essential” professions will undoubtedly be identified. One media group stated without documentation that this group was 87M strong.

The third CDC cohort, Adults with high-risk medical conditions, also is imprecise. Diabetes is but one example of a high-risk medical condition that’s listed in groupings of immunodeficiency disorders. Recent medical information about the coronavirus’ dangerous ability to induce hyperglycemia (high blood glucose) in its victims confirms the potential threat the coronavirus has for diabetics. There are more than 34 million people who have diabetes. Other immunodeficiency disorders include HIV/AIDS and cancer. Over 1.2 million people are living with HIV in the US. There are 16.9 million cancer survivors in the US. About 1.8 million people will be diagnosed with cancer this year. About 37 million US adults have chronic kidney disorders. The number of people with the above-mentioned diseases totals 89.1 million. There are many other high-risk medical conditions not mentioned here. At least one estimate of this cohort’s size was 100M.

The last CDC category of vaccine recipients is people over 65 years old, including those living in long-term care facilities. According to the Census, there are 54.2 million elders 65 years or older now living in the US. Because this group’s population is demographically determined, it’s not nearly as disputed. But where elders rest in the CDC’s four categories is very much in play.

Scott Gottlieb, a former FDA commissioner, properly stated that vaccine prioritization depends on the overall stated goal of the distribution. If the goal of vaccine prioritization is to reduce the rate of infection, he said “you would prioritize essential workers. But if your goal is to maximize the preservation of human life with a vaccine, then you would bias the vaccine toward older Americans.” Thus, determining and agreeing to the overall objective of the prioritization process significantly influences the ordering. Because human lives and hopes are at stake, this determination will be laden and fraught, especially if it’s publicly stated.

The sum total of all people in the four CDC population cohorts that I enumerated above is 170.8 million, 67% of the adult population. This number includes some double-entries, like me who is a 65+ year-old and a diabetic. So it goes...

The CDC’s four cohorts’ prioritizations are already being challenged, as expected. In addition to the “essential workers” (cohort #2), spokespeople are pressing the Committee and the CTeam to prioritize certain categorizes of citizens: those who have been “most affected by health disparities,” participating volunteers who were given placebos in the clinical trials, geographic locations where the virus has been “most active” and military personnel.

Also, a recent news article advocated that obesity be included as a “high-risk medical condition.” Over 70 million people are obese in the US. With every tick of the clock, more backers of specific groups of people will be pressing for higher ranking. Virtually everyone hopes to be at the tippy top of the highest-priority cohort possible. The incentives for expanding the numbers of each population group are strong, except bigger numbers ahead of your group means you’ll be waiting longer for a vaccine. Such are the trade-offs.

Adding additional friction to the question of who’s going to receive the vaccines when is that states – New York and California, so far – have also created committees to review the vaccines’ efficacy and will determine who gets the vaccines. Dr. Fauci said on November 30 that states will be shipped a certain amount of the vaccine and ultimately make final distribution decisions “with strong recommendations from the CDC.” Who knew he was such a strong states-rights advocate?

Ultimately, it’s hard to believe the federal government, that has spent vast sums on their development, will not have a determinative say about the vaccines’ prioritization. Also, the CDC will be providing a “recommendation,” not anything close to an order. The federal government’s formidable say and influence will certainly be reflected in its calculation of the “certain amount of the vaccine” that will be shipped to each state.

How many dosages of will be available? The honest answer to this crucial question is one too often used concerning questions about the coronavirus since it first appeared last December: We Don’t Know Yet. Adm. Brett Giroir, an assistant secretary of HHS, declared “The nation will probably have enough doses for about 20 million people by the end of the year. Given that the two leading vaccines for FDA approval require two doses, that’s 40M dosages by year-end. Other authorities have provided widely-varying dosage guestimates.

Here’s hoping, really hoping that amid the foggy fray the impending coronavirus vaccines can be sufficiently produced, will provide maximum positive effect for all of us and most importantly, can indeed severely wound our current captain of death.