Thursday, February 18, 2021

The “Summer of 2021” – looking good

I am more optimistic than government officials about the pace and extent to which COVID-19 related deaths and hospitalizations will decline and herd immunity be achieved in the U.S.   Vaccine producers are ramping up production to meet demand; states are working out kinks in vaccine administration; the emphasis on vaccinating elders directly addresses the most vulnerable population; and up to one third of the population may already carry natural immunities from infection.  These factors combined will likely result in dramatic change in spread, hospitalization, and deaths before summer.

POLITICS - the Biden Administration is attempting to keep expectations low.

President Joseph Biden said on January 22nd, “there is nothing we can do to change the trajectory of the pandemic in the next several months.”  He was criticized for that comment from all directions, but he was largely correct.  The final-stage trajectory of the pandemic was set months ago when Operation Warp Speed successfully produced two effective vaccines from Pfizer-BioNTech and Moderna - with more on the way.   The President was acknowledging that he could only impact the outcome of the pandemic on the margins. 

The Biden Administration, like administrations before, is attempting to manage expectations.  Some legitimate caution is warranted.  Producing, distributing, and administering the vaccines is a complex process and there are risks.  Too quickly abandoning safe behaviors, allowing opportunity for new variants to take hold, and significant hesitance in the population to get the vaccine, are real risks that can threaten success against the virus.  This week's severe weather slowed vaccine distribution. 

Politics are also playing a role.  Politicians often manage expectations down.  The Biden Administration is no different.  Setting low expectations to avoid blame in failing to meet more aggressive goals is common.  The flip side to lowering expectations to avoid blame is the opportunity to claim credit when expectations are exceeded. 

There are also policy implications that demand managing expectations downward.  If public opinion becomes optimistic that the pandemic is waning and will soon end it could derail Biden's American Rescue Plan.  The Biden Administration says, "we can't wait" to deliver an enormous infusion of 1.9 trillion dollars through a fully partisan legislative maneuver in the budget process.    A crisis is needed to justify and advance massive transformative legislation along partisan lines. If there is no crisis the task is much more difficult.  Expectation diminishing narratives will continue as the budget resolution is expedited through Congress.  After it is passed the narrative will likely switch to a much more positive outlook.   

GOALS - we have lost track of our goals in the pandemic

It is important to think about what we are trying to achieve.  It seems that as the pandemic dragged on goals were distorted, changed, and made unclear.   Are we now trying to vaccinate 100 percent of the population and reduce risk from the virus to zero?  Both are unattainable goals.  

The immediate goal is to reduce serious illness and death from the virus to a level more akin to the common cold.  The follow-on near term goal is to manage COVID-19 as the endemic disease it will likely become.  It will be essential to establish and maintain herd immunity, conduct virus variant monitoring, and support agile vaccine research and booster development to address dangerous variants that may emerge. In the long term, the goal is to reduce vaccine spread and presence worldwide in order to reduce the potential for a more dangerous variant to develop through mutations.  Achieving worldwide herd immunity may not be achievable until 2023 - though early success in the U.S. could quicken that pace. 

VACCINATION - production, distribution, and administration will meet the need

There were delays and missteps in the early administration of vaccines by states.  But with time and experience there is continuing improvement.  By mid-January some states were complaining that there was insufficient distribution of vaccines to address demand and their growing capacity to administer vaccinations.   More than thirty-five states have now administered over 75 percent of the vaccine doses they have received.  The remaining states are not far behind.  All are making progress.

Of the 72 million vaccine doses delivered thus far nearly 56 million or 78% have been administered.  Next week, approximately  6.8 million Pfizer  and 6.7 million Moderna vaccines are scheduled for delivery to states, U.S. territories, and some federal departments such as the Department of Defense and the Veterans Administration.  The states and organizations administering vaccines are delivering over a seven day average 1.66 million doses daily  Though this is impressive the current pace is not sufficient to meet the contractual obligations of these companies to the U.S.  

Expect vaccine deliveries to increase weekly. There are indications that increased vaccine production capacity will soon result in three million doses per day.  Pfizer struck agreements with other pharmaceutical companies to use their production facilities.  Its company representatives testified before a Michigan state legislativebody that they are ahead of schedule on the delivery.  Moderna has stated it is on track to meet its obligations.   

Over the coming months production of approved vaccines will increase and additional vaccines are likely to be authorized for use in the U.S.  In the long term many more vaccines may be approved.  There are nearly 90 vaccines currently in human trials around the world.   The U.S. government has struck contracts with several promising vaccine manufacturers.

Operation Warp Speed  placed contracts with six companies to purchase one billion vaccine doses (Pfizer-BioNTech, Moderna, Johnson&Johnson, AstraZeneca-Oxford, Novavax, and Sanofi-GlaxoSmithKline) with options for an additional two billion doses.   These are options that can be exercised when additional vaccines prove promising or production increases materialize. 

Pfizer-BioNTech and Moderna initially contracted with the U.S. government to deliver a total of 200 million vaccine doses by March 31st and 170 million more by June 30th, 2021.  Both vaccines require a two-dose regimen.  This would result in approximately 100 million vaccinated adults by the end of March and a total of approximately 185 million by the end of June.

President Biden said last week at the National Institutes of Health that both companies have agreed to speed up delivery on these initial contracts from June 30th to May 31st.   Contracts are not publicly available to confirm this timeline, but Biden said, "we’re now contractually obligated — to expedite delivery of 100 million doses, that were promised by the end of June, to deliver them by the end of May."

The sum of these early contractual obligations will result in 370 million doses from both companies by the end of May vaccinating some 185 million adults or 73 percent of the 255 million adult population.

It gets better.

The Biden Administration announced last month its intention to exercise options obtained last summer by Operation Warp Speed to purchase an additional 200 million doses of the vaccine.  Agreements were reached last week for 100 million additional doses from Pfizer-BioNtech and 100 million from Moderna.  This raises the total obligation of these companies to 600 million doses. Contracts with these two companies would supply sufficient doses to vaccinate nearly the entire U.S. population and far exceeds the requirements for 255 million adults.  The companies are obligated to deliver the additional doses by the end of July.  

Other companies will introduce vaccines in the coming months.   Johnson & Johnson submitted an emergency use application to the Federal Drug Administration (FDA) last week for their single dose vaccine.  The FDA will hold a meeting to consider the application on February 26th.  Upon approval J&J is expected to deliver about 20 million doses by April and 80 million additional doses by the end of June.   

AstraZeneca and Novavax could also begin the FDA approval phase this spring.  The U.S. has an option for 300 million doses of AstraZeneca and 110 million of Novavax.

By the end of the summer there will likely be a large excess of vaccines available.   

IMPACT on goals to reduce severe illness and death

It is only through natural immunity from infection and/or vaccination that the COVID-19 pandemic will end.  Victory comes through offense - not defense.   The offensive phase of our battle began in December.  There is building evidence that by the beginning of the summer the vaccination rate, and natural immunity from infection, will combine to reduce COVID-19 spread markedly.  Prioritizing immunization distribution by age will enhance the impact by addressing the population most susceptible to severe illness and death.

The original contracts with Pfizer-BioNtech and Moderna to deliver 370 million doses, if fulfilled as President Biden said by the end of May, will vaccinate 185 million people, or 56 percent of the 328 million U.S. population.  But the goal is not to vaccinate the entire population.  Children cannot yet recieve the vaccine.  The goal is to vaccinate the adult population of 255 million.  When one looks at it from that perspective over 70 percent of the U.S. adult population will be vaccinated by the end of May.

The prioritization of older adults enhances the ability of vaccination to reduce death and severe illness in the most vulnerable population.   Age is the major discriminating factor in COVID deaths.   Adults are far more vulnerable - and vulnerability escalates with age.  Those over 65 make up only 12 percent of the population yet represent over 80 percent of COVID related deaths.  Distributing vaccines to  those most advanced in age is the most effective way to quickly reduce deaths and hospitalizations.  

Age should remain the primary factor in the allocation of vaccine doses.  After those aged 65 and older have received the opportunity to be vaccinated the age should be lowered to 55 and then to 45.  Adults over the age of 55 represent 93 percent of COVID related deaths.  Adults over the age of 45 represent 97.5 percent of COVID related deaths.

There is insufficient data to discern precisely what percentage of vaccinations are going to which priority groups nationally.  The CDC guidance for vaccine distribution prioritizes health-care workers and long term care facility residents followed by Phase 1b frontline essential workers, people aged 75 years and older, people aged 65-74 years, and then people aged 16-64 with underlying medical conditions.  States are generally following these guidelines but there is tremendous variety in state execution.   Florida is a good example.

Florida made all persons 65 years of age and older a top priority.  Over 75 percent of vaccinations in Florida thus far were to those 65 and older.  Approximately 1.75 million of an estimated population of 4.5 million over 65 (nearly 40 percent) have thus far received the vaccine.  Florida is scheduled to receive 420,000 vaccine doses next week.  At that rate of delivery Florida could have every adult over 65 vaccinated by mid-June.  But the rate of delivery will not be static.  It is likely to climb by as much as 50 percent in coming weeks.  This would result in all 4.5 million over 65 having the opportunity to be vaccinated by early May.  This strategy could rapidly decrease hospitalizations and deaths.  This will be observable and a measurable performance indicator.

Other states are not pursuing the same strategy as Florida.  For example, Massachusetts has different priorities than Florida.  It has only delivered 35 percent of its vaccine doses to adults over 65 compared with Florida's 75 percent.   This could have significant consequences for Massachusetts and other states that are chosing to direct vaccine doses away from the age demographic that is by far the most likely to be hospitalized and die from COVID-19.

Vaccination is only one component of herd immunity.  Natural immunity from past infection also plays a role.  According to the Centers for Disease Control (CDC) a third of the U.S. population may have been infected by COVID-19 and carry antibodies.  The CDC has been gathering serological data from laboratories and other sources about antibodies present in blood samples throughout the population.   Modeling those sample results, the CDC estimates that only one in 4.6 infections are confirmed and reported.   The current 27 million cases confirmed and reported may represent 100-125 million natural infections within the population today. 

Combining the 185 million to be vaccinated by the end of May with 100 million carrying antibodies from natural infection, approximately 285 million people, or 87 percent of the U.S. population, likely will carry some level of immunity to COVID-19 by the beginning of summer.   This is approaching the highest levels estimated required to achieve herd immunity.  

Of course, there will be some overlap of adults getting vaccines who were also infected naturally.  However, the CDC estimates that natural infections are occuring largely in younger people.  Those over 65 represent only about 11 percent of the estimated natural infections.  More than 70 percent of natural infections are estimated to occur in those under 50 years of age.   

The result is herd immunity distributed largely by vaccination in older populations and natural immunity from infection in younger populations by late May.

THREATS to this optimistic projection

Viruses mutate frequently.  Most mutations are minor and either cause the death of the virus or have no impact on its potential or behavior.   But some mutations or combination of mutations can alter the virus behavior significantly enough to be called a variant of the original.  A few, such as the U.K., South Africa, and Brazil variants , have raised concerns.  The South Africa variant in particular may reduce protective antibodies against the Pfizer-BioNTech vaccine, but it was still able to neutralize the virus. All three vaccine variants are being tested against several vaccines.   Testing is not concluded; however, the vaccines are expected to provide immune response, though somewhat less effectively.   The best defense against these and other mutations is to stop the virus from spreading by vaccinating as many people as possible as quickly as possible.

This raises a related issue of concern – those who are not willing to take the vaccine.   According to the U.S. Census Bureau a recent survey indicates 14 percent of adults probably will not and 10 percent definitely will not get the vaccine.  The Kaiser Family Foundation reported that over 25 percent of the population is vaccine reluctant.  There were reports this week of lackluster vaccination participation among correctional workersnursing home workershealth care workers , and first responders in some areas. 

According to the Census survey younger people are less likely to get vaccinated.  Seventy-one percent of those over 65 definitely plan to get the vaccine while only 41 percent of adults under 44 definitely plan to get the vaccine.   There is also racial and ethnic disparity as indicated in the Census Bureau's table below.  

It seems that there is a lot less refusal to take the vaccine and more hesitance or reluctance.   The reasons people are hesitant or reluctant are many and varied.  Some younger people may have already been naturally infected and feel they do not need the vaccine.  Some are skeptical of the rapid process of vaccine development.  Some fear unknown long term side effects.  There are many variables at play. A concerted effort to get skeptics to take the vaccine will be needed.

The next three months will be critical to U.S. success.   It is essential to continue to follow spread reduction practices such as social distancing and mask wearing in confined close continuous contact environments; improve vaccine distribution and administration logistics; ensure production of Pfizer-BioNTech and Moderna vaccines meet contract obligations; approve the Johnson & Johnson vaccine as quickly as possible; control international travel from threatening virus variant areas; conduct public awareness campaigns to promote vaccination in communities and professions that are not fully participating; and aid a campaign to vaccinate the rest of the world.

SUMMER of 2021 could be a great one!

Indications are that by summer the spread of COVID-19, severe illness, and deaths will be dramatically diminished and herd immunity within reach.    When this happens there will be tremendous relief and an outpouring of pent-up economic and social activity underpinned by increased savings rates during the pandemic. The seasonal change of weather will play a positive role in decreasing spread in the coming four months.  It will also provide a burst of energy and excitement as emergence from winter always does.  

Federal, state and local governments must anticipate a major shift in focus as the public health crisis wanes in the coming months.  Those governments with the tightest lockdown culture will have the greatest difficulty extracting themselves from the micromanagement and control they have grown used to in the past year.  Focus will have to rapidly shift to fully opening the economy in parallel with declining spread and deaths.  At the federal level, defensive holding actions such as government remediation, stimulus, and assistance must shift toward putting people back to work and resuming pre-pandemic economic and social activity.

For individuals, it will take conscious effort to recognize that the pandemic is coming to an end and to break the bonds and habits of one year in isolation and fear.  But it is going to end, and maybe sooner than we are told.  As evidence builds of that happening - let freedom ring!


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