We can’t re-open the economy with dead people!

Detect, Test, Isolate, Trace and Test Again! – Your path to re-entering society, testing, testing, testing

Until we have a national scalable process to detect, test, isolate, trace and RE-TEST people for COVID-19 with the goal to build herd immunity[ii] you will have to stay home and continue to practice social distancing, as defined by your state government, for the next 12 – 24 months.

In this post, I address the assumptions presented in “Part I: Whether you like it or not — Here’s the truth about re-entering society in a post-COVID-19 world. A COVID-19 survivor’s perspective.”

The post provides evidence-based data[i] and up-to-date answers to the questions and assumptions presented in the previous post. All references and resources are provided in endnotes.  As in Part I, you may not like what I’m presenting but it is supported by data. I encourage you to read the references if you have questions about the data presented.

Part I: Assumptions – Post COVID-19

1. We all ‘StayAtHome’ and practice social distancing until May 25th, 2020.
2. A vaccine to protect humans from COVID-19 will be available, at a minimum, 18 months.
3. Billions of doses of a vaccine will be available for Americans.
4. We all agree to be monitored in a personal and private way using our mobile devices.

First, let’s address the assumption that we all “Stay at Home” and practice social distancing until May 25^th.  Unfortunately, I was wrong. It’s going to be longer than that.

Here’s why:

As of this writing, the number of confirmed COVID-19 cases surpassed 2 million globally and the death toll continues to increase in the United States. On April 14th, the Johns Hopkins Coronavirus Resource Center reported 24,574 new cases and 2,228 new deaths. As a reminder, the first case of COVID-19 in the US was reported 82 days ago on 1/22/2020.[iii]

Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, made the following statements on April 14th in an interview with The Associated Press.[iv]

“The U.S. does not yet have the critical testing and tracing procedures needed to begin reopening the nation’s economy.”

“We have to have something (testing) in place that is efficient and that we can rely on, and we’re not there yet,” Fauci said in an interview with The Associated Press.

“A May 1 target is ‘a bit overly optimistic’ for many areas of the country. Any easing off the strict social-distancing rules in place in much of the country would have to occur on a “rolling” basis, not all at once.”  

“I’ll guarantee you, once you start pulling back there will be infections. It’s how you deal with the infections that’s going count,”

“The key is ‘getting people out of circulation’ if they get infected, because once you start getting clusters, then you’re really in trouble.”

Well, according to Dr. Fauci we are in real trouble. Here’s why.

The fact that new cases are increasing daily is proof that clusters of infections are occurring, especially in states where people are not staying home or practicing social distancing.  It’s evidence-based data right before your eyes. Consider the following recent outbreaks:

South Dakota pork plant closes after over 200 workers contract COVID-19: About 240 employees at the plant contracted the virus, making up over half of the state’s positive cases.[v]

April 14: 189 new COVID-19 cases in Iowa, 6 additional deaths, outbreak at Louisa County Tyson plant.[vi]

Silent killer: Inside the coronavirus outbreak at the Canterbury nursing home. A single Virginia nursing home has seen 45 deaths from the pandemic.[vii]

The evidence presented above demonstrates that the Coronavirus is a highly contagious disease that spreads undetected where clusters of people work or live.  Therefore, when people come into close contact with each other the virus will continue to spread undetected.

Part I: Assumptions 2 & 3:

1. A vaccine to protect humans from COVID-19 will be available, at a minimum, 18 months.
2. Billions of doses of a vaccine will be available for Americans.

COVID-19 vaccines in development

There are currently vaccines in development in the US and globally.  The following are three potential COVID-19 vaccines currently in various phases of testing and are not expected to be available until early 2021.

1. CanSino Biologics of China has begun the second phase of testing its vaccine candidate, the Chinese Ministry of Science and Technology.[viii]
2. Moderna, based in Cambridge, MA, US is currently working with the National Institutes of Health on an experimental vaccine currently in human trials.[ix] Anthony Fauci, MD said there are “no red flags” so far and he hoped the next, larger phase of testing could begin around June.
3. Inovio Pharmaceuticals, based in Plymouth Meeting, Pennsylvania, is currently testing a COVID-19 vaccine and expects to have early safety date by late summer and is forecasting to produce 1 million doses by the end of 2020.[x]

What about natural immunity vs. a vaccine?

Naturally acquired active immunity[xi] occurs when a person is exposed to a live pathogen, develops the disease, and becomes immune as a result of the primary immune response. Artificially acquired active immunity can be induced by a vaccine, a substance that contains the antigen.

Vaccination against COVID-19 is the best way to prevent people from contracting the disease. Vaccines, like any medication, can cause side effects. Until we have an FDA approved vaccine to immunize the global population we must “Stay At Home,” practice social distancing, and slow the spread of the disease.  Over the next 18 – 24 months, until a vaccine is widely available, the next best option is naturally acquired immunity.

Some believe that naturally acquired immunity—immunity from having the disease itself—is better than the immunity provided by vaccines. However, natural infections, like the one produced from the Coronavirus, can cause severe complications, including death.[xi]

A vaccine to protect humans from COVID-19 will be available in a minimum of 18 months. Therefore, a vaccine is NOT going to help people get back to work or re-start the economy for at least 18months – 24months.[xii]

Part I Assumption 4: We all agree to be monitored in a personal and private way using our mobile devices.

As a COVID-19 survivor, I assume that I have immunity and that I am now part of the “herd.” But to be counted as part of the herd our government, both state and federal, will need to test me, track me and test me again to follow me on my health journey.[xiii]

First, let’s start with detection and testing because we need data in order to monitor something. Let’s take a look at the COVID-19 detection and identification pathway in the following diagram.

In order to determine if you have the Coronavirus you need a test.  Once tested you will be classified as either a “Silent Spreader,” defined by being asymptomatic, pre-symptomatic or very mildly symptomatic, or immunity to COVID-19. You will need at least 3 tests.  See table below for definitions.[xiv, xv, xvi]

Test #1: Determines if you are positive for the active Coronavirus.

Test #2: Determines if you have anti-bodies, IgM (young) or IgG (mature).

Test #3: Confirmation test for immunity based on serum levels of IgG.

A recent study suggests if we tested all New Yorkers today one in 8 people would test positive for the Coronavirus.

That would equate to 1million people who would be positive and 880,000 people who would have no symptoms!

The New England Journal of Medicine study published on April 14th emphasizes the need to test all people.

One in eight pregnant women admitted to New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center tested positive for Coronavirus. Between March 22 and April 4, 2020, a total of 215 pregnant women delivered infants after being screened for symptoms of COVID-19. Four women had symptoms and tested positive. Of the 211 women without symptoms, 210 were tested; 29 (13.7%) were positive for Coronavirus. Thus, 29 of the 33 patients who were positive at admission (87.9%) had no symptoms (asymptomatic) of COVID-19.[xvii]

As I continue to watch the number of documented cases of COVID-19 surpass 2 million globally, and recognize the current limitations to widespread testing, it’s apparent that the number of active COVID-19 infections is far greater than what is currently reported.

Regardless of the actual number of asymptomatic people, we are talking about millions of people who may be infected today without the scalable testing methods to gather the data.

Detecting who has the Coronavirus will remain an elusive mystery unless we start testing and tracking everyone. If we continue to limit our testing to only those who are being admitted to hospitals or essential healthcare workers, we are looking at biased cohorts.

How many “Silent Spreaders” are out there?  If we relax the current “Stay at Home” measures and more people go out into the world to open the economy, how many more Silent Spreaders will be among us?

What does the data tell us today?

We started with the question of ‘how do we open the economy?’

Well, as Thomas Freedman wrote in “The World is Flat” back in 2005, economic globalization has now been well established. If we want to open our economy, we must develop global solutions.

Asymptomatic or  “Silent Spreaders” will continue to spread Corona virus globally. 

So, here’s what we need:

1. We need a robust, organized and scalable process to detect and test those who may have come in contact with people who have tested positive for COVID-19.
   1. We need to test, trace and track the “Silent Spreaders” who have come into contact with COVID-19 patients and survivors.
      To date we have no system or processes to trace the interactions of people (contact tracing) from a historical perspective.  We do not have the ability, technically or legally, to track people who are “Silent Spreaders” or those who have tested positive for COVID-19 absent their permission.
   2. We need to trace and track positive COVID-19 patients and those who have come in contact with a positive COVID-19 patient in a centralized database in the US and globally.
   3. We need to test positive COVID-19 patients in an organized and scalable way to detect anti-bodies to the Coronavirus and thus confirm immunity.
      This will help us determine and track the % of the population that has ‘herd immunity’. Convalescent plasma donations and getting back to work will be options for people with immunity.
      There are currently 5 clinical trials recruiting patients in the US for the use of convalescent plasma as a treatment for patients with COVID-19 infection.[xviii]
2. We need a centralized, organized, scalable national strategy to developing, manufacturing and distributing vaccines to build herd immunity.
   The newest epidemiological models developed in the UK now recommend aggressive “suppression” of the virus through social distancing and “Stay At Home” orders. The basic tactics being urged would be to isolate sick people, try to reduce social contacts by 75%, and close schools. Those economically costly measures could continue for many months. [xix]

To date we do not have a system or process to identify, trace and track people who test positive for COVID-19.  This is critical to stop the spread, to isolate individuals, sick or not, while they build immunity and produce the herd.

The Elephant in the Room

If your state relaxes it’s “Stay at Home” order would you feel safe to interact with your friends and family members who don’t live with you? Would you feel safe to go back to work? Eat at a restaurant even the tables were 6 feet apart?

Until we have a proven vaccine that has been administered to the global population and herd immunity reaches at least 70% the Coronavirus will continue to spread, and tens of thousands of people will continue to die.

It’s your choice…do you stay at home, limit your interaction with others by practicing social distancing to slow the spread or do you take your chances to contract the Coronavirus, possibly becoming very sick or dying, to become part of the herd?

1. “Evidence-based” is a term that is used to describe the practice of medicine, the reporting of modern data analysis and more generally reporting and publishing scientific claims.  The need for reproducibility of data ensures truth and the acceptance of scientific claims. Conclusions of claims are based on the data that is reproducible, free of bias and accepted only if the evidence is consistent and systematically identified, evaluated and proven.  In the field of drug development and medicine, external evidence includes randomized controlled trials, best clinical practices that result in enhanced-patient care and outcomes.
2. Gypsyamber D’Souza and David Dowdy. What is Herd Immunity and How Can We Achieve It With COVID-19? Johns Hopkins Bloomberg School of Public Health, last access April 16, 2020. https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html.
3.  Johns Hopkins University & Medicine, Coronavirus Resource Center, last access April 14, 2020, https://coronavirus.jhu.edu/data/cumulative-cases
4. Lauren Neergaard and Julie Pace. Fauci: ‘We’re not there yet’ on key steps to reopen economy. Associated Press, last access April 14, 2020. https://apnews.com/46ee40035d500c4190489aea0adb126b.
5. Lauren Aratani. South Dakota pork plant closes after over 200 workers contract Covid-19. The Guardian, last access April 13, 2020. https://www.theguardian.com/us-news/2020/apr/13/south-dakota-pork-plant-closes-after-200-workers-contract-covid-19.
6. Andrew Pearce. April 14: 189 new COVID-19 cases in Iowa, 6 additional deaths, outbreak at Louisa County Tyson plant. KWWL.com, last access April 14, 2020. https://kwwl.com/2020/04/14/watch-live-at-11am-gov-reynolds-covid-19-press-conference-april-14/.
7. Freger, Romero, et al. Silent killer: Inside the coronavirus outbreak at the Canterbury nursing home. ABC News, last access April 14, 2020. https://abcnews.go.com/Health/silent-killer-inside-coronavirus-outbreak-canterbury-nursing-home/story?id=70126687
8. Ted Waren.Three potential coronavirus vaccines moving ahead in tests. Los Angeles Times, last access April 15, 2020. https://www.latimes.com/science/story/2020-04-15/three-potential-coronavirus-vaccines-moving-ahead-in-tests.
9. Moderna’s Work on a Potential Vaccine Against COVID-19. Moderna.com, last access April 15, 2020.  https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19
10. Andrew Dunn. A potential coronavirus vaccine funded by Bill Gates is set to begin testing in people, with the first patient expected to get it today. Business Insider, last access April 6, 2020. https://www.businessinsider.com/inovio-coronavirus-vaccine-trial-starts-in-philadelphia-kansas-city-2020-4.
11. Immunity: Active and Passive Immunity. Infoplease.com, last access April 14, 2020. https://www.infoplease.com/encyclopedia/medicine/body/anatomy-physio/immunity/active-and-passive-immunity
12. Understanding How Vaccines Work. Centers for Disease Control. July 2018. CDC.gov, last access April 12, 2020. https://www.cdc.gov/vaccines/hcp/conversations/downloads/vacsafe-understand-color-office.pdf.
13. Antonio Regalado. What is herd immunity and can it stop the coronavirus? MIT Technology Review, last accessed April 16, 2020. https://www.technologyreview.com/2020/03/17/905244/what-is-herd-immunity-and-can-it-stop-the-coronavirus/.
14. Pien Huang. What We Know About The Silent Spreaders Of COVID-19. NPR.org, last access. April 13, 2020. NPR. https://www.npr.org/sections/goatsandsoda/2020/04/13/831883560/can-a-coronavirus-patient-who-isnt-showing-symptoms-infect-others
15. [1] Research Council. 2020. Rapid Expert Consultation on the Possibility of Bioaerosol Spread of SARS-CoV-2 for the COVID-19 Pandemic (April 1, 2020). Washington, DC: The National Academies Press. https://doi.org/10.17226/25769.
16. [1] Kathleen Doheny. How COVID-19 Silent Spreaders May Be Infecting Others. Medscape.com, last access April 03, 2020. https://www.medscape.com/viewarticle/928067_print.
17. [1] Sutton, Fuchs, et al. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. New England Journal of Medicine, last accessed on April 16, 2020. https://www.nejm.org/doi/pdf/10.1056/NEJMc2009316?articleTools=true
18. [1] https://clinicaltrials.gov/ct2/results?term=plasma&recrs=a&cond=covid-19.
19. [1] Antonio Regalado. What is herd immunity and can it stop the coronavirus? Technology Review.com, last access April 16, 2020. https://www.technologyreview.com/2020/03/17/905244/what-is-herd-immunity-and-can-it-stop-the-coronavirus/.