"It is Challenging to Determine the Relationship Between a SARS-CoV-2 Infection and the Reason Someone was Hospitalized or Passed Away"

A look back at my emails with a CDC MD/PhD about an early surveillance report on "vaccine breakthrough infections"

On May 25, 2021, the CDC released COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30 2021.

At the time, I characterized the data as “ridiculous” for reporting asymptomatic COVID hospitalizations and deaths.

By this point, I’d known for over a year that whst the CDC & other public health entities said were “cases” of a disease called COVID-19 were near-synonymous with testing positive for a “novel” virus named SARS-CoV-2.

The notion of being hospitalized for or dying from something that doesn’t trigger illness or a disease-response never made sense. The language used in the May 25, 2021 report reinforced these ideas and failed to delimit mutually-exclusive patient categories.

To gain clarity, I emailed corresponding author Dr. Marc Fischer and forwarded my message to the address for the CDC COVID-19 Vaccine Breakthrough Case Investigations Team.

May 25, 2021, 3:37 p.m. (U.S. Central)

Good day, Mr. Fischer

I’ve read your recent publication on breakthrough infections and have a question about the wording of results. 

You said, "Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died. Among the 995 hospitalized patients, 289 (29%) were asymptomatic or hospitalized for a reason unrelated to COVID-19. The median age of patients who died was 82 years (interquartile range = 71–89 years); 28 (18%) decedents were asymptomatic or died from a cause unrelated to COVID-19. “

In these sentences, is “asymptomatic” distinct from “hospitalized for a reason unrelated to COVID-19” and “or died from a cause unrelated to COVID-19”? The use of “or” in each instance conveys these are mutually-exclusive categories.

Or, are “hospitalized for a reason unrelated to COVID-19” and “or died from a cause unrelated to COVID-19”another way of saying  (or definition for) “asymptomatic”?

Regards,

Jessica Hockett, PhD

Leisha Nolen, acting lead of the COVID-19 Vaccine Breakthrough Team, responded two days later.¹

She confirmed that fully-vaccinated patients² who are hospitalized and incidentally test positive for SARS-CoV-2 are NOT seen as COVID hospitalizations or deaths, which seemed to contrast sharply with how cases were treated in 2020.

May 27, 2021, 2:01 p.m. (U.S. Central)

Hi Jessica,

Thank you for reaching out. In many cases it is challenging to determine the relationship between a SARS-CoV-2 infection and the reason someone was hospitalized or passed away. For that reason, our report only gives information about the cases we know are not related to infection.

We combined both those people who were asymptomatic, as they are unlikely to be hospitalized for COVID-19 if they do not report any COVID-like symptoms, and those people whose outcomes were clearly not related to COVID-19 (for examples women who were hospitalized for deliveries or people in car accidents).

We do not feel the data is strong enough to say what percent of hospitalizations and fatalities are caused by SARS-CoV-2 infection, therefore we only say what percent are clearly not.

Kind Regards,

LCDR Leisha Nolen

Acting Lead of the Vaccine Breakthrough team

Vaccine Evaluation Unit/Vaccine Task Force 

CDC COVID-19 Response 

The most “confessional” statement in Dr. Nolen’s response is

This was the CDC running interference for the COVID shot.³ Things that were always true but not accounted for in COVID case, hospitalization, and death data suddenly became important to account for because the shot could not afford to be shown as inefficacious or (worse) harmful.

There’s no reason to believe the deployment of the COVID shot made these things more true than they were before the shot was deployed.

I asked Dr. Nolen whether there would be an effort to apply the parameters apparently being applied to “breakthrough” data to all data involving SARS-CoV-2 infections (i.e., positive tests).

May 27, 2021, 11:17 p.m. (U.S. Central)

Thank you so much for this response. 

These parameters make sense.

Give that it’s challenging to determine the relationship between a SARS-CoV-2 infection and the reason someone was hospitalized or passed away, do you know if there’s an effort underway at the CDC to apply the same parameters your vaccine breakthrough analysis describes to analyzing all SARS-CoV-2 infections (versus only breakthrough infections)?

Regards,

Jessica 

She never replied.

On June 6, 2021, I took what the report says and what Dr. Nolen told me and attempted to explain the issue in a thread. I summarize the content with my original visuals below.

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COVID-19 Vaccine Breakthrough Infections Reported to CDC — United States, January 1–April 30 2021 applied the following standards to hospitalizations and deaths of fully vaccinated patients who tested positive for SARS-CoV-2. ⁴

• Patient A was in the hospital for various reasons and symptomatic for COVID-19⁵

• Patient B was in the hospital for various reasons but did not have symptoms associated with COVID-19.

• Patient C was in the hospital for reasons “clearly not related to COVID-19 (e.g., delivering a baby, suffering from car accident injuries)” and may or may not have had symptoms associated with COVID-19.

Patients B and C were considered hospitalizations/deaths unrelated to SARS-CoV-2 infection, while Patient A was regarded as possibly related to infection.

Of the 995 hospitalized patients included in the report, 71% (n=706) were “Patient As” and 29% (n=289) were Patient Bs/Cs.

Before the COVID shot was available, all three Patient types were considered COVID hospitalizations/deaths, simply by testing positive for SARS-CoV-2.⁶

The CDC Vaccine Breakthrough team didn’t consider asymptomatic/incidental-positive hospitalizations/deaths as related to SARS-CoV-2 infection. They also didn’t feel the hospitalizations/deaths of patients with COVID-related symptoms who tested positive could necessarily be caused by SARS-CoV-2 infection.

In my opinion, the status of all patients as “fully-vaccinated” biased CDC standards for evaluating “breakthrough infections” away from blaming SARS-CoV-2 for hospitalizations and deaths. This gave a false impression of the shot’s efficacy against a virus that was never demonstrated to increase anyone’s risk of severe illness or death.

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Chicago's Dastardly Definitions and Disappearing Data During the "Delta" Wave

1. Soon after our email exchange, Dr. Nolen was named Utah Department of Health state epidemiology. Notably, Dr. Nolen was involved in the Kirkland Nursing Home “outbreak” and with the CDC’s 2014 Ebola response.

2. Per the surveillance report, “a vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine.” So, any patient who had received all recommended doses but who tested positive and was hospitalized or was hospitalized & died before 14 days has passed was excluded from the breakthrough data.

3. Note for non-U.S. readers, just in case! “Running interference” is an idiom derived from American football, meaning to intervene on someone or something’s behalf in order to protect the person or thing from criticism, distraction, etc.

4. These depictions are my own and are based on the information in the report and my emails with Dr. Nolen.

5. The laundry list of COVID-19 symptoms fails to distinguish it from other respiratory infections or from a host of other conditions/ailments.

6. Although my June 2021 self used the term “pandemic,” I have since rejected the WHO’s and U.S. government’s claim that a pandemic occurred. My current views are well-represented here.