New Long COVID Definition and Its Impact on Vaccine Injury Reporting -- A Letter from Dr. Carol Taccetta to the FDA

Expert Group Defines Long COVID as “Infection-Associated,” Yet Also Acknowledges “Symptoms and Diagnosable Conditions Characteristic of Long COVID Can Have Alternative Origins”

“As the number of cases of acute SARS-CoV-2 infection declines, an increasing fraction of patients with symptoms compatible with Long COVID will have their condition due to a different origin.” — National Academies of Sciences, Engineering, and Medicine (NASEM), https://nap.nationalacademies.org/read/27768/chapter/2?term=2025 - 8, (p. 8)

Summary:

• The NASEM report recently defined Long COVID (LC) as “an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.” (p. 2) https://nap.nationalacademies.org/read/27768/chapter/2?term=syndrom - 2

• The NASEM definition states infection as the sole cause of LC, yet the report elsewhere acknowledges that “the symptoms and diagnosable conditions characteristic of Long COVID can have alternative origins.” (p. 35) https://nap.nationalacademies.org/read/27768/chapter/5?term=origins - 35

• Symptoms of LC are increasingly becoming understood to overlap those of COVID-19 vaccine injury. https://covid19criticalcare.com/wp-content/uploads/2022/09/FLCCC-Long-COVID-Protocol-Summary-12-11-23.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10452662/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10663976/

• I could find no mention in the report of COVID vaccine-induced injury as a possible cause or even a contributing factor for LC-type symptoms or conditions.

• If a patient’s “symptoms and diagnosable conditions characteristic of Long COVID” are, by definition, “infection-associated,” would the patient’s clinician still consider a COVID vaccine as a possible cause or even as a contributing factor?

• In this setting, I wrote to the Food and Drug Administration (FDA) and asked how the new LC definition might affect vaccine injury reporting:

“…as the VAERS reports following COVID vaccination practically mirror the LC symptoms/conditions described as ‘infection-associated’ in the new NASEM report, how do you think adoption of this new NASEM definition for LC might affect VAERS reporting of potential vaccine injuries as well as the FDA’s signal detection for COVID vaccines?”

I await a reply. Here is my letter:

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June 13, 2024

Peter Marks, MD, PhD

Director, Center for Biologics Evaluation and Research

U.S. Food and Drug Administration

10903 New Hampshire Avenue

WO71-7232

Silver Spring, MD 20993

Peter.Marks@fda.hhs.gov

Dear Dr. Marks,

On June 11, 2024, the National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report initiated at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). The proposed definition of “Long COVID” or “LC” is as follows:

“Long COVID (LC) is an infection-associated chronic condition (IACC) that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”

https://nap.nationalacademies.org/booksearch.php?record_id=27768&term=figure

https://www.nationalacademies.org/news/2024/06/federal-government-clinicians-employers-and-others-should-adopt-new-definition-for-long-covid-to-aid-in-consistent-diagnosis-documentation-and-treatment

https://www.medpagetoday.com/infectiousdisease/longcovid/110595

The new LC definition accurately describes LC as occurring after COVID infection. Yet, of concern are the following points. The new LC definition/NASEM report:

• Acknowledges that “the symptoms and diagnosable conditions characteristic of Long COVID can have alternative origins;” still, the definition does attribute the LC-type symptoms/conditions to infection. The report goes on to note: “As the number of cases of acute SARS-CoV-2 infection declines, an increasing fraction of patients with symptoms compatible with Long COVID will have their condition due to a different origin.”

• Does not require laboratory evidence or reported medical history of COVID infection as “[p]revious infections may have been recognized or unrecognized.” This negates any temporal relationship between acute infection and LC.

• Does not mention COVID vaccine-induced injury as a possible etiology or even a contributing factor for LC-type symptoms/conditions. Temporal relationship to COVID vaccination is not considered.

Thus, the newly defined LC–type symptom/condition could occur anytime, diagnosed with no regard to COVID vaccination or infection history. Following the proposed NASEM definition of LC with the limiting choice of infection as etiology, a COVID vaccine-induced injury, by virtue of falling under the new definition as an LC “diagnosable condition,” could be incorrectly categorized as an “infection-associated chronic condition.”

The report goes on to say: “LC manifests in multiple ways. A complete enumeration of possible signs, symptoms, and diagnosable conditions of LC would have hundreds of entries.

Any organ system can be involved, and LC patients can present with

• single or multiple symptoms, such as shortness of breath, cough, persistent fatigue, post-exertional malaise, difficulty concentrating, memory changes, recurring headache, lightheadedness, fast heart rate, sleep disturbance, problems with taste or smell, bloating, constipation, and diarrhea.

• single or multiple diagnosable conditions, such as interstitial lung disease and hypoxemia, cardiovascular disease and arrhythmias, cognitive impairment, mood disorders, anxiety, migraine, stroke, blood clots, chronic kidney disease, postural orthostatic tachycardia syndrome (POTS) and other forms of dysautonomia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), mast cell activation syndrome (MCAS), fibromyalgia, connective tissue diseases, hyperlipidemia, diabetes, and autoimmune disorders such as lupus, rheumatoid arthritis, and Sjogren’s syndrome.”

https://nap.nationalacademies.org/booksearch.php?record_id=27768&term=figure

While it is true that LC following COVID infection “manifests in multiple ways,” it is equally true that many of these same manifestations have also been reported to VAERS as vaccine adverse events following COVID vaccination.

For example, by my searching for just one of the NASEM example LC “diagnosable conditions,” postural orthostatic tachycardia syndrome (POTS), I found 976 reports of POTS following COVID vaccination reported to VAERS:

https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6695DAE1C7F6C98E7E9ED1AC60D1

https://my.clevelandclinic.org/health/diseases/16560-postural-orthostatic-tachycardia-syndrome-pots

Here are my query criteria:

Dr. Marks, while understanding that the National Academies of Sciences is a separate organization from the FDA, I write to you now as the FDA (along with the CDC) is responsible for identifying signals through VAERS. As “[c]linicians [will be] encouraged to use the ICD-10 code for Long COVID of U09.9,” I’m concerned that the new LC definition may inhibit clinicians’ and others’ reporting of LC-type symptoms/conditions to VAERS: the “symptom”/”diagnosable condition” would be defined as having only an infectious (or post-infectious) etiology for purposes of reimbursement, disability, loss of work, etc…. This new LC definition would be adopted by the “federal government, state, tribal, local, and territorial health authorities; clinical societies and associations; public health practitioners; clinicians; payers; researchers; drug industry; employers; educators; international organizations; and patients.” Of note, I could not find anywhere in the NASEM report how the new LC definition might affect compensation for vaccine injury sufferers. 

Dr. Marks, as the VAERS reports following COVID vaccination practically mirror the LC symptoms/conditions described as “infection-associated” in the new NASEM report, how do you think adoption of this new NASEM definition for LC might affect VAERS reporting of potential vaccine injuries as well as the FDA’s signal detection for COVID vaccines?

Appreciatively,

Carol Taccetta, MD, FCAP

Receipt acknowledged by Dr. Marks: June 14, 2024

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Dr. Carol Taccetta is a U.S.-licensed physician, board-certified in pathology, with a career in drug development spanning 25 years. Key agency interactions include Dr. Taccetta’s co-drafting of a chapter in the 1989 U.S. Surgeon General’s Report (CDC), as well as serving as Sponsor’s Responsible Medical Officer for a successful New Drug Application (NDA) to the FDA.

Please note: The views expressed are Dr. Taccetta’s personal opinions and do not reflect the views of former or current employers or any professional organizations to which she belongs.

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