Coronavirus Updates July 1st 2023

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Stanford Study of Paxlovid for Long COVID Stopped Early​

— Enrollment was halted earlier than planned after interim analysis​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today

Enrollment into a small trial of nirmatrelvir/ritonavir (Paxlovid) for long COVID -- one that previously garnered attention for investigators not wearing masksopens in a new tab or window -- has been stopped early after an interim analysis, Stanford University confirmed to MedPage Today.
Two sources familiar with the STOP-PASC studyopens in a new tab or window told MedPage Today that trial enrollment had been halted. One was told by a study coordinator that a preliminary review found "inconclusive evidence" for the primary outcome of the study. Another said their first appointment was canceled just a few days before it was supposed to take place, and they were later told that all future enrollment had been halted.

"I've had neurological long COVID for more than 2 years and this was the first time I had an opportunity to participate in a trial testing a potential drug therapy," the participant whose visit was canceled told MedPage Today. "I was so eager to give it a try, I spent money from my dwindling savings account to pay for [my] trips."
Stanford Medicine spokesperson Lisa Kim confirmed that "new enrollment is closing slightly earlier than original projections based on a planned interim analysis reviewed by an external monitoring committee."
"There are no safety concerns with the study and enrolled participants are encouraged to complete follow-up activities as planned," she added.
Kim did not provide further comment on what was found during the interim analysis and did not comment on the "inconclusive" results mentioned by the study coordinator to the source.
In May, MedPage Today reportedopens in a new tab or window that some participants were concerned that some investigators were not wearing masks during clinic visits, potentially putting the participants at risk.

According to ClinicalTrials.govopens in a new tab or window, the study design specified two-way masking, for both investigators and participants. Neither Stanford nor study sponsor Pfizer would comment on whether or not the masking issue factored into the decision to stop the study early.
Pfizer spokesperson Jerica Pitts said Pfizer "funded the study and provided clinical supplies of Paxlovid and the placebo comparator at no cost." She also confirmed that new enrollment is closed at this time, "and the investigators plan to share final results as soon as the study is completed. We look forward to reviewing these results once available and will use the insights gathered to help inform planned and future studies."
STOP-PASC is a phase II study that sought to enroll 200 participants. It is not clear how many enrolled before recruitment closed.

Participants would receive a 15-day course of either nirmatrelvir/ritonavir or placebo plus ritonavir. Stanford and Pfizer did not comment on why the placebo group also received a protease inhibitor.

The study called for five patient visits over a total of 15 weeks, with the therapy or placebo given for the first 15 days. The estimated completion date was November 2023, according to ClinicalTrials.gov. The study's primary outcome is the difference at 10 weeks between the nirmatrelvir/ritonavir and placebo arms for any of six core symptoms of post-acute sequelae SARS-CoV-2 infection, or PASC: "fatigue, brain fog, dyspnea, body aches, gastrointestinal symptoms, cardiovascular symptoms."
Stanford spokesperson Kim said the results of the STOP-PASC trial "will be shared as soon as the study is completed," and that the study should be published "sometime before the end of the year" but that there is no definite timeline.
ClinicalTrials.gov currently lists the status of the study incorrectly as "recruiting."

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  Kristina Fiore leads MedPage’s enterprise & investigative reporting team. She’s been a medical journalist for more than a decade and her work has been recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to [email protected].
  
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Agency Issues Advisory on Mental Health Symptoms of Long COVID​

The U.S. Department of Health and Human Services has issued an advisory to help medical professionals better recognize the mental health symptoms that may come with long COVID.
The nine mental health symptoms highlighted in the advisory are:

• Fatigue
• Cognitive impairment, including brain fog
• Anxiety
• Depression
• Obsessive-compulsive disorder
• Sleep disorders
• Posttraumatic stress disorder
• Psychotic disorder
• Start of a substance use disorder

The advisory noted that social factors can contribute to the mental health problems for racial and ethnic minorities; people with limited access to health care; people who already have behavioral health conditions and physical disabilities; and people who are lesbian, gay, bisexual, transgender, queer, or intersex.

"Long COVID has a range of burdensome physical symptoms and can take a toll on a person's mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected," Health and Human Services Secretary Xavier Becerra said in a statement. "This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with Long COVID."



The department says about 10% of people infected with COVID have at least one long COVID symptom. Physical symptoms include dizziness, stomach upset, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic coughing, chest pain, and abnormal movements.
"We know that people living with long COVID need help today, and providers need help understanding what long COVID is and how to treat it," Admiral Rachel Levine, MD, assistant secretary for health, said in the statement. "This advisory helps bridge that gap for the behavioral health impacts of long COVID."

Sources​

U.S. Department of Health and Human Services: "HHS Issues Advisory on Mental Health Symptoms and Conditions Related to Long COVID."
Substance Abuse and Mental Health Services Administration: "Identification and Management of Mental Health Symptoms and Conditions Associated with Long COVID."

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COVID Boosters Effective, but Not for Long​

F. Perry Wilson, MD, MSCE

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson of the Yale School of Medicine.

I am here today to talk about the effectiveness of COVID vaccine boosters in the midst of 2023. The reason I want to talk about this isn't necessarily to dig into exactly how effective vaccines are. This is an area that's been trod upon multiple times. But it does give me an opportunity to talk about a neat study design called the "test-negative case-control" design, which has some unique properties when you're trying to evaluate the effect of something outside of the context of a randomized trial.

So, just a little bit of background to remind everyone where we are. These are the number of doses of COVID vaccines administered over time throughout the pandemic.

You can see that it's stratified by age. The orange lines are adults ages 18-49, for example. You can see a big wave of vaccination when the vaccine first came out at the start of 2021. Then subsequently, you can see smaller waves after the first and second booster authorizations, and maybe a bit of a pickup, particularly among older adults, when the bivalent boosters were authorized. But still very little overall pickup of the bivalent booster compared with the monovalent vaccines, which might suggest vaccine fatigue going on this far into the pandemic. But it's important to try to understand exactly how effective those new boosters are, at least at this point in time.

I'm talking about Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Preventing Symptomatic SARS-CoV-2 Infection Attributable to Omicron BA.5– and XBB/XBB.1.5–Related Sublineages Among Immunocompetent Adults — Increasing Community Access to Testing Program, United States, December 2022–January 2023, which came out in the Morbidity and Mortality Weekly Report very recently, which uses this test-negative case-control design to evaluate the ability of bivalent mRNA vaccines to prevent hospitalization.






The question is: Does receipt of a bivalent COVID vaccine booster prevent hospitalizations, ICU stay, or death? That may not be the question that is of interest to everyone. I know people are interested in symptoms, missed work, and transmission, but this paper was looking at hospitalization, ICU stay, and death.

What's kind of tricky here is that the data they're using are in people who are hospitalized with various diseases. It's a little bit counterintuitive to ask yourself, How can you estimate the vaccine's ability to prevent hospitalization using only data from hospitalized patients? You might look at that on the surface and say, Well, you can't — that's impossible. But you can, actually, with this cool test-negative case-control design.

Here's basically how it works. You take a population of people who are hospitalized and confirmed to have COVID. Some of them will be vaccinated and some of them will be unvaccinated. And the proportion of vaccinated and unvaccinated people doesn't tell you very much because it depends on how that compares with the rates in the general population, for instance. Let me clarify this. If 100% of the population were vaccinated, then 100% of the people hospitalized with COVID would be vaccinated. That doesn't mean vaccines are bad. Put another way, if 90% of the population were vaccinated and 60% of people hospitalized with COVID were vaccinated, that would actually show that the vaccines were working to some extent, all else being equal. So it's not just the raw percentages that tell you anything. Some people are vaccinated, some people aren't. You need to understand what the baseline rate is.

The test-negative case-control design looks at people who are hospitalized without COVID. Now who those people are (who the controls are, in this case) is something you really need to think about. In the case of this CDC study, they used people who were hospitalized with COVID-like illnesses — flu-like illnesses, respiratory illnesses, pneumonia, influenza, etc. This is a pretty good idea because it standardizes a little bit for people who have access to healthcare. They can get to a hospital and they're the type of person who would go to a hospital when they're feeling sick. That's a better control than the general population overall, which is something I like about this design.


Some of those people who don't have COVID (they're in the hospital for flu or whatever) will have been vaccinated for COVID, and some will not have been vaccinated for COVID. And of course, we don't expect COVID vaccines necessarily to protect against the flu or pneumonia, but that gives us a way to standardize.

If you look at these Venn diagrams, I've got vaccinated/unvaccinated being exactly the same proportion, which would suggest that you're just as likely to be hospitalized with COVID if you're vaccinated as you are to be hospitalized with some other respiratory illness, which suggests that the vaccine isn't particularly effective.

However, if you saw something like this, looking at all those patients with flu and other non-COVID illnesses, a lot more of them had been vaccinated for COVID. What that tells you is that we're seeing fewer vaccinated people hospitalized with COVID than we would expect because we have this standardization from other respiratory infections. We expect this many vaccinated people because that's how many vaccinated people there are who show up with flu. But in the COVID population, there are fewer, and that would suggest that the vaccines are effective. So that is the test-negative case-control design. You can do the same thing with ICU stays and death.

There are some assumptions here which you might already be thinking about. The most important one is that vaccination status is not associated with the risk for the disease. I always think of older people in this context. During the pandemic, at least in the United States, older people were much more likely to be vaccinated but were also much more likely to contract COVID and be hospitalized with COVID. The test-negative design actually accounts for this in some sense, because older people are also more likely to be hospitalized for things like flu and pneumonia. So there's some control there.




But to the extent that older people are uniquely susceptible to COVID compared with other respiratory illnesses, that would bias your results to make the vaccines look worse. So the standard approach here is to adjust for these things. I think the CDC adjusted for age, sex, race, ethnicity, and a few other things to settle down and see how effective the vaccines were.


Let's get to a worked example.

This is the actual data from the CDC paper. They had 6907 individuals who were hospitalized with COVID, and 26% of them were unvaccinated. What's the baseline rate that we would expect to be unvaccinated? A total of 59,234 individuals were hospitalized with a non-COVID respiratory illness, and 23% of them were unvaccinated. So you can see that there were more unvaccinated people than you would think in the COVID group. In other words, fewer vaccinated people, which suggests that the vaccine works to some degree because it's keeping some people out of the hospital.

Now, 26% vs 23% is not a very impressive difference. But it gets more interesting when you break it down by the type of vaccine and how long ago the individual was vaccinated.

Let's walk through the "all" group on this figure. What you can see is the calculated vaccine effectiveness. If you look at just the monovalent vaccine here, we see a 20% vaccine effectiveness. This means that you're preventing 20% of hospitalizations basically due to COVID by people getting vaccinated. That's okay but it's certainly not anything to write home about. But we see much better vaccine effectiveness with the bivalent vaccine if it had been received within 60 days.

This compares people who received the bivalent vaccine within 60 days in the COVID group and the non-COVID group. The concern that the vaccine was given very recently affects both groups equally so it shouldn't result in bias there. You see a step-off in vaccine effectiveness from 60 days, 60-120 days, and greater than 120 days. This is 4 months, and you've gone from 60% to 20%. When you break that down by age, you can see a similar pattern in the 18-to-65 group and potentially some more protection the > 65 age group.


Why is vaccine efficacy going down? The study doesn't tell us, but we can hypothesize that this might be an immunologic effect — the antibodies or the protective T cells are waning over time. This could also reflect changes in the virus in the environment as the virus seeks to evade certain immune responses. But overall, this suggests that waiting a year between booster doses may leave you exposed for quite some time, although the take-home here is that bivalent vaccines in general are probably a good idea for the proportion of people who haven't gotten them.


When we look at critical illness and death, the numbers look a little bit better.

You can see that bivalent is better than monovalent — certainly pretty good if you've received it within 60 days. It does tend to wane a little bit, but not nearly as much. You've still got about 50% vaccine efficacy beyond 120 days when we're looking at critical illness, which is stays in the ICU and death.

The overriding thing to think about when we think about vaccine policy is that the way you get immunized against COVID is either by vaccine or by getting infected with COVID, or both.

This really interesting graph from the CDC (although it's updated only through quarter three of 2022) shows the proportion of Americans, based on routine lab tests, who have varying degrees of protection against COVID. What you can see is that by quarter three of 2022, just 3.6% of people who had blood drawn at a commercial laboratory had no evidence of infection or vaccination. In other words, almost no one was totally naive. Then 26% of people had never been infected — they only have vaccine antibodies — plus 22% of people had only been infected but had never been vaccinated. And then 50% of people had both. So there's a tremendous amount of existing immunity out there.

The really interesting question about future vaccination and future booster doses is, how does it work on the background of this pattern? The CDC study doesn't tell us, and I don't think they have the data to tell us the vaccine efficacy in these different groups. Is it more effective in people who have only had an infection, for example? Is it more effective in people who have only had vaccination vs people who had both, or people who have no protection whatsoever? Those are the really interesting questions that need to be answered going forward as vaccine policy gets developed in the future.


I hope this was a helpful primer on how the test-negative case-control design can answer questions that seem a little bit unanswerable. I'll see you next time.

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Study: At-home rapid COVID tests may miss many infections
| Originally published on MedicalXpress Breaking News-and-Events


For the last couple of years, the rapid at-home COVID tests that can identify an infection with a simple swab of the nose have been a mainstay of efforts to diagnose infection with the SARS-CoV-2 virus and prevent its spread.

But what if these tests are often wrong?

New research conducted at Caltech suggests that in many cases, rapid tests that use a nasal swab provide false negatives—suggesting that a person is infection-free even though other parts of their respiratory tract are teeming with the virus. The findings, from the lab of Rustem Ismagilov, Ethel Wilson Bowles and Robert Bowles Professor of Chemistry and Chemical Engineering, appear in a paper published in the journal Microbiology Spectrum on June 15 .

Researchers in Ismagilov's lab tracked viral loads in three places in the human body during the course of a COVID-19 infection: the nose, the throat, and the mouth. Because the nose, throat, and mouth are so closely connected, one might expect to see similar virus levels in those locations. That turns out not to be the case.

"Generally, we saw that most people have virus first appear in their throat and in saliva, and then, sometimes days later, in their nose," says Alexander Viloria Winnett, biology graduate student and study co-author. "Actually, each sample type from a single person follows its own distinct rise and fall of viral load, so it makes a big difference which sample type is used for testing."

At the beginning of the pandemic, the gold standard for testing was the deep nasal swab (PCR test) administered by a medical professional, which is highly sensitive and accurate but uncomfortable for many people and slower to provide results. As the pandemic progressed, people more and more relied on at-home nasal rapid antigen tests, which can be performed without the assistance of a medical professional and provide results in as little as 15 minutes.

However, in their study, the Caltech researchers found that most people showed a delay of several days between when the virus first appeared in the throat or saliva and when it appeared in the nose. Importantly, 15 of the 17 study participants had high and presumably infectious levels of virus for at least a day prior to getting a positive antigen test.

"In one individual, levels of virus in throat swabs were extremely high and presumably infectious for almost two weeks while nasal-swab viral loads were undetectable or remained so low they would have been detected only by a highly sensitive PCR test," says Natasha Shelby, the Caltech COVID-19 study's administrator and a co-author on the paper. "This individual never tested positive on her daily rapid antigen tests."

Shelby says antigen tests have two major limitations: "First, they only test for virus in the nose, even though the SARS-CoV-2 virus is known to be in the mouth, and, in fact, numerous studies show it often shows up in the mouth days before the nose. Second, these rapid tests have low sensitivity, which means they require a lot of virus to indicate a positive result. People assume that these tests will be positive when people are infectious, but we now know from numerous studies that this is not always true."

That means at-home tests can indicate that a person is negative for the virus even though they are actually infected—and even currently infectious.

"Rapid tests have some benefits. You can get results in about 20 minutes, they tend to be less expensive, and they can be more portable than other testing methods," Viloria Winnett says. "But because they are only approved for nasal swabs and have low sensitivity, correct detection of infection by those tests is often delayed by several days."

Viloria Winnett says he hopes the Caltech COVID-19 study findings will spur development of home testing kits that sample both the nose and throat. Such tests are common in other parts of the world, such as the United Kingdom, but are not authorized for use in the United States.

"This has implications," Viloria Winnett says. "People are still becoming infected with COVID. We're still seeing waves, and we're still seeing the development of new variants. I don't want to be alarmist, but we still need to be aware and reactive to the pandemic. And hopefully this work can inform our initial response to other upper respiratory viruses that may emerge so testing strategies can be more effective."

Exactly why such different viral trajectories are seen in these parts of the body remains an open question that will have to be the subject of future research.

"Why is there virus in a certain sample type and not in another? It could be the route of initial infection or susceptibility of different anatomical sites to the virus. This is what I'll be trying to figure out in follow-up investigations," Viloria Winnett says.

This article was originally published on MedicalXpress Breaking News-and-Events.

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Novel drug could treat long COVID and prevent re-infection
| Originally published on MedicalXpress Breaking News-and-Events


A new drug developed by QIMR Berghofer could transform the treatment of COVID-19 by potentially protecting against infection by any SARS-CoV-2 variant and reversing the persistent inflammation that is a major driver of debilitating long COVID.

The findings of the second major study demonstrating the pre-clinical effectiveness of the peptide-based drug, NACE2i, have been published in the journal Nature Communications.

Epigeneticist and co-lead author, Professor Sudha Rao who heads QIMR Berghofer's Gene Regulation & Translational Medicine Group, said the drug was tested repeatedly by independent laboratories using a variety of pre-clinical models.

"The results of this second major study are really exciting. It shows our drug, NACE2i, stops the virus replicating and protects against re-infection," Professor Rao said. "We believe it could be a highly promising adjuvant to boost the effectiveness of existing vaccines providing long-lasting protection against any variant of the virus that tries to enter the cells.

"The other major discovery is that we uncovered the pathway that the virus uses to induce the persistent inflammation which causes organ damage found in long COVID. This study shows our drug prevents that inflammation and even repairs damaged lung tissue in pre-clinical models. It is both a prevention and a treatment."

Over the course of the pandemic, hundreds of millions of people have been infected with SARS-CoV-2 which has claimed many millions of lives. New variants continue to emerge contributing to ongoing waves of infection.

Long COVID is thought to affect between 10% and 20% of those infected with COVID-19. Debilitating long-term symptoms include fatigue, breathlessness and brain fog. It is a significant global health burden affecting everyday functioning, with many sufferers unable to work or carry out household tasks.

"We want to help patients. This is why we work in science. We are really proud of what we have achieved here. We are confident NACE2i is a potential treatment for long COVID that will relieve those debilitating symptoms and revive immune function," Professor Rao said.

The first major study by the QIMR Berghofer research team in 2021 showed the SARS-CoV-2 virus hijacks the ACE2 receptor on the cell's surface and draws it into the nucleus or control center of the cell, triggering a process that is essential for the virus to replicate.

NACE2i works by reprogramming the hijacked ACE2 receptor which disarms the virus and stops it replicating. The reprogrammed ACE2 receptor is returned to the cell surface where it acts as a lock that prevents the virus from entering the cell. This process also reverses the inflammation COVID-19 causes in the lungs.

First author and QIMR Berghofer Research Officer Dr. Wen Juan Tu said it was very exciting to see NACE2i repairing damaged lung tissue in pre-clinical models. "The images are really remarkable. In the damaged lung, you see it is missing the surface layer of the lung bronchiole area. After treatment with NACE2i, the lung is restored to normal function with a healthy surface layer," Dr. Tu said.

The QIMR Berghofer researchers have also developed a biomarker blood test to detect the presence of the protective ACE2 receptor layer around cells. They tested this in human blood samples and found it was lacking in patients who had repeated COVID-19 infections. The study found NACE2i restored this biomarker of protection.

Immunologist and co-lead author Professor Nabila Seddiki who is Research Director of Immunology & Infectious Diseases Commissariat à l'Energie Atomique (CEA), Paris-Saclay University and INSERM in France tested NACE2i in their pre-clinical COVID-19 models.

"When we looked at the results it was very clear the peptides were inhibiting inflammation in our SARS-CoV-2 models which was really great to see. We have been working together for a long time with each of us bringing our own expertise to the work and that's how we have achieved what we have," Professor Seddiki said.

The next step is to begin clinical trials of NACE2i.

—QIMR Berghofer

This article was originally published on MedicalXpress Breaking News-and-Events.

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Moderna Asks FDA to Approve XBB COVID Shot​

Lisa O'Mary

Moderna has applied for FDA approval of a new COVID-19 vaccine targeting the predominant strain of the virus called XBB.1.5. The company said it is prepared to roll out the shot this fall.

Currently, the XBB lineage of the virus accounts for 95% of all cases, including 27% of cases being XBB.1.5, and 20% of cases being XBB.1.16, according to the CDC's variant tracker.

In a news release, the company said on Thursday that the new formulation has "a robust immune response," but did not provide further details about the vaccine's effectiveness in trials.

Moderna and fellow vaccine-makers Pfizer and Novavax began developing the XBB.1.5 formulations a month and a half ago, CNBC reported.


Last week, the FDA asked manufacturers to provide a new version of the COVID vaccine for the fall based on a task force's recommendation for a formulation targeting XBB subvariants. This will be the first of what is expected to be an annual updated COVID vaccine, similar to how the flu vaccine is updated annually.


Moderna said the most common side effects of the new version of its vaccine were injection site pain, headache, fatigue, muscle pain, and chills.

In the past week, 6,649 people were hospitalized in the U.S. for COVID-19, which is a nearly 8% decrease from the week prior. There were 409 COVID deaths last week, measuring a 9% one-week increase. Public health officials are gaging how widespread and harmful the virus is through hospitalization and death rates. During the pandemic's height, the number of weekly deaths reached 26,000 in January 2021. The CDC now also reports COVID deaths in relation to all other causes of death in the U.S. Last week, COVID deaths made up 1.2% of all U.S. deaths.

It's unclear what the demand will be for the new version of the vaccine. Just 17% of people in the U.S. chose to get the most recent booster, which was called bivalent because it targeted the original virus as well as Omicron strains, according to CDC data.

Sources​

Moderna: "Moderna Files For FDA Authorization Of Its Updated COVID-19 Vaccine."

CDC: "COVID Data Tracker," "COVID-19 Vaccinations in the United States."

CNBC: "Moderna files for FDA approval of updated Covid vaccine for fall."




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No Direct Evidence COVID Started in Wuhan Lab: US Intelligence Report​

By Dan Whitcomb

(Reuters) - U.S. intelligence agencies found no direct evidence that the COVID-19 pandemic stemmed from an incident at China's Wuhan Institute of Virology, a report declassified on Friday said.

The four-page report by the Office of the Director of National Intelligence (ODNI) said the U.S. intelligence community still could not rule out the possibility that the virus came from a laboratory, however, and had not been able to discover the origins of the pandemic.

"The Central Intelligence Agency and another agency remain unable to determine the precise origin of the COVID-19 pandemic, as both (natural and lab) hypotheses rely on significant assumptions or face challenges with conflicting reporting," the ODNI report said.

The report said that while "extensive work" had been conducted on coronaviruses at the Wuhan institute (WIV), the agencies had not found evidence of a specific incident that could have caused the outbreak.


"We continue to have no indication that the WIV's pre-pandemic research holdings included SARSCoV-2 or a close progenitor, nor any direct evidence that a specific research-related incident occurred involving WIV personnel before the pandemic that could have caused the COVID pandemic," the report said.













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Does COVID-19 Vaccination Disturb Menstrual Cycling?​

Clarice R. Weinberg
DISCLOSURES
Am J Epidemiol. 2023;192(6):849-850.

Coronavirus disease 2019 (COVID-19) vaccines have been reported to have a short-term effect on the menstrual cycle, delaying the onset of the next menses. However, the analytical methods that have been used to study this are subject to a statistical phenomenon called "length-biased sampling" that calls the results into question. Those data are important and should be reanalyzed in an unbiased way.
Many premenopausal women are protective of their reproductive health, and this may have led some to avoid vaccination. Vaccination drives increased internet searches about possible effects of coronavirus disease 2019 (COVID-19) vaccination on the menstrual cycle.[1] Supporting such an effect were 2 recent papers based on the online application "Natural Cycles," which tracks menstrual cycle data. One,[2] based on 2,403 vaccinated US women between the ages of 18 and 45 years, for whom at least 6 cycles were recorded, found a statistically significant extension of the cycle length in the vaccinated cycle (less than a day on average) compared with the mean of the 3 preceding cycles. That extension was evident only in the cycle in which the vaccination occurred; the subsequent cycle was not unusual in its length. The same group recently reported a similar extension with a larger sample, based on international users of the same application.[3] Cycles that included 2 COVID-19 vaccinations showed an even larger extension, estimated at 3.7 days.
This work has been widely cited, with the BMJ Medicine article[3] being picked up by 190 news outlets, according to the Article Metrics page accompanying the article online. Such an effect would understandably have raised general concerns about effects of the vaccines on reproduction.
However, a statistical phenomenon called "length-biased sampling" needs to be considered. If you study menstrual cycle records and select a date at random from a sequence of intervals that vary some in their lengths, that date is more likely to fall in a relatively long interval than in a shorter interval. Thus, the reported effect of vaccination could be explained by length-biased sampling and might not reflect any actual effect on the menstrual cycle. The larger apparent effect of having 2 doses in a single cycle would also be expected based on length bias, given that instructions for the original Pfizer and Moderna vaccines specified a gap of at least several weeks between their 2 doses. If one were to select dates or pairs of dates at random (subject to the observed 2-dose intervals) from the sequences of cycles, both single-dose and the double-dose extensions would be expected, could resemble those reported, and could again be statistically significant. Those data deserve to be reanalyzed, with proper adjustment for length bias.

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Long Covid and Vaccines: Separating Facts From Falsehoods

The COVID-19 vaccines have been a game changer for millions of people worldwide in preventing death or disability from the virus. Research suggests they offer significant protection against long COVID.

www.medscape.com

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Long Covid and Vaccines: Separating Facts From Falsehoods​

Hallie Levine
July 14, 2023

The COVID-19 vaccines have been a game changer for millions of people worldwide in preventing death or disability from the virus. Research suggests that they offer significant protection against long COVID.

Studies have consistently found that these vaccines prevent the new onset of long COVID as well as flare-ups for people who already have the condition.

False and unfounded claims made by some antivaccine groups that the vaccines themselves may cause long COVID persist and serve as barriers to vaccination.


To help separate the facts from falsehoods, here's a checklist for doctors on what scientific studies have determined about vaccination and long COVID.

What the Research Shows​

Doctors who work in long COVID clinics have for years suspected that vaccination may help protect against the development of long COVID, noted Lawrence Purpura, MD, MPH, an infectious disease specialist at New York–Presbyterian/Columbia University Irving Medical Center, who treats patients with long COVID in his clinic.

Over the past year, several large, well-conducted studies have borne out that theory, including the following studies:

• In the RECOVER study, published in May in the journal Nature Communications, researchers examined the electronic health records of more than 5 million people who had been diagnosed with COVID and found that vaccination reduced the risk that they would develop long COVID. Although the researchers didn't compare the effects of having boosters to being fully vaccinated without them, experts have suggested that having a full round of recommended shots may offer the most protection. "My thoughts are that more shots are better, and other work has shown compelling evidence that the protective effect of vaccination on COVID-19 wanes over time," said study co-author Daniel Brannock, MS, a research scientist at RTI International in Research Triangle Park, North Carolina. "It stands to reason that the same is true for long COVID."
• A review published in February in BMJ Medicine concluded that 10 studies showed a significant reduction in the incidence of long COVID among vaccinated patients. Even one dose of a vaccine was protective.
• A meta-analysis of six studies published last December in Antimicrobial Stewardship and Healthcare Epidemiology found that one or more doses of a COVID-19 vaccine were 29% effective in preventing symptoms of long COVID.
• In a June meta-analysis published in JAMA Internal Medicine, researchers analyzed more than 40 studies that included 860,000 patients and found that two doses of a COVID-19 vaccine reduced the risk of long COVID by almost half.

The message? COVID vaccination is very effective in reducing the risk of long COVID.

"It's important to emphasize that many of the risk factors [for long COVID] cannot be changed, or at least cannot be changed easily, but vaccination is a decision that can be taken by everyone," said Vassilios Vassiliou, MBBS, PhD, clinical professor of cardiac medicine at Norwich Medical School in the United Kingdom, who co-authored the article in JAMA Internal Medicine.

Why Vaccines May Be Protective​

The COVID-19 vaccines work well to prevent serious illness from the virus, noted Aaron Friedberg, MD, clinical co-leader of the Post COVID Recovery Program at the Ohio State University Wexner Medical Center. That may be a clue to why the vaccines help prevent long COVID symptoms.

"When you get COVID and you've been vaccinated, the virus may still attach in your nose and respiratory tract, but it's less likely to spread throughout your body," he explained. "It's like a forest fire — if the ground is wet or it starts to rain, it's less likely to create a great blaze. As a result, your body is less likely to experience inflammation and damage that makes it more likely that you'll develop long COVID."

Friedberg stressed that even for patients who have had COVID, it's important to get vaccinated — a message he consistently delivers to his own patients.


"There is some protection that comes from having COVID before, but for some people, that's not enough," he said. "It's true that after infection, your body creates antibodies that help protect you against the virus. But I explain to patients that these may be like old Velcro: they barely grab on enough to stay on for the moment, but they don't last long term. You're much more likely to get a reliable immune response from the vaccine."

In addition, a second or third bout of COVID could be the one that gives patients long COVID, Friedberg adds.

"I have a number of patients in my clinic who were fine after their first bout of COVID but experienced debilitating long COVID symptoms after they developed COVID again," he said. "Why leave it to chance?"

Vaccines and "Long Vax"​

The COVID vaccines are considered very safe but have been linked to very rare side effects, such as blood clots and heart inflammation. There have also been anecdotal reports of symptoms that resemble long COVID — a syndrome that has come to be known as "long Vax" — an extremely rare condition that may or may not be tied to vaccination.
"I have seen people in my clinic who developed symptoms suggestive of long COVID that linger for months — brain fog, fatigue, heart palpitations — soon after they got the COVID-19 vaccine," said Purpura. But no published studies have suggested a link, he cautions.

A study called LISTEN is being organized at Yale in an effort to better understand post-vaccine adverse events and a potential link to long COVID.

Talking to Patients​

Discussions of vaccination with patients, including those with COVID or long COVID, are often fraught and challenging, said Purpura.

"There's a lot of fear that they will have a worsening of their symptoms," he explained. The conversation he has with his patients mirrors the conversation all physicians should have with their patients about COVID-19 vaccination, even if they don't have long COVID. He stresses the importance of highlighting the following components:

• Show compassion and empathy. "A lot of people have strongly held opinions — it's worth it to try to find out why they feel the way that they do," said Friedberg.
• Walk them through side effects. "Many people are afraid of the side effects of the vaccine, especially if they already have long COVID," explained Purpura. Such patients can be asked how they felt after their last vaccination, such a shingles or flu shot. Then explain that the COVID-19 vaccine is not much different and that they may experience temporary side effects such as fatigue, headache, or a mild fever for 24–48 hours.
• Explain the benefits. Eighty-five percent of people say their healthcare provider is a trusted source of information on COVID-19 vaccines, according to the Kaiser Family Foundation. That trust is conducive to talks about the vaccine's benefits, including its ability to protect against long COVID.

Other Ways to Reduce Risk of Long COVID​

Vaccines can lower the chances of a patient's developing long COVID. So can the antiviral medication nirmatrelvir (Paxlovid). A March 2023 study published in JAMA Internal Medicine included more than 280,000 people with COVID. The researchers found that vaccination reduced the risk for developing the condition by about 25%.


"I mention that study to all of my long COVID patients who become reinfected with the virus," said Purpura. "It not only appears protective against long COVID, but since it lowers levels of virus circulating in their body, it seems to help prevent a flare-up of symptoms."

Another treatment that may help is the diabetes drug metformin, he added.

A June 2023 study published in The Lancet Infectious Diseases found that when metformin was given within 3 days of symptom onset, the incidence of long COVID was reduced by about 41%.

"We're still trying to wrap our brains around this one, but the thought is it may help to lower inflammation, which plays a role in long COVID," Purpura explained. More studies need to be conducted, though, before recommending its use.

Sources​

Nature Communications: "Long COVID risk and pre-COVID vaccination in an EHR-based cohort study from the RECOVER program." May 2023. Long COVID risk and pre-COVID vaccination in an EHR-based cohort study from the RECOVER program | Nature Communications


BMJ Medicine: "Effect of COVID-19 vaccination on long COVID: Systematic review." February 2023. e000385.full.pdf (bmj.com)


Cambridge University Press: "The effectiveness of coronavirus disease 2019 (COVID-19) vaccine in the prevention of post-COVID-19 conditions: A systematic literature review and meta-analysis." December 2022. The effectiveness of coronavirus disease 2019 (COVID-19) vaccine in the prevention of post–COVID-19 conditions: A systematic literature review and meta-analysis | Antimicrobial Stewardship & Healthcare Epidemiology | Cambridge Core

JAMA Internal Medicine: "Risk factors associated with post-COVID-19 condition: A systematic review and meta-analysis." June 2023. Risk Factors Associated With Post-COVID-19 Condition: A Systematic Review and Meta-analysis - PubMed (nih.gov)

medRxiv: "Neuropathic symptoms with SARS-CoV-2 vaccination." May 2022. Neuropathic symptoms with SARS-CoV-2 vaccination - PubMed (nih.gov)

JAMA Internal Medicine: "Association of treatment with nirmatrelvir and the risk of post-COVID-19 condition." March 2023. Association of Treatment With Nirmatrelvir and the Risk of Post–COVID-19 Condition | Clinical Pharmacy and Pharmacology | JAMA Internal Medicine | JAMA Network

The LANCET Infectious Diseases: "Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomized, quadruple-blind, parallel-group, phase 3 trial." June 8, 2023. Outpatient treatment of COVID-19 and incidence of post-COVID-19 condition over 10 months (COVID-OUT): a multicentre, randomised, quadruple-blind, parallel-group, phase 3 trial - The Lancet Infectious Diseases

"

​

• 
  
• 
  
• 
  

​

 

[missy]

"

COVID-19: Catch up quick​

Metrics are increasing, but excess deaths are down.​

KATELYN JETELINA JUL 18

Yesterday, the New York Times suggested the pandemic is over. We are in a very different place. And, I understand the desire for a “thank goodness that’s done” mindset. And I hope COVID-19 isn’t always on top of your mind.

But COVID-19 is still around. I hope you continue to join me on the scientific discovery ride. Here is your state of affairs.

United States​

After a few quiet months, COVID-19 is increasing in the Southern and Western United States. Three early indicators—wastewater, ED visits, and test positivity— are increasing uniformly, albeit from low absolute levels. Using back-of-the-napkin math, this equates to ~1 in 1,180 people infected today. If you squint really hard, hospitalizations are starting to increase, too.

​

Note this is for Region 6— which includes several Southern states. Source: CDC
This isn’t surprising; we’ve consistently seen a Southern summer wave throughout the pandemic. While the latest Omicron subvariant soup may partly drive this uptick, it’s more likely behavior; people moving inside due to ridiculous heat.

​

SARS-CoV-2 wastewater by region (pink=South) with added annotations by KKJ
Since late January 2023, excess deaths have reached pre-pandemic levels. This has been a massive reprieve.

Since late January 2023, excess deaths have reached pre-pandemic levels. This has been a massive reprieve.

​

(CDC)
I am surprised; I always assumed that we would need to increase the excess death baseline given we added a new threat to our repertoire. But, for now, we don’t. Perhaps this is due to a combination of things:

• You can’t die twice. COVID-19 has killed the most medically fragile people over the last three years, and those premature deaths lead to fewer deaths today. In this case, excess deaths could rebound in coming years;
• Population-level immunity. Hybrid immunity is holding up greater than we expected, even among older Americans;
• Relative. COVID-19 deaths are so small relative to the entire burden of death that it’s immaterial. It’s a fraction of all daily deaths and within the margin of error;
• Another type of death could be decreasing, thus canceling out the impact of COVID-19. (I don’t think this is likely.)

This will be fascinating to follow given the upcoming respiratory season, COVID-19 still settling into seasonality, millions of people losing health insurance, and other things, like the heat wave. I don’t think excess deaths has settled just yet.

International surveillance​

Zooming out, eyes are on two particular places around the globe:

1. Okinawa, Japan. COVID-19 hospitalizations continue to increase exponentially, surpassing their winter wave and overwhelming hospitals. This is driven by XBB, changing behavior (big holiday), and a large pool of susceptible people— it’s been about six months since their last wave. Everyone is waiting to see if this transpires outside of Okinawa.
   

   ​

   The average number of COVID-19 patients per medical institution (Okinawa) by week, month, and year. Latest data from July 2. Source: Ministry of Health
2. Dominican Republic: A new Omicron variant— FL1.5.1— is showing its teeth by exponentially increasing quickly. This variant has the same spike protein as what’s currently circulating (XBB) but several non-spike mutations. It’s in its infancy, so it’s unclear if (and how) it will impact real-world metrics. It’s one to keep an eye on.

What’s next?​

The COVID-19 Modeling Hub— eight academic teams across the U.S.— just released projections for the next two years: hospitalizations and deaths will likely stay within last year’s range. Unfortunately, this means we should expect to lose 55,000 (optimistic model)- 450,000 Americans (pessimistic model) due to COVID-19.

​

Projected COVID-19 deaths in the United States for the next two seasons. Source here.
We’re waiting on a fall vaccine eligibility decision from CDC, which will happen in mid-September. Whispers on the street suggest that everyone will be eligible. The ACIP meeting should be fascinating because we will see the first cost-effectiveness analyses now that vaccines are privatized—are the benefits of the COVID-19 vaccines worth the individual cost for everyone? I would also love to see the updated CDC benefit/risk analysis for young males.

Bottom line​

COVID-19 is increasing; don’t be surprised to hear more people getting infected around you. I already am. This isn’t enough reason to change my personal behaviors, but that time may come this fall.



"

 

[missy]

"​

Opinion | Long COVID Persists as a Mass Disabling Event

We must do more to show we care

www.medpagetoday.com

Long COVID Persists as a Mass Disabling Event​

— We must do more to show we care​

by Karen Bonuck, PhD July 23, 2023

The latest CDC data on long COVID in U.S. adults and an alarming World Health Organization (WHO) statementopens in a new tab or window about its long-term impact underscore the pandemic's lingering and debilitating effects. Like the satirical film "Don't Look Upopens in a new tab or window," in which scientists couldn't focus media or politicians on the climate crisis, most Americans are content to avert their eyes from the long COVID crisis. Meanwhile, the millions now missing from public life because of it have no choice but to stare down the gamut of its sweeping sequelae.



As an NIH-funded researcher, I study child feeding and sleep, and co-direct the University Center of Excellence in Developmental Disabilitiesopens in a new tab or window. For years I have been an ally to families who have advocated for individuals with disabilities. As a mother, I've now become an advocate and supporter for my daughter as she fights a daily unseen battle and continues to struggle with long COVID, 3 years after contracting the SARS-COV-2 virus. In fact, the average person loses 21% of their healthopens in a new tab or window while living with long COVID -- equivalent to traumatic brain injury.

Long COVID: Persistent and Prevalent

Earlier this year, an Israeli studyopens in a new tab or window suggested that many long COVID symptoms resolve within a year. But you can't see what you don't measure: fatigue wasn't studied, despite ranking among the top long COVID symptoms globallyopens in a new tab or window, in the U.S.opens in a new tab or window, and even following asymptomatic infectionopens in a new tab or window. CDC data confirms my tracking of the literature and family's experience -- long COVID is prevalent and impactful. In the latest CDC dataopens in a new tab or window, just over 15% of U.S. adults ever had long COVID, and 5.8% (about 15 million) currently have it. For a condition that's fallen off the radar for those untouched by it, the percentages of U.S. adults reporting any (4.9%) and significant (1.5%) activity limitations is astonishing.

Original graphic from Joshua Ashkinaze, based on CDC data.


The persistence of long COVID (as shown above) is consistent with studiesopens in a new tab or window of people followed 2 or more years post-infection. Yet, funding for research on effective therapies or cures has been insufficient. The dearth of clinical trials has been a key target for advocates and scientists. In fact, 2 years after the NIH heralded its "RECOVERopens in a new tab or window" initiative, there is little to showopens in a new tab or window for the $1 billion that went into investigating long COVID. People are still suffering in real and devastating ways -- my 20-something daughter still finds it difficult to walk more than a few blocks and had to move back home last winter after living independently since college.

Gaslighting and a Misguided Victory Lap

Leaning into my disability advocacy hat, I have been reaching out to people across disciplines and government to sound the alarm that long COVID is a mass disabling event. And it is not going to disappear, as much as media outlets and policymakers want to move on and ignore it.



In early June, I emailed my local legislator's office, highlighting the depressing statistics and sharing my daughter's clinical and care-seeking trajectory since 2020. Like other long COVID survivors, she has endured medical gaslightingopens in a new tab or window, diagnostic odysseys, and sees no treatments on the immediate horizon. I was hopeful when I saw an email in my inbox from the legislator's office. At minimum, I expected he'd acknowledge my daughter's struggleopens in a new tab or window, or recognize the impact of long COVID on his other constituents. More optimistically, perhaps the reply would outline steps he's taking to alleviate long COVID's continuing impact and efforts his office is undertaking to press for badly needed patient-centered research.

Instead, the auto-reply cited the legislator's support for the "recent" $8.3 billion COVID relief package (passed in 2020) and referred to my home state's COVID emergency declaration (lifted in March 2022) in the present tense. This robotic non-response exemplifies the "mission-accomplished" stance of many policymakers towards long COVID. The proverbial tying of the bow on the pandemic's end exemplifies our culture's discomfort with disability -- its ubiquity, ordinariness, and unpredictability. It is easier to take the victory lap, and then quietly acknowledge those still trying to exist with the disability.



So, what can you do as a healthcare professional?

Listen to your patients -- and believe them. Chances are, your patient with "unremarkable" testing and labs, who's had unrelenting fatigue for months or years after COVID infection has had enough medical gaslighting. Honor their lived experience and show humility in what you don't know about their condition.

Educate yourself. Stay up-to-date on long COVID research, diagnosis, and treatmentopens in a new tab or window. See if your patients are eligible -- and can access -- a clinical trialopens in a new tab or window. Learn about and use (as appropriate) the new ICD-10 codeopens in a new tab or window for Postural Orthostatic Tachycardia Syndrome (POTS), a condition seen in more than halfopens in a new tab or window of long COVID patients.

Advocate. Use your voice as a healthcare provider. Given how policy decisions affect medical practice, consider researching and supporting long COVID legislation that will create patient-centered registries, fund research on post-infectious disease treatments, conduct public educationopens in a new tab or window, or offer research grantsopens in a new tab or window. See if your representative is already sponsoring these bills, and if not, consider encouraging them to do so.



You can make a difference to your patients -- or perhaps even loved ones or peers -- who've had to duct-tape their lives back together after long COVID. Help rewrite the "Don't Look Up" script for the millions with long COVID in the U.S. with your advocacy and support.

Karen Bonuck, PhD,opens in a new tab or window is co-director of the University Center of Excellence at Montefiore Einstein, a pediatric health researcher and professor of family and social medicine at Albert Einstein College of Medicine in New York City, a disabilities advocate, and a mom.

"

 

[dk168]

Pants, just been tested positive for Covid.

Started to feel unwell yesterday, tested negative; and the symptoms worsened today so I tested again, and got a positive result.

Had to cancel all my upcoming appointments and events for the next few days, and the diary was rather busy, hey ho!

I am certain I got it from the recent trip in Amsterdam as I was in packed meeting room for 2 days, and in packed public transport and planes too.

Covid is still with us, so be careful!

DK

 

[missy]

Pants, just been tested positive for Covid.

Started to feel unwell yesterday, tested negative; and the symptoms worsened today so I tested again, and got a positive result.

Had to cancel all my upcoming appointments and events for the next few days, and the diary was rather busy, hey ho!

I am certain I got it from the recent trip in Amsterdam as I was in packed meeting room for 2 days, and in packed public transport and planes too.

Covid is still with us, so be careful!

DK

I am so sorry @dk168. I hope it’s a mild case and you feel much better very soon!

 

[Begonia]

There are other really nasty viruses out there, aside from covid. I had a month off from work on holidays and caught something on day 7. Went straight into my lungs, then throat and sinuses and ears. My ears have been plugged for 10 days (no ear infection thankfully). I was every bit as sick as covid (and I got very ill there), just differently.

I dunno. I'm back to masking up. It was really awful. I'm still not well and it's week 4. About to start back at work. Some holiday.

 

[missy]

There are other really nasty viruses out there, aside from covid. I had a month off from work on holidays and caught something on day 7. Went straight into my lungs, then throat and sinuses and ears. My ears have been plugged for 10 days (no ear infection thankfully). I was every bit as sick as covid (and I got very ill there), just differently.

I dunno. I'm back to masking up. It was really awful. I'm still not well and it's week 4. About to start back at work. Some holiday.

Aww I’m sorry..Feel better soon @Begonia

That’s true with masking a plus was we didn’t get colds or the flu etc.

 

[dk168]

I am so sorry @dk168. I hope it’s a mild case and you feel much better very soon!

Thanks, just very achey which prompted me to test for Covid.

I am still alive so I am grateful, just needed to cancel 7 events and appointments up to Saturday.

DK

 

[missy]

"

Unraveling Covid mysteries​

Before vaccines dramatically lowered the risk of severe illness and death from Covid-19, the outcome from a SARS-CoV-2 infection often seemed random. The virus made some people critically ill, while causing no symptoms in a greater number of others, even some older patients with chronic diseases. Scientists have long sought to understand why. Within months, it emerged that certain genetic variations increased the chances of a severe case. Now researchers have identified a genetic variation that improves the odds of an asymptomatic one. The research is easier to understand if you think about the differences that determine whether or not someone is a good match for an organ donation. This is largely governed by genes that make human leukocyte antigen, or HLA — a protein marker used by the immune system. A patient will reject a kidney, for example, if the new organ has come from a donor with a different HLA genotype. That’s why the DNA from volunteer bone marrow donors is used to identify each individual’s HLA for matching with recipients. Different HLA variations are thought to have a role in the immune response to infections, as well as autoimmune diseases, cancers and other conditions. At the start of the pandemic, when lockdowns prevented many scientists from working in their labs, Jill Hollenbach wanted to use her expertise in the field to understand whether some people fared better or worse from a SARS-CoV-2 infection based on their version of HLA. The University of California, San Francisco immunogeneticist and her colleagues emailed people who’d volunteered to donate through the National Marrow Donor Program, inviting them to participate in a smartphone-based study designed to track symptoms and self-reported positive coronavirus tests. Almost 30,000 signed on in mid-2020. Of those, 1,428 unvaccinated participants reported a positive test, and 136 of them said the infection was symptom-free. When Hollenbach and her colleagues looked at the HLA variations these lucky individuals carried, they found one in five had a common variant called HLA-B*15:01. People with two copies of the variant (inherited from both their parents) were more than eight times likelier to remain asymptomatic than those carrying other versions of HLA. The researchers also found infection-fighting T cells in blood from HLA-B*15:01 carriers collected before the pandemic had been primed by protein fragments from previous seasonal coronavirus infections that cross-reacted with SARS-CoV-2. That yielded pre-existing immunity, enabling HLA-B*15:01 carriers to eliminate the pandemic virus before symptoms ensued. The variation is carried by about 1 in 10 people with European ancestry, who made up the bulk of the research participants. Almost a quarter of people in Finland are carriers, versus virtually none in Saudi Arabia, according to immunologist Danny Altmann, a professor of medicine at Imperial College London. Hollenbach’s findings, reported last week in the journal Nature, are important for designing next-generation approaches for generating cross-protective immunity, Altmann says. Different HLA variations may play a similar role in people with other ancestries, Hollenbach told me. Other genetic and non-genetic factors are also likely to be involved in asymptomatic SARS-CoV-2 infections, she says. Also, not everyone with HLA-B*15:01 avoids getting sick from Covid. “So what are the other factors involved? That’s part of the mystery,” Hollenbach says. “That’s still something that we’re hoping to figure out.” —Jason Gale "

 

[missy]

"

Long COVID Persists as a Mass Disabling Event​

— We must do more to show we care​

by Karen Bonuck, PhD July 23, 2023

Bonuck is a pediatric health researcher and a professor of family and social medicine.
The latest CDC data on long COVID in U.S. adults and an alarming World Health Organization (WHO) statementopens in a new tab or window about its long-term impact underscore the pandemic's lingering and debilitating effects. Like the satirical film "Don't Look Upopens in a new tab or window," in which scientists couldn't focus media or politicians on the climate crisis, most Americans are content to avert their eyes from the long COVID crisis. Meanwhile, the millions now missing from public life because of it have no choice but to stare down the gamut of its sweeping sequelae.

As an NIH-funded researcher, I study child feeding and sleep, and co-direct the University Center of Excellence in Developmental Disabilitiesopens in a new tab or window. For years I have been an ally to families who have advocated for individuals with disabilities. As a mother, I've now become an advocate and supporter for my daughter as she fights a daily unseen battle and continues to struggle with long COVID, 3 years after contracting the SARS-COV-2 virus. In fact, the average person loses 21% of their healthopens in a new tab or window while living with long COVID -- equivalent to traumatic brain injury.
Long COVID: Persistent and Prevalent
Earlier this year, an Israeli studyopens in a new tab or window suggested that many long COVID symptoms resolve within a year. But you can't see what you don't measure: fatigue wasn't studied, despite ranking among the top long COVID symptoms globallyopens in a new tab or window, in the U.S.opens in a new tab or window, and even following asymptomatic infectionopens in a new tab or window. CDC data confirms my tracking of the literature and family's experience -- long COVID is prevalent and impactful. In the latest CDC dataopens in a new tab or window, just over 15% of U.S. adults ever had long COVID, and 5.8% (about 15 million) currently have it. For a condition that's fallen off the radar for those untouched by it, the percentages of U.S. adults reporting any (4.9%) and significant (1.5%) activity limitations is astonishing.

Original graphic from Joshua Ashkinaze, based on CDC data.

The persistence of long COVID (as shown above) is consistent with studiesopens in a new tab or window of people followed 2 or more years post-infection. Yet, funding for research on effective therapies or cures has been insufficient. The dearth of clinical trials has been a key target for advocates and scientists. In fact, 2 years after the NIH heralded its "RECOVERopens in a new tab or window" initiative, there is little to showopens in a new tab or window for the $1 billion that went into investigating long COVID. People are still suffering in real and devastating ways -- my 20-something daughter still finds it difficult to walk more than a few blocks and had to move back home last winter after living independently since college.
Gaslighting and a Misguided Victory Lap
Leaning into my disability advocacy hat, I have been reaching out to people across disciplines and government to sound the alarm that long COVID is a mass disabling event. And it is not going to disappear, as much as media outlets and policymakers want to move on and ignore it.

In early June, I emailed my local legislator's office, highlighting the depressing statistics and sharing my daughter's clinical and care-seeking trajectory since 2020. Like other long COVID survivors, she has endured medical gaslightingopens in a new tab or window, diagnostic odysseys, and sees no treatments on the immediate horizon. I was hopeful when I saw an email in my inbox from the legislator's office. At minimum, I expected he'd acknowledge my daughter's struggleopens in a new tab or window, or recognize the impact of long COVID on his other constituents. More optimistically, perhaps the reply would outline steps he's taking to alleviate long COVID's continuing impact and efforts his office is undertaking to press for badly needed patient-centered research.
Instead, the auto-reply cited the legislator's support for the "recent" $8.3 billion COVID relief package (passed in 2020) and referred to my home state's COVID emergency declaration (lifted in March 2022) in the present tense. This robotic non-response exemplifies the "mission-accomplished" stance of many policymakers towards long COVID. The proverbial tying of the bow on the pandemic's end exemplifies our culture's discomfort with disability -- its ubiquity, ordinariness, and unpredictability. It is easier to take the victory lap, and then quietly acknowledge those still trying to exist with the disability.

So, what can you do as a healthcare professional?
Listen to your patients -- and believe them. Chances are, your patient with "unremarkable" testing and labs, who's had unrelenting fatigue for months or years after COVID infection has had enough medical gaslighting. Honor their lived experience and show humility in what you don't know about their condition.
Educate yourself. Stay up-to-date on long COVID research, diagnosis, and treatmentopens in a new tab or window. See if your patients are eligible -- and can access -- a clinical trialopens in a new tab or window. Learn about and use (as appropriate) the new ICD-10 codeopens in a new tab or window for Postural Orthostatic Tachycardia Syndrome (POTS), a condition seen in more than halfopens in a new tab or window of long COVID patients.
Advocate. Use your voice as a healthcare provider. Given how policy decisions affect medical practice, consider researching and supporting long COVID legislation that will create patient-centered registries, fund research on post-infectious disease treatments, conduct public educationopens in a new tab or window, or offer research grantsopens in a new tab or window. See if your representative is already sponsoring these bills, and if not, consider encouraging them to do so.

You can make a difference to your patients -- or perhaps even loved ones or peers -- who've had to duct-tape their lives back together after long COVID. Help rewrite the "Don't Look Up" script for the millions with long COVID in the U.S. with your advocacy and support.
Karen Bonuck, PhD,opens in a new tab or window is co-director of the University Center of Excellence at Montefiore Einstein, a pediatric health researcher and professor of family and social medicine at Albert Einstein College of Medicine in New York City, a disabilities advocate, and a mom.

"

 

[Daisys and Diamonds]

@dk168 in good company although im sure you both wish you wernt
the Crown Princess of Japan has covid

Crown Princess Kiko tests positive for COVID

Crown Princess Kiko has tested positive for COVID-19 and will rest at her residence until the end of this week, the Imperial Household Agency said Tuesday. The crown princess had a fever on Monday evening, and her infection with the coronavirus was confirmed, while her husband, Crown Prince...

japantoday.com

its definatly still out there
a customer's hubbie at work went for a pre-op with zero sympthoms and tested positive