Category: Covid-19 Vaccine

Four years after the coronavirus pandemic first began, though numbers of new COVID-19 cases have dramatically dropped off, doctors are now grappling with the virus in two forms: acute COVID infections and cases of long COVID.

The COVID-19 virus has been widely studied for those four years, but much less is known about long COVID, in which symptoms of the virus stick around for months or even years for some patients. Until more is knownand until any treatments have been approved specifically for long COVIDaccording to a new campaign from Moderna, the best offense is a good defense, in the form of regular coronavirus vaccines.

The campaign launched March 15, which also marked the second annual Long COVID Awareness Day. It includes a blog post encouraging readers to stay up to date on their COVID shots, plus a Moderna-branded video in which a patient named Rachel shares her story of living with long COVID since 2021.

In the video, she describes her life as being split into two by the diagnosis: into a before Rachel and an after Rachel, the latter of which is unable to do many of the things that the pre-COVID Rachel could.

Before long COVID, I was active, she says, describing days spent at the beach swimming and playing with her kids. I was optimistic, kind of like the cheerleader at work, and just always in a good mood.

In the years since her long COVID diagnosis, however, Rachel says shes been unable to work and often wakes up dizzy, nauseous and in pain. She has also experienced days-long panic attacks, sleeps a lot and sometimes has to be taken care of by her kids, rather than the other way around.

Its hard for me to be positive when I dont know whats next, she says. Long COVID is real, and for people like me, were still fighting.

The video ends with information about long COVID, including that its associated with more than 200 symptoms, that the CDC estimates at least 20% of people will develop long COVID after an acute COVID infection and that the only way to prevent long COVID is to not get COVIDfollowed by a link to the national COVID vaccine-finder website.

The accompanying blog post includes more facts and figures about the illness, citing data suggesting that around 4 million Americans are currently unable to work due to long COVID and that cases of long COVID are most prevalent among the 35-49 age group and among those who have had three or more acute COVID infections.

According to Moderna, long COVIDs biggest threats come from its ability to impact everyone, regardless of age or the severity of ones original symptoms, and the difficulty of diagnosing an illness thats associated with hundreds of symptoms that present in countless combinations.

The post ends with the declaration that the best protection against long COVID is prevention, as research suggests there is a strong association between receiving the COVID-19 primary vaccination series and a reduced risk of receiving a diagnosis of long COVID. Both the video and post stop short of pushing Modernas own Spikevax vaccine, instead encouraging those eligible to simply receive their updated COVID-19 vaccine and to talk to their doctor about any questions or concerns.

The vax push comes in the wake of plummeting revenues from both Moderna and Pfizers COVID vaccineswhich brought in $6.7 billion and $11.2 billion in total 2023 sales, respectively. Both companies are expecting to take in even less from their vaccines this year, though Modernas projected drop-off is much less steep: Its expecting Spikevax to bring in at least $4 billion in 2024, compared to Pfizers $5 billion forecast for its Comirnaty shot.

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Moderna embarks on new vax push in long COVID prevention campaign - FiercePharma

The Boston Public Health Commission is encouraging residents to stay up-to-date on their COVID boosters. (AP Photo/Mark J. Terrill, File)

Hub health officials are again urging residents to get the updated COVID vaccine, as the citys vaccination rates remain low four years after the start of the pandemic.

The Boston Public Health Commission is encouraging residents to stay up-to-date on their COVID boosters, especially those who are 65-plus or immunocompromised.

Respiratory viral illnesses remain a public health threat, but we have tools to protect against severe illness, said Bisola Ojikutu, commissioner of Public Health and executive director of the Boston Public Health Commission.

The most important is vaccination against COVID-19, flu, and RSV which is the best way to prevent hospitalization, protect ourselves and our communities, and to ensure that our health care resources wont become overwhelmed as they have in the past, Ojikutu added.

BPHC reported that 20% of people in Boston have received an updated COVID vaccine since last July. Also, about 40% of city residents have received a flu vaccine.

It is particularly important for people aged 65 and older or immunocompromised to receive updated vaccine doses this spring, BPHC said in a statement. They should get vaccinated if its been more than four months since their last vaccination or three months after having COVID-19.

This renewed vaccination push comes in the wake of the CDC releasing updated recommendations on how people can protect themselves and their communities from respiratory viruses including COVID, the flu and RSV.

The updated recommendations are to stay home until your symptoms improve and it has been 24 hours since you had a fever, without the use of fever-reducing medication. Once returning to normal activities, people should continue to take additional precautions for the next five days, including wearing a well-fitted mask.

These updates come following a decrease in rates of hospitalization and death associated with respiratory illness, and more specifically COVID.

It is important to keep in mind that people can still spread viruses even when feeling better, BPHC said. Taking enhanced precautions, including wearing a mask in public when sick, are especially important for protecting those who are most at risk, including adults aged 60 and older, children younger than 5 years old, pregnant people, and people with chronic medical conditions.

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Boston health officials urge residents to get updated COVID vaccine: Respiratory viral illnesses remain a public health threat - Boston Herald

New research suggests COVID-19 vaccines could provide benefits aside from protecting against the coronavirus: they also seem to cut the risk of heart failure and blood clots linked to SARS-CoV-2.

The study, put together by an international team of researchers, involves an analysis of data covering 10.17 million vaccinated people and 10.39 million unvaccinated people in the UK, Spain, and Estonia.

After accounting for factors including age, sex, and pre-existing conditions, those who had been vaccinated were shown to have a significantly reduced risk of cardiac and clot-related complications after having COVID-19, for up to a year.

"Our findings probably reflect the fact that the vaccines are effective in reducing infection, and minimize the risk of severe COVID-19," says data scientist Nria Mercad-Besora from the University of Oxford in the UK.

"These results could encourage COVID-19 vaccination among hesitant people who are worried about the potential risk of vaccine side effects."

Compared with people who hadn't been vaccinated, COVID-19 vaccination was linked to a 78 percent reduced risk of blood clots in the veins, a 47 percent reduced risk of blood clots in the arteries, and a 55 percent reduced risk of heart failure in the first 30 days post-infection.

While those risk reductions dropped as time went on, they were still at 50 percent, 38 percent, and 48 percent respectively at 181-365 days. While previous studies have come up with similar findings, this is one of the most comprehensive investigations to date in terms of the number of people studied and the length of time they were monitored for.

Blood clots, which can cause strokes, and heart failure are known to be far more common in the wake of a COVID-19 infection. While the research doesn't establish a clear cause and effect, it does suggest that being vaccinated against the disease also lessens the risk of further complications.

The team acknowledges it's a complicated picture, though COVID-19 vaccines have been shown to be mostly safe and effective and the benefits outweigh potential disadvantages. However, they'd like to see more research done to look at the protective effects of COVID-19 vaccines in more detail.

"The protective effects of vaccination are consistent with known reductions in disease severity, but we need to do more research to understand the effects of a booster vaccination in different populations," says Mercad-Besora.

The research has been published in Heart.

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COVID-19 Vaccines Lower Risk of Heart Failure After Virus Infection - ScienceAlert

Early May will mark the first anniversary of the officially declared end of the COVID-19 public health emergency by the U.S. Department of Health and Human Services. Nevertheless, the Centers for Disease Control and Prevention continues urging Americans to keep up with updated vaccinations.

The agency is especially concerned about demographic groups at elevated risk for serious symptoms if infected. At the top of the list are adults 65 and older.

At the nonprofit, independent news site The Conversation, an academic geriatrician is helping spread the word.

Laurie Archbald-Pannone, MD, of UVA Health in Virginia urges seniors to consider three reasons for getting a jab this spring. Heres a summary.

Compared with other age groups, older adults have the worst outcomes with a COVID-19 infection, Archbald-Pannone points out. Increased age is, simply put, a major risk factor, she adds. More:

Even now, four years after the start of the pandemic, people 65 years old and up are about twice as likely to die from COVID-19 than the rest of the population. People 75 years old and up are 10 times more likely to die from COVID-19.

Being appropriately vaccinated is as critical in 2024 as it was in 2021 to help prevent infection, hospitalization and death from COVID-19, Archbald-Pannone writes. More:

The updated COVID-19 vaccine has been shown to be safe and effective, with the benefits of vaccination continuing to outweigh the potential risks of infection.

Keeping up to date with COVID-19 immunization has a fourfold decrease in risk of developing long COVID symptoms if you do get infected, Archbald-Pannone notes. Known as immunosenescence, this puts people at higher risk of infection, including severe infection, and decreased ability to maintain immune response to vaccination as they get older. More:

The older one getsover 75, or over 65 with other medical conditionsthe more immunosenescence takes effect.

All this is why, if youre in this age group, even if you received your last COVID-19 vaccine in fall 2023, the spring 2024 shot is still essential to boost your immune system so it can act quickly if you are exposed to the virus, Archbald-Pannone concludes. The bottom line: If youre 65 or older, its time for another COVID-19 shot.

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Geriatrician gives 3 reasons older Americans should get the latest COVID jab now-ish - HealthExec

Hungarian-American biochemist and researcher Katalin Karik has been selected by Scripps Institution of Oceanography at UC San Diego as the recipient of the 2023 Nierenberg Prize for Science in the Public Interest. Karik also recently received last years Nobel Prize in Physiology or Medicinefor her groundbreaking work on COVID-19 vaccines, alongside co-collaborator Drew Weissman, a renowned physician and researcher at Penn Medicine.

She is best known for her research on messenger RNA the genetic material that tells our bodies how to make proteins and the development of mRNA COVID-19 vaccines. Karik and Weissman MD, PhD invented the modified mRNA technology used in Pfizer-BioNTech and Modernas vaccines to prevent COVID-19 infection.

The public is invited to attend the award ceremony and a presentation from Karik in a free event on March 25 at 6 p.m. at the Robert Paine Scripps Forum for Science, Society and the Environment on the Scripps Oceanography campus.

Her presentation, Developing mRNA for therapy, will look at the progress and development of mRNA over the past six decades. Karik will discuss the journey from the discovery of mRNA in 1961 to its groundbreaking milestone as the first FDA-approved mRNA product in the form of COVID-19 mRNA vaccines in 2021.

The Nierenberg Prize was created through a generous gift from the Nierenberg family to honor William A. Nierenberg (1919-2000), a renowned national science leader who served Scripps Oceanography as director from 1965 to 1986. He was a leading expert in several fields of underwater research and warfare and was known for his work in low-energy nuclear physics. He was elected to the National Academy of Sciences in 1971 and was the recipient of numerous awards and honors for professional research and public service.

The Nierenberg Prize, which includes a bronze medal and $25,000, is awarded for outstanding contributions to science in the public interest. Previous awardees include biochemist Jennifer Doudna and renowned geneticist Svante Pbo, both also recipients of the Nobel Prize; former NASA astronaut and administrator Charles Bolden; filmmaker Sir David Attenborough; and primatologist Dame Jane Goodall, among other luminaries.

I feel deeply honored to receive the Nierenberg Prize, Karik said. I did not have the fortune to know William Nierenberg, but we have a lot in common. My life, similarly to his, had a very humbled beginning. And just like his parents, I also immigrated to the United States from Eastern Europe.

Karik received her bachelors degree in biology and her PhD in biochemistry from University of Szeged in Hungary. After receiving her degrees, she worked with a research team at the Biological Research Center of the Hungarian Academy of Sciences.

In 1985, she immigrated to the United States and began collaborating with Weissman. A few years later, Karik joined the Perelman School of Medicine at the University of Pennsylvania, where she now serves as an adjunct professor of neurosurgery. From 2013 to 2022, she held the role of senior vice president at BioNTech, located in Mainz, Germany.

For four decades, Karik has researched messenger RNA technology, focusing on RNA-mediated mechanisms with the ultimate goal of developing in vitro-transcribed (IVT) mRNA for protein therapy. During IVT, genetic information is transcribed from DNA to RNA, and the generated mRNA transcript is used to produce proteins in cells.

After investigating RNA-mediated immune activation through several experiments, Karik and Weissman discovered a way to modify mRNA. In this modified version, they encapsulate the mRNA in a certain lipid that prevents inflammation and allows mRNA to work without any interference. This groundbreaking discovery was instrumental in ensuring the safety and efficacy of FDA-approved COVID-19 mRNA vaccines developed by BioNTech/Pfizer and Moderna, playing a vital role in fighting the pandemic. Karik is co-inventor on a total of 14 patents granted by the United States.

The Nierenberg family is thrilled with the selection of Dr. Katalin Karik as the 2023 winner of the Nierenberg Prize for Science in the Public Interest. Her thirty year quest against all odds to develop the practical use of messenger RNA literally changed the world with the introduction of vaccines for COVID-19, said Nicolas Nierenberg, the son of the late William A. Nierenberg for whom the prize is named. Dr. Karik is an inspiration to all of us and we are looking forward to hearing her story.

Karik and Weissman also worked together to found RNARx in 2006, a company dedicated to developing mRNA therapeutics for a wide range of diseases.

Along with Karikos pioneering research of COVID-19 vaccines, she and colleagues at BioNTech demonstrated functional use of nucleoside-modified mRNA, encoding antibodies targeting cancer and infectious diseases. Further research on this novel mRNA technology has also shown promise for the treatment of autoimmune diseases.

Karik initiated a clinical study in which tumors of patients were injected with modified mRNAs encoding cytokines, which promoted potent antitumor immunity and tumor eradication at local and remote sites.

In the last two years, Karik has received many prestigious awards celebrating her mRNA work, including the Japan Prize, the Horwitz Prize, the Paul Ehrlich Prize, the Benjamin Franklin Medal, the Canada Gairdner International Award, the Kovalenko Medal, the Tang Prize, the Warren Alpert Prize, the Princess Asturias Award, the BBVA Frontiers Award, the Breakthrough Prize and the Lasker-DeBakey Clinical Medical Research Award.

Seating is limited and registration is required for this event. If you are interested in attending, please RSVP in advance.

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Nierenberg Prize Awarded to Biochemist Katalin Karik for Pioneering Research on COVID-19 Vaccines - University of California San Diego

CLAIM

U.S. doctors found that long Covid developed in 70 percent of cases after vax injection, not after infection

DETAILS

Inadequate support: The claim that most cases of long COVID occur after vaccination, not infection, is based on poorly described anecdotes that dont provide sufficient evidence to support the claim. The preprint cited also didnt show how common these symptoms are or whether COVID-19 vaccination caused them.

KEY TAKE AWAY

Some people have reported symptoms resembling long COVID after COVID-19 vaccination. Research on these symptoms is still limited, and their potential link with COVID-19 vaccines remains undetermined. However, these cases are rare, and the risk associated with SARS-CoV-2 infection far outweighs the risk of developing long-term complications after COVID-19 vaccination. Studies are ongoing to better understand the cause of post-vaccination symptoms and their possible relationship with COVID-19 vaccines.

The original post, published on the Telegram channel Disclose.tv, had received over 200,000 views at the time of writing. The post linked to a website with the same name that reproduced an op-ed by physicians Pierre Kory and Paul Marik published in The Hill on 6 March 2024.

Disclose.tv is a Germany-based outlet that operates as a news aggregator. According to an investigation by Logically, the site originated from a forum focused on conspiracy theories.

The website itself no longer seems to publish overt conspiracies. However, Logically and Deutsche Welle (DW) News found that Disclose.tv continues to share conspiracy theories, pseudoscience, and hate content through its social media accounts, which have around five million followers. In 2017, PolitiFact included Disclose.tv in its list of websites containing deliberately false or fake stories.

Kory and Marik are the president and chief scientific officer, respectively, of the fringe medical group Front Line COVID-19 Critical Care (FLCCC) Alliance. This group extensively promoted the use of ivermectin off-label to prevent and treat COVID-19 despite a lack of evidence supporting this use.

FLCCC Alliance has also promoted other unproven therapies, like nattokinase, for treating long COVID and post-vaccination symptoms.

As we will demonstrate below, Kory and Mariks op-ed is yet another example of such unsupported claims. The op-ed doesnt provide credible evidence indicating that COVID-19 vaccination is behind most cases of long COVID. Instead, the authors relied on unverifiable anecdotes that cant support their claim, as we will show below.

Cases of post-vaccination symptoms resembling long COVID have been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS). However, studies suggest they are rare and far less common than cases of long COVID after infection, as this review will explain.

The op-ed claimed that, after evaluating over 1,000 individuals with long COVID, [a]pproximately 70 percent of these patients said their reported symptoms occurred in the minutes, hours, days and weeks after COVID vaccination, as opposed to after COVID infection.

The authors based the 70% figure on data from a private practitioner who is also a member of the fringe medical group FLCCC Alliance. The op-ed didnt include any explanation about the methodology used to calculate the 70% figure. This is important, as it provides the necessary information to assess the validity of the results. In addition, other issues make the 70% figure unreliable.

First, the fact that these symptoms began after vaccination alone isnt enough to demonstrate that the vaccine caused them, despite what the op-ed seemed to imply. A temporal association, while a necessary component for determining if there is a causal effect, is only the first step and requires further investigations.

Second, the figure is based exclusively on the patients perceptions of symptoms developed after they received a COVID-19 vaccine. There is no indication that the evaluation included analyses or tests that objectively assessed the presence and severity of these symptoms.

Finally, the op-ed didnt indicate whether the evaluation considered factors other than vaccination as a cause or contributing factor to the observed symptoms. These include, for example, a previous SARS-CoV-2 infection or the existence of underlying medical conditions.

In other words, the claim is entirely based on anecdotal descriptions of symptoms that patients self-reported from a single private practice. The problem with such data is that it is highly prone to biases, as neurologist Steven Novella explained in Science-Based Medicine.

For instance, the patients who go to that specific private practice might not be representative of the general population (selection bias), meaning the observations may not be generalizable to everyone. The fact that the observations relied on self-reporting also introduces a risk of recall bias due to the patients inaccurate or partial recollection of events. Data collected in this way is also subject to distortions (reporting bias) and biased interpretations that support either the patients or the doctors preexisting beliefs (confirmation bias).

Theres no evidence that the physician or Kory and Marik attempted to account for these potential biases in their interpretation of the data.

The high risk of bias, the lack of information about the data and methodology, and the FLCCC Alliances record of spreading misinformation cast serious doubts over the figures credibility.

To further support the claim that adverse events from COVID-19 vaccination, including persistent symptoms, are common, Kory and Marik cited a preprint by Krumholz et al. uploaded to the preprint server medRxiv on 10 November 2023[1]. A preprint is a preliminary version of a manuscript that has yet to be evaluated by other experts.

As the title of the preprint clearly states, the authors conducted A Descriptive Analysis of Reported Symptoms and Patient Experiences After Covid-19 Immunization.

The analysis involved 241 individuals aged 18 and older who participated in the Yale Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) study from May 2022 to July 2023. This study, administered online, collects information about symptoms and medical history with the purpose of better understanding long COVID and post-vaccine adverse events.

The researchers objective was to characterize chronic post-vaccination syndrome, defined by self-report in response to whether the individual thought the vaccine had injured them.

To do that, the authors used surveys to evaluate the type of symptoms, their severity and duration, the treatments participants had tried, and new medical conditions diagnosed since vaccination. The authors excluded people reporting long COVID.

Unlike The Hill op-ed, the preprint fully described the methodology used. The authors also considered variables that could influence the observations, such as demographics (age, gender, race, country of residence, marital status, household income, employment status, and insurance status), preexisting medical conditions, prior SARS-CoV-2 infection, and vaccination status, and the type of COVID-19 vaccine participants received.

The results showed a diverse range of reported symptoms beginning soon after COVID-19 vaccination. In many cases, these symptoms were severe, debilitating, and persisted for a year or more. The authors concluded that people reporting post-vaccination syndrome in the evaluated group were generally highly symptomatic, had poorer health, and had tried many treatment strategies without success.

In contrast to the op-ed, the preprint clearly stated the limitations of the analysis in its Discussion section, including the lack of a control group and the reliance on self-reporting. It also explained that the method of selecting the participants led to discrepancies compared to the overall population. Therefore, the authors concluded that it is not possible to estimate the incidence or who might be most susceptible to this condition.

The authors further highlighted that the cause of the reported symptoms remained undetermined. The net benefit of the covid-19 vaccination program is clear, the authors stated. However, the temporal relationship between vaccination and the onset of symptoms suggests a potential relationship that requires further investigation.

In summary, while the preprint documented and characterized self-reported symptoms following COVID-19 vaccination, it didnt attribute them to any specific cause. It also didnt show how common these cases are in the general population, as FactCheck.org explained. Therefore, these results dont provide sufficient evidence to support Kory and Mariks claim.

COVID-19 vaccines are safe and highly effective at reducing the risk of severe COVID-19. But as with other medical interventions, they carry a small risk of rare complications. Certain COVID-19 vaccines are associated with rare cases of severe allergic reactions (anaphylaxis) and a slightly increased risk of blood clotting, Guillain-Barr syndrome, and heart inflammation.

But these severe reactions to vaccination are infrequent. Most people only experience mild side effects that go away in a few days.

A spokesperson from the U.S. Centers for Disease Control and Prevention (CDC) told FactCheck.org that the agency is aware of reports in the Vaccine Adverse Event Reporting System (VAERS) and in the media of a wide range of long-lasting symptoms following COVID-19 vaccination (such as fatigue, headache, and difficulty concentrating).

These symptoms, which usually appear within the first weeks after vaccination, have been popularly called Long Vax due to their resemblance with long COVID symptoms. However, the clinical characteristics of these symptoms and their potential link to vaccination are currently unclear.

In July 2023, an article in Science discussed how scientists had begun acknowledging post-vaccination symptoms as a real phenomenon that warrants further research.

Some researchers suggest that post-vaccination symptoms share some similarities with two known medical conditions. The first one is small fiber neuropathy, an uncommon chronic condition that affects a persons ability to sense pain. This results in numbness, painful tingling, or burning sensations in the feet and hands[2].

The second one is a condition called postural orthostatic tachycardia syndrome (POTS)[3,4]. This condition specifically affects people when they transition from lying down to standing up, causing muscle weakness, fast heart rate, fatigue, and brain fog.

About half of the cases of small fiber neuropathy are caused by underlying medical conditions, with diabetes being the most common cause. The other half of the cases happen for no known reason. It is also unknown what causes POTS, and no diagnostic tests are available. These limitations make it difficult to study the potential connection between these conditions and COVID-19 vaccination.

To date, only a few studies have addressed long-term symptoms after COVID-19 vaccination.

One preprint uploaded to medRxiv on 17 May 2022 evaluated symptoms of neuropathy after COVID-19 vaccination in 23 participants[5]. The authors found a variety of neuropathic symptoms following COVID-19 vaccination that improved when treated with corticosteroids in some patients. Corticosteroids are a type of anti-inflammatory drug that also reduces the activity of the immune system. This led the authors to hypothesize that the symptoms observed might be the result of immune reactions, similar to what happens in COVID-19 patients. But these results havent been published in a scientific journal yet.

In December 2022, a team at Cedars-Sinai Medical Center published a study analyzing the occurrence of POTS in almost 285,000 people who had received a COVID-19 vaccine[6]. The study found that the rate of POTS symptoms was 33% higher within the 90 days following vaccination than in the three months before. However, it also found that the rate of POTS symptoms was much higher (52%) after SARS-CoV-2 infection.

Diagnosing post-vaccination symptoms is challenging due to the overlap in the reported symptoms with other conditions, including long COVID, neuropathy, PTOS, and chronic fatigue syndrome. For example, distinguishing between post-vaccine symptoms and long COVID with a high degree of certainty would require demonstrating that the person had no previous SARS-CoV-2 infection. This is difficult, given the large number of infections and the fact that many of them went unnoticed.

Because of the difficulties in making an accurate diagnosis, estimating the rate at which these symptoms occur is also complicated. However , researchers suggest that the number of cases potentially attributable to COVID-19 vaccination is likely very low, as many suspected post-vaccine symptoms are due to causes other than vaccination.

In May 2023, the Paul-Ehrlich-Institut (Germany) issued a statement saying it had found no safety signal for the occurrence of these symptoms after [COVID-19] vaccination. The agency found that the reporting rate of chronic fatigue syndrome, post-vaccination syndrome, POTS, and post-acute COVID-19 syndrome in the adverse reaction database of the European Medicines Agency was less than one suspected case per 100,000 vaccinations. The agency concluded that persistent symptoms following COVID-19 vaccination are therefore extremely rarely reported.

Likewise, the CDC spokesperson explained to FactCheck.org that to date, no unusual or unexpected patterns of long-lasting symptoms or health problems following vaccination have been linked to vaccination by COVID-19 vaccine safety monitoring systems.

Mounting evidence suggests that long-term symptoms following COVID-19 vaccination are a genuine phenomenon. However, Kory and Mariks op-ed doesnt provide evidence that these post-vaccination symptoms occur frequently in the general population or that COVID-19 vaccines are the cause.

Current evidence instead suggests that long-term post-vaccination symptoms are rare. While the temporal association suggests a potential link between these symptoms and COVID-19 vaccines, a connection between both remains unconfirmed. Further studies are warranted to better understand why these symptoms occur and how to treat them.

The rest is here:

No evidence that persistent symptoms are more frequent after COVID-19 vaccination than after infection, contrary to an ... - Health Feedback

A large European study published in Heart suggests that COVID-19 vaccines reduce the risk of heart failure and blood clots in veins or arteries for at least 6 months after SARS-CoV-2 infection.

University of Oxford investigators conducted a staggered cohort study using the electronic health records of 10.2million vaccinated and 10.4million unvaccinated COVID-nave people based on national COVID-19 vaccination campaigns in the United Kingdom, Spain, and Estonia from January to July 2021.

The study period was dominated by the Alpha and then Delta variants. Participants included adults of all ages and those at high risk for poor COVID-19 outcomes.

The study, which used vaccination as the time-varying exposure, included all COVID-19 vaccines available in Europe during the study period: AstraZeneca/Oxford, Pfizer/BioNTech, Johnson & Johnson (J&J), and Moderna.

Study outcomes of interest were ischemic stroke (IS), hemorrhagic stroke, transient ischemic attack (TIA), ventricular arrhythmia/cardiac arrest, myocarditis/pericarditis, myocardial infarction (MI, or heart attack), heart failure (HF), pulmonary embolism (PE), and deep vein thrombosis (DVT). Venous thromboembolism (VTE) was used as an aggregate of PE and DVT, and arterial thrombosis/thromboembolism (ATE) was a composite of IS, TIA, and MI.

While COVID-19 vaccines have proven effective against infection, hospitalization, and death, there have been reports of unusual blood clots after receipt of adenovirus-based COVID-19 vaccines (AstraZeneca and J&J), the authors noted, adding that a link was found between mRNA vaccines (Pfizer and Moderna) and a small risk of myocarditis.

"On the other hand, SARS-CoV-2 infection can trigger cardiac and thromboembolic complications," they wrote. "Previous studies showed that, while slowly decreasing over time, the risk for serious complications remain high for up to a year after infection."

Also, the risk of clots and myocarditis, which is inflammation of the heart muscle, is much higher after COVID-19 infection than after vaccination.

COVID vaccine effectiveness against HF, VTE, and ATE was 22%, 53%, and 45%, respectively, in the month after SARS-CoV-2 infection and 53%, 72%, and 61% at 3 to 6 months. A comparison of the Pfizerand AstraZeneca COVID-19 vaccines suggested a larger reduction in VTE from the former in the first month after vaccination, but no other differences were noted.

COVID-19 vaccination reduced the risk of post-COVID-19 cardiac and thromboembolic outcomes. These effects were more pronounced for acute COVID-19 outcomes, consistent with known reductions in disease severity following breakthrough versus unvaccinated SARS-CoV-2 infection.

"COVID-19 vaccination reduced the risk of post-COVID-19 cardiac and thromboembolic outcomes," the study authors wrote. "These effects were more pronounced for acute COVID-19 outcomes, consistent with known reductions in disease severity following breakthrough versus unvaccinated SARS-CoV-2 infection."

They called for future research on the additive effect of COVID-19 vaccination on the risk of post-vaccine and/or post-COVID cardiac events and blood clots as well as possible waning of protection over time and with emerging variants and the effect of booster doses.

The rest is here:

Vaccines cut risk of post-COVID heart failure, blood clots for at least 6 months, data suggest - University of Minnesota Twin Cities

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The following first appeared in the Substack of Eric Topol, MD, called Ground Truths.

As we recently hit March 11, 2020 the 4-year anniversary of when WHO finally declared COVID a global pandemic, and today, March 13th, when the US declared it a national emergency, we're still learning every day about SARS-CoV-2's impact, its evolution, protection from vaccination, and more. Here's a quick summary of what I think is worth reviewing:

The global excess mortality hasreached about 30 million lost livesattributable to COVID, and theGlobal Burden of Disease published a major paperthis week in The Lanceton the toll it has taken for reducing life expectancy in 204 countries summarized as "The COVID-19 pandemic caused the most severe drops in life expectancy seen in 50+ years."The study did not address disability among survivors, with multiple concurrent studies reinforcing the prevalence of long COVID in tens of millions of people.

Here in the United States, it is striking to review the updated data on partisan gap death rates, as reflected by counties who voted Republican in the 2020 election. According to Ashley Wu, graphics editor at the New York Times, the curves are continuing to diverge, both weekly and cumulatively. There was no divergence when vaccines were first administered but since that time the death rates continue to worsen in counties with 70%+ Republican voters compared with <30%.

Multiple state level data, such as Washington's, indicate the protection from death with a booster, almost halving the rate in people age 65 and older.

The JN.1 variant took over globally and a number of subvariants (JN.1.11.1, JN.1.18,JN.1.13, JN.1.18) are showing up with added spike mutations such as R346T and F456L, but without signs of wastewater levels on the rise or other concerning metrics.

But BA.2.87.1, is the major "Omicron-like" event out there that has been the subject of five recent papers/preprints (here,here,here,hereandhere). That, in itself, should tell you it's a variant of interest. It's chock full of new mutations compared with the variants that came long previously, and many of these are deletions.

In itself, it is not a threat as there's no sign it is more immunoevasive or transmissible. In fact, the consensus is that it's less evasive of our immune response, the current booster works to achieve good levels of neutralizing antibodies, and some of the monoclonal antibodies that were previously found to be resistant to earlier variants may be effective again.That's great news. But as Yunlong Cao and his team appropriately warned us,"BA.2.87.1 may not become widespread until it acquires multiple [receptor binding domain] RBD mutations to achieve sufficient immune evasion comparable to that of JN.1."

It's much too early to know whether (and when) this will take place, but after 4 years if there's anything to predict, it is that the virus will find its way (through selection) to infect more hosts and repeat human hosts.

A big study was reportedyesterday that addressed the question of protection from COVID shots against blood clotsdeep vein thrombosis and pulmonary embolism, heart attacks, strokes, and heart failure. The data are from three countriesUK, Spain and Estonia, from electronic health records of over 20 million people. All these outcomes were reduced by prior COVID vaccination compared with no vaccination, especially in the first 30 days after an infection, but many showed durable protection out to 1 year follow-up (stroke, TIA, heart failure, DVT, PE).

This is different from the 40-50% protection of vaccinations vs long COVID symptoms. It's specifically addressing major cardiovascular outcome protection from being vaccinated. Major welcome news!

I remain very disappointed and surprised by the recent change (1 March) of CDC policy towards isolation, without regard to using rapid antigen tests.Their own data shows that at least 1 in 3 people will still be infectious at 5 days after symptom onset!That's by culturable virus, the gold standard, which tracks very closely with the rapid tests. To reduce infecting others, especially high risk vulnerable individuals, no less adding to the toll of long COVID, rapid tests should be used before people circulate.

Thanks for reading Ground Truths and please share the post to your network of friends and colleagues if you found it useful.

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Opinion: COVID, 4 Years on - Medscape

Study design and participants

We studied a cohort of 2111 participants (>18 years of age) who were recruited between 14 December 2021 and 29 September 2022 to the PerMed prospective observational study from all across Israel27,36. Of the 2,111 participants, 1932 participants reported receipt of>1 doses of the BNT162b2 mRNA COVID-19 vaccine, and 856 participants reported receipt of>1 doses of the influenza vaccine. Specifically, of the 1932 participants receiving COVID-19 vaccination, during the study, 146 received their first dose, 209 their second dose, 1545 their third dose, and 685 their fourth dose. Of the 856 participants who received influenza vaccination, 791 received the seasonal dose for 20212022, 188 received the seasonal dose for 20222023, and 125 received both seasonal doses. Participant recruitment was conducted via advertisements on social media and word-of-mouth. Each participant signed an informed consent form after receiving a comprehensive explanation of the study from a professional survey company. The participants were equipped with a Garmin Vivosmart 4 smartwatch and installed two apps on their smartphones: a dedicated mobile application (PerMed App), that collected daily self-reported questionnaires37, and an application that passively recorded the smartwatch data. Further information regarding data collection architecture and the PerMed dashboard is provided in our previous works13,25,27 and the Supplementary Material (Appendix B).

We hired a professional survey company to recruit participants as well as to keep them engaged throughout the PerMed study. The survey company was responsible for guaranteeing that the participants met the studys requirements, in particular, that they agreed to wear the smartwatch and fill in the daily questionnaires at least three times a week. We implemented several measures to minimize attrition and churn of participants and consequently improve the quality, continuity, and reliability of the collected data. First, participants who did not fill out the daily questionnaire by 7 p.m. received a notification in their mobile app to fill out the questionnaire. Second, a dedicated dashboard that allowed the survey company to identify participants who continually neglected to complete the daily questionnaires at least three times a week or did not wear their smartwatch for a long duration of time was developed. These participants were contacted by the survey company (either by text messages or phone calls) and were encouraged to better adhere to the study protocol. Third, to strengthen participants engagement, a weekly personalized summary report was generated for each participant and was available inside the PerMed application. Similarly, a monthly newsletter with recent findings from the study and useful tips regarding the smartwatchs capabilities was sent to the participants. At the end of the study, participants will receive all personal insights that were obtained and can keep the smartwatch as a gift.

After joining the PerMed study, participants filled out the enrollment questionnaire, and information on participants sex, age, and underlying medical conditions, was collected. The list of underlying medical conditions consisted of hypertension, diabetes, heart disease, chronic lung disease, immune suppression, cancer, renal failure, and body mass index (BMI)>30 (BMI is defined as weight in kilograms divided by the square of height in meters). Participants filled out a daily questionnaire through the PerMed mobile application27,36. The questionnaire allowed participants to report their signs and symptoms from a closed list of local and systemic reactionspreviously observed in BNT162b2 mRNA COVID-19 or influenza vaccines31,38, with an option to add other symptoms as free text. A detailed description of the questionnaire is provided in the Supplementary Material (Appendix A pp 68).

Participants were equipped with Garmin Vivosmart 4 smart fitness trackers. Among many physiological measurements, the smartwatch provides continuous measures of heart rate, stress, and daily resting heart rate capabilities39. Since the HRV measure is not accessible through Garmins application programming interface, we used Garmins stress level measure instead, which is computed based on the HRV measure40. HRV-based stress is a measure between 1 to 100 computed by Garmin and is categorized into four tiers: rest (125), low (2650), medium (5175), and high (76100)41. Specifically, the Garmin device uses heart rate data to determine the interval between each heartbeat. The variable length of time between each heartbeat is regulated by the bodys autonomic nervous system. Less variability between beats correlates with higher stress levels, whereas an increase in variability indicates less stress41,42,43. When we examined data collected in our study, we identified a heart rate sample approximately every 15s, a stress sample every 180s, and a daily sampling of resting heart rate.

We performed several preprocessing steps on the daily questionnaire data and smartwatch physiological measures before analyzing the data. For the daily questionnaires, if participants filled in the daily questionnaire more than once on a given day we considered only the last entry reported. For the HRV-based stress and heart rate measures collected by the smartwatches, we computed the mean value for each hour of data. Then, to impute missing values, we performed a linear interpolation. Finally, data was smoothed by calculating the moving average value using a 5-h sliding window.

For each participant, we defined the 7days before vaccination as a baseline period. For the analysis which involves self-reported questionnaires and for the machine learning model, we included only participants who filled out at least one questionnaire during the baseline period and at least one questionnaire during the 7days following vaccination. Those questionnaires are required to determine whether symptoms reported by the participants should be considered side effects. We defined a reaction as a post-vaccination side effect if it had not been reported during the baseline period. For the questionnaire data, we calculated the percentage and corresponding 95% CI of participants who reported new systemic reactions in the 7days following vaccination. We used a Beta distribution to calculate the 95% CI.

For the analysis involving smartwatch measurements, we included participants who had at least one overlapping period of data (i.e., the same day of the week and same hour during the day for the heart rate and HRV-based stress measures, and the same day of the week for the daily resting heart rate) during their baseline and post-vaccination periods. The overlapping periods are required for computing the change in measurement values between the baseline and post-vaccination periods. To calculate the changes in continuous Garmin smartwatch measurements (heart rate and HRV-based stress measures) over the 07days post-vaccination, with those of the baseline period, we calculated for each participant the difference between the measurement of each hour during the seven days post-vaccination and that of the corresponding hours in the baseline period (keeping the same day of the week and the same hour during the day). For the daily resting heart rate, we calculated the differences in the same manner (keeping the same day of the week). A Randomized control trial31, and prior studies analyzing physiological measures via smartwatches and self-reported questionnaires13, demonstrate a significant decrease in local and systemic reactions within 72h post-vaccination. Consequently, our classification problem focused on determining whether a moderate to severe reaction occurred within this 72h post-inoculation period.

Based on data from the Centers for Disease Control and Prevention, we stratified the participant-reported post-vaccination side effects by the severity of the reactions they reported in the questionnaire in the post-vaccination period by the appearance of symptoms, as follows:

No reaction

Mild reaction: abdominal pain, back or neck pain, feeling cold, muscle pain, weakness, headache, dizziness, vomiting, sore throat, diarrhea, cough, leg pain, ear pain, loss of taste and smell, swelling of the lymph nodes.

Moderate to severe reaction: fast heartbeat, hypertension, chest pain, dyspnea (shortness of breath), fever, confusion, and chills.

Participants were classified into one of the three categories, based on the most severe symptom that was reported in their post-vaccination period.

We stratified participants by the severity of their reactions. Participants who did not report a reaction, or had a Mild reaction following vaccination were classified in the No- or Mild-reaction group, and the remaining participants were classified in the Moderate to severe reaction group. We developed ML models to predict and detect the participant-reported side effect severity following COVID-19 or influenza vaccinations. The prediction model utilized sociodemographics, side effects from previous doses collected from questionnaires, and smartwatch information, but only before the vaccine, while the detection model also utilized the smartwatch measures 72h post-vaccination information.

The entire data set has been randomly divided into 5 separate non-overlapping test sets. For each test set, a model is trained using all the remaining data, ensuring an equal percentage of positive cases between train and test sets to take into account imbalanced positive and negative classes.

Several machine learning techniques were evaluated for both models: Gradient Boosted Decision Trees (XGBoost), Random Forest (RF), Multi-Layer Perceptron (MLP), and K-Nearest Neighbors (KNN).

The XGBoost package was used for training Gradient Boosted Decision Trees44, while the Scikit-learn machine learning library was used to implement the other models45.

Performances of the testing samples from each model are reported by mean AUROC, sensitivity (SE), and specificity (SP). SE and SP are defined as the fraction of positive and negative individuals correctly classified, respectively. These values are based on the point in the ROC that optimized the Youden index46,47. For each classifier, we applied a grid search within our stratified cross-validation framework and optimized our model selection using the mean AUROC.

The interpretable nature of the decision tree model allows for the evaluation of feature importance estimates48. The XGBoost in-model feature importance was used to demonstrate each predictor variables effect on the detection of the participant-reported side effect severity.

For evaluation of the differences in terms of AUROC, a bootstrap test (n=1000) for the difference was used. We repeatedly sampled the dataset with replacement in a stratified manner. We trained the prediction and detection models for each bootstrap sample and computed AUROC on the unique data points that were not selected in the current bootstrap sample. Each model is trained and tested with its subset features and the best hyperparameters. For each bootstrap sample, we computed the AUROC difference between the prediction and detection models and generated a distribution of bootstrapped differences. Finally, we calculated the p-value which is the proportion ofbootstrapped differences that is less than or equal to 0.

Before participating in the study, all subjects were advised, both orally and in writing, as to the nature of the study and gave written informed consent to the study protocol, which was approved by the Tel Aviv University Institutional Review Board (0002522-1). All methods were performed in accordance with the relevant guidelines and regulations.

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Prediction and detection of side effects severity following COVID-19 and influenza vaccinations: utilizing smartwatches ... - Nature.com