Fauci Doesn’t Have An Answer To Why Those Who Recovered From Covid Are Required To Take Vaccine

Authors: JORDAN LANCASTER REPORTER September 10, 20214:03 PM E

Dr. Anthony Fauci said Thursday night on CNN that he didn’t have a “firm answer” as to why those who have been previously infected with Covid and have natural immunity are being required to take the vaccine.

Dr. Sanjay Gupta, CNN’s Chief Medical Correspondent, pointed out a recent study from Israel that found people with natural immunity from Covid due to a previous infection were much less likely to become infected, be hospitalized, or die from Covid than their counterparts who had never been infected but had received both doses of the Pfizer vaccine. The scientists also found that previously infected people were more protected if they had one dose of the Pfizer vaccine.

Gupta asked if previously infected people should also get the vaccine, and if so, how Fauci plans to make the case for those people to get it.

“You know, that’s a really good point, Sanjay. I don’t have a really firm answer for you on that,” Fauci said. “That’s something that we’re going to have to discuss regarding the durability of the response.”

Fauci also said that the study didn’t discuss how long the immunity lasts. (RELATED: Natural Immunity To COVID-19 May Last More Than A Year After Infection, New Studies Show)

“The one thing the paper from Israel didn’t tell you is whether or not as high as the protection is with natural infection – what’s the durability compared to the durability of a vaccine? So it is conceivable that you got infected, you’re protected, but you may not be protected for an indefinite period of time,” he added. “So I think that is something that we need to sit down and discuss seriously, because you very appropriately pointed out it is an issue, and there could be an argument for saying what you said.”

Study Finds Teenage Boys Six Times More Likely To Suffer Heart Problems From Vaccine Than Be Hospitalized by COVID

Authors; Paul Joseph Watson via Summit News,

Research conducted by the University of California has found that teenage boys are six times more likely to suffer from heart problems caused by the COVID-19 vaccine than to be hospitalized as a result of COVID-19 itself.

“A team led by Dr Tracy Hoeg at the University of California investigated the rate of cardiac myocarditis – heart inflammation – and chest pain in children aged 12-17 following their second dose of the vaccine,” reports the Telegraph.

“They then compared this with the likelihood of children needing hospital treatment owing to Covid-19, at times of low, moderate and high rates of hospitalisation.”

Researchers found that the risk of heart complications for boys aged 12-15 following the vaccine was 162.2 per million, which was the highest out of all the groups they looked at.

This compares to the risk of a healthy boy being hospitalized as a result of a COVID infection, which is around 26.7 per million, meaning the risk they face from the vaccine is 6.1 times higher.

Even during high risk rates of COVID, such as in January this year, the threat posed by the vaccine is 4.3 times higher, while during low risk rates, the risk of teenage boys suffering a “cardiac adverse event” from the vaccine is a whopping 22.8 times higher.

The research data was based on a study of adverse reactions suffered by teens between January and June this year.

In a sane world, such data should represent the nail in the coffin for the argument that teenagers and children should be mandated to take the coronavirus vaccine, but it obviously won’t.

In the UK, the government is pushing to vaccinate 12-15-year-olds, even without parental consent, despite the Joint Committee on Vaccination and Immunisation (JCVI) advising against it.

Meanwhile, in America, Los Angeles County school officials voted unanimously to mandate COVID shots for all

NIH orders $1.67M study on how COVID-19 vaccine impacts menstrual cycle

Authors: By Hannah Sparks September 7, 2021

The National Institutes of Health has announced a $1.67 million study to investigate reports that suggest the COVID-19 vaccine may come with an unexpected impact on reproductive health.

It’s been a little over six months since the three COVID-19 vaccines in the US — Pfizer, Moderna and Johnson & Johnson — became widely available to all adults. But even in the early days of vaccine rollout, some women were noticing irregular periods following their shots, as reported first by the Lily in April.

Shana Clauson, 45, spoke to the Washington Post’s women’s news site at the time, and again this week, about her experience after getting the jab — revealing that her period arrived earlier and heavier than what she considers normal. She was one of many who gathered on social media to share what they were seeing.

“Is this not being discussed, or is it even being looked at or researched because it’s a ‘woman’s issue?’ ” Clauson speculated to the Lily last spring.

Women, those under 40 more likely to have side effects to COVID vaccine, expert says

It would appear that the NIH heard Clauson and others’ reports, as they announced on Aug. 30 that they intended to embark on just such research — aiming to incorporate up to half a million participants, including teens and transgender and nonbinary people.

Researchers at Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University and Oregon Health and Science University have been enlisted to embark on the study, commissioned by the NIH’s National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health.

The approximately yearlong study will follow initially unvaccinated participants to observe changes that occur following each dose. More specifically, some groups will exclude participants on birth control or gender-affirming hormones, which may have their own impact on periods.

“Our goal is to provide menstruating people with information, mainly as to what to expect, because I think that was the biggest issue: Nobody expected it to affect the menstrual system, because the information wasn’t being collected in the early vaccine studies,” said NICHD director Diana Bianchi in a statement to the Lily — reportedly crediting their early coverage for helping to make the NIH aware.

‘We were worried this was contributing to vaccine hesitancy in reproductive-age women.’

NICHD director Diana Bianchi

The NIH suggests that changes to the menstrual cycle could arise out of several of life’s circumstances during a pandemic — the stress of lifestyle changes or possibly contending with illness. Moreover, the immune and reproductive systems are intrinsically linked, and the notion that the immune-boosting vaccine may disrupt the typical menstrual cycle is plausible, as demonstrated by previous studies concerning vaccine uptake.

It’s also worth noting the vaccine does not cause infertility and the Centers for Disease Control and Prevention recommends the shot even for pregnant women.

As changes to the menstrual cycle are “really not a life and death issue,” explained Bianchi, the Food and Drug Administration — fast-tracking their work — prioritized only the most critical risks associated with the COVID-19 vaccine.

The NIH, too, pulled together the initiative at breakneck speed. Funding for such a study would typically take years to see approval.

“We were worried this was contributing to vaccine hesitancy in reproductive-age women,” said Bianchi.

Scientists push back on call to endorse booster shots for all

Authors: By Ariel Hart,  Helena Oliviero– The Atlanta Journal-Constitution

Responding to the resurging pandemic and breakthrough infections, President Biden and some top health officials are pushing for the U.S. to begin vaccine booster shots by Sept. 20. But the committee of scientists who officially recommend whether to take such steps met Monday and pushed back.

The scientists said they still had fundamental questions to answer, such as whether the increase in COVID-19 infections after vaccination, so-called breakthrough cases, was related at all to waning effectiveness of the vaccines.

When the Sept. 20 date was announced “it led everyone—it led physicians, it led the public—to believe that they had access to information about these vaccines and the need for boosters that had not yet been publicly released,” said Dr. Sandra Fryhofer of Atlanta, a nonvoting member of the committee. “And to me, that kind of opened the door to a lot of confusion.”

The group, the Advisory Committee on Immunization Practices, advises the Centers for Disease Control and Prevention on whether scientific data merit approval or warnings on vaccines. From the moment its chairwoman opened Monday’s meeting, members made blunt statements that they would follow scientific data and processes on booster shots, regardless.

Other scientists were glad to hear it.

“There is a process that is being undermined by ‘science by leak,’” said Dr. Felipe Lobelo of Emory University, an epidemiologist and associate professor told the AJC. “We don’t really have strong data on when the waning starts; on whether the increased rates of infection and so called breakthrough infections…are occurring because of this waning effect— or is it because delta is more transmissible? Or is it because people are changing behaviors?”

Dr. Carlos del Rio, professor of medicine at Emory University, agreed. “The problem is by focusing on boosters we’re distracting from the biggest problem, which is all the unvaccinated people,” he said.

Without calling them “booster shots,” the FDA has authorized an extra shot for certain people with compromised immune systems, like organ transplant recipients, after they have completed their original coronavirus vaccine regimen. But no decisions have been made for other vulnerable groups, much less the general public.

That leaves Georgians who are now eager for a booster shot not knowing what comes next.

In Avondale Estates, Carolyn Chandler, 80, has marked her calendar for Oct. 16, the day she should get a booster if they’re recommended eight months from initial vaccination, as federal officials have touted.

Ever since Chandler started to see reports showing waning immunity from the vaccines, there was no question for her that she would get a booster.

“I just would like to stick around for a while,” Chandler said.

FDA Issues Warning About Increased Risk Of Heart Inflammation Caused By Moderna Jab

Authors: BY TYLER DURDENMONDAY, AUG 30, 2021 – 02:14 P

Earlier this month, we reported on leaked data from a Canadian study which arrived at a disturbing conclusion: the risk of rare side effects like myocarditis and pericarditis – types of heart inflammation that are potentially deadly in some patients – was at least 2.5x higher in the Moderna jab than in its main competitor, produced by Pfizer-BioNTech.

The leaking of the data to the press was an embarrassment for the FDA and CDC, and so they pledged to investigate. Now, less than two weeks later, the FDA has just announced that it has updated its “fact sheet” to reflect the higher risk of heart inflammation in male patients under the age of 40.

For all patients, the “post-marketing” data examined by the FDA show that the risk of experiencing these side effects is highest within 7 days of receiving the second dose.

Only Pfizer has received full approval from the FDA; the Moderna jab is still technically under the emergency authorization. Whether this will delay or in any way impact the FDA’s approval of the Moderna jab remains unclear.

Here’s the full updated text:

Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis

Questions about the link between the mRNA jabs and heart inflammation have been circulating since these side effects were first uncovered in a group of American soldiers reporting acute chest pain after their vaccinations.

The news is weighing on Moderna’s share price, which has fallen substantially since its Aug. 9 peak. It was down more than 3% on Monday afternoon.

‘Natural Immunity Is Really Better’: New Israeli Study Fuels Debate On Vaccination Versus Natural Immunity

Authors: DYLAN HOUSMAN HEALTHCARE REPORTER August 28, 20215:12 PM ET

A new study of the power of COVID-19 natural immunity versus the protection provided by vaccines is igniting further debate among scientists on how to assess risk from the virus.

The observational study of more than 700,000 Israelis, which hasn’t yet been peer-reviewed, compared three groups: those who hadn’t been infected and received two doses of Pfizer’s COVID-19 vaccine, those who had been infected and were completely unvaccinated and individuals who were previously infected and received one dose of the vaccine. The researchers found that uninfected vaccine recipients were 13 times more likely to experience a breakthrough infection than those who were previously infected.

“It’s a textbook example of how natural immunity is really better than vaccination,” Charlotte Thålin, a physician and immunology researcher at Danderyd Hospital and the Karolinska Institute in Stockholm, Sweden, told Science Magazine. “To my knowledge, it’s the first time [this] has really been shown in the context of COVID-19.”

Prior research has indicated that natural immunity to COVID-19 is strong, but no research has definitely shown that it is more protective than getting vaccinated up to this point.

The increased protection found in the study extended beyond reinfection, as natural immunity was also found to lead to fewer symptomatic cases and hospitalizations as well. The researchers also concluded that individuals who received one dose of the Pfizer vaccine in addition to recovering from previous infection had the highest level of protection of the three groups.

Data was pulled from Israel between June 1 and August 14, when the Delta variant was dominant in the country. The variant is currently driving a spike in cases and deaths in the United States. It is believed to be the largest real-world study conducted during the pandemic comparing natural immunity to vaccine protection. (RELATED: Poll: Anxiety Over COVID-19 At Highest Point Since Winter)

“The differences are huge,” added Thålin, although she warned the research couldn’t be considered conclusive. The sample size of hospitalizations in the 32,000-person analysis of the vaccinated group was only eight, and only one among the previously infected. Nobody in the entire study died, signaling that both vaccination and natural immunity provide a substantial amount of protection from death.

Researchers warned that the takeaway from the study should not be that catching COVID-19 is a superior substitute to getting vaccinated, due to the higher level of risk that comes with battling the virus versus getting the shot. “What we don’t want people to say is: ‘All right, I should go out and get infected, I should have an infection party,” Rockefeller University’s Michael Nussenzweig, an immunologist, told Science.

Pfizer Just Got ‘Full FDA Approval’ For Its COVID Vaccine. There’s Just One Thing…

Authors: Authored by ‘Sundance’ via TheConservativeTreehouse.com,

Pfizer got full FDA approval yesterday

“The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.”

With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

[…] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed.  This is nuts. That NPR article is one to bookmark when people start claiming the vaccination is effective.

How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?

Good grief, the entire healthcare system is operating on a massive hive mindset where science, and the scientific method, is thrown out the window in favor of ideological outcomes and self-fulfilling prophecies.  

The fact that the researchers and doctors, apparently under the payroll of the pharmaceutical companies that have a vested financial interest in the vaccine outcome, lost the control group on purpose is alarming.

Of course, Big Pharma will promote the vaccine as beneficial, and the controlled media will promote that message with a complete disconnect from the clinical trial details, and the FDA will grant approval on results that were intentionally constructed to produce only one outcome.

As noted by Dr. Malone, the commonsense therapeutic approach should be the primary focus, not vaccination, for ongoing healthcare systems as the COVID-19 variants will continue to evolve.  Ultimately,  the natural immunity process will be of greater overall benefit than vaccinations which will require continual boosters to deal with the ever-evolving variants (a similar approach to dealing with reoccurring and evolving flu strains).   Dr. Malone provided support for his position with concurrence from the leading U.K. Vaccinologist in Great Britain, Sir Andrew Pollard 

In essence, both Dr. Andrew Pollard (Director of the U.K. Oxford Vaccine Group), and Dr. Malone state that variants of the COVID-19 virus will continue to spread throughout the population regardless of vaccine status; and the virus will continue to evolve into more infectious but less deadly or pathogenic strains.

There simply is no way to vaccinate the population and stop the spread of COVID variants, because the vaccinated will contract and spread the virus just like the non-vaccinated.  The vaccine approach should be targeted to the elderly and those most at risk.

Specific to the position of Dr. Malone – given the untested nature of the vaccine itself; no one knows the long-term side-effects; the benefit of the vaccine should be weighed against the individual’s current health status.  Elderly populations with lower immune responses should be the target for vaccination; they are the most at risk.  However, younger -less at risk- individuals will likely benefit more from therapeutic treatment after exposure *if* they experience any symptoms at all.

The problem is…. this commonsense approach is less favorable to the interests of the pharmaceutical industry and the healthcare systems that are controlled by the financial mechanisms inside the business of healthcare.  Big Pharma would obviously make less money from a smaller target population for vaccination; ergo the therapeutic approach is a threat to the preferred approach of those who operate the business model.  This is the overarching political battle.

The influence of the massive pharmaceutical corporations, inside the institutions of government controlled healthcare on a global basis, is massive.  This outlook is the origin of the vaccinate push and vaccine narrative as the *only* and *best* solution.   Anyone who raises a point, any point, in opposition to the mandated mass vaccine approach then becomes a target to be isolated, marginalized, ridiculed and removed.

Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic

Authors: Abanoub Riad,1,2,*†Andrea Pokorná,2,3,†Sameh Attia,4Jitka Klugarová,1,2Michal Koščík,1,5,‡ and Miloslav Klugar1,2,‡Giovanni Gabutti, Academic Editor

Abstract

Background: COVID-19 vaccine side effects have a fundamental role in public confidence in the vaccine and its uptake process. Thus far, the evidence on vaccine safety has exclusively been obtained from the manufacturer-sponsored studies; therefore, this study was designed to provide independent evidence on Pfizer–BioNTech COVID-19 vaccine side effects. Methods: A cross-sectional survey-based study was carried out between January and February 2021 to collect data on the side effects following the COVID-19 vaccine among healthcare workers in the Czech Republic. The study used a validated questionnaire with twenty-eight multiple-choice items covering the participants’ demographic data, medical anamneses, COVID-19-related anamneses, general, oral, and skin-related side effects. Results: Injection site pain (89.8%), fatigue (62.2%), headache (45.6%), muscle pain (37.1%), and chills (33.9%) were the most commonly reported side effects. All the general side effects were more prevalent among the ≤43-year-old group, and their duration was mainly one day (45.1%) or three days (35.8%) following the vaccine. Antihistamines were the most common drugs associated with side effects, thus requiring further investigation. The people with two doses were generally associated with a higher frequency of side effects. Conclusions: The distribution of side effects among Czech healthcare workers was highly consistent with the manufacturer’s data, especially in terms of their association with the younger age group and the second dose. The overall prevalence of some local and systemic side effects was higher than the manufacturer’s report. Further independent studies on vaccine safety are strongly required to strengthen public confidence in the vaccine.

1. Introduction

Vaccine hesitancy (VH) refers to the “delay in acceptance or refusal of vaccines despite availability of vaccine services”; it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety [1,2,3]. In a recent nation-wide study, aversion to vaccines’ potential side effects was the most frequent cause for VH among population groups in the United Kingdom (U.K.) [4]. This finding was supported in the context of COVID-19 vaccines, because a fear of side effects was the most prominent reason to decrease the readiness of healthcare workers and students in Poland to accept the vaccination [5,6]. Consequently, a systematic review of the strategies of tackling VH revealed that raising public awareness of vaccines’ effectiveness and honesty regarding their side effects is vital for improving vaccine uptake [7]. The launch of the COVID-19 vaccine rollout in December 2020 was a landmark for overcoming this pandemic crisis; therefore, it had been recommended to split the pandemic history to pre-vaccination (B.V.; before vaccine) and post-vaccination (A.V.; after vaccine) eras. COVID-19-related literature should be defined in relation to this parameter either as B.V. or A.V. [8].

In a cross-sectional study of influenza vaccine side effects, three out of thirty-seven participants who were recently influenza-vaccinated (8%) developed oral side effects, thus implying a non-statistically significant relationship between influenza vaccine and the oral cavity [9]. The short-term side effects of vaccines vary in their clinical presentation; however, they are commonly related to prophylactic vaccines’ humoral immune response [10]. The oral cavity has been a locus for the adverse events of an array of vaccines, e.g., diphtheria, tetanus, acellular pertussis, and polio vaccines [9]. The COVID-19-related oral symptoms were attributed to the high expression of angiotensin-converting enzyme 2 (ACE2) receptors in the tongue’s epithelial cells, buccal and gingival mucosa [11,12,13,14,15,16,17,18].

Thus far, all the available data on COVID-19 vaccine side effects has been published by manufacturer-funded studies which are in compliance with the drug authorities’ guidelines and monitored by third-parties [19]. A lack of independent studies on vaccines’ safety may adversely impact the vaccine uptake, which has to be accelerated in the next few months in order to escape this viscous circle of the virus and its variants [7]. Therefore, this study’s primary objective was to estimate the prevalence of Pfizer–BioNTech COVID-19 vaccine side effects among the early vaccinated healthcare workers in the Czech Republic.

The secondary objectives were:

  1. To identify the potential risk factors of Pfizer–BioNTech COVID-19 vaccine side effects;
  2. To evaluate the correlation of general side effects, oral side effects, and skin-related side effects.

For More Information: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037149/

The Vaccinated Are Worried and Scientists Don’t Have Answers

Authors: Kristen V. Brown and Rebecca Torrence  14 hrs ago

Anecdotes tell us what the data can’t: Vaccinated people appear to be getting the coronavirus at a surprisingly high rate. But exactly how often isn’t clear, nor is it certain how likely they are to spread the virus to others. And now, there’s growing concern that vaccinated people may be more vulnerable to serious illness than previously thought.

There’s a dearth of scientific studies with concrete answers, leaving public policy makers and corporate executives to formulate plans based on fragmented information. While some are renewing mask mandates or delaying office reopenings, others cite the lack of clarity to justify staying the course. It can all feel like a mess.

“We have to be humble about what we do know and what we don’t know,” said Tom Frieden, a former director of the Centers for Disease Control and Prevention and the head of the nonprofit Resolve to Save Lives. “There are a few things we can say definitively. One is that this is a hard question to address.”

Read more: Booster Review Delayed by CDC as Debate Swirls Over 3rd Shot

Absent clear public health messaging, vaccinated people are left confused about how to protect themselves. Just how vulnerable they are is a key variable not just for public health officials trying to figure out, say, when booster shots might be needed, but also to inform decisions about whether to roll back reopenings amid a new wave of the virus. On a smaller scale, the unknowns have left music lovers unsure if it’s OK to see a concert and prompted a fresh round of hang-wringing among parents pondering what school is going to look like. 

In lieu of answers, what has emerged is a host of case studies providing somewhat different pictures of breakthrough infections. Variables including when the surveys were conducted, whether the delta variant was present, how much of the population was vaccinated and even what the weather was like at the time make it hard to compare results and suss out patterns. It’s difficult to know which data might ultimately carry more heft.

“It’s quite clear that we have more breakthroughs now,” said Monica Gandhi, an infectious disease expert at the University of California, San Francisco. “We all know someone who has had one. But we don’t have great clinical data.”

One of the best known outbreaks among vaccinated people occurred in the small beach town of Provincetown, Massachusetts, as thousands of vaccinated and unvaccinated alike gathered on dance floors and at house parties over the Fourth of July weekend to celebrate the holiday — and what seemed like a turning point in the pandemic. About three-fourths of the 469 infections were among vaccinated people. 

Read more: Are Covid Shots Working? What the Real World Tells Us

Authors of a CDC case study said this might mean that they were just as likely to transmit Covid-19 as the unvaccinated. Even so, they cautioned, as more people are vaccinated, it’s natural that they would also account for a larger share of Covid-19 infections and this one study was not sufficient to draw any conclusions. The incident prompted the CDC to reverse a recommendation it had issued just a few weeks earlier and once again urge the vaccinated to mask up in certain settings.

Still, the particular details of that cluster of cases may have made that outbreak especially bad, according to Gandhi.

“The rate of mild symptomatic outbreaks in this population was higher because of a lot of indoor activity (including intimacy), rain that weekend, not much outside time and mixture of people with different vaccination status,” she said in an email.

A newly released, far larger CDC case study of infections in New York state, meanwhile, found that the number of breakthrough infections has steadily ticked up since May, accounting for almost 4% of cases by mid-July. Those researchers cautioned that factors such as easing public health restrictions and the rise of the highly contagious delta variant might impact the results. 

Yet another CDC case study, in Colorado, found that the breakthrough infection rate in one county, Mesa, was significantly higher than the rest of the state, at 7% versus about 5%. The report suggested it was perhaps because the delta variant was circulating more widely there, but also noted the ages of patients in Mesa and the lower vaccination rate may have played a role.

Research out of Israel seems to back the idea that protection from severe disease wanes in the months after inoculation, and more recently, that breakthrough cases may eventually lead to an uptick in hospitalizations. The information is preliminary and severe breakthrough cases are still rare, but it bolsters the case that some people will need booster shots in coming months.

Case studies and data from some states in the U.S. have similarly shown an increase in breakthrough cases over time. But with the delta variant also on the rise, it’s difficult to tell whether waning immunity to any type of coronavirus infection is to blame, or if the vaccinations are particularly ineffective against the delta variant. It could be both, of course. Changing behavior among vaccinated people could be a factor, too, as they return to social gatherings and travel and dining indoors.

All that said, some facts are well established at this point. Vaccinated people infected with the virus are much less likely to need to go to the hospital, much less likely to need intubation and much less likely to die from the illness. There’s no doubt that vaccines provide significant protection. But a large proportion of the nation — almost 30% of U.S. adults — have not been vaccinated, a fact that has conspired with the highly contagious delta variant to push the country into a new wave of outbreaks. 

“The big picture here is that the vaccines are working and the reason for the spike in the U.S. is we have too little vaccine uptake,” Frieden said. 

To a certain extent, breakthrough cases of any virus are expected. In clinical trials, no Covid vaccine was 100% effective — even the best vaccines never are. The more the virus is in circulation, the greater the risk of breakthrough cases. It’s also common for some aspects of viral immunity to naturally wane over time.map: covid-vaccine-tracker-global-distribution-inline.png© Bloomberg covid-vaccine-tracker-global-distribution-inline.png

For the time being, there are simply more questions than answers. Are breakthrough infections ticking up because of the delta variant, waning immunity or a return to normal life? Are vaccinated people more vulnerable to severe illness than previously thought? Just how common are breakthrough infections? It’s anyone’s guess.

“It is generally the case that we have to make public health decisions based on imperfect data,” Frieden said. “But there is just a lot we don’t know.”

(Adds more on Israeli study in 13th paragraph.)

More stories like this are available on bloomberg.com

©2021 Bloomberg L.P.

Toxic Epidermal Necrolysis Post COVID-19 Vaccination – First Reported Case

Authors: Mohamad BakirHanan AlmeshalRifah AlturkiSulaiman ObaidAreej Almazroo


Published: August 16, 2021

Abstract

Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) is a spectrum of acute, delayed-type hypersensitivity reactions that affect the skin and the mucous membranes. Medications are the culprit cause of these disorders in addition to infections and in very rare instances vaccinations. We report a case of TEN in a 49-year-old woman with no previous medical history. The disorder developed one week after receiving the first dose of COVID-19 vaccine with no other identifiable causes. The patient received two doses of tumor necrosis factor-alpha inhibitor (etanercept) and she stopped developing new lesions after two days of the initial dose; complete healing was observed after 22 days and no side effects were observed in our patient. This case demonstrates an extremely rare complication to the COVID-19 vaccine. The benefits of receiving the COVID-19 outweigh the potential risk. 

Introduction

Toxic epidermal necrolysis (TEN) is a rare immune-mediated, life-threatening skin reaction characterized by blistering and extensive epidermal detachment of more than 30% of body surface area. The incidence is estimated to be 0.4 to 1.9 cases per million population per year worldwide and an estimated mortality rate of 25% to 35% [1, 2]. Medication is usually the cause of TEN (e.g., certain antibiotics and antiepileptics) [3]. Vaccination-induced Stevens-Johnson syndrome (SJS)/TEN is rare, with less than twenty reported cases in the published literature, with the measles vaccine being reported to cause both SJS and TEN, varicella, smallpox, anthrax, tetanus, and influenza vaccines were reported to cause SJS alone, and MMR (measles, mumps, rubella), hantavirus and meningococcal B vaccines were reported to cause TEN [4, 5, 6]. The patient usually develops a fever and other flu-like symptoms one to three weeks after being exposed to medication followed by painful erythematous to purpuric skin lesions that tend to coalescence. Next erosions and vesiculobullous lesions and epidermal detachment over wide body surface area develop. Mucous membranes are also involved, and the patient develops oral ulcers, vaginal ulcers, and possible acute conjunctivitis [7]. In this paper, we report a case of TEN following the administration of the Pfizer COVID-19 vaccine (Pfizer, Inc., New York, USA).

For More Information: https://www.cureus.com/articles/68051-toxic-epidermal-necrolysis-post-covid-19-vaccination—first-reported-case