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Tuesday, March 1, 2022

Don’t use these 3 unauthorized COVID tests, FDA warns

 There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests. The agency “is concerned about the risk of false results when using” all three, it said on Tuesday, March 1, about certain COVID-19 antigen tests by companies Celltrion, ACON Laboratories and SD Biosensor. Each company has issued their own recalls for their particular kits. Avoid the Celltrion DiaTrust COVID-19 Ag Rapid Test found in bright green and white packaging and the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) found in a dark blue box, the FDA says. Additionally, don’t use SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test found in a white and magenta box.

If you have a test by any of these three companies, compare the packaging with the photos shared by the FDA of the unauthorized tests. Other COVID-19 tests by each company are authorized. Don’t use this Celltrion DiaTrust COVID-19 Ag Rapid Test, the FDA says. 

Don’t use this SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test, the FDA says. FDA At least 162,000 unauthorized Celltrion COVID-19 tests that were distributed involve using a nasal swab to detect virus antigens, according to the FDA. They have “the same name as an FDA authorized version of the test for point of care settings but is not the same test,” the agency warns. You can continue to use Celltrion’s DiaTrust COVID-19 Ag Home Test and the safe DiaTrust COVID-19 Ag Rapid Test that are both FDA-authorized and “not affected” by the agency’s warning. The unauthorized tests by ACON Laboratories is also a nasal swab test to detect antigens and has “lettering and symbols in the lower right corner of the box, including the letters ‘CE.’”


https://www.miamiherald.com/news/coronavirus/article258939508.html

Will Russian invasion of Ukraine affect Sputnik V vaccine's production?

 Russia has been hit with severe economic sanctions by the West following its invasion of Ukraine. Top government officials and the country's businessmen face punitive measures as the West mounts pressure on Moscow to de-escalate its military offensive in Ukraine

Among those hit by sanctions is the Russian Direct Investment Fund (RDIF), which is the sovereign wealth fund of the Russian Federation, and its Chief Executive Officer (CEO) Kirill Dmitriev. RDIF is the backer of Sputnik V Covid-19 vaccine, which has been developed by the government's Gamaleya Research Institute.

In a statement, RDIF called the sanctions "politically motivated" and lobbied by large Western pharmaceutical companies.

"Imposition of sanctions against RDIF, which from the moment it was established has stood for building international relations and supporting constructive ties, demonstrates that the US has picked the course to destroy constructive dialogue between countries," the statement read.

"The restrictions imposed by the US authorities complicating RDIF efforts on the international promotion of the Russian vaccine products, have been lobbied by a number of large Western pharmaceutical companies. As a result of such unfair competition, billions of people around the world may be deprived of access to effective and safe Russian-made vaccines," the statement added.

RDIF has claimed that its Sputnik V vaccine showed "best results" against the Omicron variant, surpassing the Pfizer vaccine by more than two times in terms of antibodies generated after vaccination.

"RDIF believes that the announced measures to restrict its operations are politically motivated and go against the principles of humanitarian cooperation," the statement by RDIF read.

SPUTNIK V's GLOBAL PRESENCE

According to RDIF, Sputnik V Covid-19 vaccine has been authorised in 71 countries, including India, with a total population of more than four billion people.

Developed by Gamaleya Research Institute, part of Russia’s Ministry of Health, the vaccine has an efficacy rate of 91.6 per cent among fully vaccinated people, according to a study by The Lancet.

SPUTNIK V's PRESENCE IN INDIA

Outside Russia, India is the largest leading production hub for Sputnik V and its single-dose version, Sputnik Light. In India, the RDIF has a tie-up with Dr Reddy's for the production of Sputnik V.

The RDIF has also reached agreements with other leading pharmaceutical companies, including Serum Institute of India, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen, to produce the Russian vaccines in India.

Sputnik V received the emergency use authorisation in India last year, while Sputnik Light got the approval from the country's Drugs Controller General of India (DCGI) last month.

WILL WESTERN SANCTIONS AFFECT SPUTNIK V PRODUCTION?

Despite its presence in 71 countries, Sputnik V is yet to receive emergency use approval from the World Health Organisation and European Medicines Agency, the European Union's drug regulator.

The WHO was supposed to visit Russia last month to inspect the factories where Sputnik V is produced, but Moscow's actions in Ukraine threaten to put this development in a limbo.

Further, the West has blocked key Russian banks from the Society for Worldwide Interbank Financial Telecommunication (SWIFT), the global financial messaging system, which could affect the exports of the Russian medicines and vaccines.

This comes even as the RDIF has claimed that it was "never involved in any political activities, does not interact in any way with Ukraine and follows the world’s best investment practices".

The effects of the Ukraine war started showing up even before the sanctions hit. On February 23, Germany's Bavarian region said it will block the production of Sputnik V, even if it is approved by the EMA.

The RDIF has vowed to use all available means to protect its "rights, reputation and lawful interests" against the Western sanctions, including seeking judicial recourse in relevant jurisdictions.

https://www.indiatoday.in/world/russia-ukraine-war/story/russia-ukraine-war-news-updates-invasion-sputnik-v-vaccine-production-1919572-2022-03-02

Biden announces new COVID-19 initiative that gives Americans free pills

 US President Joe Biden on Tuesday (Mar 1) said his administration has launched a new initiative that will allow Americans to get tested for COVID-19 at a pharmacy and immediately receive free pills if they test positive.

"We're launching the 'Test to Treat' initiative so people can get tested at a pharmacy, and if they're positive, receive antiviral pills on the spot, at no cost," Biden said during his State of the Union speech.

The United States has ordered more of these treatments than any other country in the world, Biden said, adding Pfizer Inc will offer the US 1 million pills in March and more than double that in April.  The Pfizer pill, he said, reduces the chances of ending up in the hospital by 90 per cent.

The Biden administration will announce on Wednesday a national preparedness plan for COVID-19, mapping out how "to move forward safely and get back to our more normal routines", the White House said in a statement.

The White House previously said it is lifting requirements that fully vaccinated people wear masks on the White House campus, effective Tuesday. It also told federal agencies they can drop COVID-19 requirements that employees and visitors wear masks in federal buildings in much of the country.

During his speech, Biden noted the progress America has made in fighting the coronavirus but warned Americans must prepare for new variants.

"I cannot promise a new variant won't come. But I can promise you we'll do everything within our power to be ready if it does," he said.

The US is now in a position to deploy new vaccines within 100 days instead of months or years, he said.

https://www.channelnewsasia.com/world/biden-announces-new-covid-19-initiative-gives-americans-free-pills-2531166

Israel drops almost all COVID health rules as it exits Omicron wave

Israel on Tuesday rolled back almost all of its COVID-19 health rules as a recent wave of infections receded, leaving in place just a handful to prevent a reversal of the positive development.

As the country transitions to the more relaxed status, the most notable rule to remain is a requirement to wear a face mask in indoor public spaces. The current requirement for masks in some large outdoor gatherings is canceled.

In addition, the Green Pass certificate, granted to those who are vaccinated, recovered, or recently tested negative for the coronavirus, will only be needed to enter old age homes.

Also, under the new guidelines, both vaccinated and unvaccinated tourists of all ages will be allowed into the country, as long as they submit a negative PCR test before boarding the flight and take another one after landing in Israel. Citizens will no longer need to test before returning home (though it’s suspected that some airlines will still insist on a test), but will still need to test upon arrival.

A Green Pass was previously needed to attend almost any public event and many venues, but the rules of its use have been gradually rolled back as infections dropped, leaving only the care home requirement still in place.

Existing Green Pass certificates will be extended until May 31 for those who have had at least three vaccine doses or a shot in the previous six months. Those who have recovered from COVID-19 can obtain a Green Pass for six months following their recovery, valid also until May 31.

A requirement for children in middle school and high school to take regular twice-weekly antigen tests at home ended, and it will be canceled for younger children on March 10.

The changes come as the count of new daily cases has ebbed to barely a ninth of what it was a month ago.

Back then, when the latest wave was at its height, the moving average of new daily diagnoses was about 75,000. Health Ministry figures released Tuesday showed there were 8,372 new cases diagnosed the previous day.

At points in January there were more than half a million people infected — 1 in 20 Israelis — but the new numbers showed there are 72,270 active patients in the country.

The number of seriously ill patients has more than halved since February 6, from 1,242 to 582, the lowest it has been since January 19.

The death toll since the start of the pandemic is 10,204.

https://www.timesofisrael.com/israel-drops-almost-all-covid-health-rules-as-it-exits-omicron-wave/

How the FDA botched the vaccine-approval process for young children

 Parents and policy analysts are suffering from whiplash after watching the Food and Drug Administration get excited about, then ultimately abort, authorization of Pfizer’s Covid-19 vaccine for children aged six months to four years. The series of events is unprecedented and unnecessary, and it further undermines the agency’s credibility at precisely the moment the public needs faith in vaccine regulators.

The FDA initially gave Pfizer a layup. The company did not have to run a large trial showing the vaccine lowers the risk of severe outcomes; instead, the agency would settle for a trial that showed that antibody levels generated in kids were close enough to levels generated in older age groups—a type of study design called “non-inferiority,” which has been faulted for being overly permissive.

Pfizer succeeded in meeting this mark for kids aged five to 11 with a ten-microgram dose, leading to emergency-use authorization (EUA) at those ages. It tried again in the six-month to four-year-old cohort with a lower dose—three micrograms (the adult dose is 30). Unfortunately, in December 2021, Pfizer announced that its trial fell short, and modified it to see whether a third jab could get it to the mark.

In late January, something unusual happened. While investigators were still testing the third dose, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, suggested on CBS Face the Nation that federal officials were considering approving the two doses while waiting for the ongoing trial. In fact, just three days later, the agency asked Pfizer to submit whatever results it had for consideration of granting EUA.

Inviting a company to submit the results of an ongoing trial that had already failed to meet its mark was a bizarre, even unprecedented, decision. Paul Offit, director of vaccine communication for the Children’s Hospital of Pennsylvania, said, “It doesn’t make sense we would approve a two-dose vaccine on the assumption the third dose would make up for deficiencies of the two doses.”

In the days that followed, more information emerged from anonymous leaks. Another measure (or endpoint) of the vaccine’s efficacy, the number of cases of SARS-CoV-2, varied between the recipients; fewer kids who got the vaccine tested positive for the virus. News reports said that the reduction in cases was 57 percent. A frenzied discussion online ensued. Observers speculated that the number of events must be low, so the 57 percent reduction should be taken with a grain of salt. The true reduction could be much higher or lower—or, in statistical parlance, the 95 percent confidence interval was likely wide. Others worried that it would be important to see the breakdown of how many infections were due to the Delta and Omicron variants. After all, Omicron was the dominant variant in the moment, and three studies had shown that the vaccine had poor effectiveness against Omicron.

In any case, ambiguities remained even with this secondary endpoint. An important question was whether the kids who tested positive were symptomatic. During the holiday season, many families traveled or tested asymptomatic children to try to foster safer gatherings. Could some of the difference in cases be due to that massive testing? This mattered, because the goal of vaccination is to reduce the harms of the virus—feeling bad, being hospitalized, or worse—not merely to attain fewer asymptomatic positives.

A vaccine advisory meeting was scheduled for February 15, and many waited eagerly for dissemination of trial data, which were slated to be made public the Friday beforehand (February 11). On February 10, however, more leaked data emerged. The New York Times reported the sample size of the study, and that there were just 50 total infections, with a 57 percent reduction in cases. These data were sufficient for statisticians to estimate roughly the confidence interval, which was going to be very wide (anywhere from 25 percent to 75 percent), prompting more debate about whether it was prudent for the FDA to approve the shot.

Then, in a stunning about-face, Pfizer announced on February 11 that it was pulling its EUA from consideration. Gottlieb told reporters that there were too few cases, and too few symptomatic cases, in the trial. The numbers were unreliable, and the FDA and Pfizer would wait for the third-dose results to come in. Some observers were upset and argued that the vaccine should be made available, or that at least all data be made public—the latter an entirely reasonable request.

Few have grappled with the implications for this series of events, which represents an unforced error in vaccine regulation. First, the FDA vaccine division is operating at diminished capacity. Marion Gruber and Philip Krause, the director and deputy director of that division, famously resigned in the fall of 2021 after decade-long careers in response to pressure from the White House to approve boosters for all adults. As such, trust is already low in some quarters. Second, vaccine regulation is a reputational field. To an outside observer, it looks as if the agency does not know what it is doing. The agency has asked Pfizer to show that antibody levels are non-inferior—does it want this information or not? If the agency is happy with a reduction in Covid cases, it could have explicitly asked Pfizer to make this the primary endpoint of the study.

But it is unscientific to run a trial and then accept any endpoint that looks favorable. Scientists call it the Texas Sharpshooter fallacy: someone fires indiscriminately at the side of a barn and then paints a bullseye where several bullets happened to bunch together. The FDA appeared to be inviting such gaming.

Worse, just two weeks later, important data emerged suggesting that the vaccine was much less effective at blocking infection in the older, five- to 11-year-old age group. Investigators speculate that one potential reason was the lower dose. But if the dose is responsible for the inferior performance in five- to 11-year-olds, what would have happened had authorities authorized an even lower dose in those aged six months to four years?

The American public witnessed a two-week media cycle in which some parents became excited by the prospect of imminent approval, while others grew concerned at the possibility of school or daycare mandates based on a study that had failed to meet its primary endpoint. As an expert in drug regulatory policy and author of two books on this topic, I have never witnessed anything comparable to this episode. At least some of the dysfunction may be due to a lack of leadership in vaccine products within the agency. Some experts praised the FDA for making the right call in the end and deciding not to make the shot available. But this is like cheering an arsonist for putting out a fire he himself started. The federal government is spending the FDA’s credibility like monopoly money at precisely the time we need faith in vaccine regulators.

The Moral Atrocity of 'Top Surgery'

 Beverly* from Oregon emails me: “Urgent need help with ROGD daughter please answer ASAP.” Her daughter announced out of the blue that she’s a boy (this is called Rapid Onset Gender Dysphoria, or ROGD). I’m a child and adolescent psychiatrist, and I receive messages like this almost daily. That’s because unlike most of my colleagues, I won’t automatically affirm a child’s new identity, or refer her to a clinic where she’ll be put on experimental hormone therapy.

Beverly has reason to panic. She learned not only that her daughter, a 15-year-old, has declared herself to be a boy, but that her daughter’s best friend and main influence, Mia, just had her breasts removed as part of her own male identification process. Beverly is beside herself. “Do doctors really do that to a 16-year-old?” she asks incredulously. “They sure do,” I reply.

Increasingly, confused girls with mental-health issues are lining up to have their breasts removed, erroneously believing my colleagues who tell them the operation will alleviate their emotional pain and allow them to emerge as their authentic selves. Girls as young as 13 are having “top surgery,” a euphemism for a bilateral mastectomy—the removal of both breasts—in order to create, as gender surgeons put it, a “masculinized” chest. “Bilateral mastectomy” sounds jarring and clinical; it’s a treatment for cancer, after all—one that women agonize over. 

Mind you, these are the same people who insist that five-year-olds use anatomically accurate terms, not childish nicknames, for their genitals. They soberly instruct us to teach the words “scrotum” and “vulva” to kindergarteners. But the vague, trivial-sounding terms “top” and “bottom” surgeries—that language is fine. As if the consequences of those major operations—infertilitysexual dysfunctioninfection, and chronic pelvic pain, to name a few—aren’t permanent and debilitating.

As an intern in pediatrics, when one of my patients needed a medical procedure, I was required to obtain informed consent from the parents or guardian of the minor. I was obligated to explain, accurately and comprehensively, the risks—both immediate and long-term—of the procedure. I wonder how accurate and comprehensive are the consents obtained by surgeons who perform double mastectomies on minors. Mia’s mother was almost certainly told that mastectomies for minors with gender dysphoria are evidence-based treatment, supported by well-documented standards of care. But did the surgeon mention that this deceptive reassurance is being challenged in court, with the help of an amicus brief by the Society for Evidence-Based Gender Medicine?  

SEGM’s arguments against mastectomies for girls like Mia are compelling. They point out that long-term outcomes are highly uncertain and that many girls have untreated mental-health issues. They explain why the evidence supporting mastectomies in minors is low-quality and unreliable. According to SEGM, mastectomies on minors are an “experimental procedure on vulnerable youth” whose brains and identities are still developing. Leading gender clinics and psychiatric associations worldwide are rejecting these procedures. They’re saying that girls who want their breasts removed need in-depth psychotherapy, not a surgeon’s scalpel.

I know many girls like Mia, and I’m well aware that she can’t tolerate talking about her periods, let alone pregnancy, because she’s fleeing womanhood. But her identity is still evolving; if she’s like other gender-confused girls, she wore lace push-up bras less than a year ago. In the next decade, she will go through many more changes—and one of them, I hope, will be re-acceptance of her female biology. She may follow the same path as Daisy Chadra, a young woman who lived as a man for five years and had her breasts “amputated” (her word). What she lost is irreplaceable, but Daisy’s back at peace with her female biology. There appear to be thousands like her, who regret the medical and surgical interventions they believed would solve their emotional problems. Transgender activists claim regret is rare, but this de-transitioners’ site alone has 26,000 members. If Mia someday joins their growing ranks, she may experience her flat, scarred chest as a loss.

And what if she decides to have a child? The surgeon was obligated to discuss with the mother the consequences of Mia’s breast removal—not only to her daughter but also to her grandchildren. Because in this case, organ removal may have negative consequences for two generations. 

Nursing is a cornerstone of mother-infant bonding, and when she signed on the dotted line, Mia’s mother agreed to deprive her daughter and grandchildren of the opportunity to nurse. At the moment, it may have seemed irrelevant, but for consent to be informed, the surgeon was obligated to consider long-term consequences. No bottle, pacifier, plush toy, bouncer, swing, rocker, sound machine, mobile, light show, or vibrating mat will soothe an unhappy baby like nursing. Breast milk is considered the gold standard by pediatricians and the World Health Organization. It provides lasting health benefits for both mother and child.

Mia cannot fathom the magic of mother-child bonding, or the many other wonders of her female biology. If she’s like most kids, her sex education, instead of inspiring a sense of awe for her female physiology, taught that the differences between herself and a guy are due to socialization, not biology—and that it’s normal for her to reject reality and identify as a boy. But her surgeon, and her mother, should have known better. Is it really necessary to point out that adults have more wisdom than children, and that they must resist their impulses to give in to a child’s demands just because she is distressed and feels certain?

The surgeons and “gender specialists” who support or perform these procedures on children must be held accountable. Take, for example, Johanna Olson–Kennedy from Children’s Hospital L.A., a pediatrician who believes that there should be no minimum age for a double mastectomy. What if a girl regrets it? Olson–Kennedy says: “If you want breasts at a later point in your life, you can go and get them.” 

Children are being victimized on the altar of an ideology that seeks to obliterate a fundamental truth of civilization—the reality of male and female.  

Finally, the investigations are starting. Let the truth come out: the radical social agendas that animate sexuality education; the capture of the medical, mental health, social work, and educational professions; the undermining and silencing of parents. Let’s hear expert witnesses explain the denial of biological truths, the false and dangerous promises made to vulnerable kids, and the informed consents for irreversible medical interventions that were hardly informed.

Give a public platform to the victims—those who’ve been sterilized and scarred, and their families, who’ve been traumatized and betrayed. When enough people learn the truth and stand up, when the dogma is successfully challenged, and when schools, doctors, and therapists promoting the dogma are exposed, we can start to write an end to this medical calamity.

* This and other names have been changed for this article.

Why exercise gets harder the less you do

 Doing less exercise could deactivate a vital protein in the body, causing further inactivity and making exercise more difficult, new research suggests.

University of Leeds scientists have discovered that deactivating the Piezo1 protein, a blood flow sensor, reduces the density of capillaries carrying blood to the muscles.

This restricted blood flow means activity becomes more difficult and can lead to a reduction in how much exercise is possible, the team found.

They say the results help to explain the biology of why exercise becomes harder the less you do.

The paper, Endothelial Piezo1 sustains muscle capillary density and contributes to physical activity, is published today in Journal of Clinical Investigation.

The experiments were carried out in mice, but the Piezo1 protein is found in humans, suggesting the same results could occur.

Lead author Fiona Bartoli, a Postdoctoral Researcher in the University of Leeds' School of Medicine, said: "Exercise protects against cardiovascular disease, diabetes, depression and cancer. Unfortunately, many people fail to exercise enough, for reasons such as injury and computer usage. This puts people at more risk of disease. The less people exercise, the less fit they become, often leading to a downward spiral.

"Although many responses to exercise are known, how the benefits of exercise are initially triggered at a molecular level is mysterious. Our study highlights the crucial link between physical activity and physical performance made at this level by Piezo1. Keeping our Piezo1s active by exercising may be crucial in our physical performance and health."

During the experiment, scientists compared two groups of mice -- a control group, and a group whose Piezo1 levels had been disrupted for 10 weeks. Walking, climbing and running wheel activity was observed, with the Piezo1 mice showing a striking reduction in activity levels. This suggests an important role for Piezo1 in sustaining normal physical activity.

The researchers considered whether the Piezo1 mice were less interested in exercise, but they found no differences in the amount or duration of activity between the two groups. Instead, there were fewer running wheel revolutions per exercise session, and slower running speed, suggesting a lowered ability to exercise, without a lesser desire.

Supervising author Professor David Beech, in the University of Leeds' School of Medicine, said: "Our work sheds new light on how Piezo1's role in blood vessels is connected to physical activity. A lot was already known about its role in blood vessel development, but far less was known about its contribution to vessel maintenance in adults.

"Our discovery also provides an opportunity to think about how loss of muscle function could be treated in new ways: if we activate Piezo1, it might help to maintain exercise capability."

The study is funded by the British Heart Foundation.


Story Source:

Materials provided by University of LeedsNote: Content may be edited for style and length.


Journal Reference:

  1. Fiona Bartoli, Marjolaine Debant, Eulashini Chuntharpursat-Bon, Elizabeth L. Evans, Katie E. Musialowski, Gregory Parsonage, Lara C. Morley, T. Simon Futers, Piruthivi Sukumar, T. Scott Bowen, Mark T. Kearney, Laeticia Lichtenstein, Lee D. Roberts, David J. Beech. Endothelial Piezo1 sustains muscle capillary density and contributes to physical activityJournal of Clinical Investigation, 2022; 132 (5) DOI: 10.1172/JCI141775