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Health

Juul Settles Multistate Youth Vaping Inquiry for $438.5 Million

Juul Labs, which is struggling to survive in the United States, on Tuesday tentatively agreed to pay $438.5 million to settle an investigation by nearly three dozen states into marketing and sales practices they allege they started the teenage e-cigarette crisis.

The company said it did not acknowledge any wrongdoing in the settlement but was trying to “resolve past issues” while awaiting a decision from the Food and Drug Administration on whether it can continue to sell its products. Juul has attempted to reposition itself as a seller of vaping products that could help adults quit smoking traditional cigarettes to restore its tarnished reputation and improve its diminished market value.

The preliminary agreement prohibits the company from marketing to youth, funding education in schools and misrepresenting the nicotine content of its products. But Juul had already halted several marketing practices and withdrawn many of its flavored pods, which appealed to teenagers, several years ago, under public pressure from lawmakers, parents, and health experts when the vaping crisis was at its height.

“We believe this will go a long way in stemming the influx of vaping among youth,” Connecticut Attorney General William Tong said at a news conference Tuesday. “We are under no illusions and cannot claim that it will discourage the youth from vaping. It remains an epidemic. It’s still a big problem. But we essentially took away a large chunk of the former leader.”

The cross-country investigation found the company was targeting young people by hiring young models, using social media to woo teenagers and giving out free samples, he said. And, he added, the research found that the company had a “weak” age verification system for its products and that 45 percent of its Twitter followers were between the ages of 13 and 17.

Virginia Attorney General Jason Miyares pointed out in a statement that the company’s previous strategy of selling flavors like mango and crème brûlée appealed to the youth, as did its device’s sleek design, which was easy to conceal. A condition of the settlement prohibited the company from depicting anyone under the age of 35 in its marketing images, Mr Miyares’ statement said.

Juul said Tuesday that the settlement agreement was “aligned with our current business practices, which we began implementing following our company-wide reset in the fall of 2019.”

“We remain focused on the future as we work to fulfill our mission to move adult smokers away from cigarettes – the leading cause of preventable deaths – while tackling underage smoking,” the company’s statement said.

The agreement does not resolve all of the Company’s litigation. While Juul previously reached settlements in lawsuits filed by attorneys general in North Carolina, Washington, Louisiana and Arizona, nine similar cases remain. Major lawsuits filed by New York and California, among others, remain pending. And about 3,600 lawsuits from individuals, school districts and local governments were consolidated in a lawsuit that is still moving through a California court.

Juul is still selling tobacco- and menthol-flavored capsules and vaping products while its application for permanent sale is under FDA review. The agency originally denied the company’s application in June, saying Juul failed to provide sufficient evidence that its products would benefit public health, citing “inadequate and conflicting” data from the company.

Juul received a temporary pardon in court. It has since argued that it has helped two million adult smokers quit traditional cigarettes and has taken issue with the agency’s conclusions on chemicals in its products. The FDA then relented its rejection and announced that it would conduct an additional review of “scientific issues” in the application.

States differ in how they use settlement funds, which must be paid over six to 10 years. A spokeswoman for the Connecticut Attorney General said her share (more than $16 million) would go towards vaping and nicotine cessation and addiction treatment. Texas estimated it would receive nearly $43 million, and Virginia put its share at $16.6 million.

Meredith Berkman, co-founder of Parents Against Vaping E-Cigarettes, said she was pleased to learn of the settlement. She became involved with the group after Juul sent a representative to her son’s ninth-grade high school to speak at a gathering in 2018. Her son passed on that the rep had called the product “perfectly safe,” a conversation Ms. Berkman told a congressional hearing in 2019.

Since then, she said, the group has heard from hundreds of families who claim their teens have become addicted to vaping Juul and other nicotine and marijuana devices. Some young people became seriously ill from vaping and others had to go to drug rehabilitation to get rid of nicotine addiction.

“It was Juul who showed up and opened this horrible Pandora’s box,” Ms. Berkman said. “No amount of money can undo the damage caused by Juul’s targeting and marketing to teenagers, whose use of the company’s stealth-by-design flavored products caused many children to experience severe nicotine addiction and physical harm.”

E-cigarette use among teens appears to have declined in recent years, although the coronavirus pandemic had brought new momentum to the leading monitor of teenage tobacco use, a survey conducted in schools by the Centers for Disease Control and Prevention. In March, that survey showed that nearly 8 percent, or about two million college students, said they had used e-cigarettes in the past 30 days.

While Juul was once the youth favorite, the survey showed that the candy and fruit flavored Puff Bar vapes were the most popular among youth, with Juul ranking fourth among college students. Data from IRI, a market research firm, suggests the brand was attracting more adult customers by closely competing for market leadership with another brand, Vuse Vapes, with about 30 percent of recent sales.

Altria, which bought a 35% stake in Juul for $12.8 billion in December 2018, said in a recent filing with investors that the company’s stake is now worth about $450 million — almost the same amount that Juul had just agreed to settle investigations from nearly three dozen states and Puerto Rico.

After Juul received a thorough scrutiny of its seal of approval among youngsters, it lost significant market share and value when it gave in to public pressure and stopped selling the flavors that appealed most to youngsters.

Although the vaping market still accounts for a small percentage of overall cigarette and other inhalation product sales, the FDA has repeatedly fallen short in its efforts to curb youth-friendly e-cigarettes, which continue to emerge in new candy colors and flavors. After the agency tried to crack down on existing brands, companies and the market turned to synthetic nicotine to evade regulation.

In March, Congress gave the FDA authority to take synthetic nicotine off the market. But the agency is methodical, reviewing about a million applications it received this spring from manufacturers of non-tobacco nicotine products. She has to exercise a degree of caution in order for her judgments to stand up in court.

The agency also continues to review and approve some marketing authorization applications that were submitted years ago for leading vapes, typically sold in gas stations and convenience stores. However, she recently said she does not expect to complete the review of the applications already submitted before next year.

Involved in the settlement: Alabama, Arkansas, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Maryland, Maine, Mississippi, Montana, Nevada, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming.

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Health

CVS to purchase house well being large Signify Well being for about $Eight billion

A CVS logo is displayed at one of their stores near Bloomsburg.

Paul Weber Light Rocket | Getty Images

CVS Health has reached an agreement to acquire home health care company Signify Health for about $8 billion, the companies announced Monday.

CVS said it would pay $30.50 per share in cash for Signify, an acquisition that would build on its growing healthcare services. Signify provides technology and analytics to support patient care at home.

“This acquisition will enhance our connection to consumers at home and enable providers to better meet patient needs as we execute on our vision to redefine the healthcare experience,” said Karen Lynch, President and CEO of CVS Health, in a press release.

The deal comes as competitors from Amazon to Walgreens continue to push into the healthcare sector. In July, Amazon announced it would acquire primary care provider One Medical for about $3.9 billion.

According to FactSet, shares of Signify Health are up nearly 45% over the past month to a market value of about $6.7 billion at $28.77 per share at the close. The Wall Street Journal reported Aug. 2 that Signify is evaluating strategic alternatives, including a sale.

Shares of Signify, which went public in February 2021, rose sharply in late August after reports that Amazon was among the bidders.

Last month, CVS announced plans to acquire or invest in a primary care business by the end of the year.

The Signify deal follows other acquisitions and moves into primary healthcare. CVS previously acquired insurer Aetna and Caremark, the pharmacy benefits manager, and customers can get vaccines or emergency supplies at MinuteClinic outposts in their stores. It has recently introduced mental health therapy in some stores.

The companies expect the acquisition, which is subject to regulatory approval, to close in the first half of next year.

Private equity firm New Mountain Capital owns about 60% of Signify’s common stock and has agreed to back the deal, the companies said.

CVS Health and Signify Health will host a conference call for analysts and investors Tuesday at 8:30 a.m. ET to discuss the transaction.

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Health

The Curious Gap in My Head

Ich raste mitten in der Nacht in einem New Yorker Krankenhaus in die Welt – eine überstürzte Geburt, wie die Ärzte es nannten.

In meinen ersten Lebensstunden, nach sechs Atemaussetzern, brachten mich die Ärzte eilig auf die Neugeborenen-Intensivstation. Ein Assistenzarzt steckte mir seinen kleinen Finger in den Mund, um den neugeborenen Saugreflex zu testen. Ich habe nicht fest genug gesaugt. Also rollten sie mein rosa, 7-Pfund-11-Unzen Körper in einen Gehirnscanner.

Und siehe da, da war ein riesiges Loch auf der linken Seite, direkt über meinem Ohr. Mir fehlte der linke Schläfenlappen, eine Region des Gehirns, die an einer Vielzahl von Verhaltensweisen beteiligt ist, von der Erinnerung bis zum Wiedererkennen Emotionen und gelten als besonders wichtig für die Sprache.

Meine Mutter, erschöpft von der Arbeit, erinnert sich, dass sie nach Sonnenaufgang aufgewacht ist zu einem Neurologen, Kinderarzt und einer Hebamme, die am Fußende ihres Bettes stehen. Sie erklärten mir, dass mein Gehirn in ihrer Gebärmutter geblutet hatte, ein Zustand, der als perinataler Schlaganfall bezeichnet wird.

Sie sagten ihr, ich würde nie sprechen und müsste in eine Institution gebracht werden. Die Neurologin hob ihre Arme an ihre Brust und verdrehte ihre Handgelenke, um die körperliche Behinderung zu veranschaulichen, die ich wahrscheinlich entwickeln würde.

In jenen frühen Tagen meines Lebens rangen meine Eltern die Hände und fragten sich, wie mein und ihr Leben aussehen würden. Begierig darauf, Antworten zu finden, schrieben sie mich in ein Forschungsprojekt an der New York University ein, das die Auswirkungen von perinatalen Schlaganfällen auf die Entwicklung verfolgte.

Aber Monat für Monat überraschte ich die Experten und traf alle typischen Meilensteine ​​von Kindern in meinem Alter. Ich schrieb mich an regulären Schulen ein, zeichnete mich im Sport und in der Wissenschaft aus. Die Sprachkenntnisse, die den Ärzten bei meiner Geburt am meisten am Herzen lagen – Sprechen, Lesen und Schreiben – entpuppten sich als meine beruflichen Leidenschaften.

Mein Fall ist sehr ungewöhnlich, aber nicht einzigartig. Das schätzen Wissenschaftler Tausende von Menschen leben wie ich ein normales Leben, obwohl große Teile unseres Gehirns fehlen. Unsere unzähligen Neuronennetzwerke haben es geschafft, sich im Laufe der Zeit neu zu verdrahten. Aber wie?

Meine Kindheitserinnerungen sind gefüllt mit Forschern, die mir mit Stiften und Klemmbrettern folgen. Mein Gehirn wurde mehrmals im Jahr gescannt und ich wurde mit verschiedenen Rätseln, Wortsuchen und Bilderkennungstests beauftragt. Am Ende jedes Testtages gaben mir die Forscher einen Aufkleber, den ich in einer Blechdose neben meinem Bett aufbewahrte.

Als ich etwa 9 Jahre alt war, wollten Forscher sehen, wie sich mein Gehirn verhält, wenn ich erschöpft bin. Manchmal blieb ich mit meiner Mutter die ganze Nacht wach, aß chinesisches Essen und sah mir Filme von Katharine Hepburn und Spencer Tracy an. Am nächsten Tag stolperte ich halbwach in die Klinik, und Wissenschaftler klebten mir Elektroden auf die Kopfhaut. Als lange Drähte wie Medusas Schlangen von meinem Kopf fielen, durfte ich endlich einschlafen, glücklicherweise nicht wissend, dass die Forscher nach Anomalien in meinen Gehirnwellen suchten.

Im Laufe der Jahre stellten die Wissenschaftler fest, dass ich nicht wie die anderen Kinder in der Studie war: Ich hatte keine Defizite, die ich im Laufe der Zeit verfolgen konnte. Als ich ungefähr 15 Jahre alt war, trafen mein Vater und ich uns im vollgestopften Manhattaner Büro von Dr. Ruth Nass, der pädiatrischen Neurologin, die die Forschung leitete. Sie fragte mich, ob ich tatsächlich einen perinatalen Schlaganfall gehabt hätte. Jedenfalls sagte sie offen, dass mein Gehirn so anders sei als das der anderen, dass ich nicht mehr im Arbeitszimmer sein könne.

Ich hatte nichts dagegen. Ich hatte andere Dinge in meinem Leben, wie den Beginn der High School, Cross-Country-Training und Schwärmereien. Aber ich hatte auch genug über Neurowissenschaften gelernt, um mich völlig in das Thema einzumischen. Als ich 17 war und in mein letztes Jahr an der High School kam, Ich schrieb Dr. Nass an und fragte, ob ich ein Praktikum in ihrem Labor machen könnte. Sie stimmte bereitwillig zu.

Eines Tages im Labor fragte ich sie, ob sie mir meine Studienunterlagen zeigen könne. Wir betraten einen Raum, der mit Stapeln von Plastikeimern gefüllt war, jeder randvoll mit Ordnern und losen Papieren. Sie schnappte sich eine Mappe und las sie leise. Dann blickte sie über ein Stück Papier und sagte: „Du warst die schlechteste Teilnehmerin, weil es dir vollkommen gut ging! Du hast alle meine Daten weggeworfen.“

Dr. Nass, die 2019 verstarb, und ihre Kollegen veröffentlichten viele Studien zu perinatalen Schlaganfällen. In einer Studie aus dem Jahr 2012 fanden sie beispielsweise heraus, dass Babys, die an diesen Schlaganfällen litten, im Vergleich zur allgemeinen pädiatrischen Bevölkerung ein höheres Risiko für Aufmerksamkeits- und Verhaltensprobleme hatten. Viele dieser Kinder, die von 1983 bis 2006 aus Südkalifornien und New York City rekrutiert wurden, litten an Krampfanfällen und Muskelschwäche auf einer Seite ihres Körpers. Die meisten hatten auch beschädigte oder fehlende Bereiche, bekannt als Läsionen, in ihrer linken Hemisphäre, wie ich. Ich nehme an, dass einer dieser Datenpunkte meiner war.

Ich ging aufs College und studierte Neurowissenschaften. Nach meinem Abschluss im Jahr 2015 habe ich zwei Jahre in einem Labor gearbeitet und Gehirnerschütterungen untersucht. Ich verbrachte Stunden im Magnetresonanzraum und beobachtete, wie die Gehirne anderer Leute vor mir auf einem Computerbildschirm erschienen.

Aber ich habe nie viel über mein eigenes Gehirn nachgedacht, bis ich in diesem Frühjahr im Wired-Magazin auf eine Geschichte über eine Frau gestoßen bin, die genau wie ich ist: erstaunlich normal, abgesehen von einem fehlenden Schläfenlappen.

Seit mehr als einem Jahrhundert gilt die linke Gehirnhälfte als Zentrum der Sprachproduktion und des Sprachverständnisses.

Diese Idee wurde erstmals 1836 von Dr. Marc Dax vorgeschlagen, einem Arzt, der beobachtete, dass Patienten mit Verletzungen der linken Gehirnhälfte nicht mehr richtig sprechen konnten. 25 Jahre später beobachtete Dr. Pierre Paul Broca einen jungen Mann, der die Fähigkeit zu sprechen verloren hatte und nur noch eine Silbe aussprechen konnte: „Tan“. Eine Gehirnbiopsie nach dem Tod des Patienten ergab eine große Läsion im vorderen Teil der linken Hemisphäre, die heute als Broca-Areal bekannt ist.

In den frühen 1870er Jahren sah Dr. Carl Wernicke, ein Neurologe, mehrere Patienten, die fließend sprechen konnten, aber ihre Äußerungen machten wenig Sinn. Eine dieser Patientinnen hatte einen Schlaganfall im hinteren linken Schläfenlappen, und Dr. Wernicke kam zu dem Schluss, dass dieser Bereich des Gehirns – jetzt Wernicke-Areal genannt – neben dem Broca-Areal als zweites Sprachzentrum dienen muss.

Aber andere Neurowissenschaftler haben argumentiert, dass die Sprachverarbeitung noch umfassender ist und nicht auf bestimmte Gehirnregionen beschränkt ist.

„Ich glaube, dass die Sprache im Gehirn über das gesamte Gehirn verteilt ist“, sagte Jeremy Skipper, der Leiter des Language, Action and Brain Lab am University College London (und mein ehemaliger College-Psychologieprofessor).

Studien haben gezeigt, dass geschriebene Wörter den Teil des Gehirns aktivieren können, der mit der Bedeutung des Wortes verbunden ist. Zum Beispiel aktiviert das Wort „Telefon“ einen Bereich, der mit dem Gehör zusammenhängt, „Kick“ löst eine Region aus, die an der Bewegung der Beine beteiligt ist, und „Knoblauch“ aktiviert einen Teil, der Gerüche verarbeitet.

Die Bereiche des Gehirns, die traditionell der Sprache zugeschrieben werden, haben viele andere Funktionen, sagte Dr. Skipper. „Es kommt nur darauf an, mit welchen anderen Teilen des Gehirns sie zu welcher Zeit und in welchem ​​Kontext sprechen.“

Der Wired-Artikel beschrieb eine anonyme Frau aus Connecticut, die keine Ahnung hatte, dass ihr ein linker Schläfenlappen fehlte, bis sie sich als Erwachsene einem unabhängigen Gehirnscan unterzog. In den letzten Jahren, heißt es in dem Artikel, war sie Teil eines Forschungsprojekts unter der Leitung von Evelina Fedorenko, einer kognitiven Neurowissenschaftlerin am Massachusetts Institute of Technology.

Im April schrieb ich Dr. Fedorenko eine E-Mail ihr von meinem fehlenden linken Schläfenlappen zu erzählen und ihr anzubieten, an ihrer Forschung teilzunehmen. Sie antwortete viereinhalb Stunden später, und bald buchte ich ein Flugticket von meinem Zuhause im ländlichen Colorado nach Boston.

Derzeit gibt es acht Teilnehmer, mich eingeschlossen, an Dr. Fedorenkos „Interessant Brain Project“, sagte sie mir. Ich habe sie nicht getroffen, aber vier von uns hatten vermutlich perinatale Schlaganfälle, die zu Schäden an unserer linken Hemisphäre führten. Zwei Teilnehmer haben gutartige Zysten in ihrer rechten oder linken Hemisphäre, einer hatte einen Schlaganfall in der rechten Hemisphäre und einem wurde wegen eines Tumors Hirngewebe aus der linken Hemisphäre entfernt.

„Das Gehirn hat eine unglaubliche Neuroplastizität“, sagte Hope Kean, eine Doktorandin in Dr. Fedorenkos Labor, die im Rahmen ihrer Dissertation die Interesting Brain-Studie durchführt.

Es scheint, dass sich Netzwerke im Gehirn auf eine bestimmte Weise anordnen, aber wenn Sie als Baby wichtige Gehirnregionen verlieren – wenn das Gehirn noch sehr plastisch ist – können diese Netzwerke umgeleitet werden, sagte Frau Kean.

Ich kam an einem heißen Julitag in Dr. Fedorenkos Labor in Cambridge an. Ich lag auf einem Bett, das in die enge Röhre des MRT-Geräts geschoben wurde, mit einem käfigähnlichen Gerät über meinem Kopf. Ms. Kean befestigte einen Spiegel an der Kopfbedeckung, damit ich einen Bildschirm auf der Rückseite des Scanners sehen konnte. Als die Maschine anfing, ihre hämmernden, dröhnenden Geräusche von sich zu geben, erinnerte ich mich an all die Male, als ich als Kind drinnen eingenickt war, eingelullt von ihren donnernden Akkorden.

Auf dem Bildschirm blitzten schnell Wörter auf, und eine Stimme las sie laut vor und bildete zufällige Sätze wie: „Auf Teenager-Pumps findet sich nur die geringste Andeutung eines Absatzes.“ Dann wechselten die Wörter zu einer willkürlichen Ansammlung von Buchstaben und erzeugten unverständliche Geräusche.

Nachdem der Scan abgeschlossen war, drängten sich die Forscher und ich um einen Computerbildschirm, wo ich zum ersten Mal eine Scheibe meines Gehirns sah. Ich starrte ungläubig, verblüfft, dass meine neuronalen Leitungen um dieses große, längliche Loch, wo mein Schläfenlappen hätte sein sollen, umgeleitet worden sein könnten, in den Raum hinter meiner linken Schläfe und Augenhöhle.

Im Gehirn einer typischen Person würden die Sätze, die ich im Scanner hörte und las, den linken Schläfen- und Frontallappen stark aktivieren, während die Unsinnsgeräusche dies nicht tun würden.

Die Studien der Forscher fanden heraus, dass sich das Gehirn der Patientin aus Connecticut durch Seitenwechsel angepasst hatte: Bei ihr aktivierten diese Sätze laut einer in der Zeitschrift Neuropsychologia veröffentlichten Fallstudie die rechten Schläfen- und Stirnlappen.

Mein Gehirn überraschte jedoch wieder einmal alle.

Eine vorläufige Analyse der Scans zeigte, dass ich auch ohne linken Schläfenlappen Sätze mit meiner linken Hemisphäre verarbeite.

„Ich hatte gedacht, dass jede große frühe Läsion der linken Hemisphäre zur Migration des Sprachsystems in die rechte Hemisphäre führt!“ sagte Dr. Fedorenko. „Aber so ist Wissenschaft cool. Überraschungen bedeuten oft coole Entdeckungen.“

Ein möglicher Grund für diese Entdeckung ist laut Dr. Fedorenko, dass sich meine Läsion hauptsächlich in der Vorderseite meiner linken Hemisphäre befindet und genug gesundes Gewebe auf der Rückseite übrig bleibt, damit das Sprachsystem Wurzeln schlagen kann.

In den nächsten Jahren werde ich für zusätzliche Scans und Tests ins Labor zurückfliegen, und Dr. Fedorenko hofft, noch mehr Menschen mit ungewöhnlichen Gehirnen für die Teilnahme an dieser Studie gewinnen zu können.

Ich denke immer noch an die Studie, in der ich als kleines Kind war, und an all die anderen Kinder, deren perinatale Schlaganfälle viele von ihnen schwer behindert hatten. Aus irgendeinem mysteriösen Grund hat sich mein Gehirn um seinen fehlenden Lappen herum entwickelt, während ihres damit zu kämpfen hatte. Warum wurde ich nicht mit den Entwicklungs- und kognitiven Problemen geboren, und sie waren es? Warum hat sich meine linke Seite neu verdrahtet, um mir die Silben, Wörter und Sätze zu geben, die mein Leben so bereichert haben?

Es sind diese Fragen, die mich dankbar machen, an dieser Studie beteiligt gewesen zu sein – und erneut Forschungsteilnehmerin zu sein.

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Covid-19 omicron pictures out there, however their effectiveness is unclear

The US this week approved the first major revision of Covid-19 vaccines in a bid to stem an expected spate of infections and hospitalizations this fall.

However, it is unclear how much protection the new booster shots will offer. The Food and Drug Administration and the Centers for Disease Control and Prevention have cleared the footage without data from clinical trials testing the newly formulated doses in humans.

The new boosters, approved for people 12 and older, target the highly contagious and immune-avoidable subvariant omicron BA.5, which sparked a surge in breakthrough infections over the summer. The shots also targeted the original strain of the virus, which first emerged in Wuhan, China, in 2019.

The country’s top health authorities acted urgently this summer to ensure the new boosters are rolled out in time for the fall. They are concerned that the declining effectiveness of legacy vaccines creates an opportunity for omicron to trigger another wave of hospitalizations this winter as people spend more time indoors, where the airborne virus spreads more easily.

According to CDC epidemiologist Heather Scobie, deaths and hospitalizations among the elderly, the most commonly vaccinated age group in America, have risen since April as Omicron continues to mutate into more transmissible subvariants that evade the protection of the original vaccines.

dr Peter Marks, who heads the FDA’s office that reviews vaccines, said the new boosters aim to restore the high level of protection vaccines showed in early 2021. However, Marks acknowledged that federal government experts just don’t know yet whether the boosters will meet the high bar that these doses set.

“We don’t yet know exactly if we’ll reach the same level, but that’s the goal here. And we think the evidence we’ve seen suggests that,” Marks told reporters during a news conference following the FDA approval Wednesday.

The FDA will be monitoring to see if the boosters are meeting that goal, Marks said. When Pfizer and Moderna’s syringes were approved in December 2020, they offered more than 90 percent protection in preventing Covid.

Marks told reporters it will likely be at least a few more months before human data on the BA.5 boosters is available to the public. But he said the FDA used essentially the same process to authorize the new boosters it’s relied on for years to switch virus strains in flu shots.

“We’re pretty confident that what we have is very similar to the situation that we’ve done in the past with influenza mutations where we’re not conducting clinical trials for them in the United States,” Marks said. “We know from how the vaccine works and from the data we have that we can predict how well the vaccine will work.”

The new boosters could prevent 2.4 million infections, 137,000 hospitalizations and 9,700 deaths if no new variant emerges, according to a forecast by a team of scientists predicting the course of the pandemic, called the Covid-19 Scenario Modeling Hub.

However, according to the scientists, this forecast is based on optimistic assumptions about the coverage and effectiveness of boosters. The model assumes that vaccines will prove 80% effective in preventing disease and the public will largely embrace the new boosters. There is no efficacy data on the new shots and it is unclear how strong the public demand for them will be.

The CDC estimates that an early fall immunization campaign with booster shots could save the United States between $63 billion and $109 billion in medical costs by preventing hospitalizations and ICU admissions.

Pfizer and Moderna originally developed new boosters to target the first version of Omicron, BA.1, which caused the massive wave of infections and hospitalizations last winter. But keeping up with the rapid evolution of the virus has proven to be a challenge.

By the time the country’s top health leaders began providing new boosters in earnest in April, more transmissible subvariants had already pushed omicron BA.1 out of circulation. In June, the FDA urged vaccine makers to shift gears and target Omicron BA.5 after it rose to dominance.

That decision didn’t leave Pfizer and Moderna enough time to complete human clinical trials of the new boosters before a fall launch of the vaccine.

As a result, the FDA and CDC rely on human data from the clinical trials of the BA.1 syringes to understand how the BA.5 boosters might work. They also relied on data from studies testing the BA.5 boosters in mice.

The CDC’s Independent Advisory Committee supported the shooting Thursday in an overwhelming vote.

However, some members of the panel also had concerns about the lack of human data.

“I’m really struggling with a vaccine that doesn’t have clinical data that’s reported for people, for those who would actually get the vaccine,” said Dr. Oliver Brooks, a committee member and chief medical officer at Watts HealthCare Corp. in Los Engel.

dr Pablo Sanchez, the only member of the CDC committee who voted against the injections, called the decision to recommend the new boosters without human data premature.

“There’s already a lot of hesitation with vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University.

dr Doran Fink, deputy chief of the FDA’s Division of Vaccine Review, told the hesitant committee members that the new booster shots use the exact same manufacturing process as the old vaccines and contain the same total amount of mRNA, the code that instructs human cells to produce the proteins that evoke an immune response to fight off Covid.

Fink said the BA.1 and the BA.5 recordings are similar enough to use data from the BA.1 human trials to get a good idea of ​​how the new BA.5 boosters work will work.

Pfizer and Moderna presented data at the CDC meeting showing that the BA.1 vaccines elicited a stronger immune response in humans than the old vaccines. The mouse studies by both companies on the BA.5 syringes also showed a stronger immune response.

CDC Director Dr. Rochelle Walensky said last week that a longer wait for human data from the BA.5 shots could mean the boosters are out of date by the time a new variant emerges.

“It’s always about too slow versus too fast,” Walensky told Conversations on Health Care in a radio interview. “One of the challenges is when we wait for that data to show up in human data… we’re going to be using what I think might be an outdated vaccine.”

Moderna completed recruitment for its clinical trials last week and expects results by the end of the year. Pfizer’s clinical trials are ongoing, although the company hasn’t given a timeline for when it will have data.

Brooks questioned why the FDA chose a BA.5 vaccine when clinical data is available for the BA.1 vaccines that vaccine manufacturers originally developed. Canada and the UK have approved new booster shots targeting omicron BA.1

Fink said the US approved BA.5 based on advice from the FDA’s independent committee, data from South Africa indicating that natural infection by the subvariant provides broader protection than infection by BA.1, and the fact that BA.5 is dominant.

Although committee members were somewhat reluctant to proceed without the human data, they agreed that the new boosters should have a similar safety profile to the old vaccines, as they use the same platform. The Covid vaccines have been given to millions of people in the US with mostly mild side effects.

According to the FDA, the most common side effects from the human trials of BA.1 syringes were pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever.

dr Sara Oliver, a CDC official, told the committee that the risk of myocarditis, an inflammation of the heart muscle, after a BA.5 booster is unknown. However, health authorities believe it will be similar to the risk seen with the old vaccines.

The Pfizer and Moderna vaccines have been associated with an increased risk of myocarditis in young men and adolescent boys, mainly after the second dose. However, according to the CDC, the risk of myocarditis is higher from Covid infection than from vaccination.

dr Grace Lee, the chair of the CDC committee, tried to reassure the public that there is a robust monitoring system to monitor safety and that the panel will meet again if new concerns arise.

“I just want to make sure members of the public know we’re continuing to monitor closely,” Lee said. “We have systems and teams that continue to monitor and meet.”

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California Biotech Govt Is Responsible in $77 Million Blood-Testing Scheme

A biotech executive in California was convicted Thursday of orchestrating a $77 million scheme of making false and fraudulent claims for Covid-19 and allergy testing, federal prosecutors said.

CEO, Mark Schena, 59, served as president of Arrayit Corporation, a biomedical company that claims to have invented technology to test for any disease by pricking just a drop of blood on your finger. According to Arrayit’s website, its “microarray” technology could test for ovarian cancer, Parkinson’s disease, colon cancer and male fertility, among others.

Mr. Schena was found guilty on a total of nine federal charges, including conspiracy to commit wire fraud and healthcare fraud and three counts of securities fraud. He faces up to 20 years in prison for conspiracy to commit healthcare fraud and conspiracy to commit wire fraud, and 20 years for each count of securities fraud.

Beginning in 2018, Mr. Schena paid kickbacks and bribes to recruiters and doctors to perform allergy testing for 120 different allergens, including hornet stings, shrimp, peanuts, dairy and Bermuda grass, regardless of medical necessity, federal prosecutors said.

The US Department of Justice said he then developed “a misleading marketing plan” that falsely promoted the test’s accuracy “when in reality it was not a diagnostic test.”

According to the department, Mr. Schena filed fraudulent claims with Medicare and private insurance companies for unnecessary allergy testing. The company billed Medicare more per patient for blood-based allergy testing than any other lab in the United States, the Justice Department said. Some commercial insurers have been billed more than $10,000 per test.

When Arrayit’s allergy testing business collapsed during the coronavirus pandemic, the company turned its attention to Covid-19 testing, claiming to have developed a blood-based test using its alleged technology.

Because Arrayit falsely claimed its Covid test was more accurate than a PCR test, the US Food and Drug Administration had told Mr Schena that Arrayit’s test was not accurate enough to receive an emergency use authorization. Mr. Schena kept this rejection secret from the investors.

Mr. Schena referred to investors as the “father of microarray technology” and falsely stated that he was shortlisted for the Nobel Prize, the Justice Department said.

A phone number listed for the company was disconnected. An attorney for Mr Schena, Todd A. Pickles, declined to comment Friday.

Arrayit compared itself at least once to Theranos, the failed blood testing startup, on its Facebook page, writing that its technology could use drops of blood “that are 250,000 times smaller than the volume of the Theranos nanotainer,” according to the First Complaint of the Department of Justice in 2020.

Elizabeth Holmes, the founder of Theranos, who once promised to revolutionize healthcare through a simple blood test, and Ramesh Balwani, a former top executive at the company, have been accused of exaggerating the capabilities of its blood-testing devices to appeal to investors and customers.

In January, Ms Holmes was convicted of four counts of fraud and in July Mr Balwani was found guilty of 12 counts of fraud.

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CDC clears reformulated Covid pictures concentrating on omicron in time for varsity

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The Centers for Disease Control and Prevention have released reformulated Covid shots targeting the latest Omicron subvariants for the fall, allowing many people to get an extra boost in days.

The agency’s independent committee on vaccines voted 13-1 in favor of the shots on Thursday after reviewing the available safety and efficacy data in a nearly seven-hour session. CDC Director Dr. Rochelle Walensky approved the injections a few hours later, clearing the way for pharmacies to administer the injections soon.

Pfizer’s Omicron boosters were approved for ages 12+, while Moderna’s updated shots were approved for ages 18+. The eligible age groups can receive the boosters no earlier than two months after the completion of their primary series or their last booster with the old vaccinations.

Walensky said her decision followed “a thorough scientific evaluation and sound scientific discussion.”

“If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to get it,” she said in a statement.

Pfizer plans to ask the Food and Drug Administration to also approve the new boosters for children ages 5 to 11 in early October, company executives told the committee Thursday.

The original vaccines are no longer used as a booster dose in people aged 12 and over as the reformulated vaccines are now online.

Public health officials expect another wave of Covid infections this fall as immunity to the legacy vaccines wanes, more contagious omicron subvariants spread and people spend more time indoors as the weather turns colder and families close gather for the holidays.

The CDC and FDA hope the new boosters will provide more durable protection against infection, mild illness, and serious illness. The reformulated shots target omicron BA.5, the dominant variant of Covid, as well as the strain that emerged in China more than two years ago.

The US has so far secured 171 million doses of the new boosters from Pfizer and Moderna. More than 200 million people are entitled to the recordings, according to the CDC. dr Sara Oliver, a CDC official, told the committee Thursday there should be enough vaccine supplies to meet demand this fall.

No omicron BA.5 human data

There is no human trial data on the new BA.5 boosters, so it is unclear how they will perform in the real world. The CDC and FDA used human clinical trial data for vaccinations against the original version of Omicron, BA.1, which elicited a stronger immune response than the old vaccines.

Pfizer and Moderna originally developed Omicron boosters for BA.1, but the FDA told the companies to change gears in June and develop BA.5 shots instead after the subvariant became dominant. The decision to focus on BA.5 did not leave enough time to wait for data from human trials before a vaccine launch in the fall.

The lack of human data for the BA.5 vaccines has caused some controversy, but Dr. Peter Marks, a senior FDA official, said the agency has followed the same process it has used for years to change strains for flu vaccines. Marks said Wednesday flu vaccine strains are being changed even without human clinical data.

dr Pablo Sanchez, the only committee member who voted against the injections, called the recommendation premature and said the US should have waited for human data before proceeding with the boosters.

“There’s already a lot of hesitation with vaccines — we need the human data,” said Sanchez, a professor of pediatrics at Ohio State University. But Sanchez said he believes the new boosters are safe and he will likely receive one himself.

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Board member Dr. Oliver Brooks, chief medical officer at Watts HealthCare Corporation in Los Angeles, questioned why the FDA chose a BA.5 vaccine when clinical data is available for the BA.1 vaccine that vaccine manufacturers are initially developing had. Brooks eventually voted for the shots.

But dr Sarah Long, also a committee member, said there was no reason to believe the BA.5 boosters will be inferior to the old vaccines as they also contain the original Covid strain and have the potential to increase hospitalizations and deaths along the way in the future to reduce autumn and winter. Long also voted in favour.

mouse studies

FDA and CDC officials have said that the omicron BA.1 and omicron BA.5 boosters are similar enough that the immune response data of the BA.1 vaccine should give a good indication of how the BA.5 vaccine will work. Omicron BA.1 and BA.5 are according to Dr. Jacqueline Miller, who works on vaccine development at Moderna, are closely related and share a difference of four mutations.

Moderna completed enrollment in clinical trials on the BA.5 shots last week and should have results by the end of the year, Miller told the CDC committee on Thursday. Pfizer’s clinical trial is also ongoing, although the company hasn’t said when it expects results.

Health authorities also reviewed data on the BA.5 shots from mouse studies. Moderna presented data showing that the BA.5 shots increased antibodies in mice more than four-fold compared to the old shots. The mice express the same cellular protein as humans, to which the virus attaches. Pfizer’s BA.5 booster increased antibodies in mice by 2.6-fold compared to the original vaccine.

security

According to the FDA, the most common side effects from the human trials of BA.1 injections were pain, redness, swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever.

Oliver, the CDC official, told the committee that health officials do not expect a difference in the safety profile of the BA.1 and BA.5 shots because the subvariants differ by only a few mutations.

However, Oliver noted that the risk of myocarditis following a BA.5 booster dose is unknown. Young men and adolescent boys are at increased risk of myocarditis after the second dose of Pfizer and Moderna, but the risk of myocarditis from Covid infection is higher, according to the CDC.

“We know that the risk of myocarditis is unknown, but expect a risk similar to that seen after the monovalent vaccines,” Oliver said. The monovalent vaccines are the old vaccines that have been given to millions of people in the US over the last two years.

Old vaccines are losing their effectiveness

The original vaccines, which were first approved in December 2020, no longer offer any meaningful protection against infection because the virus has mutated so much in the last two years. The shots were developed against the first strain to appear in China, so they are no longer tailored to attack the expanding Omicron subvariants.

Infections, hospitalizations and deaths have all fallen dramatically since last winter’s massive Omicron outbreak, but have leveled off at stubbornly high levels this summer. Omicron BA.5 is the most contagious and immune-avoidable variant to date, and breakthrough infections have become increasingly common as a result.

The effectiveness of the old vaccines against hospitalization also decreased after omicron BA.5 became dominant. A third dose was 77% effective at preventive hospitalization four months after receiving the shot, but protection dropped to as much as 34% at 120 days, according to CDC data. A fourth dose in people aged 50 and over was 56% effective in preventing hospitalization at four months.

Deaths and hospitalizations from Covid among people aged 65 and older have increased since April, according to Heather Scobie, a CDC epidemiologist who presented data during Thursday’s meeting. The number of deaths has increased, particularly among people aged 75 and over, Scobie said.

The CDC has shifted to a more focused public health response, with a focus on protecting the most vulnerable — the elderly, those with serious illnesses and those with weakened immune systems. Though there’s no data on the real-world effectiveness of the new boosters, the US is moving quickly to introduce them in hopes they’ll protect people this fall.

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A Child’s Blood Sodium Ranges Had been Dangerously Excessive. What Was the Trigger?

The couple sat in silence as they drove home from Blank Children’s Hospital in Des Moines. Her 5-month-old appeared to be dwarfed by the baby carrier strapped to the back seat. He was tiny. He hadn’t grown since he was 2 months old. He weighed just 10 pounds – barely three pounds more than when he was born.

The baby was breastfed from birth, but his mother immediately noticed that he struggled with it more than his three older brothers. She tried putting her breast milk in a bottle to see if that would be easier for her baby to handle. When that didn’t help, she tried adding baby food. He often spat; sometimes it seemed as if more was coming out than was going in. His pediatrician prescribed him an acid-reducing medication. It didn’t seem to do much either.

Despite his size, he looked healthy. He was active. He was able to achieve all of his milestones. He could hold his head up. He could turn around. His fontanelle, the soft spot on his head, was flat—as it should be. His pediatrician advised patience, but when the boy still hadn’t gained any weight at his 4-month visit, she sent blood samples to the lab.

In the late afternoon, the parents received a call with the results. The baby had worrisome abnormalities in his blood chemistry. The salt level in his blood was very high, so high that he could trigger a seizure. In fact, it was so high that he could die if not addressed. Parents rushed the little boy to Blank Children’s Hospital.

Samples taken in the hospital’s emergency room quickly confirmed the anomaly. The child’s sodium level was 159, more than 10 points above normal. The high number not only told his doctors that he had too much sodium, but also that he didn’t have enough water in his body, that he was very dehydrated.

Normally, when there is too much sodium in the body, the brain triggers the urge to drink in order to absorb more water. The brain also tells the kidneys to retain as much water as possible.

The brain communicates all of this with a hormone called vasopressin. Problems with vasopressin can cause a condition first described in the 1700s as diabetes insipidus (DI) — a disease that produces copious and watery (rotten) urine.

The combination of the child’s high sodium levels and watery, dilute urine immediately led doctors to suspect he had DI. His high sodium levels should have caused his brain to send a vasopressin message to his kidneys to hold on to as much water as possible. And yet his urine consisted almost entirely of water. Why? Wasn’t the pituitary gland in his brain able to make the hormone? Or was there a problem on the news-receiving side in his kidneys?

No matter where the problem started, there were medications that could help. Doctors give the baby two drugs that are normally used to control high blood pressure and that cause the kidneys to excrete sodium. Almost immediately, the baby’s sodium began to drop. This indicated that the baby had DI. If so, was the problem in the brain, where the hormone is made, or in the kidneys? How the problem was handled depended on where it originated.

An MRI was done to look for signs of a problem in the pituitary gland. It looked normal. The problem, his doctors thought, was probably in his kidneys. They sent samples to look for a genetic reason for his abnormality, but those results would not be available for weeks.

In the meantime, they continued to give the baby the medicines that helped him get rid of the salt. And slowly the levels dropped. After a few days on these drugs, the baby’s chemistry was perfectly normal. His parents were told he should start gaining weight now. But he did not do it. By the day the doctors decided the baby was well enough to go home, it still hadn’t gained an ounce.

Parents were instructed to feed the child every three hours 24/7 to help him get the maximum number of calories. They should contact their pediatrician and see a genetics specialist. Then they were sent home. They had a strong feeling that their baby was not ready to leave the hospital. He was brought in with a diagnosis of failure to thrive and he’s still not doing well. He was in the zero percentile on the growth chart. Zero. They brought this argument to the boy’s doctors. He will gain weight now that his chemistry is normal they were told. Just give him time.

The child’s parents felt that he did not have time, that his life was still in danger. So early the next morning, parents and baby were back in the car. They had talked their way through to an appointment with the genetics specialists at the University of Iowa Stead Family Children’s Hospital in Iowa City, two hours away. When they got there, the parents shared their concerns. Was the baby’s inability to gain weight because of his DI? Or was there something else going on?

The child had been tested for cystic fibrosis at Blank Hospital. The test was inconclusive. Dozens of other medical conditions can affect a baby’s growth. Parents and baby were sent to the lab to have blood drawn to check for other genetic abnormalities and to the cardiology department to make sure his heart was normal.

The geneticist also wanted the baby to be evaluated by a pediatric gastroenterologist. It was clear he was having trouble feeding and seemed to spit out much of what he was able to eat. The geneticist turned to Dr. Eyad Hanna, who saw the child later that day. It was only minutes before the gastroenterologist decided the child was too small to send home. Like the child’s parents, he feared that if the baby couldn’t gain weight in the hospital, he might not be able to make it at home either. The baby was taken into Hanna’s care and fed around the clock to try to help him get back on the growth curve. Hanna also turned to a pediatric kidney specialist, Dr. Pat Brophy, who recommended adding plain water to make up for the water the boy lost with his urine. Doctors usually advise mothers not to give their babies water because breast milk contains enough water. But this clearly wasn’t a normal baby. And because of the reflux and difficulty breastfeeding the baby, Brophy also recommended placing a tube in the baby’s stomach — a gastrostomy, or G-tube — to ensure it could get enough calories, medication, and much-needed extra water.

The baby continued to spit up copious amounts of the milk and water he was given. Usually, this type of spitting goes away as an infant’s esophagus lengthens and stomach enlarges. But this baby would not grow at all without more food. Hanna recommended adding baby food and dry food to the milk. He had her enlarge the hole in the bottle’s nipple so the thickened liquid could flow through easily.

And then they waited. Test results trickled in. He didn’t have cystic fibrosis. His heart was perfectly normal. But even as the negative results began to roll in, the baby’s parents could see that he was doing better just because he was getting the calories and most importantly, the water he needed. Every night he got the equivalent of an 8-ounce glass of water through his G-tube. Every day he was fed every three hours to get a total of 1,300 calories. And slowly he started gaining weight – 30-40 grams per day. He stayed in the hospital for almost two weeks, and by the time he and his parents were able to go home he had gained over a pound. He needed a few more months to get back on the growth curve. Only then did they get the results of the genetic test, which confirmed what they already knew: the baby had DI

This baby is now 7 years old. He’s learning to live with his DI. He continues to take the medications that help him get rid of his sodium. He often has to go to the toilet. And he has to drink lots and lots of water to replace whatever he loses in his urine. He’s not as big as his brothers – not yet and maybe never. But he’s still growing and thriving, and that’s more than enough for his parents.

Lisa Sanders, MD, is a contributing writer for the magazine. Her latest book is Diagnosis: Solving the Most Baffling Medical Mysteries. If you have a solved case you want to share, write to her at Lisa.Sandersmdnyt@gmail.com.

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Texas reviews what often is the first U.S. dying from monkeypox

Texas health officials said Tuesday that a patient diagnosed with monkeypox died in what may be the nation’s first-known fatality from the virus.

The patient was an adult with a severely compromised immune system who lived in the Houston area, health officials said. The case is under investigation to determine what role monkeypox played in the individual’s death, officials said.

“Monkeypox is a serious disease, particularly for those with weakened immune systems,” said Dr. John Hellerstedt, the Texas state health commissioner. “We continue to urge people to seek treatment if they have been exposed to monkeypox or have symptoms consistent with the disease.”

Monkeypox is generally not life threatening, but people with compromised immune systems are at higher risk of severe disease. Patients typically develop lesions that often look similar to pimples or blisters and cause excruciating pain.

Eight countries have reported a total of 15 deaths from monkeypox since the global outbreak began this year, according to the Centers for Disease Control and Prevention. Deaths were previously reported in Cuba, Brazil, Ecuador, Ghana, India, Nigeria, Spain and the Central African Republic.

The US is battling the largest monkeypox outbreak in the world right now. More than 18,000 cases have been reported across the country, with infections now confirmed in every state as well as Puerto Rico and Washington, DC, according to CDC data.

Across the world, nearly 49,000 cases of monkeypox have been reported in 99 countries, the data shows.

The virus is primarily spreading through sexual contact among gay and bisexual men, according to the CDC. About 94% of confirmed cases were associated with sex and nearly all of the patients are men who have sex with men, Demetre Daskalakis, deputy head of the White House monkeypox response team, told reporters Friday.

The outbreak in the US is disproportionately affecting Black and Hispanic men. About 30% of monkeypox patients are white, 32% are Hispanic and 33% are Black, according to CDC data. Whites make up about 59% of the US population while Hispanics and Blacks account for 19% and 13%, respectively.

CDC Director Dr. Rochelle Walensky on Friday said health officials are cautiously optimistic the spread of the virus may be slowing as new cases fall in major cities.

“We’re watching this with cautious optimism, and really hopeful that many of our harm-reduction messages and our vaccines are getting out there and working,” Walensky told reporters Friday.

The US is hoping to contain the outbreak by administering vaccines, expanding testing, distributing antiviral treatments, and educating gay and bisexual men about the virus.

The federal government has distributed 1.5 million doses of the monkeypox vaccine so far. More than 3 million doses should be available to states and local jurisdictions when the latest distribution round is complete, according to Dawn O’Connell, head of the office responsible for the national stockpile at the Health and Human Services Department.

The monkeypox vaccine, called Jynneos, is administered in two doses 28 days apart. It is the only vaccine approved by the Food and Drug Administration in the US for monkeypox. Jynneos is manufactured by Bavarian Nordic, a biotech company based in Denmark.

To increase the limited supply, the FDA has authorized a different method to administer the vaccine. The vaccine is now being given through intradermal injection for adults, or between the layers of the skin. This method uses a lower volume dosage which allows health-care providers to extract five doses from each vial.

There is no data on the real-world efficacy of the vaccine in the current outbreak, according to the CDC. But health officials have emphasized that it’s crucial for people to receive two doses in order to trigger the strongest response from the immune system. Protection against the virus is likely highest two weeks after the second dose, according to the CDC.

The World Health Organization and the CDC have said people at high risk can reduce their chances of exposure to monkeypox by limiting their sexual partners until the second week after they receive the second dose of the vaccine. People can also reduce their risk of exposure by avoiding sex parties until they are vaccinated, according to the CDC.

For people who have monkeypox or whose partners have the virus, the best way to avoid infection is by avoiding sex of any kind while sick, according to the CDC. It’s particularly important to avoid touching any rash and not to share objects or materials such as towels, sex toys, fetish gear or tooth brushes.

The CDC is also encouraging people to exchange contact information with any new sexual partners.

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Did My Cat Simply Hit On Me? An Journey in Pet Translation

My cat is a bona fide chatterbox. Momo will meow when she is hungry and when she is full, when she wants to be picked up and when she wants to be put down, when I leave the room or when I enter it, or sometimes for what appears to be no real reason at all

But because she is a cat, she is also uncooperative. So the moment I downloaded MeowTalk Cat Translator, a mobile app that promised to convert Momo’s meows into plain English, she clammed right up. For two days I tried, and failed, to solicit a sound.

On Day 3, out of desperation, I decided to pick her up while she was wolfing down her dinner, an interruption guaranteed to elicit a howl of protest. Right on cue, Momo wailed. The app processed the sound, then played an advertisement for Sara Lee, then rendered a translation: “I’m happy!”

I was dubious. But MeowTalk provided a more plausible translation about a week later, when I returned from a four-day trip. Upon seeing me, Momo meowed and then purred. “Nice to see you,” the app translated. Then: “Let me rest.” (The ads disappeared after I upgraded to a premium account.)

The urge to converse with animals is age-old, long predating the time when smartphones became our best friends. Scientists have taught sign language to great apes, chatted with gray parrots and even tried to teach English to bottlenose dolphins. Pets — with which we share our homes but not a common language — are particularly tempting targets. My TikTok feed brims with videos of Bunny, a sheepadoodle who has learned to press sound buttons that play prerecorded phrases like “outside,” “scritches” and “love you.”

MeowTalk is the product of a growing interest in enlisting additional intelligences — machine-learning algorithms — to decode animal communication. The idea is not as far fetched as it may seem. For example, machine-learning systems, which are able to extract patterns from large data sets, can distinguish between the squeaks that rodents make when they are happy and those that they emit when they are in distress.

Applying the same advances to our creature companions has obvious appeal.

“We’re trying to understand what cats are saying and give them a voice” Javier Sanchez, a founder of MeowTalk, said. “We want to use this to help people build better and stronger relationships with their cats,” he added.

To me, an animal lover in a three-species household — Momo the cranky cat begrudgingly shares space with Watson the overeager dog — the idea of ​​a pet translation app was tantalizing. But even MeowTalk’s creators acknowledge that there are still a few kinks to work out.

A meow contains multitudes. In the best of feline times — say, when a cat is being fed — meows tend to be short and high-pitched and have rising intonations, according to a recent study, which has not yet been published in a scientific journal. But in the worst of times (trapped in a cat carrier), cats generally make their distress known with long, low-pitched meows that have falling intonations.

“They tend to use different types of melody in their meows when they try to signal different things,” said Susanne Schötz, a phonetician at Lund University in Sweden who led the study as part of a research project called Meowsic.

And in a 2019 study, Stavros Ntalampiras, a computer scientist at the University of Milan, demonstrated that algorithms could automatically distinguish between the meows that cats made in three situations: when they were being brushed, while waiting for food or after being left alone in a strange environment.

MeowTalk, whose founders enlisted Dr. Ntalampiras appeared after the study, expands on this research, using algorithms to identify cat vocalizations made in a variety of contexts.

The app detects and analyzes cat utterances in real-time, assigning each one a broadly defined “intent,” such as happy, resting, hunting or “mating call.” It then displays a conversational, plain English “translation” of whatever intent it detects, such as Momo’s beleaguered “Let me rest.” (Oddly, none of these translations appear to include “I will chew off your leg if you do not feed me this instant.”)

MeowTalk uses the sounds it collects to refine its algorithms and improve its performance, the founders said, and pet owners can provide in-the-moment feedback if the app gets it wrong.

In 2021, MeowTalk researchers reported that the software could distinguish among nine intents with 90 percent accuracy overall. But the app was better at identifying some than others, not infrequently confusing “happy” and “pain,” according to the results.

And assessing the accuracy of a cat translation app is tricky, said Sergei Dreizin, a MeowTalk founder. “It’s assuming that you actually know what your cat wants,” he said.

I found that the app was, as advertised, especially good at detecting purring. (Then again, so am I.) But it’s much harder to determine what the calls mean in each category — if they carry a consistent meaning at all — without actually having a way of, you know, communicating with cats. (Cat-ch-22?)

After all, the precise purpose of purring, which cats do in a wide variety of situations, remains elusive. MeowTalk, however, interprets purrs as “resting.”

“But to be candid,” Mr. Sanchez said, “it can mean. …” He rephrased. “We don’t know what it means.”

At times I found MeowTalk’s grab-bag of conversational translations unsettling. In one moment, Momo sounded like a college acquaintance responding to a tossed-off text message: “Just chilling!” In another, she became a Victorian heroine: “My love, I’m here!” (This spurred my fiancé to begin addressing the cat as “my love,” which was also unsettling.) One afternoon I hoisted Momo off the floor and, when she mewed, glanced at my phone: “Hey baby, let’s go somewhere private! ”

“A lot of translations are kind of creatively presented to the user,” Dr. Ntalampiras said. “It’s not pure science at this stage.”

dr Schötz said that over the years she had seen several cat translation products, but that she had yet to find one that truly impressed her. “I’m looking forward to seeing something that really works, because that would be just brilliant,” she said.

In the meantime, Mr. Sanchez said he had also heard from users who had found an unexpected use for the app, which stores recordings of the meows it captures: listening to these recordings after their animal had died. It’s a “very magical experience,” he said.

Dogs could soon have their own day. Zoolingua, a start-up based in Arizona, is hoping to create an AI-powered dog translator that will analyze canine vocalizations and body language.

Dog owners have been overwhelmingly enthusiastic about the concept, said Con Slobodchikoff, the founder and chief executive of Zoolingua, who spent much of his academic career studying prairie dog communication. “Good communication between you and your dog means having a great relationship with your dog,” he said. “And a lot of people want a great relationship with their dog.”

(But not everyone, he added: “One small minority says, ‘I don’t think that I really want to know what my dog ​​is trying to communicate to me because maybe my dog ​​doesn’t like me.’”)

Still, even sophisticated algorithms may miss critical real-world context and cues, said Alexandra Horowitz, an expert on dog cognition at Barnard College. For instance, much of canine behavior is driven by scent. “How is that going to be translated, when we don’t know the extent of it ourselves?” dr Horowitz said in an email.

The desire to understand what animals are “saying,” however, does not seem likely to abate. The world can be a lonely place, especially so in the last few years. Finding new ways to connect with other creatures, other species, can be a much needed balm.

Personally, I would pay at least two figures for an app that could help me know whether my dog ​​truly needs to go outside or just wants to see if the neighbor has put bread out for the birds. (Maybe what I really need is a canine lie-detection app.) For now, I will simply have to use my own judgment and powers of observation.

After all, our pets are already communicating with us all the time, Dr. Horowitz noted. “It’s far more interesting to me to learn my own dog’s communications,” she said, “especially the idiosyncrasies that are formed between particular people and particular animals, than pretend that an app can — presto! — translate it all.”

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Disney World to require Covid-19 vaccinations for unionized staff

Guests wear masks. upon need. to attend Magic Kingdom’s Official Reopening Day at Walt Disney World in Lake Buena Vista, Florida on Saturday, July 11, 2020.

Joe Burbank | Orlando Sentinel | Getty Images

Disney has reached an agreement with its unions that all unionized employees at Walt Disney World in Florida will be fully vaccinated against Covid-19 by October 22, 2021.

The move comes almost a month after Disney mandated that all of its salaried and non-union workers in the U.S. be fully vaccinated against the coronavirus by the end of September.

No agreement has been reached with unions on the west coast that look after Disneyland Resort employees.

The Service Trades Council Union, which is made up of six member unions representing about 43,000 Disney performers in Florida, said the company will host on-site vaccine events for employees over the next few weeks.

“Vaccines are safe, effective and free,” the union said in a memo to members on Monday. “As of today, the Pfizer vaccine is FDA approved and offered by the company to get rid of this deadly virus.”

On Monday, the Food and Drug Administration fully approved the Covid-19 vaccine from Pfizer and BioNTech, making it the first in the US to receive the coveted award and giving even more companies, schools and universities more confidence in accepting vaccine mandates gave.

So far, the mRNA vaccine, now marketed as Comirnaty, has been on the US market under emergency approval granted by the FDA in December.

Workers with illnesses or “sincere” religious beliefs are entitled to an exemption, the union said.

Disney considers its employees fully vaccinated if they are at least two weeks after vaccination is complete, whether after the second dose of the Pfizer or Moderna vaccine or after a single vaccination of the Johnson & Johnson vaccine.

Disney has updated its safety guidelines in line with local health regulations since the pandemic began, both domestically and internationally. Most recently, the company required proof of a Covid vaccination or a negative Covid test before entering its Paris amusement park according to French guidelines.