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Saturday, July 30, 2022

Banana Boat spray sunscreen sold nationwide recalled due to presence of carcinogen benzene

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Three batches of Banana Boat’s Hair and Scalp sunscreen are being recalled after tests detected trace levels of the carcinogen benzene, Edgewell Personal Care Company said in a press release Friday. 

“While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can,” it said.

No injuries or deaths related to the products have been reported, Edgewell added.

Specifically, the recalled products are 6 ounce Banana Boat Hair and Scalp Sunscreen Spray SPF 30 with lot codes 20016AF (expiration date December 2022), 20084BF (expiration date February 2023), and 21139AF (expiration date April 2024).

banana-boat-recall.png
Three batches of Banana Boat sunscreen were recalled on July 29, 2022.

Edgewell Personal Care Company


The products were sold to retailers and online, the company said. All retailers have been notified, and customers who purchased the recalled products can get a full refund from Banana Boat. 

If you have the products listed above, you are encouraged to throw them out.

Visit the Banana Boat website or contact Edgewell Personal Care at 1-888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. EDT for more information.

Benzene is a human carcinogen, which means exposure to it can cause cancers including leukemia and blood cancer of the bone marrow, as well as blood disorders.



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Friday, July 29, 2022

COVID vaccines for Omicron expected as early as September

California aims to make its own insulin brand to lower price

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Gov. Gavin Newsom and state lawmakers still have many details to work out, including contracting with a private company to do most of the work. But the budget was a put-his-money-where-his-mouth-is moment for Newsom, who has been calling for the state to launch its own brand of generic drugs to lower the overall price of medication.

“Nothing epitomizes market failures more than the cost of insulin,” Newsom said in a video posted to his Twitter account. “California is now taking matters into our own hands.”

This wouldn’t be the first time California has made its own medicine. In 1990, about half of all cases of infant botulism — a rare illness that affects the large intestine — were in California. The California Department of Public Health got a federal grant to develop and test a treatment. The treatment won federal approval in 2003, and California has been making it ever since.

But the market for infant botulism treatments is small, with about 110 cases reported each year, according to the U.S. Centers for Disease Control and Prevention. One course of California’s botulism treatment costs more than $57,000, according to a legislative analysis.

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Meanwhile, about 7 million people in the United States require insulin to manage their diabetes. The human body converts most of the food we eat into sugar. The pancreas then produces insulin, which converts that sugar into energy. People who have diabetes don’t produce enough insulin. People with Type 1 diabetes must take insulin every day to survive.

Insulin was first discovered in 1920s by a team of Canadian scientists. They sold the patent to the University of Toronto for just $1, hoping the school would license the product to multiple companies to prevent a monopoly that would lead to high prices.

But over time, the insulin market was slowly cornered. Today, just three companies produce most of the world’s insulin. In the United States, the line between an insulin manufacturer and a patient is not straight. It zigs and zags between insurance companies and pharmacy benefit managers — third parties that managed prescription drug benefits for health plans.

It’s that system that has kept the cost of insulin much higher in the United States than other countries, as more companies benefit from the higher price tag, said Kasia Lipska, an associate professor at the Yale School of Medicine.

“It creates this really weird incentive,” Lipska said.

California will try to break that incentive. The reason more companies haven’t entered the insulin market is because if they did, the established manufacturers would just undercut them, making it impossible to recoup their investment, said Anthony Wright, executive director of Health Access California, a consumer advocacy group.

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But California is in a different position because aside from selling insulin, it also buys the product every year for the millions of people on its publicly funded health plans. That means if California’s product drives down the price of insulin across the market, the state would still benefit.

“That’s why California’s market power matters,” Wright said. “To a Wall Street investor, driving down the cost of insulin means you might not be able to get your investment back. To California, driving down the price of insulin is a real savings to both taxpayers as well as to our residents.”

Still, there’s no guarantee California’s plan will work. For one thing, insurers and pharmacy benefit managers might not cover California’s insulin products, making it more difficult for patients to get them.

Sarah Sutton, director of public affairs for the Pharmaceutical Research and Manufacturers of America, said a better idea would be for California to focus on “commonsense solutions” to address the role pharmacy benefit managers play in insulin pricing.

“That would bring real relief to patients right now,” she said.

Dr. Mark Ghaly, secretary of the California Health and Human Services Agency, said he hopes a state as large as California making its own insulin would significantly diminish the role of pharmacy benefit managers in insulin pricing.

If successful, Ghaly said he thinks the price of California-branded insulin would be so competitive that patients could buy it off the shelf cheaper than going through their insurance plan.

“We expect to save hundreds of millions of dollars for California because of this,” Ghaly said. “This gives us an opportunity to create a blueprint for healthcare affordability that has been so far out of reach for states and, frankly, the federal government, and it’s really exciting to see where it can go.”



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Allergan Reaches Tentative $2.37 Billion Deal to Settle Opioid Suits

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A bipartisan group of state attorneys general announced Friday morning that it had struck an agreement in principle with the pharmaceutical company Allergan for $2.37 billion to resolve more than 2,500 opioid-related lawsuits brought by states, local governments and tribes nationwide who have suffered during the ongoing opioid epidemic.

The company declined to comment, but a quarterly earnings report on Friday by Allergan’s parent company, AbbVie, characterized the amount as “a charge related to a potential settlement of litigation involving Allergan’s past sales of opioid products.”

The proposed settlement is a companion agreement to a $4.25 billion deal in principle announced earlier in the week from Teva Pharmaceuticals. If a significant majority of states and communities sign on, the combined deal, when finalized, could be worth $6.6 billion, lawyers familiar with the negotiations said. That is higher than a nationwide settlement struck with Johnson & Johnson or an offer from Purdue Pharma, opioid manufacturers with much higher public profiles.

The deals are linked largely because, in 2016, Teva bought Allergan’s generic drug portfolio, including its substantial opioid business. Teva made this week’s settlement contingent in part on Allergan’s reaching its own deal for opioid liability.

“We’ve worked hard to get the best result for Americans harmed by the opioid crisis, and it’s rewarding to take another step in the right direction,” said Tom Miller, the attorney general for Iowa, whose office led the bipartisan group in the negotiations with Allergan and Teva. “We continue to make it a priority to hold manufacturers responsible, while ensuring victims of this epidemic receive the help they need.”

Unlike Teva’s deal, under which plaintiffs can elect to receive a portion of the payout in medications used to reverse drug overdoses and treat addiction rather than in cash, Allergan’s offer is all cash with no product, lawyers familiar with the negotiations said. Teva’s payments to states and communities would be disbursed over 13 years, while Allergan’s would be over six years. The amounts for both pharmaceutical companies include the settlement figures that were already struck over the past year with a handful of states and counties.

Both Allergan and Teva sold branded as well as generic opioid painkillers. Lawyers for thousands of entities asserted that these manufacturers, like so many others, exaggerated the benefits of opioids to doctors and the public and played down the drugs’ addictive properties. In addition, although the companies are required to report suspicious orders to authorities, both failed to do so, lawyers said.

Teva had said that the potential agreement was not an admission of wrongdoing.

The deals still have a ways to go before money actually starts flowing to communities. Issues such as allocation of funds, tighter monitoring of suspicious orders and the creation of a public repository of internal documents have yet to be resolved.

Josh Stein, the North Carolina attorney general, commented on the arc of the opioid epidemic and the litigation to emerge from it. “In 2020, nine North Carolinians died each day from opioid overdose,” he said. “There is no amount of money that could ever repair that kind of loss. But there is hope in recovery, and, thanks to our ongoing work to hold these companies accountable, people across this state are getting the treatment and support they need to get healthy. And we’re still not done.”



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Wednesday, July 27, 2022

Gunmakers made $1 billion selling AR-15s to civilians, study finds

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Major U.S. gunmakers marketing a weapon used in a number of mass shootings have tallied more than $1 billion in revenue from selling the firearms to civilians during the past 10 years, according to a report released on Wednesday. 

Five manufacturers — Daniel Defense, Smith & Wesson, Sturm Ruger, Sig Sauer and Bushmaster Firearms — collectively sell thousands of military-style semiautomatic rifles to civilians every year, according to the findings of the House Committee on Oversight and Reform.

The marketing of AR-15s has come under scrutiny from lawmakers and gun safety advocates following several mass shootings that involved the firearm, including the Uvalde shooting that left 19 children and 2 teachers dead. The shootings have renewed calls for regulations that would either ban or restrict sales of AR-15s, with a recent complaint alleging the firearms are marketed to teens and young men “who are attracted to violence and military fantasies.”

Gunmakers who appeared at a Wednesday hearing held by the House Oversight Committee defended their products, blaming “evil” people for the deaths in recent shootings that involved the firearms. 

“I am deeply disturbed by these horrific acts committed by evil people,” said Marty Daniels, the CEO of Daniels Defense, whose firearm was used in the Uvalde shooting. He later added, “I believe that these murders are local problems that have to be solved locally.”

In a prepared statement, Daniels said that he was concerned the hearing was focusing on a “type of firearm that was used in fewer than 4% of the homicides that involved firearms in 2019.”

While gun manufacturers are profiting from the increasing popularity of AR-15 firearms, gunfire victims and their families are confronted with the equivalent in hospital bills. A separate report released last week by the U.S. Congress Joint Economic Committee found gun violence victims and their families pay more than $1 billion a year in medical costs. 

Surge in gun sales

The report said its findings are based on data provided by five gun manufacturers whose weapons have been used in mass shootings. Georgia-based Daniel Defense saw its revenue from AR-15-style rifles triple to more than $120 million last year from $40 million in 2019, the House committee found.

Ruger’s earnings from such weapons did almost as well, nearly tripling to $103 million in 2021 from $39 million two years earlier, the report noted. Smith & Wesson’s revenue from all long guns, including AR-15-style rifles, more than doubled to $253 million from $108 million in that same time, it said. 

AR-15-style semiautomatic rifles and similar firearms are sold on credit by companies that don’t track or monitor related deaths or injuries but market the weapons to young men as a way to show their masculinity, the panel said in summarizing its probe into the sale and marketing of assault weapons. 

“The business practices of these gun manufacturers are deeply disturbing, exploitative and reckless,” Rep. Carolyn Maloney, a Democrat from New York and chair of the committee, said in a statement. “These companies use aggressive marketing tactics to target young people — especially young men.”

Gun control advocates recently filed a complaint with the Federal Trade Commission calling for a probe of the marketing practices of Daniel Defense, saying the company targets young men like the Uvalde shooter through first-person shooter video games such as “Call of Duty” and via social media images with pop-culture elements that are attractive to teens and children.

—With reporting by Aimee Picchi.



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Tuesday, July 26, 2022

Mom’s monkeypox mix-up caused by bedbugs and concerned grandma, son says

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Midway medical emergency
A rescue official speaks to a flight attendant after a Delta Airlines flight was quarantined on the tarmac at Chicago’s Midway Airport April 26, 2012 for a medical emergency.

CBS/Kayla Maree Sanders via Twitter


(CBS/AP) Passengers aboard a Chicago-bound flight from Detroit were reportedly kept from disembarking for three hours because a female passenger was suspected to have monkeypox.

Yikes! Bedbugs!! 15 best bug-busting tips for travelers

CBS News reported the plane landed Thursday afternoon at Midway International Airport. The CDC says emergency medical personnel determined the woman’s rash was not related to monkeypox.

The CDC said in a statement monkeypox was suspected because the passenger had been in Africa and a family member was concerned that it had caused the rash.

“Based on the patient’s symptoms and photographs of the rash, it does not appear that the signs and symptoms are consistent with a monkeypox infection,” the CDC said in a statement. “The ill passenger was advised to seek medical care and the rest of the passengers were released from the plane.” The agency added there was little risk to other passengers.

Just what exactly is monkeypox?

According to the World Health Organization, monkeypox is a disease transmitted from infected monkeys to humans through direct contact with their blood, bodily fluids, or rashes. The potentially fatal disease is similar to smallpox, starting with a fever and pain, then progressing to an eruption of skin rashes on the face, palms and feet that turn into pus-filled blisters. Onset of symptoms can vary between six and 16 days, but symptoms can last up to three weeks. Fewer than 10 percent of people with monkeypox die, according to the WHO, and most fatalities occur in young children.

With the CDC calling the incident a false alarm, the passenger’s son came forward to say confusion about the rash stemmed from what his mom believes to be bedbugs.

Roger Sievers of Red Wing, Minn., told the Star Tribune that his mother, Lise, was adopting two special needs children from Uganda. He says while she was talking to her mother (his grandmother) by phone on during the layover in Detroit Thursday, Lise Sievers described a rash she suspected was caused by bedbugs.

Roger said his grandmother then called a hospital to ask what treatment her daughter might need for sores contracted in Africa. Health officials wearing facemasks went to meet the plane when it landed.

“Somewhere along the way things got confused,” Roger Sievers told the Star Tribune. “You call a hospital and you say that someone is coming in on an international flight and they have [pus-filled] bumps, then the CDC gets called right away,” he said.

Sievers told the paper he hopes the incident turns the spotlight to international adoption of children who don’t have access to sufficient medical care. He also still holds his grandmother in high regard.

“It was all misinformation from a speculative call that my grandmother made,” Roger Sievers. “She’s just a concerned old lady. As sweet as can be. And she makes a mean banana bread, I can tell you that right now.”

Click below for tips on how to reduce your risk of getting bedbugs:



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U.S. monkeypox cases are from at least two separate outbreaks, CDC says

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The U.S. is facing at least two separate outbreaks of monkeypox, federal health officials said Friday, based on samples of virus that have been genetically sequenced from some cases so far. 

A CDC official said the sequenced monkeypox cases — which now include patients in Massachusetts, Florida, Virginia and Utah — suggest the majority of cases spotted in the U.S. are linked to the variant that has been spreading in Europe. Those also appear similar to the virus spotted in an infected traveler to Maryland from Nigeria last year.

However, at least two of the U.S. cases do not appear to be closely linked to the virus spreading in Europe. Instead, they look similar to a virus sample from a traveler to Texas last year. 

“It’s not clear what all this means, but it’s likely that within the last couple of years, there have been at least two different instances where monkeypox virus spilled over to people in Nigeria, from the animal that maintains it,” Jennifer McQuiston, head of the CDC’s monkeypox response, told reporters at a briefing on Friday. 

“That virus likely began to spread through person-to-person close contact, possibly intimate or sexual contact,” McQuiston added. 

The CDC’s finding comes as both the domestic and global tally of monkeypox cases has climbed sharply over the past few weeks, amid a push from health authorities to find and test potential cases of the at-times painful rash and lesions.  

The majority of cases, but not all, have been in men who have sex with men with links to recent travel abroad. However, McQuiston said Friday that at least one U.S. case “does not have a travel link or know how they acquired their infection.” 

“It’s possible there could have been other cases in travelers that were missed, but I don’t think that monkeypox has been circulating widely within the United States,” she said.

A total of at least 23 cases have been tallied so far by health authorities across the U.S., including one case in a Florida resident who was tested in the United Kingdom. California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, New York, Pennsylvania, Utah, Virginia and Washington state have reported at least one case.

The CDC is also aware of more than 700 confirmed cases around the world. 

“I actually think the finding of these two cases with distinct lineages is actually a positive sign that our surveillance network that we’re working to increase, and make sure that people with a rash get tested, is working,” McQuiston added.

No deaths have been reported in the U.S. so far. Authorities say they believe the risk to the general public is low, since the virus is generally spread through intimate skin-to-skin contact. 

However, officials emphasized they did not want to minimize the monkeypox’s threat to those who might catch or spread the disease.

“The rash caused by monkeypox virus can spread widely across the body or present in sensitive areas like the genitalia. It can be really painful and some patients have reported needing prescription pain medicine to manage that pain. The sores can also cause long term scarring on the skin,” said McQuiston. 

The CDC recently issued warnings for travelers to take precautions to avoid catching monkeypox, including to wear a mask and avoid contact with things like wild game meat and contaminated clothing.

McQuiston said the CDC is also mulling launching a new health alert and other outreach to medical providers to raise awareness around the outbreak to help spot cases, including on the possibility that patients could be co-infected with monkeypox and other diseases.

Out of more than 400 close contacts of the U.S. cases so far, authorities have identified at least 56 who are considered high-risk contacts.

That figure is from a report also published Friday in the CDC’s Morbidity and Mortality Weekly Report, documenting the response to the first 17 U.S. cases of monkeypox. 

While the first case in the current outbreak tested positive for monkeypox on May 18, the report reveals that the earliest U.S. case spotted in Massachusetts developed their symptoms on May 4. They were later hospitalized on May 12, due to pain from their rash. 

Some at-risk providers who came into contact with the hospitalized person were later offered vaccine, in hopes of heading off potential infections.

“We want to ensure that people with high-risk exposures have rapid access to vaccines, and, if they become sick, can receive appropriate treatment,” Dr. Raj Panjabi, the White House’s senior director for global health security and biodefense, told reporters. 

Panjabi said that the Biden administration has deployed some 1,200 doses of vaccine and 100 treatment courses to at-risk contacts and patients in the outbreak. Most have been of the recently-approved Jynneos vaccine, produced by Bavarian Nordic, which several states say they have sought out from the federal government’s stockpile. 

Officials said U.S. stockpiles of Jynneos have climbed, but declined to offer a specific figure citing “national security.” 

“We continue to have more than enough vaccine available. We do have them pre-positioned in several sites around the country,” Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services, told reporters. 

O’Connell’s agency oversees the national stockpile of both Jynneos and the older ACAM2000 vaccines, which have also been requested by at least one state. 

O’Connell said authorities had been cautious about shipping too many doses of Jynneos out of Bavarian Nordic’s cold storage, which shortens the shelf life of the vaccines.

“We’re working closely with Bavarian Nordic to make sure that we’re pre-positioning the vaccine that we think we currently need,” said O’Connell. 



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U.S. spots first monkeypox case in a pregnant woman as cases climb

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The U.S. has spotted its first case of monkeypox this year in a pregnant woman, Centers for Disease Control and Prevention officials said over the weekend. The baby was delivered safely and both are “doing well.”

Pregnant women are among those the agency warns may be “at especially increased risk for severe outcomes” from monkeypox. 

“There has been a case of a pregnant woman who delivered,” the CDC’s Dr. John Brooks told a webinar hosted by the Infectious Disease Society of America on Saturday.

Brooks said the baby did not appear to have contracted the disease from their mom during the pregnancy, as has been reported during some previous outbreaks abroad. 

CDC officials said the newborn was given an infusion of immune globulin, an antibody treatment which the agency has permission from the Food and Drug Administration to deploy during monkeypox outbreaks. 

“That neonate received the IG prophylactically. And both mom and baby are doing well,” said the CDC’s Dr. Brett Petersen on the webinar. 

A CDC spokesperson did not return a request for comment on where the case in a pregnant mother was identified.

News of the infection comes as the CDC’s tally in the current outbreak has reached 3,487 nationwide across 45 states as well as the District of Columbia and Puerto Rico, as of Monday.

The sum of American monkeypox cases is on pace to eclipse that of Spain’s. The World Health Organization reported on Tuesday that Spain had the most cases of any nation, at 3,596 total.

It also comes just days after health authorities confirmed the first two U.S. cases of monkeypox in children. 

Both of those children – a toddler in California and infant from the U.K. who was traveling through Washington, D.C. – are reported to be faring well, despite being in the age group that has seen the worst mortality in previous monkeypox outbreaks abroad.

As the outbreak has grown, health authorities have warned that the virus risks increasingly infecting these higher risk groups. 

So far, monkeypox cases in the current global outbreak have been reported predominantly among men who have sex with men. Last week, the CDC said it was aware of just eight cases in women.

“I am concerned about sustained transmission because it would suggest that the virus is establishing itself and it could move into high-risk groups including children, the immunocompromised and pregnant women,” the World Health Organization’s Dr. Tedros Adhanom-Ghebreyesus said last month.

The CDC says data on exactly how often monkeypox leads to severe outcomes in pregnant people remains limited. Diagnosing monkeypox during pregnancy can also be challenging, the agency says in its guidance, before the disease’s characteristic rash appears. 

A 2017 study of four pregnant women with monkeypox in the Democratic Republic of the Congo saw two result in miscarriages and one fetal death. Smallpox, monkeypox’s more lethal cousin, had also been linked to potentially higher severity in pregnancy before it was eradicated.

The CDC currently urges that “pregnant, recently pregnant, and breastfeeding people should be prioritized for medical treatment if needed.” 

The antiviral drug tecovirimat, also known as TPOXX, can also be used to treat pregnant patients and appeared not to result in worrying side effects when deployed in animal studies. The Jynneos vaccine, which is being offered for people at risk in the U.S., was also studied in pregnant animals and did not raise any concerns.

However, both the drug and vaccine have not been specifically trialed in people during pregnancy.

“Because human data is lacking, healthcare providers should discuss the risk and benefits with the patient using shared decision making,” the CDC says.

The current outbreak has seen no deaths in the U.S. despite reports of at-times excruciating rashes and lesions that can last for weeks. 



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PTV Group launches PTV Model2Go to automize the building of transportation models

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  • Basic supply model for any city within a week
  • A revolution in urban and transportation modelling
  • Cloud-based process combines smart automation technology with data sources, e.g. from Here, TomTom, OpenStreetMap, GTFS
  • Model-based decision-making now viable even for small projects

Karlsruhe, 26 July 2022. PTV Group, the market leader for mobility software, launches a new technology to automize the building of standardized transport models for the first time. With PTV Model2Go, basic transportation models can be set up for any city or region worldwide within just a week. Users such as cities, consulting companies or research institutions receive a ready-made foundation on which they can directly implement simple and complex use cases.

Building a base model manually usually takes month and requires lots off knowhow and resources. With PTV Model2Go, users may no longer deal with time-consuming processes such as data collection, data integration, and the technical setup of the model. The new cloud-based process combines smart automation technology with various data sources, including networks from Here or TomTom as well as public General Transit Feed Specification (GTFS) data on public transport networks, and OpenStreetMap data. The automated process of model generation is not only faster and less cost- and resource-intensive, but also significantly less error-prone.

“Model-based analyses often don’t come into use because the model building process is expensive and time-consuming. Thus, Model2Go is a real game-changer in urban and transportation planning. It drastically reduces the time, effort, and cost of model-building, making model-based decisions viable even for small projects”, says Christian U. Haas, CEO of PTV Group. “This is particularly important today, where our mobility is changing very rapidly, and cities must quickly adapt to new challenges.”

PTV’s first release of Model2Go is PTV Model2Go Supply, which represents the network supply of different modes of transport. Besides the road network and associated parameters such as route types, speeds and capacities, the automated model also contains the public transport network, timetables, points of interest and structural data. Traffic zones can be generated as well.

The Model2Go Supply model is ready for immediate use after delivery for analysis and visualization for several basic use cases. Examples are accessibility analyses – for cars, bikes, or transit – infrastructure planning or operational planning in public transport. Users can also customize the fundaments of Model2Go with additional data and modelling for more complex use cases, such as transportation studies, potential analysis or in traffic development planning.

In addition to PTV Model2Go Supply, PTV Group is developing a second version of the product called PTV Model2Go Demand which includes observed travel data and will be coming soon.

Model collection: Model2Go around the world
For the product launch and to underline the diversity, PTV experts have built 6 ready-to-use Model2Go example models for the cities of Amsterdam, Atlanta, Berlin, Cape Town, Manila and Paris, for different areas of application. This collection can be extended easily with multiple use cases for any desired city in the world.

The Atlanta model, for example, can be used to assess the existing roadway infrastructure based on network free flow speeds, the number of lanes for all links, junction geometries, and estimates of signal timing. The Berlin model covers all information of the city’s public transport supply and enables users to evaluate network and timetable variants and operating concepts.

For more information or a live demo of the PTV Model2Go city collection please contact Stefanie Schmidt (stefanie.schmidt@ptvgroup.com) to arrange an appointment or visit: https://www.myptv.com/en/mobility-software/ptv-model2go

For further information please contact:
Internet: www.ptvgroup.com

Stefanie Schmidt, Lead PR & Communications
Phone: +49-721-9651-7451, stefanie.schmidt@ptvgroup.com

PTV Planung Transport Verkehr GmbH
Haid-und-Neu-Str. 15, 76131 Karlsruhe

To download image material and texts please go to https://company.ptvgroup.com/en/resources/newsroom

PTV. Empowering mobility.
PTV Group is a leading global software company for traffic planning, simulation, and real-time management as well as a provider of optimization solutions for logistics. With more than 40 years of experience in the fields of mobility and logistics, the Germany-based company provides software products based on proprietary algorithms ranging from microscopic and macroscopic modeling and simulation of traffic to real-time traffic management, benefiting more than 2,500 cities and municipalities. In addition, PTV is one of the leading companies providing software for the planning and optimization of logistics processes, especially in the field of route planning and tour optimization. Bridgepoint acquired a majority stake in the company in February 2022 in order to further accelerate its growth together with Porsche Automobil Holding SE, which continues to hold a minority stake in PTV.



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Sunday, July 24, 2022

‘Parentese’ is Truly a Lingua Franca, Global Study Finds

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We’ve all seen it, we’ve all cringed at it, we’ve all done it ourselves: talked to a baby like it was, you know, a baby.

“Ooo, hellooooo baby!” you say, your voice lilting like a rapturously accommodating Walmart employee. Baby is utterly baffled by your unintelligible warble and your shamelessly doofus grin, but “baby so cuuuuuute!”

Regardless of whether it helps to know it, researchers recently determined that this sing-songy baby talk — more technically known as “parentese” — seems to be nearly universal to humans around the world. In the most wide-ranging study of its kind, more than 40 scientists helped to gather and analyze 1,615 voice recordings from 410 parents on six continents, in 18 languages from diverse communities: rural and urban, isolated and cosmopolitan, internet savvy and off the grid, from hunter gatherers in Tanzania to urban dwellers in Beijing.

The results, published recently in the journal Nature Human Behavior, showed that in every one of these cultures, the way parents spoke and sang to their infants differed from the way they communicated with adults — and that those differences were profoundly similar from group to group.

“We tend to speak in this higher pitch, high variability, like, ‘Ohh, heeelloo, you’re a baaybee!’” said Courtney Hilton, a psychologist at Haskins Laboratories at Yale University and a principal author of the study. Cody Moser, a graduate student studying cognitive science at the University of California, Merced, and the other principal author, added: “When people tend to produce lullabies or tend to talk to their infants, they tend to do so in the same way.”

The findings suggest that baby talk and baby song serve a function independent of cultural and social forces. They lend a jumping off point for future baby research and, to some degree, tackle the lack of diverse representation in psychology. To make cross-cultural claims about human behavior requires studies from many different societies. Now, there is a big one.

“I’m probably the author with the most papers on this topic until now, and this is just blowing my stuff away,” said Greg Bryant, a cognitive scientist at the University of California, Los Angeles, who was not associated with the new research. “Everywhere you go in the world, where people are talking to babies, you hear these sounds.”

Sound is used throughout the animal kingdom to convey emotion and signal information, including incoming danger and sexual attraction. Such sounds display similarities between species: A human listener can distinguish between happy and sad noises made by animals, from chickadees and alligators to pigs and pandas. So it might not be surprising that human noises also carry a commonly recognizable emotional valence.

Scientists have long argued that the sounds humans make with their babies serve a number of important developmental and evolutionary functions. As Samuel Mehr, a psychologist and director of The Music Lab at Haskins Laboratories who conceived the new study, noted, solitary human babies are “really bad at their job of staying alive.” The strange things we do with our voices when staring at a newborn not only help us survive but teach language and communication.

For instance, parentese can help some infants remember words better, and it allows them to piece together sounds with mouth shapes, which gives sense to the chaos around them. Also, lullabies can soothe a crying infant, and a higher pitched voice can hold their attention better. “You can push air through your vocal tract, create these tones and rhythms, and it’s like giving the baby an analgesic,” Dr. Mehr said.

But in making these arguments, scientists, mostly in Western, developed countries, have largely assumed that parents across cultures modify their voices to talk to infants. “That was a risky assumption,” said Casey Lew-Williams, a psychologist and director of the Baby Lab at Princeton University who did not contribute to the new study. Dr. Lew-Williams noted that baby talk and song “seems to provide an on-ramp for language learning” but that “there are some cultures where adults don’t talk as often to kids — and where they talk a lot to them.” Theoretical consistency, while nice, he said, runs the risk of “washing over the richness and texture of cultures.”

An increasingly popular joke among academics holds that the study of psychology is actually the study of American college undergraduates. Because white, urban-residing researchers are overrepresented in psychology, the questions they ask and the people they include in their studies are often shaped by their culture.

“I think people don’t realize how much that bleeds into how we understand behavior,” said Dorsa Amir, an anthropologist at the University of California, Berkeley, who collected recordings from the Shuar in Ecuador for the new study. “But there are very different ways of being human.”

In a previous study, Dr. Mehr led a search for universal characteristics of music. Of the 315 different societies he looked at, music was present in every one. A vindicating finding and a rich data set, but one that raised more questions: How similar is the music in each culture? Do people in different cultures perceive the same music differently?

In the new study, the sounds of parentese were found to differ in 11 ways from adult talk and song around the world. Some of these differences might seem obvious. For instance, baby talk is higher pitched than adult talk, and baby song is smoother than adult song. But to test whether people have an innate awareness of these differences, the researchers created a game — Who’s Listening? — that was played online by more than 50,000 people speaking 199 languages from 187 countries. Participants were asked to determine whether a song or a passage of speech was being addressed to a baby or an adult.

The researchers found that listeners were able to tell with about 70 percent accuracy when the sounds were aimed at babies, even when they were totally unfamiliar with the language and culture of the person making them. “The style of the music was different, but the vibe of it, for lack of a scientific term, felt the same,” said Caitlyn Placek, an anthropologist at Ball State University who helped to collect recordings from the Jenu Kuruba, a tribe in India. “The essence is there.”

The new study’s acoustic analysis also listed out these worldwide characteristics of baby and adult communication in a way that brought on new questions and realizations.

For instance, people tend to try out many different vowel sounds and combinations when talking to babies, “exploring the vowel space,” as Mr. Moser put it. This happens to be quite similar to the way adults sing to each other around the world. Baby talk also closely matches the melody of song — “the ‘songification’ of speech, if you like,” Dr. Hilton said.

This could potentially point to a developmental source of music — maybe “listening to music is one of those things that humans are just wired up to do,” Dr. Mehr said.

But the jury is still out as to how these cross-cultural similarities fit into existing theories of development. “The field going forward will have to figure out which of the things in this laundry list are important for language-learning,” Dr. Lew-Williams said. “And that’s why this kind of work is so cool — it can spread.”

Dr. Mehr concurred. “Part of being a psychologist is to step back and look at just how weird and incredible we are,” he said.



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Friday, July 22, 2022

U.S. confirms first two cases of monkeypox in children

Like the Rest of Us, Biden Learns to Live With the Risks of the Virus

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WASHINGTON — One after another, President Biden hugged and kissed them.

At a packed ceremony in the East Room of the White House on July 7, Mr. Biden bestowed the Presidential Medal of Freedom, the nation’s highest civilian honor, on 16 Americans, some in their 80s or 90s. After reaching around to hang the medal on their necks, the president embraced most of them, shook hands with a few and gave three a smooch on the cheek.

It is highly unlikely that Mr. Biden — who tested positive for Covid-19 on Thursday — became infected with the coronavirus during that event. But the fact that the celebration happened at all underscores how much the White House has dropped most of the extraordinary measures it once employed to protect the commander in chief from a disease that has killed more than one million Americans.

In the early days, Mr. Biden was a president in a bubble, governing the country mostly by Zoom inside the Oval Office. He rarely traveled. He held few in-person meetings. And most of the ceremonial trappings of the office — like the medal ceremony — were canceled or postponed, victims of the lockdowns that were deemed necessary to stop the spread.

But like many other Americans, Mr. Biden has loosened up in recent months. Protected by multiple doses of the vaccine, the president and his aides have changed their risk assessments and have begun to live with the coronavirus.

“Whatever your thing is — whether it’s being the president of the United States, going to school, going to work, doing the things you enjoy, being with who we love — it can’t be put off forever,” said Andy Slavitt, who advised the White House on its Covid-19 response early in the Biden administration.

Mr. Slavitt said Covid-19 has become a disease that “comes around as frequently as a common cold but with much more severe consequences. It’s a much more uncomfortable middle state for people to adjust to.”

Inside the West Wing, there was never much doubt that Mr. Biden would eventually contract the disease. By this week, many of the people around him already had: Vice President Kamala Harris; Jen O’Malley Dillon, his deputy chief of staff; Karine Jean-Pierre, his press secretary; several cabinet members, including the attorney general; Doug Emhoff, the second gentleman; and Jen Psaki, his former press secretary — twice.

On Friday, Mr. Biden’s physician said his symptoms had improved. The president had a temperature of 99.4 degrees late Thursday evening, according to Dr. Kevin O’Connor, in a letter released on Friday. He wrote that Mr. Biden was still experiencing a runny nose and fatigue, and that he had an “occasional nonproductive, now ‘loose’ cough.”

“His voice is deeper this morning,” Dr. O’Connor wrote. “His pulse, blood pressure, respiratory rate, and oxygen saturation remain entirely normal, on room air.”

The deeper tone in Mr. Biden’s voice was noticeable on Friday, when he participated by video in a briefing on declining gas prices. Mr. Biden cleared his throat multiple times during his remarks and could be heard coughing.

Dr. Ashish K. Jha, the coordinator for the administration’s Covid-19 response, said that Mr. Biden’s temperature of 99.4 on Thursday was not considered a low-grade fever by the White House and that it fell “within the normal range.” He added, however, that he was unaware of Mr. Biden’s temperature recorded Friday morning. The White House referred to guidance from the Centers for Disease Control and Prevention that states a person is considered to have a fever “when he or she has a measured temperature of 100.4 degrees” or feels warm to touch.

But in his letter, Dr. O’Connor indicated that he did not feel that the president’s temperature of 99.4 was normal until after it responded to Mr. Biden taking Tylenol. Dr. Jha said later on Friday that it was routine for doctors to report the highest temperature of their patients, even if it was not a fever.

“He did mount a temperature yesterday evening to 99.4°F, which responded favorably to acetaminophen (Tylenol),” Dr. O’Connor wrote. “His temperature has remained normal since then.”

Dr. Jha said Dr. O’Connor did not prescribe the Tylenol for the temperature, but rather for Mr. Biden’s “discomfort.” Dr. Jha declined to say what discomfort the president was experiencing. Officials have said he does not have a sore throat or a headache, and have not indicated he has other aches and pains.

The White House went to great lengths this week to show that Mr. Biden’s work life had not been dramatically affected by his diagnosis.

The White House Twitter account posted three photos of the president working at a desk in the White House residence. In one, he can be seen talking on the phone. In another, he is signing a law designed to give people more access to baby formula.

Mr. Biden was elected in no small measure because he persuaded voters to trust that he could bring the pandemic under control and reopen the country.

In the last 18 months, Mr. Biden has achieved much of that goal. Because of the widespread availability of vaccines and treatments, most communities have reopened stores, bars, sporting venues and schools. There are few mask mandates still in place.

Mr. Biden now travels abroad (he shook hands with numerous world leaders during a trip last week to Israel and Saudi Arabia). He holds political events around the country, flying on Air Force One and riding in the motorcade. And in-person events at the White House are a weekly occurrence again.

But the pandemic is not over.

According to the C.D.C., most of the country is now classified as areas with high community transmission. The latest Omicron subvariant to become dominant, BA.5, is vastly more contagious than the original coronavirus, though doctors say the vaccines remain effective at preventing hospitalization and death.

So Mr. Biden has to walk a careful line, demonstrating that he is just like every other American eager to be done with Covid-19, even as he keeps his eye on the possibility that the pandemic could come roaring back.

The White House tried to do that on Friday by using the president’s diagnosis as a case study for why Americans should get vaccinated and boosted.

“We’re in a much, much better place than where we were 18 months ago, when the president took office,” Dr. Jha said, adding that the current level of about 400 Covid-19 deaths per day was “unacceptable.” He also added a grim warning.

“This virus,” he said, “is going to be with us forever.”



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Family Dollar recalls more than 400 products that were improperly stored

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Family Dollar is recalling more than 430 products, such as toothpaste, over-the-counter drugs and hemorrhoid ointment, that had been stored at the wrong temperature before being inadvertently shipped to stores across the U.S.

The recall covers a slew of items regulated by the Food and Drug Administration that were shipped to stores on or around May 1, 2022, through June 10, 2022, the discount retailer said Thursday in a notice posted by the FDA. The recall comes because the products were “stored outside of labeled temperature requirements,” the notice stated.

Earlier this year, products sold at Family Dollar stores in six states were recalled after more than 1,000 dead rodents were found at a distribution facility in West Memphis, Arkansas. Family Dollar closed more than 400 stores as a result, and the company is being sued by the state of Arkansas. 

The latest recall includes name brands including Alka Seltzer, Bayer, Benadryl, Claritin, Colgate, Crest, Dove, Old Spice Pepcid, and Tylenol. (See the full list here.)

Family Dollar stores that received the recalled products have been notified and told to stop selling them, the company said. 

People can return any of the recalled products to the Family Dollar store where they were purchased without a receipt. The recalled products were not shipped to Family Dollar stores in Delaware, and there are no Family Dollar stores in Alaska or Hawaii, the company said.

Customers with questions can contact Family Dollar customer service at (844) 636-7687 between 9 a.m. and 5 p.m. Eastern time.

Family Dollar’s parent company, Chesapeake, Virginia-based Dollar Tree, operates 16,100 Dollar Tree and Family Dollar stores retail discount stores as of April 30, Dollar Tree said in a regulatory filing in late May. 



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U.S. confirms first two cases of monkeypox in children

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Health officials have confirmed the first U.S. cases of monkeypox in children, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Thursday. 

Walensky disclosed the cases at a virtual event with The Washington Post on Friday, saying that both children “are doing well.” 

Children, especially those under 8 years old, are among those the Centers for Disease Control and Prevention warns are at “especially increased risk” for severe monkeypox disease. 

Last week, CDC officials told reporters that at that point, they were only aware of monkeypox cases in adults. Most cases so far have been among men who have sex with men. 

But the agency acknowledged that state and local health authorities had only relayed additional demographic information to them for less than half of all tallied cases.

“We have seen now two cases that have occurred in children. Both of those children are traced back to individuals who come from the men-who-have-sex-with-men community, the gay men’s community,” Walensky said.

She added that these cases have been generally “adjacent to the community most at risk.”

Dr. Patrick Hickey, a pediatrics professor at Uniformed Services University in Maryland, posted Wednesday on Twitter that he had heard from his colleagues of monkeypox cases “in 2 (unrelated) pregnant women and a toddler.” 

The CDC did not return a request for comment about the cases. 

A spokesperson for Maryland’s health department said the state was not sharing any demographic information about monkeypox cases there “at this time.” 

As of Thursday, the CDC had tallied a total of 2,593 cases of monkeypox in the U.S. across 44 states, as well as the District of Columbia and Puerto Rico. 

While the virus has led to many adult patients enduring pain and sometimes severe complications, many of the cases have so far resolved after several weeks without intensive treatment or hospitalization.

But health authorities warn that monkeypox may pose greater dangers to children.

In countries that have seen an endemic spread of monkeypox before 2022, the World Health Organization warns that young children have died at higher rates from the disease.

During the current outbreak, a handful of countries have also spotted cases of monkeypox in children under 18 years old. 

The CDC’s European counterpart tallied at least five cases on Wednesday. Authorities in Spain’s capital announced on Wednesday that they had detected a case in a 7-month-old baby who likely caught the virus from their parents. 

In the Netherlands, doctors reported they were unable to identify how a boy under 10 years old had caught the virus. No secondary cases were identified from the infection.

As is the case with adults, medicines like the antiviral tecovirimat or TPOXX are available for treating monkeypox cases in children and have been safely given to children in the past. However, the CDC says no clinical studies have specifically investigated use of the antiviral in children.

For vaccination, Food and Drug Administration has only formally approved the Jynneos monkeypox shots for use in adults. However, federal health officials have said the Biden administration has worked out arrangements to be able to offer doses for children in the current outbreak. 

In June, CDC officials said that they had offered doses of the Jynneos vaccine to at least one pediatric patient. This week, a hospital in New Jersey announced they had facilitated vaccination of a 3-year-old who had been exposed to a positive case. 

CDC scientists have estimated that monkeypox symptoms during the current outbreak take a little over a week on average to develop, following exposure to an infected person. 

During that incubation period, the CDC says taking the two-dose monkeypox vaccine can still reduce the severity of the disease or even prevent it from developing. 

“CDC recommends that the vaccine be given within 4 days from the date of exposure in order to prevent onset of the disease. If given between 4–14 days after the date of exposure, vaccination may reduce the symptoms of disease, but may not prevent the disease,” the agency says in its guidance.

A spokesperson for the Food and Drug Administration declined to confirm how many requests the agency has granted for use of the vaccine in children. 

Bavarian Nordic plans to collect data based on the CDC’s use of the vaccine, a company spokesperson confirmed.





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New York reports first U.S. polio case in nearly a decade

COVID continues to hit nursing homes harder, AARP data shows

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It’s difficult to make a direct comparison in rates between nursing homes and the general population because of differences in data collection. While health officials regularly track facilities’ COVID data, many Americans use home tests and do not necessarily report their results to their local health departments. 

Cases were also up 42 percent among staff, according to the AARP data. The majority of nursing home staff are women, disproportionately women of color, according to the nonpartisan Kaiser Family Foundation. 

While deaths at nursing homes are higher than they have been in previous months, they are not as high as they were early in the pandemic, which Hauser attributes to high vaccination rates in nursing homes: On average across the country, 88 percent of residents and 89 percent of nursing home staff have received their primary series of COVID-19 vaccines.  

“I don’t envision another month where we have upwards of 20,000 people dying [like early in the pandemic],” he said. 

However, low and slow-to-rise rates of booster vaccinations, particularly among staff, are a concern. According to AARP, only 51 percent of nursing home staff have received a booster as of June. Seventy-two percent of nursing home residents have received a first booster nationwide. 

There is not yet enough data to track second boosters among residents and staff, though Hauser anticipates having second booster numbers in the coming months. 

“Just about everyone [living] in a nursing home is eligible for a second booster and so are a lot of the staff,” Hauser said. 

Booster rates for both residents and staff vary widely depending on the state. In Florida, only 59 percent of nursing home residents have received boosters. In New York, 77 percent of residents have received a first booster — above the U.S. average of 71.6 percent.  

Most nursing homes nationwide do not require boosters and there is currently no national mandate

According to the CDC, the vaccine provides excellent protection against severe disease and death. However, it has been less effective in protecting against mild and moderate disease from newer variants of the virus. It is still unclear if vaccination reduces risk of post-COVID complications.

Download Modern Healthcare’s app to stay informed when industry news breaks.

Donna Gregory, 53, works for a nursing home in Cheektowaga, New York, a suburb of Buffalo. She remembers the horror of the early pandemic: “It was horrible. We lost so many residents,” she said. 

Staff from local funeral homes refused to enter out of fear, so Gregory and other nursing home staff were responsible for putting residents into body bags — when they were even available. 

“We had to be the undertakers. We had to put [disinfecting] spray in their mouths. [If there were no body bags] we’d cover their faces with a pillowcase or a towel. Then we’d put them on the gurney and take them to the door,” Gregory recalled. 

While cases are currently up in Gregory’s nursing home, the situation is not as dire as it was then. “There’s no comparison,” she said. 

Gregory is fully vaccinated and boosted — her nursing home requires it of staff. She contracted COVID-19 for the first time this January during the first omicron wave. 

Gregory described her initial COVID infection as relatively mild and flu-like. However, she has since been hospitalized twice for heart problems, including one night in the intensive care unit.

“I’ve seen a cardiologist and the only thing they can tell me was that it may be due to the virus,” Gregory said. People who have had COVID-19 appear to be at higher risk of developing heart problems, but the reasons are not yet well understood. 

One thing that is different about the current wave, according to Hauser: It’s everywhere. 

“When numbers are low in one area of the country, it really just means that the impacts happened last month, or they’re going to happen next month,” he said. 

Hauser also encouraged caution when it comes to praising any particular state’s handling of the pandemic. 

“There’s a desire, if a particular state is doing well at this point in time, to attribute low cases in that state to something that state has done,” he said. “I don’t think it has anything to do with that…The reality is that it’s everywhere. There’s no state that’s being spared from the virus.”

This story originally published by The 19th.



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Thursday, July 21, 2022

Deep in a Covid Wave, Europe Counts Cases and Carries On

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ROME — Customers in the Rome bookstore paid no attention to the circular stickers on the floor instructing them to stamp out Covid by maintaining “a distance of at least 1 meter.”

“These are things from the past,” said Silvia Giuliano, 45, who wore no mask as she browsed paperbacks. She described the red signs, with their crossed-out spiky coronavirus spheres, as artifacts “like bricks of the Berlin Wall.”

All across Europe, faded stickers, signs and billboards stand as ghostly remnants of past struggles against Covid. But while the vestiges of the pandemic’s deadliest days are everywhere, so is the virus.

A common refrain heard throughout Europe is that everyone has Covid, as the BA.5 Omicron subvariant fuels an explosion of cases across the continent. Governments, however, are not cracking down, including in the previously strictest nations, in large part because they are not seeing a significant uptick in severe cases, nor crowded intensive care units, nor waves of death. And Europeans have clearly concluded they have to live with the virus.

Seats bearing faded blue social-distancing signs urging Paris Metro riders to keep this spot free are almost always taken. Droves of unmasked Germans pass by tattered signs in stores and restaurants reading “Maskenpflicht” or mask requirement. In a construction-materials store north of Madrid, the cashier walks the aisles without a mask before sitting behind a window of Plexiglas. On a recent day in Caffè Sicilia in Noto, Sicily, the feet of three different people stood in a single “Keep Safe Distance” circle as they clamored over cannoli.

And many people are traveling again, both within Europe and from outside its borders, bringing much-needed tourist money to nations desperate to bolster their economies.

“This is the way it is,” said Andrea Crisanti, a professor of microbiology who served as a top consultant to Italian leaders during the coronavirus emergency. One silver lining, he said, was that summer infections would create more immunity for the traditionally more difficult winter months. But letting the virus circulate at such enormous levels, he said, also created a “moral duty” on the part of governments to protect the elderly and otherwise vulnerable who remained at risk of serious disease despite vaccination.

“We need to change our paradigm. I don’t think the measures aimed at reducing transmission have any future,” he said, listing reasons including social exhaustion with restrictions, greater acceptance of risk, and the biology of a virus had become so infectious that “there is nothing that can stop it.”

That seems the case everywhere in Europe, where officials take solace in the apparently low incidence of serious disease and death, even as some experts worry about the toll on the vulnerable, the possibility that routine infection could lead to long Covid and the increased potential for mutations leading to more dangerous versions of the virus.

The “element of randomness” that generated the new mutations was “concerning,” said Christophe Fraser, an epidemiologist at the University of Oxford. Across Britain, Covid cases have tripled or more since late May, according to a survey run by the country’s Office of National Statistics.

“Infections are showing no signs of decreasing, with rates approaching levels last seen in March this year at the peak of the Omicron BA.2 wave,” said Sarah Crofts, who heads the analytical team for the statistics office. Hospitalizations have more than quadrupled since May, according to government data. But deaths caused by the virus, while on the rise, were not approaching the levels recorded at the start of the year.

“Overall, from a public health perspective, we need to remain vigilant, but this isn’t a cause to reverse course,” said Neil Ferguson, an epidemiologist at Imperial College London.

Some shifts have taken place. In April, Europe’s drug regulator, the European Medicines Agency, gave advice that second booster shots would only be needed for those over 80, at least until there was “a resurgence of infections.” On July 11, it decided that moment had arrived, recommending second booster shots for everyone over 60 and all vulnerable people.

“This is how we protect ourselves, our loved ones and our vulnerable populations,” the European commissioner for health and food safety, Stella Kyriakides, said in a statement, adding: “There is no time to lose.”

Across Europe, the authorities are trying to strike a balance between reassurance and complacency. In Germany, the Robert Koch Institute, the federal organization responsible for tracking the virus, has said “there is no evidence” that the BA.5 iteration of the virus is more lethal, but the country’s health minister, Karl Lauterbach, has shared tweets posted by a hospital doctor in the German city of Darmstadt, saying that his clinic’s Covid ward was fully occupied with severely symptomatic patients.

Germany’s vaccine board has yet to update its advice on a fourth shot, and for now recommends a second booster only for those over 70 and at-risk patients.

In France, where an average of 83,000 cases a day have been reported in the last week, about a third more than a month ago, the health minister, François Braun, has steered away from new restrictions. He told RTL radio last week that “we have decided to bet on the responsibility of the French,” as he recommended wearing masks in crowded places and encouraged a second vaccine booster dose for the most vulnerable people.

He has seemed confident that France, where nearly 80 percent of people are fully vaccinated, and its hospitals, could weather the new wave of infections and has focused more on collecting data to track the virus. “Minimal but necessary measures” were the right approach, Mr. Braun recently told the law commission of France’s Parliament. Last week, a proposal to give the government continued powers to require proof of vaccination or of a negative coronavirus test when entering France failed to pass the Parliament.

In Spain, where the vaccination rate is above 85 percent and more than half the eligible population have received a booster, the pandemic has felt like an afterthought as Spaniards reverted to their usual beach holidays and eagerly welcomed tourists. Officials, encouraged by the low occupancy of intensive care wards, said monitoring the situation would suffice.

Not everyone was satisfied.

“We’ve forgotten practically everything,” said Rafael Vilasanjuan, director of Policy and Global Development at the Barcelona Institute for Global Health, a research body.

But other parts of Europe were even more hands-off. In the Czech Republic, where there are no restrictions at all, including in hospitals, the virus is running rampant and officials openly predict an increasing spike in cases.

“The current wave copies trends in other European countries that are a few weeks ahead of us and they have not seen any major impact on their health system,” said a deputy health minister, Josef Pavlovic.

Bars and restaurants and movie theaters were full in Denmark, where cases are up 11 percent in the last two weeks, including hundreds of people at a music festival this month. “The figures are positive — no more people are getting seriously ill from the new variant,” Soren Brostrom, the director general of the Danish Health Authority, said in a statement.

The Danish Health Authority expects a spread of infections in the fall and plans to offer booster shots then.

In Italy, the first Western country to face the full force of the virus, reports of new cases have climbed steadily since mid-June, although they fell in the past week. The average daily number of deaths more than doubled over the past month, but hospitals have not been overwhelmed. The health minister, Roberto Speranza, announced that the country would follow the European regulator’s recommendation to offer a second Covid-19 booster shot to everyone over 60 — not only those over 80 and vulnerable patients.

“In the present situation you need to implement an integrated policy to protect the vulnerable people who, in spite of the vaccination, still are a risk of developing severe, severe disease,” said Mr. Crisanti, the former consultant to Italian leaders on the virus, who lamented what he said was a still enormous number of deaths every day from an infectious disease.

He predicted that over time, as vulnerable older people died, deaths caused by the virus would fall and the virus would become increasingly endemic. He said the immune systems of people who age into the 70- to 90-year-old age bracket in the future would have memories of, and protection against, the virus.

At that point, the tattered signs of Europe’s struggle with Covid would truly belong to another era. In the meantime, though, another woman in the Roman bookstore, this one in an N95 mask, worried that the stickers under her feet would become relevant again.

“Reality,” she said, “goes faster than laws.”

Reporting was contributed by Constant Méheut from Paris, Gaia Pianigiani from Siena, Italy; Erika Solomon from Berlin; Cora Engelbrecht from London; Francheska Melendez from Madrid, Hana de Goeij from Prague and Jasmina Nielsen in Denmark.



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What is Paxlovid? What to know about Pfizer’s COVID drug that President Biden is taking

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Health officials are renewing their pleas to eligible Americans to get prescriptions to Paxlovid, Pfizer’s COVID pills, to curb their risk of hospitalization and death from the disease, as COVID-19 cases and hospitalizations rise. President Biden announced Thursday that he has contracted COVID and that he is taking Paxlovid to treat its symptoms 

Figures published by the Biden administration this week count more than 2.7 million twice daily, five day courses of Paxlovid, or “ritonavir-boosted nirmatrelvir,” that have been taken by patients through July 17. The drugs themselves are purchased and distributed for free by the federal government.

Use of Paxlovid far outstrips that of  other available COVID-19 treatments authorized by the Food and Drug Administration, like Merck’s Lagevrio antiviral pills or the monoclonal antibody drug bebetelovimab from Eli Lilly. 

Here’s the latest about what we know about the pills: 

Who’s eligible to take Paxlovid pills?

In December, the FDA authorized use of Paxlovid to treat COVID-19 in adults, as well as children who weigh at least 40 kilograms, or around 88 pounds.

The agency’s checklist for prescribing Paxlovid also requires that patients: 

  • Test positive for the virus, including by either by a lab swab or at-home rapid test
  • Have at least one risk factor” for severe COVID-19, like being older than 65 years old or underlying conditions like asthma
  • Show COVID-19 symptoms, that started less within five days ago, which aren’t so severe to require hospitalization 

There are some additional reasons that can disqualify people from being able to take Paxlovid, like having severe kidney failure (also known as “renal impairment”).

Several commonly used drugs, like the cholesterol drug rosuvastatin or the seasonal allergy spray fluticasone, also risk potentially dangerous interactions with ritonavir, a key component of Paxlovid. 

Each dose of Paxlovid is made up of three total tablets that patients must swallow: two of nirmatrelvir and one of ritonavir, which is needed to boost its effectiveness. 

In these cases, doctors can help their patients figure out whether to cut back or pause the use of their other medications while taking Paxlovid. 

“Potential drug interactions are an important consideration. However, several commonly used medications with potential interactions such as statins, oral contraceptives, and HIV medications can be easily managed under provider supervision,” the FDA’s top drug official, Dr. John Farley, recently said on a podcast posted by the agency.

Where can I get a prescription for Paxlovid

Pfizer’s pills have been distributed around the country to thousands of pharmacies and health systems around the country. 

To get a prescription for the drug, health officials have been advising Americans to turn first to their primary care or family physician. 

However, health authorities have also deployed other ways to try to make it easier to obtain the pills. 

For example, the Biden administration has been touting “test to treat” sites where Americans can get tested for the virus, get a prescription from a healthcare provider, and then fill their prescription all at one location. 

These include places like health centers or health clinics based at the same location as a drug store.

Last month, the FDA also said it would allow pharmacists to prescribe and dole out Pfizer’s Paxlovid pills on the spot under some limitations

However, many pharmacies say it will take a while for them to sort out policies and reimbursement with insurers before rolling out the process. The Centers for Medicare and Medicaid Services also says that Medicare cannot cover the cost of pharmacists prescribing the drug, under law.

“Pharmacist prescribing of Paxlovid will take time to implement and operationalize,” the National Association of Chain Drug Stores wrote in a letter to the Biden administration last week.

How effective is Paxlovid and what do we know about rebound infection?

The FDA’s initial authorization of Paxlovid was based on a trial run by Pfizer in at-risk unvaccinated adults. Its results showed that patients’ risk of severe COVID-19 was 89% lower, compared to a placebo. 

Lab data published this week in The New England Journal of Medicine also suggest that Paxlovid works against the BA.5 subvariant now dominant in the U.S.

However, the company has also disclosed that other trials it has since run among “standard-risk” patients – which included people with at least one risk factor who were also vaccinated – fell short of their goals, though they showed some improvement. 

Other studies have also turned up more modest improvements in real-world use of Paxlovid. 

In a study through February that has yet to be peer-reviewed, doctors at Massachusetts General Brigham found that the drug appeared to lower the risk of Omicron hospitalization by 45% among patients who were prescribed Paxlovid. A healthcare system in Israel turned up a similar 46% risk reduction.

That has led to concerns among some doctors that doctors may be overprescribing Pfizer’s pills, which could raise the risk that  the virus may eventually develop resistance to the drug. 

These concerns have been compounded by reports of so-called “rebound” cases, where patients appear to fully recover after completing Pfizer’s pills only to see symptoms later return for a few more days. 

“After I finished the five days of Paxlovid, I reverted to negative on an antigen test for three days in a row. And then on the fourth day, just to be absolutely certain, I tested myself again. I reverted back to positive,” Dr. Anthony Fauci, the president’s chief medical adviser, told Foreign Policy last month.

Nonetheless, Fauci said he ended up taking a second course of Paxlovid to battle his rebound symptoms.

Scientists are already trying to study how often and why these rebound cases occur. 

A review of Pfizer’s original trial data published by the FDA found that a rebound in virus shed by patients, under the broadest definition, may have happened in as many as 8.1% of trial participants who took Paxlovid compared to 5.4% of those who got a placebo. 

The agency also asked Pfizer to study how these “viral RNA rebounds” are translating into an actual return of symptoms, though it acknowledged that accurately investigating this “likely will be challenging due to a lack of objective, standardized measures for identifying and quantifying mild COVID-19 symptoms.” 



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