Posts tagged with "COVID-19"

FDA moves closer to clearing Moderna and J&J COVID booster shots this week

October 12, 2021

Millions of Americans will be one step closer to receiving a COVID-19 booster shot this week when a key Food and Drug Administration advisory panel meets Thursday and Friday, October  14 and 15, to debate extra doses of the Moderna and Johnson & Johnson vaccines, reports CNBC.

The FDA’s Vaccines and Related Biological Products Advisory Committee meetings come less than a month after U.S. regulators authorized COVID booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditions; and those who work or live in high-risk settings, like health and grocery workers.

More than 7 million Americans have received a booster dose in the United States as of Saturday, October 9, according to the latest data available from the Centers for Disease Control (CDC).

Members on independent committees by the FDA and CDC and Prevention said at the time they were frustrated that only Pfizer recipients would be eligible to get the extra shots, leaving out millions of Americans who got Moderna or J&J’s shots.

The FDA advisory group is scheduled Thursday to discuss data on the safety and effectiveness of a Moderna booster shot in adults. On Friday, the committee is expected to debate J&J booster shots for adults. The FDA could make a final decision within days of the meetings, handing it off to the CDC and its vaccine advisory committee to make their own decision.

The CDC’s next vaccine advisory meeting is scheduled to take place from October 20 to October 21, when it’s expected to discuss the boosters.

Research contact: @CNBC

Biden to pledge 500 million more Pfizer vaccine doses for poor nations at U.N. COVID Summit

September 23, 2021

President Joe Biden was expected to announce on  Wednesday, September 22 that the United States will purchase 500 million additional doses of the coronavirus vaccine developed by Pfizer  and BioNTech to donate to developing countries, senior administration officials told The Wall Street Journal.

Biden was scheduled to make the announcement at a virtual COVID-19 summit on the sidelines of the United Nations General Assemblybringing the total U.S. commitment to 1.1 billion doses to be shared overseas.

According to the Journal, the decision comes as Biden is seeking to expand America’s role in helping to accelerate global vaccination efforts in low- and lower-middle-income countries that have struggled with access to shots.

The new batch of Pfizer vaccines will be manufactured in the United States and begin shipping out in January, officials said. The donation doubles an earlier U.S. pledge of 500 million Pfizer doses to developing countries by the end of June 2022.

The donated vaccines are being routed through Covax, an international program backed by the World Health Organization and tasked with supplying vaccines to the world’s poorest nations.

Although the United states has so far offered the largest donation total of any country, some international aid groups have called on the Biden Administration and other wealthy nations to do more to help inoculate the global population. Only 2% of people in low-income countries have received a first dose of the vaccine, according to the University of Oxford’s Our World in Data project, prompting some health experts to warn that more lives could be lost to COVID-19 in 2022 than 2021.

The U.S. previously sent more than 110 million doses overseas, most of which were manufactured by Moderna Inc. and Johnson & Johnson, with recipient countries ranging from wealthy allies such as Canada to developing nations like Haiti.

Biden also planned to use Wednesday’s summit to call on other world leaders to help expand global access to the vaccine and take steps to make testing, therapeutics and personal protective equipment more available around the world, officials said. He intended to further urge leaders to help low- and lower-middle-income nations vaccinate at least 70% of their populations by September next year.

Research contact: @WSJ

Biden to deliver six-step plan on COVID

September 10, 2021

On Thursday, September 9, President Joe Biden was expected to outline new approaches to control the COVID-19 pandemic in the United States, which rages on despite the wide availability of vaccines, reports Thomson Reuters Foundation News.

In his speech, Biden planned to focus on six areas—among them, new plans to get more people vaccinated, enhancing protection for those who already have had shots, and keeping schools open, according to a White House official.

In addition, the official said, the president would discuss increasing testing and mask-wearing, protecting an economic recovery from the pandemic-induced recession, and improving healthcare for people infected with the disease.

“We know that increasing vaccinations will stop the spread of the pandemic, will get the pandemic under control, will return people to normal life,” White House Press Secretary Jen Psaki told reporters on Wednesday. “We have more work to do, and we are still at war with the virus.”

Increasing infections have raised concerns as children head back to school, while also rattling investors and upending company return-to-office plans.

Just over 53% of Americans are fully vaccinated, including almost two-thirds of the adult population, according to CDC data. The disease has killed more than 649,000 Americans.

With many Americans still skeptical of the shots, the White House already has announced plans to give those who are fully vaccinated booster shots for more additional protection.

In doing so, they have rejected arguments from the World Health Organization and other advocates that rich countries should hold off on booster shots before more people worldwide have been inoculated.

Research contact: @thomsonreuters

Missing in action: The baffling disappearance of the go-to lawyer for Capitol riot defendants

September 1, 2021

The mysterious disappearance of the lawyer, John Pierce, began on last Tuesday, August 24, prosecutors say, when he missed a hearing for one of the many cases in which he is representing a defendant in the Capitol riot investigation. The young associate who took his place said that Pierce had a “conflict.” At the time, no one seemed to give it much mind, according to a report by The New York Times.

But in the days that followed, Pierce—who is defending more cases connected to the riot than any other lawyer nationwide—missed additional hearings, and the details of his decampment started changing.

On Wednesday, his associate told a judge in one case that Pierce had gotten COVID-19 and was in the hospital on a ventilator—but only after telling a prosecutor in another case that Pierce had been in a car accident. That same evening, a different associate told a reporter that Pierce had, in fact, been hospitalized, but was getting care for “dehydration and exhaustion.”

Finally, on Monday, August 30—after Pierce had still failed to reappear—the government got involved. Federal prosecutors issued letters to several judges in 17 Capitol riot cases, informing them that no one in the Justice Department had heard from Pierce in a week and that “multiple” phone numbers for his law firm appeared to have been disconnected.

His criminal cases had come to a “standstill,” the prosecutors said, endangering the rights of his clients. If Pierce did not surface soon, they added, somethin —although it was not clear what—would have to be done.

The New York Times tried to reach Mr. Pierce several times by text and phone in recent days, but he did not respond.

Pierce’s unexplained absence was the only latest twist in his outsized role in defending those accused of participating in the Capitol attack. His clients — among them members of the Proud Boys and the Oath Keepers militia — have stood out not only for their number, but also for the scorched-earth battle that he has vowed to wage on their behalf.

A self-described pro-Trump populist, Pierce has promised, for example, to force the government to give him video footage of the Capitol for several days before and after January 6, and has said he will demand information about every police officer working at the building that day. He also has vowed to subpoena hostile witnesses such as Speaker Nancy Pelosi—ostensibly to learn what she may have known about security at the Capitol before the attack.

Without citing evidence, Pierce has said he intends to implicate the F.B.I. and the intelligence community by showing that the riot was something like a grand act of entrapment or an inside job. He has often talked about his cases with a conspiratorial zeal, painting himself as something like a lonely legal warrior out to save his clients from an overreaching government.

“I’m like Gerard Butler in ‘300,’” Pierce said in an interview before dropping out of sight, comparing himself to the action star who played a Spartan king. “I’m in the hot gates at Thermopylae, holding the pass against the million-man Persian army.”

While the government has not yet weighed in on the merits on his claims, prosecutors did express concern in their letters filed on Monday about the young associate, Ryan Joseph Marshall, who has been standing in for Pierce at the hearings he has missed.

For one thing, Marshall is not a licensed lawyer, prosecutors said, and has taken actions on behalf of clients “that he is not permitted” to take. Moreover, they went on, it remains unclear if and when Marshall will be able to get his law license—given that he is under indictment in two criminal cases accusing him of corruption, theft and fraud in Pennsylvania.

Pierce’s situation is not his first encounter with personal and professional setbacks. Last year, his law firm nearly collapsed in a swirl of debts and resignations. Then his most prominent client, Kyle Rittenhouse, the young man charged with murder at a racial justice protest in Wisconsin last year, fired him in a highly public spat that included allegations that a charity arranged for the defense had engaged in financial improprieties.

His work in the Capitol cases began just after the attack when he took several members of the far-right nationalist group, the Proud Boys, as clients. He also has been hired by L. Brent Bozell IV, the son of a prominent conservative commentator, as well as by a Florida pastor and a Minnesota pub worker.

In recent weeks, however, at least two clients have fired Pierce, complaining that he seemed unresponsive and appeared at times to be unversed in the details of their cases. Last week, the wife of yet another client, Kenneth Harrelson, a member of the Oath Keepers from Florida, sent a letter to her friends and associates, complaining that her husband was having “issues” getting Mr. Pierce “to do his job.”

Such complaints have come atop concerns that the sheer number of Pierce’s clients has exposed him to accusations of conflict of interest. He is, for example, representing both James Cusick Jr., the Florida pastor; as well as Cusick’s son Case. Both are charged with breaching the Capitol with another of his clients, David J. Lesperance, a member of the Cusicks’ church.

In a separate case, Mr. Pierce has been hired by another father-and-son pair, Kevin and Nathaniel Tuck, two former Florida police officers who have been charged in an indictment with a Florida Proud Boy he also represents.

However, all of that only can only come to pass if he returns to court—and the government seems worried that might never happen.

“Unfortunately, it seems that Mr. Pierce may be hospitalized and unable to communicate,” prosecutors wrote on Monday, “and it is unclear when Mr. Pierce will recover.”

Research contact: @nytimes

Like falling off a log? Viral milk crate challenge on TikTok is denounced by orthopedists

August 26, 2021

The latest challenge to take the Internet by storm involves precariously stacked milk crates, balance—and some painful falls, The Guardian reports.

To complete the challenge, which recently started on TikTok, participants face a set of milk crates piled up in the shape of a pyramid—and attempt to climb to the top and then back down again without toppling over.

As videos of people falling painfully go viral on social media and rack up millions of views, doctors across the US are coming out to warn people of the dangerous injuries that can occur.

“It’s perhaps even worse than falling from a ladder,” Shawn Anthony, an orthopedic surgeon at Mount Sinai Hospital in New York City told The Washington Post this week, adding, “It’s very difficult to brace yourself from the falls I’ve seen in these videos. They’re putting their joints at an even higher risk for injury.”

With many hospitals nationwide already overwhelmed by COVID-19 patients and running short on space and staff, health departments are urging people to reconsider their choices before taking on the challenge.

George Gantsoudes, a Virginia-based orthopedic surgeon, wrote on Twitter: “The orthopaedic surgeries required to fix problems caused by this may fall under the umbrella of ‘elective surgeries’.”

On Monday, the Baltimore city health department tweeted: “With COVID-19 hospitalizations rising around the country, please check with your local hospital to see if they have a bed available for you, before attempting the #milkcratechallenge.”

The Food and Drug Administration (FDA) also weighed in on the challenge after comedian Conan O’Brien  joked about how he needed federal officials to grant permission to the challenge before attempting it—playing off the FDA’s approval of Pfizer’s COVID-19 vaccine earlier this week.

“Waiting for FDA approval before I take the Milk Crate Challenge,” O’Brien tweeted on Monday. The FDA responded shortly after, writing: “Although we regulate milk, we can’t recommend you try that. Perhaps enjoy a nice glass of 2% and return all those crates to the grocery store?”

The milk crate challenge is the latest of a slew of dares that have gone viral on TikTok. In recent months, the video-sharing platform has seen a rise of dangerous challenge—among them, the blackout challenge, which encouraged young people to hold their breath until they passed out, and the Benadryl challenge, which challenged young people to intentionally consume large amounts of the antihistamine to induce hallucinations.

In a statement about the most recent challenge, a TikTok spokesperson said: “TikTok prohibits content that promotes or glorifies dangerous acts, and we remove videos and redirect searches to our community guidelines to discourage such content. We encourage everyone to exercise caution in their behavior whether online or offline.”

Research contact: @guardian

The play’s the thing: Toys ‘R’ Us is back with a little help from Macy’s

August 23, 2021

Toys “R” Us is getting a new lease on life, thanks to Macy’s. The two companies are partnering to sell toys on Macy’s website. The brands are also opening Toys “R” Us shop-in-shops at 400 department stores next year.

It’s the second attempt to revitalize the Toys “R” Us brand within three years, according to a report by CNN.

This relaunch is new owner WHP Global’s first significant strategy shift for the toy store. The New York-based brand management company bought the storied retailer in March with plans to build a “global network and digital platform” for Toys “R” Us.

For Macy’s, using the recognizable name could grow its toy business to compete against Target and Walmart. The department store said its toys sales have grown “exponentially” in the past year as parents try to entertain their homebound kids during the pandemic.

“Toys “R” Us is a globally recognized leader in children’s toys and our partnership allows Macy’s to significantly expand our footprint in that category, while creating more occasions for customers to shop with us across their lifestyles,” said Macy’s Chief Merchandising Officer Nata Dvir in a press release.

WHP Global bought Toys “R” Us from Tru Kids, which bought the failed brand in a 2018 liquidation sale. Tru Kids had big plans to open about a dozen standalone stores across US malls, but only opened two in New Jersey and Texas. Both later closed with the company blaming COVID-19.

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The store-within-a-store concept has been growing in popularity, with big chains like Target and Nordstrom looking for ways to keep shoppers coming back to their stores. Target is opening mini Apple shops and Ulta makeup shops at dozens of its locations and Kohl’s has partnered with Sephora to open 70 shops.

Research contact: @CNN

Jabra unveils research on the sounds we’ve missed most during lockdown

June 25, 2021

 Jabra, a Danish brand specializing in audio equipment and teleconferencing, has unveiled a new research report that pinpoints which sounds people worldwide missed the most during the COVID-19 pandemic lockdown. Respondents overwhelming missed the sounds of social activities, the study found, according to a release posted on PR Newswire.

Indeed, the top five sounds that respondents missed include the following:

  1. Live music at concert (65%)
  2. Splashing and laughter around a swimming pool (60%)
  3. Cutlery and dinner noises at a restaurant (58%)
  4. Theatre applause (56%)
  5. Bar/pub noises (53%)

However, just 31% of participants overall said they missed the sounds of the gym—with those in the UK being particularly averse (only 20% of Britons yearned for gym sounds).

Europeans as a group craved live music the most—with 77% in Italy placing it at number one; 73% in Spain; and 68%, in Germany. In fact, the research found that music is the sound and experience missed most everywhere but in the United States; where respondents put the sound of splashing and laughter at a swimming pool at the top of the list (74%).

The past year has been a trying one, but has given most people a greater appreciation for the smaller things in life, and this is reflected in some of the sounds people have been missing. It’s no surprise that the sounds of the beach and the sea were high on most people’s lists, in addition to the sound of nightlife and crowds cheering at sports events.

Interestingly enough, sounds that previously would have gone unnoticed now appear to coveted—including children playing in schoolyards, the noise of traffic,

Others missed the real-life voices of their family and friends, the tune of ‘Happy Birthday,’ or the simple request to “give me a hug.”

Research contact: @PRNewswire 

Taking ‘extraordinary measures,’ White House backs suspending patents on vaccines

May 7, 2021

The Biden Administration came out on Wednesday, May5, in support of waiving intellectual property protections for coronavirus vaccines—thereby, siding with international efforts to bolster production amid concerns about vaccine access in developing nations, The New York Times reports.

Under former President Trump, the United States had been a major holdout at the World Trade Organization over a proposal to suspend some of the world economic body’s intellectual property protections—enabling drugmakers worldwide to gain access to the closely guarded trade secrets of how the vaccines have been made.

However, the Times notes, President Biden had come under increasing pressure to throw his support behind the proposal, drafted by India and South Africa and backed by many congressional Democrats.

Katherine Tai, the United States Trade Representative, announced the Administration’s position on Wednesday afternoon, as the pandemic continued to spiral in India and South America.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in a statement. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

Support from the White House is not a guarantee that a waiver will be adopted. The European Union has also been standing in the way, and changes to international intellectual property rules require unanimous agreement. Tai said the United States would participate in negotiations at the World Trade Organization over the matter, but that they would “take time given the consensus-based nature of the institution and the complexity of the issues involved.”

Standing against her will be the pharmaceutical industry, which responded angrily to the extraordinary decision. Stephen J. Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the announcement “an unprecedented step that will undermine our global response to the pandemic and compromise safety.”

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” he said in a statement, adding that the move would have the effect of “handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”

The pharmaceutical industry has argued that a suspension of patent protections would undermine risk-taking and innovation.

“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.

However, the Times reports, global health activists, who have been pressing for the waiver, praised the Administration’s decision. It is “a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one,” said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge (I-MAK).

But the activists said a waiver alone would not increase the world’s vaccine supply. It must be accompanied by a process known as “tech transfer,” in which patent holders supply technical know-how and personnel. Activists also are demanding that Biden use his leverage to ensure that manufacturing is scaled up around the globe, and not just by the pharmaceutical companies that now hold the patents.

“Handing needy countries a recipe book without the ingredients, safeguards and sizable work force needed will not help people waiting for the vaccine,” Dr. Michelle McMurry-Heath, the president and chief executive of the Biotechnology Innovation Organization (BIO), said in a statement. “Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new Covid variants.”

Shares of the pharmaceutical companies BioNTech, Moderna and Novavax dropped on Wednesday afternoon as news broke of the Biden administration’s decision.

Research contact: @nytimes

Pfizer’s new at-home pill to treat COVID could be available by the end of this year

April 28, 2021

Pfizer’s experimental oral drug to treat COVID-19 at the first sign of illness could be available by the end of the year, CEO Albert Bourla told CNBC on Tuesday, April 27.

In March, the company—which developed the first FDA-authorized COVID-19 vaccine in the United States in cooperation with German drugmaker BioNTech—began an early-stage clinical trial testing a new antiviral therapy for COVID. The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens, such as HIV and hepatitis C.

If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed nationwide by year-end, Bourla told CNBC’s “Squawk Box.”

Health experts say the drug, taken by mouth, could be a gamechanger because people newly infected with the virus could use it outside of hospitals. Researchers hope the medication will keep the disease from progressing and prevent hospital trips.

In addition to the drug, Pfizer is still testing its vaccine in 6-month to 11-year-old children. Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say.

Earlier this month, the company asked the FDA to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% effective in a study.

Bourla told CNBC on Tuesday he is “very optimistic” that the FDA will approve the use of the shot in adolescents.

Research contact: @CNBC

Kimbal Musk’s quest to start one million gardens

March 29, 2021

While Elon Musk, age 49, is intent on reaching for the skies with SpaceX, his younger brother, Kimbal, age 48, is more concerned with the ground beneath his feet—with a goal of creating one million home gardens within the next year, according to an article first published by Rolling Stone and picked up by Yahoo.

Since 2010, the junior Musk has:

  • Launched an initiative to put “learning gardens” in public schools across America (now at 632 schools and counting);
  • Courted Generation Z into the farming profession by converting shipping containers into high-tech, data-driven, year-round farms; and
  • Spoken out vociferously against unethical farming practices and vociferously forthe beauty and community of slow food.

What’s more, this year, on the first day of spring, is kicking off a new campaign with Modern Farmer’s Frank Giustra to create one million at-home gardens in the the next 12 months.

Aimed at reaching low-income families, the Million Gardens Movement was inspired by the pandemic, during which food insecurity—and a desire to go back to nature to address the problem— have been at the forefront of so many people’s lives.

“We were getting a lot of inquiries about gardening from people that had never gardened before,” Giustra told Rolling Stone during a recent interview. “People were looking to garden for a bunch of reasons: to supplement their budget, because there was a lot of financial hardship, to help grow food for other people, or just to cure the boredom that came with the lockdown. To keep people sane—literally, keep people sane—they turned to gardening.”

The program offers free garden kits that can be grown indoors or outdoors, and will be distributed through schools that Musk’s non-profit, Big Green, already has partnered with. It also offers free curriculum on how to get the garden growing and fresh seeds and materials for the changing growing seasons.

“I grew up in the projects when I was young, in what we now call food deserts,” says EVE, one of the many celebrities who have teamed up with the organization to encourage people to pick up a free garden or to donate one. “What I love about this is that it’s not intimidating. Anyone can do this, no matter where you come from, no matter where you live. We are all able to grow something.”

Musk told Rolling Stone that, while the idea for a million gardens was not his, he was enthusiastic about it from day one” “Frank [Giustra] and his team pitched us on joining forces and doing the Million Gardens Movement. And we loved it. We thought it was a great idea.

“Because of COVID, we had been forced to pivot our model from the learning gardens because we couldn’t really teach people in the gardens anymore. And so we had done this trial of what we call little green gardens, which are round, beautiful sort of beige sacks, and you can come in and pick these up from a local school in your community. You can grow them on a windowsill as long as there’s some light. You can grow them indoors, which enables any city to be able to use them.”

He further explained, “What we would be doing with these little green gardens is inspiring people to garden and empowering them to garden. The average garden generates about $600 to $700 worth of food a year. So it provides actual food to your family. You’re having a lower carbon footprint because you’re not shipping food around. It’s great for mental health. Think about COVID and how crazy we all are. This gets you out there. It connects you to your kids. Gardening is such a beautiful thing to do for yourself, for the community, for the environment.”

He urges readers to go the Million Gardens Movement website: “If you sign up now to grow a garden AND donate $20, we will give a garden to a family in need, and send you a limited edition Million Gardens Movement bracelet!”

Research contact: @RollingStone