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FDA Panel Backs First-of-a-Kind COVID-19 Pill From Merck

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. 

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. 

The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on the FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age. 

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit. 

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the United Kingdom. 

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of the coronavirus. 

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. 

“With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. 

Effectiveness, dangers

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. 

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. 

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. 

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” 

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. 

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely. 

Pfizer drug

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. 

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. 

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. 

The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. 

Both drugs require patients to take multiple pills, twice a day for five days. 

 

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1st French Omicron Case on Indian Ocean Island of Reunion

Japan and France confirmed their first cases of the new variant of the coronavirus on Tuesday as countries around the world scrambled to close their doors or find ways to limit its spread while scientists study how damaging it might be.

The World Health Organization has warned that the global risk from the omicron variant is “very high” based on early evidence, saying it could lead to surges with “severe consequences.”

French authorities on Tuesday confirmed the first case of the omicron variant in the French island territory of Reunion in the Indian Ocean. Patrick Mavingui, a microbiologist at the island’s research clinic for infectious diseases, said the person who has tested positive for the new variant is a 53-year-old man who had traveled to Mozambique and stopped in South Africa before returning to Reunion.

The man was placed in quarantine. He has “muscle pain and fatigue,” Mavingui said, according to public television Reunion 1ere.

Japan on Tuesday confirmed its first case in a visitor who recently arrived from Namibia, a day after banning all foreign visitors as an emergency precaution against the variant. A government spokesperson said the patient, a man in his 30s, tested positive upon arrival at Narita airport on Sunday and was isolated and is being treated at a hospital.

Cambodia barred entry to travelers from 10 African countries, citing the threat from the omicron variant. The move came just two weeks after Cambodia reopened its borders to fully vaccinated travelers on Nov. 15.

The new version was first identified days ago by researchers in South Africa.

WHO said there are “considerable uncertainties” about the omicron variant. But it said preliminary evidence raises the possibility that the variant has mutations that could help it both evade an immune-system response and boost its ability to spread from one person to another.

The WHO stressed that while scientists are hunting evidence to better understand this variant, countries should accelerate vaccinations as quickly as possible.

Despite the global worry, doctors in South Africa are reporting patients are suffering mostly mild symptoms so far. But they warn that it is early. Also, most of the new cases are in people in their 20s and 30s, who generally do not get as sick from COVID-19 as older patients. 

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New Twitter CEO Steps From Behind the Scenes to High Profile 

Newly named Twitter CEO Parag Agrawal has emerged from behind the scenes to take over one of Silicon Valley’s highest-profile and politically volatile jobs. 

But his prior lack of name recognition, coupled with a solid technical background, appears to be what some big company backers were looking for to lead Twitter out of its current morass. 

A 37-year-old immigrant from India, Agrawal comes from outside the ranks of celebrity CEOs, which include the man he’s replacing, Jack Dorsey, Facebook’s Mark Zuckerberg or SpaceX and Tesla’s Elon Musk. Those brand-name company founders and leaders have often been in the news — and on Twitter — for exploits beyond the day-to-day running of their companies.

Having served as Twitter’s chief technology officer for the past four years, Agrawal’s appointment was seen by Wall Street as a choice of someone who will focus on ushering Twitter into what’s widely seen as the internet’s next era — the metaverse. 

Agrawal is a “‘safe’ pick who should be looked upon as favorably by investors,” wrote CFRA Research analyst Angelo Zino, who noted that Twitter shareholder Elliott Management Corp. had pressured Dorsey to step down. 

Elliott released a statement Monday saying Agrawal and new board chairman Bret Taylor were the “right leaders for Twitter at this pivotal moment for the company.” Taylor is president and chief operating officer of the business software company Salesforce. 

Agrawal joins a growing cadre of Indian American CEOs of large tech companies, including Sundar Pichai of Google parent Alphabet, Microsoft’s Satya Nadella and IBM’s Arvind Krishna. 

He joined San Francisco-based Twitter in 2011, when it had just 1,000 employees, and has been its chief technical officer since 2017. At the end of last year, the company had a workforce of 5,500. 

Agrawal previously worked at Microsoft, Yahoo and AT&T in research roles. At Twitter, he’s worked on machine learning, revenue and consumer engineering and helping with audience growth. He studied at Stanford and the Indian Institute of Technology, Bombay. 

While Twitter has high-profile users like politicians and celebrities and is a favorite of journalists, its user base lags far behind old rivals like Facebook and YouTube and newer ones like TikTok. It has just over 200 million daily active users, a common industry metric.

As CEO, Agrawal will have to step beyond the technical details and deal with the social and political issues Twitter and social media are struggling with. Those include misinformation, abuse and effects on mental health. 

Agrawal got a fast introduction to life as CEO of a high-profile company that’s one of the central platforms for political speech online. Conservatives quickly unearthed a tweet he sent in 2010 that read “If they are not gonna make a distinction between muslims and extremists, then why should I distinguish between white people and racists.”

As some Twitter users pointed out, the 11-year-old tweet was quoting a segment on “The Daily Show,” which was referencing the firing of Juan Williams, who made a comment about being nervous about Muslims on an airplane.

Twitter did not immediately respond to a message for comment on the tweet. 

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Jury Seated in Trial of Former ‘Empire’ Actor Jussie Smollett

A jury was seated Monday to hear the case against Jussie Smollett, who says he was the victim of a racist and homophobic assault in downtown Chicago that authorities say was a hoax concocted and staged by the former “Empire” actor.

Two brothers, who worked with Smollett on the TV show, say he paid them $3,500 to pose as his attackers on a frigid night in January 2019. The men now stand at the center of the case that prosecutors will lay before jurors this week.

Smollett, who arrived at the courthouse in Chicago on Monday with his mother and other family members, is accused of lying to police about the alleged attack and has been charged with felony disorderly conduct. The Class 4 felony carries a prison sentence of up to three years, but experts have said it is likely that if Smollett is convicted, he would be placed on probation and perhaps ordered to perform community service. 

Twelve jurors plus three alternate jurors were sworn in and were expected to begin hearing opening arguments late Monday in a trial Judge James Linn said he expects to take about one week. During jury selection, Linn asked potential jurors if they have been the victim of a hate crime, if they have watched “Empire” or “TMZ,” a program and website about celebrities, or if they belong to any civil rights or pro-police organizations. Cameras are not allowed inside the courtroom, and the proceedings are not being livestreamed, unlike in other recent high-profile trials. 

Whether Smollett, who is Black and gay, will testify remains an open question. But the siblings, Abimbola and Olabinjo Osundairo, will take the witness stand where they are expected to repeat what they have told police officers and prosecutors: They carried out the attack at Smollett’s behest.

Jurors also may see surveillance video from more than four dozen cameras that police reviewed to trace the brothers’ movements before and after the reported attack, as well as a video showing the brothers purchasing a red hat, ski masks and gloves from a beauty supply shop hours earlier. 

Smollett’s attorneys have not spelled out how they will confront that evidence, and the lead attorney, Nenye Uche, declined to comment ahead of this week’s proceedings. But there are clues as to how they might do so during the trial. 

Buried in nearly 500 pages of Chicago Police Department reports is a statement from an area resident who says she saw a white man with “reddish brown hair” who appeared to be waiting for someone that night. 

She told a detective that when the man turned away from her, she “could see hanging out from underneath his jacket what appeared to be a rope.” 

Her comments could back up Smollett’s contention that his attackers draped a makeshift noose around his neck. Further, if she testified that the man was white, it would support Smollett’s statements — widely ridiculed because the brothers, who come from Nigeria, are Black — that he saw pale or white skin around the eyes of one of his masked attackers. 

Given there is so much evidence, including the brothers’ own statements that they participated in the attack, it is unlikely that Smollett’s attorneys will try to prove they did not take part. That could perhaps lead the defense to contend that Smollett was the victim of a very real attack at the hands of the brothers, perhaps with the help of others, who now are only implicating the actor so they won’t be charged, too.

The $3,500 check could be key, although Smollett says he wrote it to pay one of the brothers to work as his personal trainer. 

“I would assume the defense is going to zero in on that,” said Joe Lopez, a prominent defense attorney not involved with the case.

What they will almost certainly do is attack the brothers’ credibility, reminding jurors that they are not facing the same criminal charges as Smollett, despite admitting they took part in the staged attack. 

“Everything Smollett is responsible for, they are responsible for,” said David Erickson, a former state appellate judge who teaches at Chicago-Kent College of Law and is not involved in the case.

Finally, Smollett’s career could take center stage. Prosecutors could make the same point that then-Police Superintendent Eddie Johnson made when he announced Smollett’s arrest in 2019: Smollett thought the attack would win him more fame and a pay raise.

But Lopez said the defense attorneys might ask the jury the same question he asked himself.

“How would that help him with anything?” he asked. “He’s already a star.” 

 

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Biden Urges Calm, Vaccination, in Face of Omicron Variant

U.S. President Joe Biden says a highly transmissible COVID-19 variant, dubbed omicron, is a cause for “concern, not panic” and defended his much-criticized decision to restrict travel from the southern African region, where it was first reported. VOA’s Anita Powell reports from the White House.

Produced by: Barry Unger

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Twitter Founder and CEO Jack Dorsey Steps Down

Twitter founder and CEO Jack Dorsey is stepping down as the company’s leader.  

In a news release, Twitter said Dorsey would be replaced by Parag Agrawal, who has been the company’s chief technology officer since 2017. The move is effective immediately.  

“I’ve decided to leave Twitter because I believe the company is ready to move on from its founders. My trust in Parag as Twitter’s CEO is deep. His work over the past 10 years has been transformational. I’m deeply grateful for his skill, heart, and soul. It’s his time to lead,” Dorsey said in a statement.

Dorsey made his resignation official in a tweet Monday and attached a letter with an explanation of why he was leaving.  

“not sure anyone has heard but, I resigned from Twitter,” he wrote.

On Sunday, Dorsey tweeted “I love twitter.”

Dorsey, 45, founded the microblogging platform in 2006 and was CEO until 2008 when he was pushed aside only to return to the top spot in 2015.  

Last year, Elliott Management, a major stakeholder in the company, wanted Dorsey to choose between being CEO of Twitter or CEO of Square, a digital payment company he founded.  

Twitter’s stock rose on the news, but trading of the shares was suspended.

Some information in this report came from Reuters.

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Merriam-Webster Chooses Vaccine as the 2021 Word of the Year

With an expanded definition to reflect the times, Merriam-Webster has declared an omnipresent truth as its 2021 word of the year: vaccine.

“This was a word that was extremely high in our data every single day in 2021,” Peter Sokolowski, Merriam-Webster’s editor-at-large, told The Associated Press ahead of Monday’s announcement. 

“It really represents two different stories. One is the science story, which is this remarkable speed with which the vaccines were developed. But there’s also the debates regarding policy, politics and political affiliation. It’s one word that carries these two huge stories,” he said.

The selection follows “vax” as word of the year from the folks who publish the Oxford English Dictionary. And it comes after Merriam-Webster chose “pandemic” as tops in lookups last year on its online site.

“The pandemic was the gun going off and now we have the aftereffects,” Sokolowski said.

At Merriam-Webster, lookups for “vaccine” increased 601% over 2020, when the first U.S. shot was administered in New York in December after quick development, and months of speculation and discussion over efficacy. The world’s first jab occurred earlier that month in the UK.

Compared to 2019, when there was little urgency or chatter about vaccines, Merriam-Webster logged an increase of 1,048% in lookups this year. Debates over inequitable distribution, vaccine mandates and boosters kept interest high, Sokolowski said. So did vaccine hesitancy and friction over vaccine passports.

The word “vaccine” wasn’t birthed in a day, or due to a single pandemic. The first known use stretches back to 1882 but references pop up earlier related to fluid from cowpox pustules used in inoculations, Sokolowski said. It was borrowed from the New Latin “vaccina,” which goes back to Latin’s feminine “vaccinus,” meaning “of or from a cow.”  

The Latin for cow is “vacca,” a word that might be akin to the Sanskrit “vasa,” according to Merriam-Webster. 

Inoculation, on the other hand, dates to 1714, in one sense referring to the act of injecting an “inoculum.”

Earlier this year, Merriam-Webster added to its online entry for “vaccine” to cover all the talk of mRNA vaccines, or messenger vaccines such as those for COVID-19 developed by Pfizer-BioNTech and Moderna. 

While other dictionary companies choose words of the year by committee, Merriam-Webster bases its selection on lookup data, paying close attention to spikes and, more recently, year-over-year increases in searches after weeding out evergreens. The company has been declaring a word of the year since 2008. Among its runners-up in the word biography of 2021:

INSURRECTION: Interest was driven by the deadly Jan. 6 siege on the U.S. Capitol. Arrests continue, as do congressional hearings over the attack by supporters of President Donald Trump. Some of Trump’s allies have resisted subpoenas, including Steve Bannon. Searches for the word increased by 61,000% over 2020, Sokolowksi said.

INFRASTRUCTURE: President Joe Biden was able to deliver what Trump often spoke of but never achieved: A bipartisan infrastructure bill signed into law. When Biden proposed help with broadband access, eldercare and preschool, conversation changed from not only roads and bridges but “figurative infrastructure,” Sokolowski said.

“Many people asked, what is infrastructure if it’s not made out of steel or concrete? Infrastructure, in Latin, means underneath the structure,” he said. 

PERSEVERANCE: It’s the name of NASA’s latest Mars rover. It landed Feb. 18, 2021. “Perseverance is the most sophisticated rover NASA has ever sent to the Red Planet, with a name that embodies NASA’s passion, and our nation’s capability, to take on and overcome challenges,” the space agency said.  

The name was thought up by Alexander Mather, a 14-year-old seventh-grader at Lake Braddock Secondary School in Burke, Virginia. He participated in an essay contest organized by NASA. He was one of 28,000 K-12 students to submit entries. 

NOMAD: The word had its moment with the 2020 release of the film “Nomadland.” It went on to win three Oscars in April 2021, including best picture, director (Chloé Zhao) and actress (Frances McDormand). Zhao became the first woman of color to win best director.  

The AP’s film writer Jake Coyle called the indie success “a plain-spoken meditation on solitude, grief and grit. He wrote that it “struck a chord in a pandemic-ravaged year. It made for an unlikely Oscar champ: A film about people who gravitate to the margins took center stage.”

Other words in Merriam-Webster’s Top 10: Cicada (we had an invasion), guardian (the Cleveland Indians became the Cleveland Guardians), meta (the lofty new name of Facebook’s parent company), cisgender (a gender identity that corresponds to one’s sex assigned at birth), woke (charged with politics and political correctness) and murraya (a tropical tree and the word that won the 2021 Scripps National Spelling Bee for 14-year-old Zaila Avant-garde).

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Louis Vuitton Star Designer Virgil Abloh Dies After Battle With Cancer

Virgil Abloh, fashion’s highest profile Black designer and the creative mind behind Louis Vuitton’s menswear collections, died on Sunday of cancer, Vuitton’s owner LVMH said.

The French luxury goods giant said Abloh, 41, had been battling cancer privately for years.

“Virgil was not only a genius designer, a visionary, he was also a man with a beautiful soul and great wisdom,” LVMH’s billionaire boss Bernard Arnault said in a statement.

Abloh, a U.S. national who also worked as a DJ and visual artist, had been men’s artistic director for Vuitton, the world’s biggest luxury brand, since March 2018.

His arrival at LVMH marked the marriage between streetwear and high-end fashion, mixing sneakers and camouflage pants with tailored suits and evening gowns. His influences included graffiti art, hip hop and skateboard culture.

The style was embraced by the group as it sought to breathe new life into some labels and attract younger customers.

In July this year, LVMH expanded his role, giving him a mandate to launch new brands and partner with existing ones in a variety of sectors beyond fashion.

LVMH also bought a 60% stake in Abloh’s Off-White label, which it folded into the spirits-to-jewelry conglomerate.

“For over two years, Virgil valiantly battled a rare, aggressive form of cancer, cardiac angiosarcoma,” a message posted to his Instagram said. “He chose to endure his battle privately since his diagnosis in 2019, undergoing numerous challenging treatments, all while helming several significant institutions that span fashion, art, and culture.”

Abloh drew on messages of inclusivity and gender-fluidity to expand the Louis Vuitton label’s popularity, weaving themes of racial identity into his fashion shows with poetry performances and art installations.

With an eye to reaching Asian consumers grounded by the coronavirus pandemic, the designer sent his collections of colorful suits and utilitarian-flavored outerwear off to Shanghai last summer, when many labels canceled fashion shows.

“Virgil Abloh was the essence of modern creativity,” said an Instagram post by Alexandre Arnault, one of Bernard Arnault’s sons and executive vice president for product and communications at U.S. jeweler Tiffany, which LVMH bought this year.

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WHO Calls for Renewed COVID Prevention Efforts Amid Omicron’s Spread

The World Health Organization says renewed efforts to prevent the spread of the coronavirus is needed as scientists scramble to determine the risks posed by the new omicron variant. Low vaccine rates combined with public fatigue over safety measures are putting more people in Africa at risk.

Experts say it’s no surprise a new variant of the coronavirus has been discovered.

Fewer than 8 percent of Africans are vaccinated against COVID-19, creating an environment for the illness to spread and mutate.

Dr. Mary Stephen is a technical officer for the World Health Organization’s Africa office. 

She said in the absence of vaccines, the public needs encouragement to uphold other measures to reduce the spread and save lives.

“We cannot be tired; we have to continue to make sure we are complying with wearing of our face masks, keeping our distance away, avoiding unnecessary mass gatherings, ensuring good hand hygiene, so that it’s another layer of protection in addition to the vaccination,” she said.

South African scientists detected the omicron variant last week.

Research is under way to determine how transmittable it is and its reaction to vaccines.

Amid uncertainty, Britain, the United States and European Union reacted by imposing travel bans to southern Africa.

Stephen, however, said the variant has already crossed continents and that halting flights to African countries that have long enforced testing for travelers is the wrong response. 

“The world should react to them with solidarity. The solution is not about banning travel but our ability to identify these cases, identify the potential risks, mitigate the risks, while we are still facilitating international travel because we have seen the devastating effects that COVID had on the economy,” she said.

Jeremiah Tshukudu is all too familiar with the economic toll of the pandemic.

The 45-year-old Uber driver said two of his cars were repossessed last year because he could no longer afford the payments during lockdown.

Tshukudu said he fears he’s about to take another financial hit with the new variant.

“I see us like losing close to let’s say 50% of what we’ve been earning recently. Relying on Uber, business was down, that means I wouldn’t be able to provide for the family,” he said.

Despite the pandemic’s impact on him, Tshukudu said he’s still hesitant about getting vaccinated.

With the threat of a new variant, experts are hoping people like him will reconsider.

Dr. Michelle Groome is with South Africa’s National Institute for Communicable Diseases. 

“Hopefully, you know, with some concern over coming fourth wave, hopefully, you know, those that were on the fence may actually go and vaccinate,” she said.

More than 3,200 people in South Africa tested positive for COVID-19 on Saturday, a marked increase from the day before.

The government is campaigning for more people to get vaccinated and even offering grocery vouchers to those who get their shot.

Government data show that at least 41 percent of South African adults have now been vaccinated.

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