Lesotho Wire

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.

Source: Voice of America

NASA called off a spacewalk Tuesday because of menacing space junk that could puncture an astronaut’s suit or damage the International Space Station.

Two U.S. astronauts were set to replace a bad antenna outside of the space station. But late Monday night, Mission Control learned that a piece of orbiting debris might come dangerously close. There wasn’t enough time to assess the threat so station managers delayed the spacewalk until Thursday.

It’s the first time a spacewalk has been canceled because of threat from space junk.

The space station and its crew of seven have been at increased risk from space junk since Russia destroyed a satellite in a missile test two weeks ago.

It wasn’t immediately clear whether the object of concern was part of the Russian satellite wreckage. During a news conference Monday, NASA officials said the November 15 missile test resulted in at least 1,700 satellite pieces big enough to track, and thousands more too small to be observed from the ground but still able to pierce a spacewalker’s suit.

NASA officials said astronauts Tom Marshburn and Kayla Barron faced a 7% greater risk of a spacewalk puncture because of the Russian-generated debris. But they said it was still within acceptable limits based on previous experience.

Marshburn and Barron arrived at the space station earlier this month.

Source: Voice of America

U.S. President Joe Biden met at the White House Monday with chief executives of major retailers to learn about supply chain challenges during the busy holiday season.

“The business leaders we gathered here today represent a broad swath of American shopping: brick and mortar and online stores, national and local grocery chains, our nation’s largest retailer, and makers and sellers of toys, electronics and health supplies,” the president said.

“I want to hear from each of you about what you’re seeing this holiday season,” he told the business leaders.

The Biden administration has been struggling to fix supply chain problems, including backlogged ports and a shortage of truck drivers to haul goods across the country. The supply chain issues, fuel prices that rose markedly earlier this year and other factors have contributed to rising U.S. inflation.

Walmart CEO Doug McMillon said, “While we’re all concerned about the supply chain, we have more inventory than we did a year ago, and we have the inventory that we need to be able to support the business.”

He told the meeting virtually, “We are seeing progress. The port and transit delays are improving.” Walmart has seen a 26% increase in shipping containers getting through U.S. ports in the past month, according to McMillon.

Food Lion President Meg Ham told the meeting the company’s supply chain “is strong and robust, and we have ample product inside of our stores for customers to choose from during this holiday.”

The White House said other participants at Monday’s meeting, both in person and virtual, included the CEOs of Best Buy, Samsung North America, Qurate Retail Group, Todos Supermarket, Etsy, Mattel, CVS Health and Kroger.

Source: Voice of America

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.

Source: Voice of America

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.

Source: Voice of America