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. 

 

Fauci: Existing Coronavirus Vaccines Provide ‘Some’ Protection Against Omicron Variant

The top U.S. infectious disease expert said Tuesday that vaccinated Americans have “some degree of protection” against the new omicron variant of the coronavirus, but that scientists will not know for a few weeks how vaccines may need to be altered to best fight it. 

Dr. Anthony Fauci, President Joe Biden’s top medical adviser, said at a White House coronavirus news briefing that the omicron “mutation profile is very different from other variants” of the coronavirus. 

While he said the three existing vaccines used in the U.S. could prevent people who have been inoculated from getting seriously ill from the omicron variant, it “remains uncertain … speculative” whether they will fully work against people getting sick. 

“We believe it is too soon to tell about the severity” of the omicron variant, he said. “We should have a much better idea in the next few weeks.” 

To date, he said, 226 cases of the omicron variant have been identified in 20 countries across the globe, but none so far in the United States. Health officials, however, say they assume the variant eventually will spread to the United States. 

“We are actively looking for the omicron variant in the U.S.,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. 

Stephane Bancel, chief executive of Moderna, which produces one of the vaccines used in the U.S., predicted in an interview with the Financial Times that existing vaccines would be much less effective in combating the omicron variant than the previous four variants of the coronavirus. 

“There is no world, I think, where (the effectiveness) is the same level … we had with delta,” Bancel said, referring to the highly contagious variant that is the predominant strain throughout the U.S. and was first detected in India in late 2020. 

His comments sent U.S. stock indexes tumbling, as investors feared the effect of the omicron variant on the world economy, in which many countries are still struggling from the coronavirus onslaught that started in early 2020. 

Bancel said it could take months for pharmaceutical companies to manufacture effective new vaccines to deal with the specific molecular makeup of the omicron variant. 

Dutch officials said Tuesday that they detected the omicron variant in tests almost two weeks ago, days earlier than when two flights from South Africa transported infected passengers to the Netherlands. 

Walensky said 45 million adults are unvaccinated in the U.S., and millions more children, ages 5 to 18, are eligible to get shots, but their parents have yet to get them inoculated. 

In addition, Jeffrey Zients, the White House COVID-19 response coordinator, said that 100 million vaccinated people in the U.S. are eligible for booster shots but have yet to get them.

He, too, said that vaccinations provide “some protection” against the omicron variant and that “boosters help that.” 

“We want to make sure Americans are doing all they can to protect themselves,” he said. 

 

Biden Heads to Minnesota to Promote Infrastructure Plan

U.S. President Joe Biden on Tuesday visits a Minnesota technical college to sell Americans on his recently approved $1 trillion infrastructure plan, which the administration says will train millions of Americans “for the high-growth jobs of the future” that will build the massive infrastructure Biden says the U.S. needs to compete globally.

This is Biden’s first visit to the state known as the “Land of 10,000 Lakes” since he was elected president. He plans to visit Dakota County Technical College in Rosemount, Minnesota, to speak to students about the legislation and how it affects them. 

“The majority of jobs supported by the president’s Bipartisan Infrastructure Bill will not need a four-year college degree,” White House press secretary Jen Psaki said Monday, ahead of the trip. “And the programs provided by community and technical colleges like Dakota County Technical College will provide the training and skill development needed to help workers access the jobs created.”

The public, two-year technical college serves nearly 13,000 students across multiple disciplines, including construction and manufacturing.

The White House estimates that under the new law, Minnesota will receive $4.5 billion for federal-aid highways; $302 million for bridges; $818 million for public transportation; $680 million to improve water infrastructure; and $100 million that aims to cover every resident with high-speed internet. 

The legislation also will provide about $68 million to expand the state’s electric vehicle charging network, and Minnesota will receive a slice of the $50 billion the law allocates to strengthening infrastructure against the impacts of climate change.

A Futuristic Tool Helps Viewers Access Black History

To make Black history more accessible, an Oakland, California man designed his own augmented reality app. Matt Dibble has the story.

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. 

Cyber Monday Caps Holiday Shopping Weekend as Virus Lingers

Americans are spending freely and going back to store shopping, knocking out some of the momentum in online sales from last year when Americans were making many of their purchases exclusively via the internet.

Shopper traffic roared back on Black Friday, but it was still below pre-pandemic levels, in part because retailers spread out big deals starting in October. The early buying is expected to also take a bite out of online sales on Monday, coined Cyber Monday by the National Retail Federation in 2005.

In fact, Adobe Digital Economy Index said that it was the first time online sales on Thanksgiving and Black Friday hadn’t grown, and Cyber Monday could likewise see a decline compared with a year ago. Adobe, which tracks more than one trillion visits to U.S. retail sites, had previously recorded healthy online sales gains since it first began reporting on e-commerce in 2012.

Still, Cyber Monday should remain the biggest online spending day of the year. For the overall holiday season, online sales should increase 10% from a year ago, compared with a 33% increase last year, according to Adobe.

A possible game changer is the omicron variant of the coronavirus, which could put a damper on shopping behavior and stores’ businesses. The World Health Organization warned Monday that the global risk from the omicron variant is “very high” based on early evidence, saying the mutated coronavirus could lead to surges with “severe consequences.”

Jon Abt, co-president and a grandson of the founder of Abt Electronics, said that holiday shopping has been robust, and so far overall sales are up 10% compared to a year ago. But he said he thinks Cyber Monday sales will be down at the Glenview, Illinois-based consumer electronics retailer after such robust growth from a year ago. He also worries about how the rest of the season will fare given the new variant.

“There are so many variables,” Abt said. “It’s a little too murky.”

Here is how the season is shaping up:

Cyber Monday still king but cooling 

Consumers are expected to spend between $10.2 billion and $11.3 billion on Monday, making it once again the biggest online shopping day of the year, according to Adobe. Still, spending on Cyber Monday could drop from last year’s level of $10.8 billion as Americans are spreading out their purchases more in response to discounting in October by retailers, according to Adobe.

Both Black Friday and Thanksgiving Day online shopping came in below Adobe’s prediction. On Black Friday, online sales reached $8.9 billion, down from the $9 billion in 2020, the second largest day of the year. On Thanksgiving Day, online sales reached $5.1 billion, even from the year-ago period.

Harley Finkelstein, president of Canadian e-commerce platform Shopify, which has 1.7 million independent brands on its site, said that so far, Cyber Monday is off to a strong start. Sales on his platform were up 21% on Black Friday compared with 2020 and more than double compared with 2019. He said he believes that independent brands will see better percentage sales gains online than big national chains, as shoppers gravitate more toward direct-to-consumer labels and look for brands with social conscience. And he says these brands have been able to get the inventory. Among some of the hot items on Shopify are children’s couches from Nugget and luxurious linens from Brooklinen.

“I think it is a tale of two different worlds,” he added.

Black Friday back but not the same 

Overall, Black Friday store traffic was more robust than last year but was still below pre-pandemic levels as shoppers spread out their buying in response to earlier deals in October and shifted more of their spending online. Sales on Friday were either below or had modest gains compared with pre-pandemic levels of 2019, according to various spending measures.

Black Friday sales about 30%, compared with the year-ago period, according to Mastercard SpendingPulse, which tracks all types of payments, including cash and credit cards. That was above its 20% growth forecast for the day. Steve Sadove, senior adviser for Mastercard, said the numbers speak to the “strength of the consumer.” For the Friday through Sunday period, sales rose 14.1% compared with the same period in 2020 and were up 5.8% compared to 2019, Mastercard reported.

Customer counts soared 60.8% on Black Friday compared with a year ago, but were down 26.9% on the same day in 2019, according to RetailNext, which analyzes store traffic with monitors and sensors in thousands of stores. Sales rose 46.4% on Black Friday but were down 5.1% in 2019, according to RetailNext. Sensormatic, another firm that tracks customer traffic, reported a 47.5% surge in traffic on Black Friday compared with a year ago but that number fell 28.3% compared with 2019.

The changing discount landscape 

Unlike in years past, many big box stores like Walmart didn’t market their discounted goods as “doorbusters,” in their Black Friday ads, choosing instead to stretch the deals out throughout the season or even the day. And the discounts are smaller this season as well.

Shoppers were also expected to pay on average between 5% to 17% more for toys, clothing, appliances, TVs and others purchases on Black Friday this year compared with last year, according to Aurelien Duthoit, senior sector advisor at Allianz Research. That’s because whatever discounts are offered will be applied to goods that already cost more.

And for the first time, discounts on Cyber Monday compared with a year ago are expected to be weaker, according to Adobe. Still, Cyber Monday remains the best day to buy TVs with discount levels at 16%, compared with 19% discounts last year. Other categories where consumers will find deals include clothing at a 15% markdown, compared with 20% last year. Computers are being discounted at 14%, compared with 28% last year, according to Adobe.

Overall holiday sales could be record breaking. For the November and December period, the National Retail Federation predicts that sales will increase between 8.5% and 10.5%. Holiday sales increased about 8% in 2020 when shoppers, locked down during the early part of the pandemic, spent their money on pajamas and home goods.

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. 

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

Biden Meets with CEOs on Supply Chain Issues 

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. 

Some information in this report came from the Associated Press and Reuters. 

 

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.

UN: Pandemic to Cost Global Tourism $2.0 Trillion in 2021

The coronavirus pandemic will cost the global tourism sector $2.0 trillion in lost revenue in 2021, the U.N.’s tourism body said Monday, calling the sector’s recovery “fragile” and “slow.”

The forecast from the Madrid-based World Tourism Organization comes as Europe is grappling with a surge in infections and as a new heavily mutated COVID-19 variant, dubbed Omicron, spreads across the globe.

International tourist arrivals will this year remain 70-75% below the 1.5 billion arrivals recorded in 2019 before the pandemic hit, a similar decline as in 2020, according to the body.

The global tourism sector already lost $2.0 trillion (1.78 trillion euros) in revenues last year due to the pandemic, according to the UNWTO, making it one of sectors hit hardest by the health crisis.

While the U.N. body charged with promoting tourism does not have an estimate for how the sector will perform next year, its medium-term outlook is not encouraging.

“Despite the recent improvements, uneven vaccination rates around the world and new Covid-19 strains” such as the Delta variant and Omicron “could impact the already slow and fragile recovery,” it said in a statement.

The introduction of fresh virus restrictions and lockdowns in several nations in recent weeks shows how “it’s a very unpredictable situation,” UNWTO head Zurab Pololikashvili told AFP.

“It’s a historical crisis in the tourism industry but again tourism has the power to recover quite fast,” he added ahead of the start of the WTO’s annual general assembly in Madrid on Tuesday.

“I really hope that 2022 will be much better than 2021.”

While international tourism has taken a hit from the outbreak of disease in the past, the coronavirus is unprecedented in its geographical spread.

In addition to virus-related travel restrictions, the sector is also grappling with the economic strain caused by the pandemic, the spike in oils prices and the disruption of supply chains, the UNWTO said.

Pololikashvili urged nations to harmonize their virus protocols and restrictions because tourists “are confused and they don’t know how to travel.”

International tourist arrivals “rebounded” during the summer season in the Northern Hemisphere thanks to increased travel confidence, rapid vaccination and the easing of entry restrictions in many nations, the UNWTO said.

“Despite the improvement in the third quarter, the pace of recovery remains uneven across world regions due to varying degrees of mobility restrictions, vaccination rates and traveller confidence,” it added.

Arrivals in some islands in the Caribbean and South Asia, and well as some destinations in southern Europe, came close to, or sometimes exceeded pre-pandemic levels in the third quarter.

Other countries, however, hardly saw any tourists at all, particularly in Asia and the Pacific, where arrivals were down 95% compared to 2019 as many destinations remained closed to non-essential travel.

A total of 46 destinations — 21% of all destinations worldwide — currently have their borders completely closed to tourists, according to the UNWTO.

A further 55 have their borders partially closed to foreign visitors, while just four nations have lifted all virus-related restrictions — Colombia, Costa Rica, Dominican Republic and Mexico.

The future of the travel sector will be in focus at the WTO annual general assembly, which will run until Friday.

The event — which brings together representatives from 159 members states of the U.N. body — was original scheduled to be held in Marrakesh.

But Morocco in late October decided not to host the event due to the rise in COVID-19 cases in many countries.

Before the pandemic, the tourism sector accounted for about 10% of the world’s gross domestic product and jobs.

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.

Zimbabwe Says It’s Prepared for Omicron Variant

Zimbabwe’s government says the country is very prepared to handle the new COVID-19 variant – omicron – first reported in neighboring South Africa. The World Health Organization says a fourth wave of the pandemic is most likely to hit Africa.

Zimbabwe’s Vice President Constantino Chiwenga – who doubles as the country’s health minister – has asked the nation not to be concerned about omicron.

“The country should not panic because we are very prepared. The ramping up of our vaccination program in the past month has seen marked increase in the vaccination uptake. That is the prevention which we are going to have for our people if any other variant comes. At least when your body is protected it is much better than when you are found naked,” said the vice president.

Zimbabwe has fully inoculated about 2.8 million people since February, when it began its vaccination program to contain the COVID-19 pandemic. The government has a target of vaccinating at least 10 million Zimbabweans — or 60% of the population — by the end of the year, a figure which might be difficult to reach given the scarcity of resources and short time left.

Itai Rusike, head of the nonprofit Community Working Group on Health, said Zimbabweans should panic about the new variant – initially named B.1.1.529 – since the country shares porous borders with South Africa and Botswana.

“And this new variant is coming at a time when the festive season is upon us. A whole lot of Zimbabweans, they use undesignated entry points. That poses a serious health challenge as they would not be properly screened and monitored as they come back to the country. What we want to encourage the government of Zimbabwe, is for them to strengthen their surveillance and monitoring system especially the land borders and make sure that the screening and monitoring at the entry points is also strengthened,” said Rusike.

Meanwhile, Humphrey Karamagi, a medical officer at the World Health Organization Regional Office for Africa, said on the WHO Twitter account that a fourth wave of COVID-19 is likely to hit the continent.

“A fourth wave in Africa is almost a certainty, as long as we have these factors in play, which is new variants coming up and the fact that people can be reinfected. And also, if we are getting new population who may not have been exposed. We would then have subsequent waves. Vaccination helps a lot in terms of reducing the severity of the disease [and] also reducing the risk of infection. The vaccine is not a magic bullet. So the vaccine is to work together with the public health measures to reduce the potential and risks of subsequent waves,” said Karamagi.

The WHO says COVID-19 has infected about 6.1 million people in Africa and claimed 152,113 lives. The world health body also says more than 227 million vaccine doses have been administered in Africa.

Australian Government Vows to Unmask Online Trolls

Australia’s government said Sunday it will introduce legislation to unmask online trolls and hold social media giants like Facebook and Twitter responsible for identifying them.

Prime Minister Scott Morrison, whose conservative coalition government faces an election in the first half of 2022, said the law would protect Australians from online abuse and harassment.

“The online world should not be a wild west where bots and bigots and trolls and others can just anonymously go around and harm people and hurt people, harass them and bully them and sledge them,” Morrison told reporters.

“That is not what can happen in the real world, and there is no case for it to be able to be happening in the digital world.”

Attorney General Michaelia Cash said the legislation, reportedly to be introduced to parliament by early 2022, is needed to clarify that the social media platforms, and not the users, were responsible for defamatory comments by other people.

Confusion had been sown by a High Court ruling in September that found Australian media, as users managing their own pages on a social network, could be held liable for defamatory third-party comments posted on their pages, Cash said.

Under the planned Australian legislation, the social media companies themselves would be responsible for such defamatory content, not the users, she said.

It would also aim to stop people making defamatory comments without being identified, she said.

“You should not be able to use the cloak of online anonymity to spread your vile, defamatory comments,” the attorney general said.

The legislation would demand that social media platforms have a nominated entity based in Australia, she said.

The platforms could defend themselves from being sued as the publisher of defamatory comment only if they complied with the new legislation’s demands to have a complaints system in place that could provide the details of the person making the comment, if necessary, Cash said.

People would also be able to apply to the High Court for an “information disclosure order” demanding a social media service provide details “to unmask the troll,” the attorney general said.

In some cases, she said, the “troll” may be asked to take down the comment, which could end the matter if the other side is satisfied.

Australia’s opposition leader Anthony Albanese said he would support a safer online environment for everyone.

But he said the government had failed to propose action to stop the spread of misinformation on social media and accused some of the government’s own members of spreading misinformation about COVID and vaccinations.

COVID Variant Spreads to More Countries as World on Alert

The new potentially more contagious omicron variant of the coronavirus popped up in more European countries on Saturday, just days after being identified in South Africa, leaving governments around the world scrambling to stop the spread.

The U.K. on Saturday tightened its rules on mask-wearing and on testing of international arrivals after finding two cases. New cases were confirmed Saturday in Germany and Italy, with Belgium, Israel and Hong Kong also reporting that the variant has been found in travelers.

In the U.S., Dr. Anthony Fauci, the government’s top infectious diseases expert, said he would not be surprised if the omicron variant was already in the United States, too.

“We have not detected it yet, but when you have a virus that is showing this degree of transmissibility … it almost invariably is ultimately going to go essentially all over,” Fauci said on NBC television.

Because of fears that the new variant has the potential to be more resistant to the protection offered by vaccines, there are growing concerns around the world that the pandemic and associated lockdown restrictions will persist for far longer than hoped.

Nearly two years since the start of the pandemic that has claimed more than 5 million lives around the world, countries are on high alert. Many have already imposed travel restrictions on flights from southern Africa as they seek to buy time to assess whether the omicron variant is more transmissible than the current dominant delta variant.

In Britain, Prime Minister Boris Johnson said it was necessary to take “targeted and precautionary measures” after two people tested positive for the new variant in England.

“Right now this is the responsible course of action to slow down the seeding and the spread of this new variant and to maximize our defenses,” he told a news conference.

Among the measures announced, Johnson said anyone arriving in England must take a PCR test for COVID-19 on the second day after their arrival and self-isolate until they provide a negative test. And if someone tests positive for the omicron variant, then he said their close contacts will have to self-isolate for 10 days regardless of their vaccination status — currently close contacts are exempt from quarantine rules if they are fully vaccinated.

He also said mask-wearing in shops and on public transport will be required and said the independent group of scientists that advises the British government on the rollout of coronavirus vaccines has been asked to accelerate the vaccination program. This could involve widening the booster program to younger age groups, reducing the time period between a second dose and a booster and allowing older children to get a second dose.

“From today we’re going to boost the booster campaign,” he said.

 

Britain’s Department of Health said the two cases found in the U.K. were linked and involved travel from southern Africa. One of the two new cases was in the southeastern English town of Brentwood, while the other was in the central city of Nottingham. The two confirmed cases are self-isolating with their households while contact tracing and targeted testing takes place.

The British government also added four more countries — Angola, Malawi, Mozambique and Zambia — to the country’s travel red list from Sunday. Six others — Botswana, Eswatini (formerly Swaziland), Lesotho, Namibia, South Africa and Zimbabwe — were added Friday. That means anyone permitted to arrive from those destinations will have to quarantine.

Many countries have slapped restrictions on various southern African countries over the past couple of days, including Australia, Brazil, Canada, the European Union, Iran, Japan, New Zealand, Thailand and the United States, in response to warnings over the transmissibility of the new variant. This goes against the advice of the World Health Organization, which has warned against any overreaction before the variant was thoroughly studied.

Despite the banning of flights, there are mounting concerns that the variant has already been widely seeded around the world.

Italy and Germany were the latest to report confirmed cases of the omicron variant.

An Italian who had traveled to Mozambique on business landed in Rome on Nov. 11 and returned to his home near Naples. He and five family members, including two school-age children, have since tested positive, the Italian news agency LaPresse said. All are isolating in the Naples suburb of Caserta in good condition with light symptoms.

The variant was confirmed by Sacco hospital in Milan, and Italy’s National Health Institute said the man had received two doses of the vaccine. Italy’s health ministry is urging all regions to increase tracing of the virus and sequencing to detect cases of the new variant first identified in South Africa.

In Germany, the Max von Pettenkofer Institute, a Munich-based microbiology center, said the omicron variant was confirmed in two travelers who arrived on a flight from South Africa on Nov. 24. The head of the institute, Oliver Keppler, said that genome sequencing has yet to be completed, but it is “proven without doubt that it is this variant,” German news agency dpa reported.

 

The Dutch public health institute said the omicron variant was “probably found in a number of the tested persons” who were isolated after arriving Friday in Amsterdam on two flights from South Africa. The institute said in a statement that further sequencing analysis is underway to determine for sure that it is the new variant. The results were expected Sunday. A total of 61 people were tested.

Israel said it detected the new strain in a traveler who had returned from Malawi and was tracing 800 travelers who returned recently from southern African countries. And Australia said early Sunday its scientists were working to determine whether two people who tested positive for COVID after arriving from southern Africa are infected with the omicron variant.

The variant’s swift spread among young people in South Africa has alarmed health professionals even though there was no immediate indication whether the variant causes more severe disease.

Several pharmaceutical firms, including AstraZeneca, Moderna, Novavax and Pfizer, said they have plans in place to adapt their vaccines in light of the emergence of omicron. Pfizer and its partner BioNTech said they expect to be able to tweak their vaccine in around 100 days.

Professor Andrew Pollard, the director of the Oxford Vaccine Group, which developed the AstraZeneca vaccine, expressed cautious optimism that existing vaccines could be effective at preventing serious disease from the omicron variant, noting that most of the mutations appear to be in similar regions as those in other variants.

“At least from a speculative point of view we have some optimism that the vaccine should still work against a new variant for serious disease, but really we need to wait several weeks to have that confirmed,” he told BBC radio.

Some experts said the variant’s emergence illustrated how rich countries’ hoarding of vaccines threatens to prolong the pandemic.

Fewer than 6% of people in Africa have been fully immunized against COVID-19, and millions of health workers and vulnerable populations have yet to receive a single dose. Those conditions can speed up spread of the virus, offering more opportunities for it to evolve into a dangerous variant.

“One of the key factors to emergence of variants may well be low vaccination rates in parts of the world, and the WHO warning that none of us is safe until all of us are safe and should be heeded,” said Peter Openshaw, a professor of experimental medicine at Imperial College London.

U.S. Secretary of State Antony Blinken spoke Saturday with his South African counterpart, Naledi Pandor, and they stressed the importance of working together to help African nations vaccinate their populations, the State Department said in a statement. It said Blinken praised South Africa’s scientists for quickly identifying the omicron variant and the government for its transparency in sharing this information, “which should serve as a model for the world.” 

 

US Praises South Africa’s Quick Detection, Sharing Variant Information

The United States praised South Africa on Saturday for quickly identifying the latest coronavirus variant, omicron, and sharing this information with the world.

Secretary of State Antony Blinken spoke with South Africa’s international relations and cooperation minister, Naledi Pandor, and they discussed cooperation on vaccinating people in Africa against COVID-19, the State Department said in a statement.

“Secretary Blinken specifically praised South Africa’s scientists for the quick identification of the omicron variant and South Africa’s government for its transparency in sharing this information, which should serve as a model for the world,” the statement said.

First detected in South Africa, the omicron variant of the coronavirus that causes COVID-19, was deemed by the World Health Organization a “variant of concern” on Friday.

Earlier Saturday, Pandor’s office issued a statement saying that the country is being punished for detecting the new variant as more countries rush to enact travel bans and restrictions.

By Saturday, more than a dozen countries had announced temporary travel restrictions on South Africa and other countries in the region after cases were reported in Europe and the Middle East. 

FDA: Merck COVID pill effective, experts will review safety

Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.

The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. 

Given those risks the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases.  

Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children.

Other side effects were mild and rare, with about 2% of patients experiencing diarrhea.

Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies.

“While the clinical safety data base was small, there were no major safety concerns identified,” FDA reviewers concluded.

Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. 

Theoretically, FDA cautioned, those changes could lead to dangerous new variants.

FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks.

All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. 

The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans.

France Says it is Willing to Discuss Autonomy for Guadeloupe

France is willing to discuss autonomy for the French Caribbean territory of Guadeloupe if it is in the interests of the people who live there, government minister Sebastien Lecornu said.

Guadeloupe and the nearby French island of Martinique have seen several days of protests against COVID-19 measures that have spilled over into violence.

Lecornu, the minister for France’s overseas territories, said in a YouTube video issued late on Friday that certain elected officials in Guadeloupe had raised the question of autonomy, changing its status as an overseas region.

“The government is ready to talk about this. There are no bad debates, as long as those debates serve to resolve the real everyday problems of people in Guadeloupe,” he said.

That was one of a series of initiatives he said the government in Paris would be taking in Guadeloupe, including improving healthcare, infrastructure projects, and a scheme to create jobs for young people.

The French government this week announced that it would be postponing a requirement that public sector workers in Guadeloupe and Martinique get a COVID-19 vaccination.

That had sparked protests, fanning long-standing grievances over living standards and the relationship with Paris.

In Guadeloupe there is a historic mistrust of the French government’s handling of health crises after many people were exposed to toxic pesticides used in banana plantations in the 1970s.

 

 

India’s Serum Institute Resumes Vaccine Exports to COVAX Vaccine Sharing Program

The world’s largest vaccine maker, the Serum Institute of India has resumed exports of coronavirus vaccines to COVAX the partnership that is distributing vaccines to developing countries. The resumption of exports comes at a critical time when a new variant found in South Africa is causing concern around the world.

India suspended exports of vaccines in March this year following a severe surge in infections during the second wave of the COVID-19 pandemic as it used its stocks to ramp up its domestic inoculation program.

The first shipments went out Friday.

“This will go a long way in restoring vaccine supply equality in the world,” Serum Institute chief executive Adar Poonawalla said on Twitter.

The company said in a press statement that said that it expects the supply of vaccines to COVAX to increase substantially in early 2022. The Serum Institute of India was expected to be one of the main suppliers to the vaccine sharing facility which was created to ensure global equitable access to COVID-19 vaccines after the outbreak of the pandemic.

The Serum Institute linked the resumption of exports to surpassing its target of producing 1 billion doses of the AstraZeneca vaccine by the end of this year – it has produced 1.25 billion doses so far.

Gavi, the Vaccine Alliance, which leads the COVAX program along with the World Health Organization, called the restart of exports from India an important development “as it enters its busiest period yet for shipping vaccines to participating economies.”

The export curbs by India were a huge setback to efforts by COVAX, which had been relying on supplies of the affordable and easy to store AstraZeneca vaccine from India’s Serum Institute to distribute to low-income countries. The vaccine is called Covishield in India.

“While COVAX’s portfolio is now much more diversified than it was earlier this year when we received our first SII deliveries, COVISHIELD remains an important product which has the potential to help us protect hundreds of millions of people in the months ahead,” according to Seth Berkley, chief executive of GAVI, the Vaccine Alliance.

India has allowed exports to resume as its vaccination program makes substantial progress and vaccine supplies improve – about 80% of the country has received one dose and about 40% is fully vaccinated. Cases of coronavirus have also reduced dramatically – on Friday, India reported about 9,000 cases.

However, a new variant found in South Africa, dubbed omicron, is causing widespread concern and has prompted experts in India to caution against complacency. Designated a variant of concern by the World Health Organization, omicron has already been found in Belgium, Botswana, Israel and Hong Kong and has prompted several countries, including the United States and Britain to impose travel curbs.

India has said it is scaling up screening of passengers from overseas. At a meeting held Saturday to review the pandemic, Prime Minister Narendra Modi asked officials to review plans to ease international travel restrictions.

“In light of the new variant, we remain vigilant with a focus on containment and ensuring increased second dose coverage,” he tweeted. 

US Shoppers Return for ‘Black Friday,’ But Many Have Already Bought

Americans returned to stores for the “Black Friday” kickoff of the holiday shopping season, but online data shows that consumers have been spending big for weeks amid worries over shortages.

The day after the U.S. Thanksgiving celebration is the traditional start to the holiday shopping season, and normally sees Americans line up outside stores before they open to clinch deals on popular items.

After the pandemic kept crowds away last year, many shoppers were out in force Friday, a sign of how COVID-19 vaccines have returned life in the United States to something closer to normal.

“I just wanted to make sure that this Christmas was a good Christmas for all my friends and family,” said a masked Sylvia Gonzalez as she waited in line outside the jewelry chain Pandora in New York.

But even before retailers opened their doors early Friday morning, e-commerce shoppers in the United States had already spent $76 billion since early November, up more than 20% from the year-ago period, according to data from software company Adobe, which has projected somewhat fewer promotions this year in light of rising costs.

The jump has added to companies’ optimism about the season, suggesting some shoppers heeded calls from businesses to purchase items early this year after port backlogs and other logistics problems sparked worries that popular goods would be in short supply.

Toys led the buying spree, with Adobe pointing to actions by “anxious parents increasingly aware of supply chain challenges.”

The National Retail Federation projects overall spending could rise as much as 10.5% to $859 billion.

Nonetheless, out-of-stock listings online are up 261% compared with two years ago, according to Adobe.

Item in hand

Retailers and market watchers are broadly optimistic about the holiday shopping season in light of low unemployment and relatively strong household finances due in part to pandemic stimulus bills enacted by the government.

Countering those positive trends are lingering supply chain problems, spiking consumer prices that have affected household staples such as food and fuel, and the COVID-19 pandemic, which is still far from over.

On Friday, stock markets worldwide tumbled on worries that the latest strain of the virus found in South Africa could derail the global recovery.

Reminders of the pandemic were visible throughout shopping districts in the New York borough of Manhattan.

Signs at Macy’s reminded customers to keep 2 meters apart, and pop-up COVID-19 testing sites were positioned outside stores where mostly masked crowds were large, but not as sizeable as before the pandemic.

“In 2018, it was more like the New York you heard of,” said German tourist Ilke Zienteck. “Now, it’s a little bit like a small town.”

Still, the hum of customers inside shops suggested that many had adjusted to the “new normal” of pandemic living.

There were obvious gaps at some stores. At a Best Buy near Grand Central Station, a shelf of Apple accessories was almost completely empty, while the camera bags section had few remaining offerings.

Other chains like Victoria’s Secret and Foot Locker have acknowledged shortages of some choice products.

Taylor Schreiner, a digital research expert at Adobe, expects more consumers to order online and pay for expedited shipping, or pick up goods at stores.

“It’s not just because people want it quickly,” he said in an interview. “Having the item in hand is the surest way to have the gift for the person.”

January glut?

An emerging worry in the industry is that retailers will be stuck with goods originally intended for the holidays but that don’t arrive until January.

Macy’s is generally canceling orders for items with a Christmas motif but plans to keep other items if they are cold-weather-oriented and could sell later in the winter, executives said earlier this month.

Gap Chief Financial Officer Katrina O’Connell said the apparel chain was planning to hold some items for next winter.

“If we think items are going to be too late for the holiday season, we won’t put them in stores or online and have them generate markdowns,” she said earlier this week on a conference call with Wall Street analysts. “We’ll hold them for next year.”

Gap has been one of the companies hardest hit by supply chain problems due to lengthy factory shutdowns in Vietnam caused by the country’s COVID-19 restrictions, which contributed to a loss of some $300 million in sales in the most recent quarter.