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The U.S. Food and Drug Administration authorized the emergency use of an antiviral COVID-19 pill, the pill’s maker Pfizer Inc. said Wednesday.

The company says the pill, which is to be taken with another antiviral drug, ritonavir, is 90% effective in preventing hospitalization and death in high-risk people.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” Dr. Gregory Poland of the Mayo Clinic told The Associated Press. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group—that’s stunning.”

The pill is the first at-home treatment for the virus and is approved for use in those 12 and older who are at high risk.

Pfizer says it’s ready to start delivery of the drug immediately in the U.S. and will produce 120 million courses in 2022.

The U.S. government has a contract with the company for 10 million courses priced at $530 per course.

The drug will be sold under the name Paxlovid and will have to be taken every 12 hours for five days once COVID-19 symptoms appear. Potential users of the new drug will have to show a positive virus test.

Drug giant Merck is also working on a similar drug.

Despite the promise, health officials say getting a vaccine is still the best way to stave off the worst effects of the virus. 

Some information in this report comes from The Associated Press and Reuters.
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Researchers in Australia have identified a gene that indicates the kidney has its own way of resisting damage. However, they have also identified a mutation of the gene that can in patients with, for example, diabetes, trigger the development of renal disease. 

A gene called VANGL1 has been found to help stop the immune system from attacking the kidney. But Australian researchers say the genetic mutation, which is present in about 15% of the population worldwide, can cause renal disease in patients with diabetes and other autoimmune conditions.   

The mutation is highly prevalent among indigenous people on the Tiwi Islands, 80 kilometers from the city of Darwin in the Northern Territory. According to the study, just less than 50% of the islands’ residents have the genetic mutation.   

The islands’ recorded rates of kidney disease are four times those of mainland indigenous Australians and about 11 times that of non-Indigenous Australians, according to researchers. 

Dr. Simon Jiang is from the John Curtin School of Medical Research at Australian National University. He says the mutation is mostly benign in healthy adults. 

“If your body is not inflamed and you are otherwise healthy, it is probably not too much of an issue. It is when you have another condition that occurs on top of it. And so in the Tiwi Islands, rates of infection, of diabetes and probably some immune diseases, are a lot higher than the rest of Australia. And so, when you have that process happening within your body, what is initially a reasonably benign mutation suddenly takes on a new turn and becomes something that is really bad news for the kidney,” Jiang said.  

The study could lead to better transplant screening that would identify potential donors who have the genetic mutation. 

The study was published Wednesday in the journal Cell Reports Medicine. 
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The United Nations estimates 7.7 million people, half of Somalia’s population, will require humanitarian assistance and protection in 2022.It is appealing for $1.5 billion to assist 5.5 million of the most vulnerable among them.

Decades of conflict, recurrent climatic shocks, disease outbreaks, and increasing poverty, including the socio-economic impact of the COVID-19 pandemic are devastating the lives and livelihoods of people in Somalia.

They are facing acute hunger. Many are on the verge of famine because the rains have failed to fall for a third year in a row.U.N. Humanitarian Coordinator for Somalia, Adam Abdelmoula says 80 percent of the country is affected by drought. 

Speaking on a video link from the capital Mogadishu, he tells VOA 169,000 people have abandoned their homes in search of water, food, and grazing land for their livestock. 

“When I visited the countryside, I saw many dead animals,” he said. “The people I met with, including one woman told me that she lost all her 200 goats, and two camels and her donkey and she and her three children are living under a tree…and the elderly people I met with told me they had not seen this level of drought since the 1970s and 80s.”

Abdelmoula says conditions in Somalia are dire. He expresses concern about a less than adequate response to the U.N. appeal given the fierce competition for funds. He says Somalia has been pushed to the back burner because of emerging crises elsewhere, especially Tigray in northern Ethiopia and Afghanistan. 

He adds the international community would be making a big mistake were it to abandon Somalia.

“When this happened back in the 90’s, some serious consequences ensued. This includes mass migration, starvation and famine, the emergence of al-Shabab and the political instability and widespread piracy,” he said.

Recent projections indicate drought could displace up to 1.4 million Somalis in the coming six months, adding to the nearly 3 million people already displaced by conflict and natural disasters. 

Humanitarian coordinator Abdelmoula says at least 1.2 million children under age five are likely to be acutely malnourished in 2022.He warns some 300,000 children projected to be severely malnourished are at risk of dying without imminent assistance.
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U.S.-based drugmaker Moderna says that initial laboratory tests show a third shot of its current COVID-19 vaccine is effective against the fast-spreading omicron variant of the coronavirus. 

In a statement released Monday, the company said a half dose of the vaccine given as a booster increased the antibodies levels 37 fold, while a full dose of the vaccine — which is used in the full dose regimen — boosted antibodies levels over 80 fold.

Dr. Paul Burton, Moderna’s chief medical officer, says the study — which has not been peer-reviewed — proves the company’s vaccine is effective, “extremely safe” and “will protect people through the coming holiday period and through these winter months, when we’re going to see the most severe pressure of omicron.” 

U.S. federal health officials authorized both the Moderna and the two-shot Pfizer COVID-19 vaccine to be used as booster shots for all adults last month.

Moderna’s announcement comes a day after Dr. Anthony Fauci, the top infectious disease expert in the United States, warned that omicron is “raging through the world” as he urged Americans to get vaccinated and get a booster shot.

The World Health Organization said Sunday that omicron, which was first detected last month in a handful of southern African nations, is now present in 89 countries.

New York state marked a third consecutive day of record-setting new infections Sunday with nearly 22,500 confirmed cases. The rising number of infections has triggered closures of numerous theater shows and restaurants in New York City in a scene reminiscent of March 2020 when COVID-19 first struck. Residents have been standing in long lines for hours at city-run testing sites.

The outbreak continues to affect three of the major professional sports leagues in North America. The National Hockey League postponed a total of 27 games Saturday and Sunday, and has postponed at least 12 more games through December 23 because they involved travel between the U.S and Canada. The National Football League was forced to move a handful of Sunday games to Monday and Tuesday due to widespread COVID-19 outbreaks among several teams, with more than 100 players combined entering the league’s health and safety protocols.

And the National Basketball Association announced it was postponing five games Sunday with players on a handful of teams testing positive for the coronavirus, bringing the total number of postponed games to seven.

The surge has also reached the halls of the U.S. Congress, with two prominent lawmakers, Democratic Senators Elizabeth Warren and Cory Booker, both announcing Sunday they had tested positive. Warren and Booker each said they had been vaccinated and gotten a booster shot.

Meanwhile, Israel announced Monday that it has banned travel to 10 nations — Belgium, Canada, Germany, Hungary, Italy, Morocco, Portugal, Switzerland, Turkey and the United States — due to the rapid spread of omicron. Under the country’s “red list,” Israelis who return from these nations are required to quarantine, even if they are vaccinated.

Israel’s health ministry reported 175 cases of the new variant on Sunday 

Some information for this report came from the Associated Press and Reuters. 
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CNN is closing its offices in the United States to all nonessential employees as COVID-19 cases increase, the network said on Saturday in an internal memo to staff seen by Reuters.

CNN, part of AT&T Inc’s WarnerMedia division, will close its offices to all employees who do not have work in the office, the memo said.

“We are doing this out of an abundance of caution,” CNN President Jeff Zucker said in the memo. “And it will also protect those who will be in the office by minimizing the number of people who are there.”

Employees who need to come to the office will be required to wear a mask at all times, CNN said.

The network will also make changes to its studios and control rooms to minimize the number of people at offices, according to the memo.

The news was first reported by The Wall Street Journal.

The network had set a tentative return-to-office date in January and it isn’t known if that date will move, the Journal reported, citing a person familiar with the matter.

CNN requires all employees to be vaccinated against the COVID-19 to come to office or to work on field with other employees.

In August, the company terminated three of its workers for coming to the office unvaccinated.

 
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“The Netherlands is shutting down again,” Prime Minister Mark Rutte said Saturday in a televised address. The new measures, beginning Sunday, Rutte said, are because of a “fifth wave” of COVID-19, due to the highly contagious omicron variant.

Under the new rules, all non-essential shops will be closed to at least mid-January. Only two guests will be permitted to visit a household at one time. Four guests, however, will be allowed during the upcoming holidays from Dec. 24-26 and New Year’s Eve and New Year’s Day.

Schools will be immediately closed until at least Jan. 9.

While the Netherland boasts an 85% inoculation rate of its population, only 9% have received booster shots.

Jaap van Dissel, the chief of the Dutch outbreak management team, said the shutdown will give people time to get their booster jabs and gives hospitals time to prepare for the possible surge in COVID cases.

Other European countries are also moving to reimpose restrictions to contain the variant’s spread.

The new variant has fueled infections in Britain close to the peak levels of early 2021, while other European countries and the United States are also experiencing surges.

Scientists are warning the British government needs to go further to prevent hospitals from being overwhelmed amid the surge. The warning comes after the government reimposed an indoor mask requirement and ordered people to show proof of vaccination or a recent negative coronavirus test when entering night clubs or large venues.

Britain’s Health Security Agency said Friday that 65 patients were hospitalized in England with omicron.

In France, the government said it would start inoculating children ages 5-11 beginning Wednesday. As he declared Friday the omicron variant was spreading like “lightning,” Prime Minister Jean Castex proposed requiring proof of vaccination for those entering public establishments.

The measure, which requires parliamentary approval, has triggered plans for protests Saturday in Paris, where the New Year’s Eve fireworks display has been canceled.

Anti-lockdown protests also are planned for Saturday in Turin, Italy.

Egypt has detected its first three cases of the new variant, according to the country’s health ministry. The ministry said Friday the three infected people were among 26 travelers who tested positive for coronavirus at Cairo International Airport.

The ministry did not say where the three came from, but the Masrawy news outlet reported they were among travelers from South Africa, which announced the discovery of the variant on Nov. 25.

In China, Beijing will maintain its relatively strict containment measures, while the rest of the country will remain flexible. “There is no one-fit-for-all policy” for local governments, a Chinese government said Saturday at a news conference.

China has identified two cases of the omicron variant and has mostly contained the spread of COVID-19 since it was first discovered in the central Chinese city of Wuhan in late 2019.

A recent study has found the risk of reinfection with omicron is more than five times higher compared to the delta variant, and it has shown no sign of causing milder symptoms.

“We find no evidence of omicron having different severity from delta,” said the study by Imperial College London. The study noted, however, that data on hospitalizations is still limited.

The study, conducted in England between Nov. 29 and Dec. 11, was based on 333,000 cases of infections involving different variants of the coronavirus.

More than 5.3 million people have died of COVID-19 globally since the coronavirus emerged two years ago, according to the Johns Hopkins University Coronavirus Resource Center.

Administering vaccines

The center reported more than 8.6 billion doses of vaccines had been administered worldwide as of midday Saturday, a massive logistical campaign complicated by omicron’s surge.

Several countries are racing to accelerate vaccination campaigns as mounting evidence supports the need for booster doses to combat the omicron variant.

Turkish President Recep Tayyip Erdogan said Saturday that his country would send 15 million doses of vaccines to Africa, where infections are surging and vaccination rates are low. Erdogan made the announcement at a summit of African leaders in Istanbul.

“It is disgraceful for humanity that only 6% of Africa’s population has been vaccinated,” Erdogan said.

A vaccine developed in India, Covovax, was granted emergency approval Friday by the World Health Organization. WHO vaccines chief Mariangela Simao said the approval “aims to increase access particularly to lower-income countries.”

In Europe, European Union governments agreed to order more than 180 million doses of a BioNTech-Pfizer vaccine adapted for omicron, the head of the European Commission said Friday.

Japan’s Prime Minister Fumio Kishida said Friday the government plans to accelerate booster shots to around 31 million vulnerable people. He also said he spoke Friday with Pfizer CEO Albert Bourla about oral treatments.

South Africa, which first identified the omicron variant, said Friday it would donate about 2 million doses of Johnson & Johnson’s vaccine to other African countries next year via a medical supplies platform established by the African Union.

Some information in this report came from Agence France-Presse, The Associated Press and Reuters. 

 
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The Occupational Health and Safety Administration said Saturday that it would not issue citations tied to its coronavirus vaccination mandate before Jan. 10, so that companies have time to adjust to and implement the requirements.

The federal agency separately said there would be no citations of companies regarding its testing requirements before Feb. 9.

The announcement came after the U.S. Court of Appeals for the Sixth District in Cincinnati decided on Friday that the mandate for large employers could go forward, reversing a previous court decision made after 27 Republican-led states, conservative groups, business associations and some individual companies challenged the mandate.

OSHA said in a statement that it would not issue citations before the listed dates “so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard.”

The mandate was previously slated to take effect Jan. 4.

The Biden administration’s vaccine requirement applies to companies with 100 or more employees and covers about 84 million U.S. workers. Employees who are not fully vaccinated have to wear face masks and be subject to weekly COVID-19 tests. There are exceptions, including for those who work outdoors or only at home.

Administration officials estimate that the mandate will save 6,500 lives and prevent 250,000 hospitalizations over six months. 
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The head of the World Health Organization says the continuing surge of COVID-19 cases is a result of the unequal distribution of vaccines.

Speaking at the First International Conference on Public Health in Africa, WHO Director-General Tedros Adhanom Ghebreyesus noted that it has been just over a year since the first COVID-19 vaccines began to be administered.

He said, “A year ago, we all hoped that by now vaccines would be helping us all emerge from the long, dark tunnel of the pandemic. Instead, as we enter the third year of the pandemic, the death toll has more than tripled, and the world remains in its grip. COVID-19 has now killed more than 5 million people. And they’re just the reported deaths.”

Tedros told the virtual conference that the rapid development of not one, but several safe and effective vaccines, is a triumph of science. But he said, “the inequitable distribution of vaccines has been a failure for humanity.”

The WHO chief said that while more than 8.5 billion doses have been administered globally – the largest vaccination campaign in history, only 8% of Africa’s eligible population is fully vaccinated.

“We have often said that as long as vaccine inequity persists, the more opportunity the virus has to spread and mutate in ways no one can prevent or predict. And so, we have omicron,” the director-general said.

Tedros noted, however, that vaccine-sharing programs are “picking up speed.” He said, “In the past 10 weeks, COVAX has shipped more vaccines than in the first nine months of the year combined.”

 
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Egyptian health authorities said they have identified the country’s first cases of the highly transmissible omicron variant of the coronavirus.

Three people were found to have the variant among 26 travelers who tested positive for coronavirus at Cairo International Airport, the Health Ministry said in a statement late Friday. It didn’t say where the three came from.

The local Masrawy news outlet reported the three were among travelers from South Africa.

The ministry said two of the people infected showed no symptoms, while the third suffered from mild symptoms. The three have been isolated in a Cairo hospital, it said.

Authorities on Friday reported more than 900 confirmed new cases of coronavirus and 43 deaths over the previous 24 hours.

Egypt has reported a total 373,500 cases, including 21,277 fatalities, since the pandemic began. 

 
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Pfizer Inc on Friday forecast that the COVID-19 pandemic would not be behind us until 2024 and said a lower-dose version of its vaccine for 2- to 4-year-olds generated a weaker immune response than expected, potentially delaying authorization.

Pfizer Chief Scientific Officer Mikael Dolsten said in a presentation to investors that the company expects some regions to continue to see pandemic levels of COVID-19 cases over the next year or two. Other countries will transition to “endemic” with low, manageable caseloads during that same time period.

By 2024, the disease should be endemic around the globe, the company projected.

“When and how exactly this happens will depend on evolution of the disease, how effectively society deploys vaccines and treatments, and equitable distribution to places where vaccination rates are low,” Dolsten said. “The emergence of new variants could also impact how the pandemic continues to play out.”

Pfizer developed its COVID-19 vaccine with Germany’s BioNTech SE, and currently expects it to generate revenue of $31 billion next year. It plans to make 4 billion shots next year.

The drugmaker also has an experimental antiviral pill called Paxlovid which reduced hospitalizations and deaths in high-risk individuals by nearly 90% in a clinical trial.

Three analysts estimate sales of $15 billion to $25 billion for it next year, according to IBES data from Refinitiv.

Pfizer’s forecast came after the emergence of the omicron variant last month, which has more than 50 mutations compared with the original version of the virus. That has reduced the effectiveness of two doses of the vaccine against infection, and spurred fear of rapid spread around the globe.

Prior to the omicron variant, top U.S. disease doctor Anthony Fauci forecast the pandemic would end in 2022 in the United States.

Pediatric vaccine

The Pfizer vaccine is authorized in the United States for people aged 5 and older. But it said on Friday that its study in children between the ages of 2 and 4 who were given two 3-microgram doses of the vaccine found it did not create the same immune response that a larger dose of the vaccine had in older children.

The 3-microgram dose did generate a similar immune response in children aged 6 to 24 months, the company said. The company said it will now test a three-dose course in both age groups, as well as in older children. It had previously expected data from 2- to 4-year-olds this year but said it did not expect the delay would meaningfully change plans to file for emergency use authorization in the second quarter of 2022.

Pfizer and BioNTech have also been developing a version of their vaccine tailored to combat the quick-spreading omicron variant, although they have not decided whether it will be needed. They expect to start a clinical trial for the updated vaccine in January, Pfizer executives said.

Variant-specific shots, if needed, could boost sales in 2022. The highly transmissible omicron variant of the coronavirus has been det

ected in over 77 countries and has spread to about one-third of U.S. states.The vaccine was around 95% effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose. Early data suggests that three doses of the shot may be necessary to protect against the omicron variant. 

 
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New York state reported Friday that just over 21,000 people had tested positive for COVID-19 the previous day, the highest single-day total for new cases since testing became widely available.

Just under half of the positive results were in the city, where lines were growing at testing stations, the Rockettes Christmas show was canceled for the season and some Broadway shows nixed performances because of outbreaks among cast members.

One-day snapshots of virus statistics can be an unreliable way to measure trends, but the new record punctuated a steady increase that started in the western part of the state in late October and has taken off in New York City in the past week as the omicron variant spreads.

“This is changing so quickly. The numbers are going up exponentially by day,” Gov. Kathy Hochul said during a Friday appearance on CNN.

The steep rise in infections should be of great concern, but it was inevitable, given the quick spread of the newest variant, said Dr. Denis Nash, the executive director of the Institute for Implementation Science in Population Health at the City University of New York.

“We were already headed for a winter surge with delta, which is a very concerning thing in its own right,” Nash said.

“But then you layer on top of that the new omicron variant, which is more transmissible from an infection standpoint,” he said, noting that current vaccines may be unable to contain the “more invasive” new variant.

Statewide, New York averaged 13,257 positive tests per day over the seven-day period that ended Thursday. That is up 71% from two weeks ago.

The state’s previous one-day high for positive tests came on Jan. 14, 2021, when just under 20,000 people tested positive.

New York City Mayor Bill de Blasio has warned that omicron is in “full force,” but said the city’s hospitals are “very strong and stable right now” and far better able to handle COVID-19 than when the pandemic began. Treatments have improved, and more than 70% of eligible city residents are fully vaccinated, he noted. 
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The U.S. Centers for Disease Control and Prevention on Friday issued guidelines for keeping children in school even if they are unvaccinated or partially vaccinated and have been exposed to someone with COVID-19.

During a virtual briefing by the White House COVID-19 response team, CDC Director Rochelle Walensky said the test-to-stay protocol involves testing twice in a seven-day period anyone who has had close contact with someone infected with COVID-19. She said if exposed children meet certain criteria and continue to test negative, they can stay in school instead of quarantining at home.

Walensky said numerous jurisdictions have been experimenting with test-to-stay strategies. Some were testing every day, some every other day, and some twice a week. From those experiments, she said, the CDC will recommend no less than twice-weekly testing to adequately adhere to test-to-stay protocols.

The CDC also published studies conducted in the United States and internationally that looked at how COVID-19 is spread in schools, which helped form the basis for test-to-stay recommendations.

Walensky reported at least 39 U.S. states have more than 75 confirmed cases involving the omicron variant. She said the delta variant continues to circulate widely and remains the dominant strain in the United States, but omicron is spreading rapidly and is expected to become the dominant strain in the coming weeks.

The CDC director said omicron has been found among those who are vaccinated and boosted, and health officials believe these cases are milder or asymptomatic because of vaccine protection. “What we do know is we have the tools to protect ourselves against COVID-19,” she said.

White House Coronavirus Response Coordinator Jeff Zients said the U.S. is fully prepared to confront the variant, with ample supplies of vaccines and boosters.

“This is not a moment to panic, because we know how to protect people,” Zients said. “And we have the tools to do it.”

Some information for this report came from The Associated Press and Reuters,
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Japanese Prime Minister Fumio Kishida said Friday his government is seeking to accelerate its COVID-19 booster shots campaign and has reached out to the head of U.S. pharmaceutical company Pfizer to secure additional vaccines.

Kishida told reporters the government has been negotiating to receive 120 million doses of Pfizer’s COVID-19 vaccine ahead of schedule. He said during his call with the company’s CEO, Albert Bourla, he also agreed to purchase two million doses of Pfizer’s oral COVID-19 treatment, Paxlovid.

The government started arrangements Thursday to adjust the timeframe for workers and patients in elder-care facilities to receive booster shots to six months after their second shots. Health officials shortened the original eight-month timeline between initial vaccinations and booster shots after the discovery of the new omicron variant of coronavirus, the virus that causes COVID-19.

Japan has confirmed a handful of omicron variant cases. The Tokyo Metropolitan Government confirmed on Friday that a man in his 20s who attended a soccer match near the capital was found positive for omicron.

Japanese Chief Cabinet Secretary Hirokazu Matsuno also confirmed 70 coronavirus cases have been found at the U.S. Camp Hansen military base in the southern island prefecture of Okinawa.

Matsuno said the Japanese government has urged U.S. officials there to thoroughly quarantine infected persons, identify close contacts at an early stage, and strengthen measures to prevent the spread of infection.

Some information for this report was provided by The Associated Press and Reuters.
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