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.

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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.

 

 

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World Reacts to New COVID Variant

U.S. President Joe Biden announced the United States will restrict travel from South Africa and seven other African countries, effective Monday.

Any non-U.S. citizen who has been in one of the eight nations during the 14 days before coming to the United States will be denied entry. The restrictions do not apply to American citizens and lawful permanent residents; however, they must test negative before traveling, as must all international travelers.

Biden made the announcement Friday after consulting with Dr. Anthony Fauci, his chief medical adviser. Besides South Africa, the other countries are Botswana, Zimbabwe, Namibia, Lesotho, Eswatini, Mozambique and Malawi.

Biden took the action after the World Health Organization (WHO) designated the new variant, B.1.1.529, a variant of concern and dubbed it omicron.

In his announcement, Biden said he had two important messages for the American people: For those fully vaccinated, “get a booster shot as soon as you are eligible.” And “for those not yet fully vaccinated, get vaccinated today.”

What is omicron?

Omicron is the fifth WHO-designated variant of concern. It was first detected in recent weeks in South Africa, which has seen an exponential rise in COVID-19 cases.

There are about 30 mutations on the virus’ spike protein, and scientists worry that some of them could make the virus easier to transmit. But scientists do not yet know whether omicron is in fact more transmissible or dangerous.

Worries about the new variant sent financial markets reeling Friday and pushed the price of oil down by $10 a barrel.

The WHO said understanding the variant could take weeks and cautioned against travel restrictions. Its director of emergencies, Mike Ryan, urged “no knee-jerk responses.”

Ryan’s advice went unheeded as travel restrictions were immediately reinstated in places including Britain, the European Union, Canada and the U.S. Other countries, such as India, Japan, Israel, Turkey, Switzerland and the United Arab Emirates enacted some form of travel curbs, Reuters reported.

Some epidemiologists warned that they were likely too late. Omicron has already been found in Belgium, Botswana, Israel and Hong Kong. Dozens of passengers disembarking in the Netherlands from flights from South Africa initially tested positive for the coronavirus.

 

“Travelers with a positive test result will be placed in isolation at a hotel at or near Schiphol,” Dutch health authorities said in a statement. “Of the positive test results, we are researching as quickly as possible whether they are the new variant of concern.”

Travel restrictions and quarantine requirements in Switzerland in reaction to omicron have caused the World Trade Organization to postpone its biennial meeting, originally set to begin Tuesday. One of the main agenda items for the gathering was improving the availability of COVID-19 vaccines.

Several of the ministers and delegates would not be able to attend the meeting because of the restrictions, Director-General Ngozi Okonjo-Iweala said. “This has not been an easy recommendation to make, she said. “But as Director-General, my priority is the health and safety of all MC12 participants – ministers, delegates and civil society.”

But some authorities have held out hope that early detection of the new variant, coupled with the new restrictions, could have a bigger impact than the initial response to delta variant, Jeffrey Barrett, director of COVID-19 Genetics at the Wellcome Sanger Institute in Hinxton, England, told The Associated Press.

“With delta, it took many, many weeks into India’s terrible wave before it became clear what was going on and delta had already seeded itself in many places in the world and it was too late to do anything about it,” he said. “We may be at an earlier point with this new variant, so there may still be time to do something about it.”

The South African government has called the travel restrictions “rushed” and raised concerns about the impact on business.

The CEO of South Africa’s inbound tourism association, David Frost, says the effects will be devastating on the sector.

“We got off the red list in October, and it was sorely needed. We’ve been shut down for over 18 months,” Frost said. “You know, the industry really is on its knees. The impact of this is absolutely dire to livelihoods, to families.”

South African Tourism Minister Lindiwe Sisulu told The New York Times that her country is feeling “punished” for the omicron research its scientists have done.

Dr. Michelle Groome, head of the Division of Public Health Surveillance and Response at South Africa’s National Institute for Communicable Diseases, said social distancing and mask use could help combat the virus, but she questioned the efficacy of travel bans.

“We haven’t been able to contain the spread initially of the original virus, and all subsequent variants have spread globally, you know,” Groome said. “I think there’s limited value in terms of these restrictions.”

Instead, she said, vaccinating more of the population would help prevent the most severe cases and deaths.

Low vaccination rates

Roughly 35% of the South Africa’s adult population is vaccinated, a figure far below targets of 70%.

Figures are even lower across much of the African continent.

Experts have warned vaccine inequality would create a breeding ground for virus mutations.

Astrid Haas is an independent urban economist in Kampala, Uganda.

“In Europe now and in North America, in particular, they’re talking about booster shots and third vaccines, whereas we know now from the WHO that less than 10% of African countries are going to even meet their vaccine target for this year. … Just a very sad manifestation of the global vaccine inequity,” she said.

In the absence of vaccinations, lockdowns may be on the horizon.

Some information for this report came from The Associated Press and Reuters. 

 

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Tourists Rush to South Africa Airport After Travel Bans Issued

Anxious-looking travelers thronged Johannesburg international airport and stood in long queues on Friday, desperate to squeeze onto the last flights to countries that had just shut their doors to South Africa.

Many cut short their holidays, rushing back from safaris and vineyards when Britain announced late Thursday night that all flights from South Africa and its neighbors would be banned the following day.

A flurry of nations — including the United States, Canada and several European countries — have followed suit, concerned about the discovery of a new coronavirus variant, renamed omicron, with several mutations fueling an infection resurgence in South Africa.

United Kingdom citizen Toby Reid, a 24-year-old trader in London, was camping on Cape Town’s Table Mountain with his girlfriend when the ban was announced.

“At about 5:30 a.m., we got up to see if we could catch the sunrise, and at six in the morning, we found out that there was still a possibility to get back,” he told AFP while standing in line for check-in at the Johannesburg airport just hours later.

The couple managed to grab the last two seats on an evening flight to Frankfurt, Germany.

Others who were not so lucky discussed options at ticket counters, eyes widening at proposed prices and convoluted itineraries.

“There should have been more notice,” muttered Christian Good, 50, returning to Devon, England, via Frankfurt with his husband after a beach holiday.

By chance, the pair had originally planned to return on that flight, meaning they would arrive home before mandatory hotel quarantine begins on Sunday — a requirement for citizens returning from “red list” countries.

“It’s ridiculous. We will always be having new variants,” his husband, David, exclaimed, passports in hand.

“South Africa found it, but it’s probably all over the world already,” he told AFP.

The variant has so far been detected in Belgium, Botswana, Israel and Hong Kong.

‘Tired of this’

At the airport, red “canceled” signs flashed next to London-bound flights listed on the departures board.

Other destinations were still in limbo.

A KLM flight to Amsterdam was delayed by several hours after passengers were suddenly compelled to produce negative COVID-19 results.

Rapid PCR tests were offered at the airport, with results guaranteed in two hours, but at a cost of $86, compared with the standard fee of around $52 for results delivered in roughly 12 hours.

An AFP correspondent observed Some African passport holders being told they would not be allowed to fly to Europe.

Earlier, travelers milled around a closed Air France check-in desk, waiting to find out whether an evening flight to Paris would take off as scheduled, just hours after France announced its own ban.

Among them were U.K. citizen Ruth Brown, 25, who lives in South Africa and had planned to return home for the first time since 2019 next week.

Britain kept South Africa on its red list until early October, meaning many of its citizens have been unable to travel back since the pandemic started because of the costly hotel quarantine.

They had only a few weeks of leeway before the status was revoked.

“We are tired of this situation,” said Brown, who spent the morning on the phone trying to change her flight.

“Apparently (this one) is full, but we are trying to see if we can still get seats,” she sighed.

Further down the line, Elke Hahn cradled a toddler.

She had traveled to South Africa with her partner to adopt the child and was desperate to get back to their home in Austria.

The child’s paperwork was only valid for a specific flight route that had since been changed.

“We will have to get another flight, but I don’t know how that will work,” she said. 

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Fauci: US Must Study Data Before Deciding on Travel Ban Over New COVID Variant

Top U.S. infectious disease official Anthony Fauci said Friday that a ban on flights from southern Africa was a possibility and the United States was rushing to gather data on the new COVID-19 variant. 

 

No decision to halt flights had yet been made, he said. The Wall Street Journal, citing people familiar with the matter, said White House officials were discussing potential travel restrictions on southern African countries. Those officials were expected to meet with agency officials Friday afternoon to make a recommendation, the newspaper said, without specifying which agency. 

 

The White House referred to Fauci’s earlier comments when asked about the report and declined further comment. Global authorities have reacted with alarm to the new variant, detected in South Africa, with the European Union and Britain among those tightening border controls as scientists seek to find out if the mutation is vaccine-resistant. 

 

The World Health Organization (WHO), however, has cautioned against hasty measures and South Africa said a British ban on flights seemed rushed. 

 

“There is always the possibility of doing what the UK has done, namely block travel from South Africa and related countries,” Fauci said in an interview on CNN. 

 

“That’s certainly something you think about and get prepared to do. You’re prepared to do everything you need to protect the American public. But you want to make sure there’s a basis for doing that,” he said. 

 

“Obviously as soon as we find out more information we’ll make a decision as quickly as we possibly can.”

 

Fauci said U.S. scientists would speak with South African counterparts Friday about the new variant, called B.1.1.529, which has raised concern about its transmissibility and whether it might evade immune responses. 

 

He added there was no indication the new variant was already in the United States. 

 

 

 

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New COVID-19 Variant Detected in South Africa

South African scientists are scrambling to determine how quickly a newly discovered variant of the coronavirus can spread and if it is resistant to vaccines.  The new strain has led Britain to reimpose flight bans on six southern African countries, which could deal another heavy blow to their economies. 

Coronavirus cases are once again on the rise in South Africa. 

Amid the spike, several mutations of a new variant called the B 1.1.529 have been detected in the country, Botswana and Hong Kong. 

It has sparked concern it could compete with the previously dominant delta variant and trigger another wave of the pandemic.

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

“There’s the potential that this could be more transmissible and that this, there is potential immune escape, but we don’t know yet,” said Groome. “We are busy conducting some laboratory tests, obviously, we can have a look at how, you know, this new variant reacts both to, you know, serum from people who have been infected previously, as well as vaccinated, which will give us a better idea of the potential immune escape.”  

The uncertainty has prompted travel restrictions. 

Britain added six African countries to its so-called red list today, requiring quarantine for incoming travelers and temporarily banning flights.

The European Union also is looking at halting air travel from southern Africa. 

The South African government has called the decisions “rushed” and raised concerns about the impact on business. 

The CEO of South Africa’s inbound tourism association, David Frost, says the effects will be devastating on the sector.  

“We got off the red list in in October and it was sorely needed. We’ve been shut down for over 18 months,” said Frost. “You know, the industry really is on its knees. The impact of this is absolutely dire to livelihoods, to families.”

While social distancing and mask use can help combat the virus, Dr. Groome also questions the efficacy of travel bans.  

“We haven’t been able to contain the spread initially of the of the original virus, and all subsequent variants have spread globally, you know,” said Groome. “I think there’s limited value in terms of these restrictions.”  

Instead, she says vaccinating more of the population would help prevent the most severe cases and deaths.

Roughly 35 percent of the South Africa’s adult population is vaccinated, a figure far below targets of 70 percent. 

Figures are even lower across much of the continent.

Experts have warned vaccine inequality would create a breeding ground for the virus to mutate. 

Astrid Haas is an independent urban economist in Kampala, Uganda.  

“In Europe now and in North America, in particular, they’re talking about booster shots and third vaccines, whereas we know now from the WHO, that less than 10% of African countries are going to even meet their vaccine target for this year. …Just a very sad manifestation of the global vaccine inequity,” said Haas.

In the absence of vaccinations, lockdowns may be on the horizon. 

Such measures already have taken a harsh economic toll across southern Africa. 

Haas says the halt to retail and other services has made it hard for many people to survive.  

“Particularly with respect to the urban poor is that a lot of income is used to purchase food, or a high proportion of income is used to purchase food, and when they are not able to make income, then that affects food security as well,” said Haas.

South African President Cyril Ramaphosa is convening the country’s coronavirus council this weekend in response to the new variant. 

The government says it will announce any new measures in coming days. 

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Cases Soar but Swiss Reject Lockdown as COVID Law Vote Looms

Like many others in Europe, Switzerland is facing a steep rise in coronavirus cases. But its federal government, unlike others, hasn’t responded with new restrictive measures. Analysts say it doesn’t want to stir up more opposition to its anti-COVID-19 policies, which face a crucial test at the ballot box this weekend as critics have grown increasingly loud.

On Sunday, as part of the country’s regular referendums, Swiss voters will cast ballots about the so-called “COVID-19 law” that has unlocked billions of Swiss francs (dollars) in aid for workers and businesses hit by the pandemic. The law has also imposed the use of a special COVID certificate that lets only people who have been vaccinated, recovered, or tested negative attend public events and gatherings.

If the Swiss give a thumbs-up, the government may well ratchet up its anti-COVID efforts.

The vote offers a relatively rare bellwether of public opinion specifically on the issue of government policy to fight the coronavirus in Europe, the global epicenter of the pandemic. The continent enjoys relatively high rates of vaccination compared with countries in Africa, Asia and the Middle East, but has been nearly alone in facing a surge in cases in recent weeks.

Polls suggest a solid majority of Swiss will approve the measure, which is already in effect and the rejection of which would end the restrictions — as well as the payouts. But in recent weeks, opponents have raised heaps of cash for their campaign and drawn support from abroad, including a visit from American anti-vaccination campaigner Robert F. Kennedy Jr. to a rally in the capital, Bern, this month.

Swiss weekly NZZ am Sonntag reported that campaigners have sent hundreds of petitions to government offices around the country alleging that the language in the referendum question is vague and makes no mention of the “COVID certificate” that affords access to places like restaurants and sporting events.

On Tuesday, Swiss health authorities warned of a rising “fifth wave” in the rich Alpine country, where vaccination rates are roughly in line with those in hard-hit Austria and Germany — at about two-thirds of the population. Infection rates have soared in recent weeks. The seven-day average case count in Switzerland shot up to more than 5,200 per day from mid-October to mid-November, a more than five-fold increase — with an upward curve like those in neighboring Germany and Austria.

Austria has responded with a much-ballyhooed lockdown, and Germany — which is forming a new government as Chancellor Angela Merkel’s tenure nears its end — has taken some steps like requiring workers to provide their employers with proof of vaccination, recovery or a negative test set to take effect next week.

The Swiss Federal Council, the seven-member executive branch, went out of its way on Wednesday to say: “It’s not the time to decree a tightening of measures nationwide,” while opting for a region-by-region approach and calling on citizens to act responsibly through mask-wearing, physical distancing, and proper airing of indoor areas.

That’s even though the council admitted in a statement that cases — particularly among the young — are rising and “the number of daily infections has reached a record for the year and the exponential rise is continuing.” Hospitalizations — notably among the elderly — are rising too, it said, but not as fast.

Swiss Health Minister Alain Berset has insisted his government hasn’t tightened restrictions because COVID-19 patients still make up only a small percentage of people in intensive-care units.

“But we also know that the number of hospitalizations lags behind the number of infections,” said Pascal Sciarini, a political scientist at the University of Geneva. “One can imagine that if Switzerland didn’t have this particular event — the vote on Sunday — we’d already be preparing (the) next steps.”

The Swiss council may simply be holding its breath through the weekend, he suggested.

“I wouldn’t be surprised if as early as next week, the tone changes,” Scarini said. “It’s starting to budge … the Federal Council is surely going to wait until after the referendum.” 

 

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When Aliens Attack: Australia’s Native Species Under Threat

A new report warns that Australia’s native wildlife is in the “grip of an unprecedented alien attack.” Experts at the national science agency, the CSIRO, are predicting that much of the country’s unique flora and fauna is in danger of disappearing by 2050 unless urgent action is taken.

Nonnative species have invaded Australia and threaten to overrun indigenous plants and animals.

Invasive pests include European rabbits, which infest two-thirds of Australia, feral cats, pigs, foxes and cane toads.

Introduced species are endangering more than 80% of Australia’s threatened species.

A report, Fighting Plagues and Predators: Australia’s Path Towards a Pest and Weed-Free Future, highlights what researchers believe is “a looming wave of new extinctions.”

The study was compiled by the CSIRO, the Commonwealth Scientific and Industrial Research Organization, a government agency.

Andy Sheppard, CSIRO’s research director for biosecurity, said Australia’s colonization by the British more than 200 years ago has left a devastating environmental legacy.

“Look, Australia, as a lot of post-British colonial countries suffered from a huge amount of introduction of exotic species early in their colonization histories,” he said. “You know, there were societies set up to deliberately introduce stuff so that the Europeans felt more at home. Australia just like New Zealand has suffered enormously as a result. Australia unfortunately has the worst record internationally for mammalian extinction, and that is largely to do with the activities of feral cats and feral foxes.”

The report released Tuesday estimated the cost of the damage caused by invasive species in Australia – mostly weeds, feral cats, rabbits and fire ants – at about $18 billion dollars each year and growing.

The study said that “urgent, decisive, coordinated action” was needed to stop the spread of invasive species and protect Australia’s “irreplaceable native animals and plants.”

Traditionally, chemical baits and biological controls have been used to manage feral pest populations. The methods are controversial, and some animal welfare advocates have criticized them as inhumane.

Scientists in Australia are working on genetic pest control techniques. Testing is under way on mice, but a so-called “working system” could be up to five years away. One potential biocontrol involves disrupting the breeding cycles of rodents to limit their ability to reproduce.

 

 

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World Leaders Struggle to Raise Vaccination Rates as COVID-19 Surges

With the Northern Hemisphere heading into winter and COVID-19 cases on the rise across Europe and North America, political leaders from Washington to Brussels are struggling to persuade a pandemic-weary public to get vaccinated against the disease that has killed more than 5 million people and sickened hundreds of millions around the world.

In the United States, a high-profile push by President Joe Biden to force all businesses with more than 100 employees to require workers to get vaccinated or submit to regular testing is snarled in court challenges. Across Europe this week, protests, some violent, flared as various governments announced that they would implement stricter measures to combat the disease, including many that limit the ability of unvaccinated people to take an active part in public life.

Worldwide, countries have responded to the continued presence of COVID-19, now nearly two years after it was first detected, with a variety of measures, from blanket vaccine mandates for all eligible individuals to more targeted requirements for people at particular risk, like health care workers.

Plentiful vaccines, variable uptake

According to Johns Hopkins University’s Coronavirus Resource Center, nearly 7.5 billion doses of vaccine have been administered since shots became available. Those doses have not been spread evenly around the world. The bulk of vaccines have been purchased by wealthy countries, like the United States and much of Europe.

That would seem to suggest that Europe and North America would be well protected from a winter surge of the virus, but even among countries where vaccines are plentiful, the percentage of the population that has chosen to get vaccinated against COVID-19 varies sharply.

According to data collected by Johns Hopkins University, only 59.7% of the American public is fully vaccinated, compared with 76.9% in Canada and 50.4% in Mexico. In Europe, vaccine uptake varies widely, from 86.9% in Portugal to just 12.6% in Armenia.

In Central Europe, cases are spiking in Germany and Denmark, where the rates of vaccination are 68.1% and 76.4%, respectively. Both countries are well above the global average in the percentage of people vaccinated, indicating that the disease can still spread rapidly, even where vaccination rates are relatively high.

This has leaders around the world searching for ways to compel more people to get vaccinated, with varied success.

Different approaches to vaccination

A handful of countries — Indonesia, Micronesia, and Turkmenistan — have implemented blanket requirements that all adults receive a vaccination.

This week, Austria became the first European country to announce that vaccination will be compulsory, with a requirement that all adults be vaccinated by February. The announcement came as the government announced it would be enforcing a fourth national lockdown to reduce the spread of the virus, prompting protests across the country.

Many other countries have taken a less extensive approach, tying vaccination status to the ability to work and take part in public activities, including going to restaurants, concerts, and other events.

With other European countries announcing stricter limits on what the unvaccinated are able to do, as well as broader restrictions on public life in general, protests broke out this week in the Netherlands, Belgium, Germany, and Croatia, among other nations.

Many European countries have adopted a “vaccine passport” system that limits access to public venues to people who can show proof of vaccination or of recent recovery from COVID-19.

Government employees face requirements

Among the most common measures being taken around the globe is the requirement that government employees be vaccinated in order to remain in their jobs. In addition to the U.S., countries with a requirement that public sector workers be vaccinated include Canada, Costa Rica, Denmark, Fiji, Hungary, Italy, Latvia, Russia, Saudi Arabia, Tunisia, Turkey, and Ukraine.

Of those, many have added a mandate for private sector workers as a whole; others have limited the requirement to private sector workers who deal with customers.

Some countries, among them Denmark, France, Lebanon, Morocco, and the Netherlands, have limited mandates to health care workers but have implemented restrictions on the activities of the unvaccinated.

US vaccine resistance

In the United States, President Biden’s attempt to require private businesses with more than 100 employees to require vaccination or testing is in limbo. The proposal, which would take effect in January, would affect about 84 million U.S. workers, on top of existing mandates on health care workers, federal employees and contractors, and the U.S. military.

However, the push by the Democratic president has been met with pushback from Republican politicians across the country. Multiple Republican state attorneys general have filed lawsuits to stop the mandate from coming into force. A federal judge placed a stay on the mandate, preventing its enforcement.

The cases have been consolidated before the 6th U.S. Circuit Court of Appeals, in Cincinnati, where the Biden administration is requesting that the stay on the mandate be lifted.

Supreme Court-bound

Brian Dean Abramson, an adjunct professor of vaccine law at Florida International University and the author of the BloombergLaw/American Health Law Association treatise Vaccine, Vaccination, and Immunization Law, told VOA that the fate of the mandate remains unclear.

According to Abramson, the Occupational Safety and Health Administration, the bureau within the Labor Department that crafted the mandate, left itself open to a number of challenges. For example, it is claiming that the new mandate is necessary to protect workers from a dangerous disease, but simultaneously claiming that health care workers can continue to observe a standard put in place earlier this year that is considerably less stringent.

Regardless of its fate in the 6th Circuit, Abramson said, the case is probably headed for the highest court in the land.

“What I do think is fairly inevitable, is that this will get to the U.S. Supreme Court rather quickly,” he said. “And I think we could see the Supreme Court receiving this, having some kind of expedited argument, and issuing a decision before the end of the year.” 

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Cameroonian Fishermen Harvest Invasive Aquatic Fern to Create Energy Source

Cameroon’s largest lake, Lake Ossa, has been invaded by Salvinia molesta, an aquatic fern native to Brazil that hinders navigation, makes fishing impossible and blocks water access. To combat the spreading plant, a local aid group is training fishermen to harvest the fern and transform it into organic coal.

Florent Tsanga and other fishermen meet twice a week to remove what they can.

Since Salvinia molesta invaded Cameroon’s largest lake in 2016, Tsanga’s life has changed for the worse.

He said his children do not go to school because of the salvinia. When the lake was good, in the ’80s and ’90s, he said, the children went to school. But these days, he can’t afford it.

Lake Ossa is a wildlife reserve that’s home to freshwater turtles, crocodiles, manatees and more than 18 species of fish.

A local aid group has trained community fishermen to transform the salvinia into organic coal.

After the fern is collected, it is dried and burned. The resulting powder is mixed with other substances and then passed through a mold to create charcoal pieces for domestic use.

Because the aquatic plant grows back every seven days, the aid group is also experimenting with a biological solution — raising a weevil that will feed specifically on salvinia. The group has released the weevil in a pilot site in the lake.

They hope the insect will multiply, feed on the salvinia leaves, and produce larva that will attach to new plant growth.

“And birth is where the new leaves are coming out, and at that level, you have proteins that the plant uses to grow,” explained Aristide Kamla, founder of African Marine Mammal Conservation Organization. “The larva will hijack those proteins and therefore will stop the growth of the plant. So, not only the weevil will stop the growth of the plants, but it will also destroy the biomass already present.”

The Cameroon government has agreed to a pilot test of this biological solution but has not discounted other methods, said Sylvain Hector Ebog, the conservator of the Lake Ossa Wildlife Reserve.

“We would like to see the mechanical method applied as well as the biological control,” Ebog said, adding that biological control might take much longer. “We can apply both methods. We are looking for funding.”

While the fishermen in Lake Ossa are willing to sell the salvinia charcoal to make some money, they said they would rather see a solution to clean up the lake so that they can resume fishing.

 

 

 

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European Nations Add Boosters, Plan Shots for Children Amid COVID Surge

European countries expanded COVID-19 booster vaccinations, began plans to get shots to young children and tightened some curbs Thursday as the continent battled a surge in coronavirus cases and concerns about its economic fallout grew.

Slovakia went into a two-week lockdown, and the Czech government declared a 30-day state of emergency involving early closure of bars and clubs and a ban on Christmas markets. Germany crossed the threshold of 100,000 COVID-19-related deaths.

Europe is at the heart of the latest COVID-19 wave, reporting a million new infections about every two days and now accounting for nearly two-thirds of new infections worldwide.

The European Commission proposed Thursday that EU residents would need to have booster shots if they wanted to travel to another country in the bloc next summer without the need for tests or quarantines.

More boosters in France

In France, authorities announced that booster shots would be made available to everyone over 18, rather than just the over-65s and those with underlying health issues.

Many countries are rolling out or increasing the use of booster shots, although the World Health Organization wants the most vulnerable people worldwide to be fully vaccinated first.

In Africa, where just 6.6% of the population of 1.2 billion is fully vaccinated, many countries are struggling with the logistics of accelerating their inoculation campaigns as deliveries of vaccines finally pick up, the head of Africa’s disease control body said Thursday.

The European Centre for Disease Prevention and Control on Wednesday recommended vaccine boosters for all adults, with priority for those over 40.

The number of new daily cases in Germany hit a record of 75,961 on Thursday and its total death toll reached 100,119 since the start of the pandemic, according to the Robert Koch Institute for infectious diseases.

Data showed the surge is weighing on consumer morale in Germany, Europe’s largest economy, dampening business prospects in the Christmas shopping season.

Shots for young kids

There is a growing push in some countries for vaccinating young children.

The EU’s medicines watchdog Thursday approved use of Pfizer and BioNTech’s vaccine in 5- to 11-year-olds at a lower dose, after authorizing it for children as young as 12 in May. The European Commission is expected to issue a final decision Friday.

Poland, Hungary and the Czech Republic were preparing to inoculate younger children following the European Medicines Agency’s approval, although deliveries of the lower doses are not due until December 20.

In France, where the number of infections is doubling every 11 days, Health Minister Olivier Veran said he would ask health regulators to examine whether 5- to 11-year-olds should be able to get vaccinated.

Nearly half a million lives across Europe have been saved because of vaccinations, among people aged 60 years and over since the vaccine roll-out began, the World Health Organization’s regional office said Thursday in a study with the European Centre for Disease Prevention and Control.

Stricter curbs

Many European countries are toughening curbs. The state of emergency announced by the Czech Republic allows the government to order restrictions on public life. Authorities there ordered bars and clubs to close at 10 p.m., banned Christmas markets and capped attendance at cultural and sports events at 1,000 people.

Slovakia’s two-week lockdown from Thursday followed neighboring Austria, which began a lockdown Monday. Slovakia, with one of the EU’s lowest vaccination rates, reported a critical situation in hospitals and new infections that topped global tables.

Authorities ordered all but essential shops and services closed and banned people from traveling outside their districts unless going to work, school or a doctor. Gatherings of more than six people were banned.

French authorities said rules on wearing face masks would be tightened and checks on health passes used for entry to public places would be increased. But officials said there was no need to follow European countries that have reimposed lockdowns.

In Germany, Greens co-leader Annalena Baerbock said the new government, comprising the Social Democrats (SPD), Greens and Free Democrats (FDP), had set itself 10 days to decide if further restrictions would be needed.

Much of Germany already has introduced rules to restrict access to indoor activities to people who have been vaccinated or have recovered.

Warning in Netherlands

In the Netherlands, the number of coronavirus patients in hospital has hit levels not seen since early May, and experts have warned that hospitals will reach full capacity in little more than a week if the virus is not contained.

The Dutch government said it would take strong measures to curb infections. National broadcaster NOS reported Thursday that the government’s leading Outbreak Management Team had advised the closure of restaurants, bars and nonessential stores by 5 p.m. as part of a new package of lockdown measures.

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USAID Says Wheat Seeds Sent to Northeast Syria Meet ‘High Standards’

The U.S. Agency for International Development (USAID) says the wheat seeds it recently provided to farmers in northeast Syria meet “high standards for safety and quality.”

The announcement comes after claims by the Syrian government that the seeds donated by the U.S. agency “are not suitable for cultivation.”

Last week, USAID donated 3,000 tons of wheat seeds to Syria’s northeast to help address wheat shortages in a region hit by a growing drought.

The Syrian government claimed Tuesday, however, that a sample analysis of the U.S.-provided seeds found they are not suitable for cultivation.

The “seeds contain a high rate of nematodes [plant-parasitic worms], which reached 40 percent, and this poses a great danger to agriculture in the region, especially as its effects cause great damage that is exacerbated by the passage of time,” Said Hajji, head of the government’s agriculture directorate in Hasaka province, was quoted by Syria’s state-run SANA news agency as saying.

The Syrian government official warned local farmers in northeast Syria against using the seeds, urging people to destroy them.

A USAID spokesperson, however, told VOA in a statement that the wheat seeds go through treatment and testing for safety and quality before they are donated.

“USAID is supplying Adana and Cihan wheat seed varieties to Syrian farmers, which are sourced from the region and undergo a series of tests at a qualified lab in (the) Kurdish Region of Iraq to verify their quality before they are transported and distributed to farmers in northeast Syria,” the spokesperson said.

The U.S. official added that the “seeds are tested for purity, germination rate, smut, presence of barley, insects, Cephalonia, nematodes, and to ensure they are effectively treated with fungicide.”

Some local farmers told the Kurdish news network Rudaw they have received wheat seeds from USAID partners and have already cultivated them in their farmlands.

Northeast Syria is largely under the control of the U.S.-backed Syrian Democratic Forces (SDF), a Kurdish-led military alliance that has been a major U.S. partner in the fight against the Islamic State (IS) terror group in the war-torn country.

The government of Syrian President Bashar al-Assad has minimal presence in the area, doesn’t recognize an SDF-led local administration and opposes the presence of about 900 American troops, who are deployed in northeast Syria as part of an international coalition against IS.

John Saleh, a Washington-based Syrian affairs analyst said, “The Assad regime, along with its main backer, Russia, don’t want to see development in the Kurdish region, especially if it is supported by the U.S.”

He told VOA the Syrian government wants northeast Syria to remain economically weak in the hope that it will control it again if U.S. forces depart at some point.

“Therefore, they spread these types of absurd rumors to create fear and panic among farmers who are in desperate need for help during these tough economic times,” Saleh said. 

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US Nurses Leaving Hospital Bedsides  

“I could not understand how this highly educated, powerful trauma nurse is now the patient.”

A registered nurse who asks that we call her “Gi” is talking about herself. While working in the emergency room of her community hospital at the height of the COVID-19 pandemic, Gi started crying unconsolably, unable to speak or function. She was having a panic attack and was later hospitalized in an in-patient psychiatric facility, diagnosed with PTSD. Gi is back at a hospital bedside now – as a hospice nurse. 

A pandemic of nurses suffering 

Gi is not alone. The number of nurses with mental health issues has grown substantially during the COVID-19 pandemic. A survey by the International Council of Nurses (ICN) shows that the number of nurses reporting mental health issues since the pandemic started has risen from 60% to 80% in many countries.  

“Nurses are suffering,” says ICN CEO Howard Catton. He cites violent attacks, “along with the exhaustion, grief and fear faced by nurses who are caring for patients.” 

The American Nurses Foundation says 1 of 3 nurses indicate they are “emotionally unhealthy.” 

 

‘Normal systems breaking down’ 

Nurses say the mental health strain arises from a variety of issues.The industry was already facing a staffing shortage prior to COVID-19, and many nurses juggled multiple jobs caring for increasing numbers of patients.Now the recommended ratio of 1 nurse for 2 patients is stretched to a ratio of 1 to 3, to the detriment of patients and nurses alike. 

“Clara,” who has spent her career as a nurse, says she’s up against “tremendous workloads, tremendous volumes, with not enough resources.”One misstep can make the difference between life and death – and potentially ruin a career.

“It’s a constant pressure on your shoulders, a constant downward pressure, you have to move faster, you have to do better, you have to work harder,” she said. 

Alex Kaspin was suffering from a panic disorder from being overworked, overtired and overwhelmed. She recently stepped away from a Philadelphia emergency room when the COVID-19 numbers were matched by the city’s rising homicide rate.

 

“At that point,” says Kaspin, “all normal systems were breaking down.” Kaspin says her hospital was operating in a “triage situation.” It did not have enough nurses to attend to patients in regular rooms.So the emergency room was filled with in-patients, and the waiting room became the emergency room.

‘Please give me the vaccine now’ 

Between rising violence in the United States and the increase in COVID-19 patients, Kaspin felt she could not deliver health care at the standards she set for herself.Adding to the stress were patients unvaccinated against COVID-19. 

She is haunted by her memories of several COVID-19 patients in their 20s. “Right before we put the breathing tube down, the last thing they say is. ‘I want the vaccine now. Please give me the vaccine now.’ “ 

Pennsylvanian Jen Partyka calls vaccine hesitancy a willful ignorance she’s never seen in her 27 years of nursing.

“You are willfully creating a situation that I can’t keep up with as a nurse manager,” says Partyka. She will always do her best for her patients, she says, but she feels differently when she learns they are unvaccinated.“You are willfully harming others.”

 

Experts say getting more people vaccinated will tremendously lower patient numbers. 

Chip Kahn is the president and CEO of the Federation of American Hospitals. He says there is no “short term, magic bullet,” but what is needed is “less COVID.”

No more banging pots of support 

Abigail Donley worked in a Manhattan ICU during the early phases of the pandemic.She left her job to co-found IMPACT in Healthcare to work to change policies to benefit workers and patients.IMPACT’s December campaign promotes safe staffing levels.

 

Donley says nurses were once viewed as COVID-19 heroes.“People were banging the pots for them at seven o’clock, but now they can’t get a raise,” Donley said on Skype. “They can’t get a bonus. They can’t get child care. They don’t have maternal health care.” 

A growing number of nurses are leaving the hospital bedside for a less daunting work schedule and better pay.Travel nursing agencies send nurses where they are needed to stem the dwindling staffing numbers, offering as much as triple the salary that other nurses receive.

“Michelle” helped set up the COVID-19 unit at the hospital where she had worked for 10 years.This month she left her $30-an-hour registered nursing job to be a travel nurse in an intensive care unit in another city. She calls her new salary “crazy.”

“I’m leaving that system and going to a travel nursing position, and I’ll be making $120 an hour,” she told VOA. 

Kahn says agencies are “gouging” hospitals when they offer travel nurses such high salaries. He agrees it is much better to have a strong, in-house team rather than temporary staffing.

When asked why hospitals don’t retain veteran nurses by offering higher salaries and other benefits, Kahn says, “There’s no way that that any institution could afford to pay the broad base of their nurses anywhere near what they’re paying for the travel nurses.”

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NASA Launches Craft to Hit Asteroid

The U.S. space agency NASA has launched a spacecraft on a mission to test the ability to knock an asteroid off a potentially harmful collision course with Earth. 

The Double Asteroid Redirection Test, or DART, will take 10 months to reach the asteroid Dimorphos before slamming into it at 24,000 kilometers per hour. 

Dimorphos does not pose any danger to Earth, but gives scientists a way to examine the concept of moving a potentially harmful object far enough and early enough off its course so that it flies past Earth. 

The DART spacecraft is about the size of a small car and carries a briefcase-sized craft that will be deployed shortly before the impact to record video of the event. 

NASA says the mission costs about $330 million. 

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

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Jury Holds Pharmacies Responsible for Role in Opioid Crisis

CVS, Walgreens and Walmart pharmacies recklessly distributed massive amounts of pain pills in two Ohio counties, a federal jury said Tuesday in a verdict that could set the tone for U.S. city and county governments that want to hold pharmacies accountable for their roles in the opioid crisis.

Lake and Trumbull counties blamed the three chain pharmacies for not stopping the flood of pills that caused hundreds of overdose deaths and cost each of the two counties about $1 billion, their attorney said.

How much the pharmacies must pay in damages will be decided in the spring by a federal judge.

It was the first time pharmacy companies had completed a trial to defend themselves in a drug crisis that has killed a half-million Americans in the past two decades.

The counties were able to convince the jury that the pharmacies played an outsized role in creating a public nuisance in the way they dispensed pain medication into their communities.

“The law requires pharmacies to be diligent in dealing drugs. This case should be a wake-up call that failure will not be accepted,” said Mark Lanier, an attorney for the counties. “The jury sounded a bell that should be heard through all pharmacies in America,” Lanier said.

Attorneys for the three pharmacy chains maintained they had policies to stem the flow of pills when their pharmacists had any concerns and would notify authorities about suspicious orders from doctors. They also said it was the doctors who controlled how many pills were being prescribed for legitimate medical needs.

Spokespeople for CVSHealth and Walgreen Co. said the companies disagree with the verdict and will appeal.

“As plaintiffs’ own experts testified, many factors have contributed to the opioid abuse issue, and solving this problem will require involvement from all stakeholders in our health care system and all members of our community,” CVS spokesperson Mike DeAngelis said in a statement.

Walgreen spokesperson Fraser Engerman said the company believes the court erred “in allowing the case to go before a jury on a flawed legal theory that is inconsistent with Ohio law.”

“As we have said throughout this process, we never manufactured or marketed opioids nor did we distribute them to the ‘pill mills’ and internet pharmacies that fueled this crisis,” Engerman said in a statement. “The plaintiffs’ attempt to resolve the opioid crisis with an unprecedented expansion of public nuisance law is misguided and unsustainable.”

Two other chains — Rite Aid and Giant Eagle — had settled lawsuits with the two Ohio counties.

Lanier said during the trial that the pharmacies were attempting to blame everyone but themselves.

The opioid crisis has overwhelmed courts, social services agencies and law enforcement in Ohio’s blue-collar corner east of Cleveland, leaving behind heartbroken families and babies born to addicted mothers, Lanier told jurors.

Roughly 80 million prescription painkillers were dispensed in Trumbull County alone between 2012 and 2016 — equivalent to 400 for every resident.

In Lake County, about 61 million pills were distributed during that period.

The rise in physicians prescribing pain medications such as oxycodone and hydrocodone came at a time when medical groups began recognizing that patients have the right to be treated for pain, Kaspar Stoffelmayr, an attorney for Walgreens, said at the opening of the trial.

The problem, he said, was that “pharmaceutical manufacturers tricked doctors into writing way too many pills.”

The counties said pharmacies should be the last line of defense to prevent the pills from getting into the wrong hands.

They didn’t hire enough pharmacists and technicians or train them to stop that from happening and failed to implement systems that could flag suspicious orders, Lanier said.

The trial before U.S. District Judge Dan Polster in Cleveland was part of a broader constellation of federal opioid lawsuits — about 3,000 in all — that have been consolidated under the judge’s supervision. Other cases are moving ahead in state courts.

Kevin Roy, chief public policy officer at Shatterproof, an organization that advocates for solutions to addiction, said the verdict could lead pharmacies to follow the path of major distribution companies and some drugmakers that have reached nationwide settlements of opioid cases worth billions.

So far, no pharmacy has reached a nationwide settlement. “It’s a signal that the public, at least in select places, feels that there’s been exposure and needs to be remedied,” Roy said.

Roy noted that courts have not been consistent on whether public nuisance law applies to such cases.

“There’s been a variety of different decisions lately that should give us reason to be cautious about what this really means in the grand scheme,” he said.

It was one of five trials so far this year in the U.S. to test claims brought by governments against parts of the drug industry over the toll of prescription painkillers.

Trials against drugmakers in New York and distribution companies in Washington state are underway now. A trial of claims against distribution companies in West Virginia has wrapped up, but the judge has not yet given a verdict.

Earlier in November, a California judge ruled in favor of top drug manufacturers in a lawsuit with three counties and the city of Oakland. The judge said the governments hadn’t proved that the pharmaceutical companies used deceptive marketing to increase unnecessary opioid prescriptions and create a public nuisance.

Also in November, Oklahoma’s supreme court overturned a 2019 judgment for $465 million in a suit brought by the state against drugmaker Johnson & Johnson.

Other lawsuits have resulted in big settlements or proposed settlements before trials were completed.

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NASA, ESA Delay Launch of New Space Telescope

The U.S. space agency, NASA, and its European counterpart, the European Space Agency (ESA), have delayed the long-awaited launch of the James Webb space telescope to no earlier than December 22.

In statements, both agencies say the launch is being held up for additional testing of the orbiting observatory after what appeared to be a minor incident during preparations at the launch facility in Kourou, French Guiana.  

NASA says technicians were preparing to attach the telescope to the launch vehicle adapter, which is used to integrate the observatory with the upper stage of the rocket that will take it into orbit. They say the sudden, unplanned release of a clamp band — which secures the Webb to the launch vehicle adapter — caused a vibration throughout the observatory.

The agency says a NASA-led review board was immediately convened to investigate and perform additional testing to ensure the incident did not damage any of the instrument’s sensitive components. The space agency said it, along with mission partners the ESA and the Canadian space agency will provide an update when the tests are complete late this week.

The Webb telescope, originally scheduled for launch December 18, is designed to replace the aging Hubble telescope. NASA says it is designed to explore every phase of cosmic history — from within our solar system to the most distant observable galaxies and everything in between.  

When ready, the telescope will be launched from the South American site aboard a French-made Ariane 5 rocket.

Some information for this report was provided by the Associated Press.

 

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Australian Team Probes Southern Ocean in Deep-Water Earthquake Research

A mission is underway to retrieve scientific data from the rugged ocean floor in the Southern Ocean, formerly known as the Antarctic Ocean, that could explain what triggers underwater earthquakes and tsunamis.   

Some of the world’s most violent underwater earthquakes are unleashed beneath the hostile waters of the Southern Ocean, but researchers don’t know why. Sophisticated noise and motion sensors could help unlock the secrets of how Tectonic plates – or pieces of the Earth’s crust – start to collide, a process known as subduction.   

For the past year, an array of 27 seismometers positioned on the ocean floor has formed a giant telescope pointing to the planet’s core.  The instruments are now being retrieved.    

Professor Hrvoje Tkalčić, a chief scientist from the Australian National University’s Research School of Earth Sciences hopes the study will help to explain how and why earthquakes occur.    

“We cannot predict when exactly they will happen, how large they will be. But we can understand better their physical mechanism and we can also understand better the Earth’s structure in that area, and this is critical to predict the propagation of the seismic waves from the hyper-center of these earthquakes to any other point on the Earth’s surface, including a possible generation of tsunami,” Tkalčić said.      

Scientists hope the study will give them a better understanding of how earthquakes and tsunamis might affect Australia and New Zealand, which lies within the seismically active region known as the “Pacific Ring of Fire.”    

The expedition is scouring some of the world’s steepest underwater mountain ranges to depths of more than 3.5 miles in a remote area known as Macquarie Ridge, halfway between New Zealand and Antarctica. 

Researchers say the techniques could also be applied to other oceans. 

The international study is a collaboration with various Australian institutions, the University of Cambridge and the California Institute of Technology.   

The three-week voyage began in Wellington, New Zealand on November 10. 

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