The EU’s drug regulator has backed the emergency use of Merck’s pill for the treatment for clinically vulnerable Covid-19 patients as cases surge across the continent.

On Friday, the European Medicines Agency (EMA) “issued advice” backing the emergency use of the drug developed by Merck in collaboration with Ridgeback Biotherapeutics, although it has not yet been authorized by national authorities.

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© Reuters / Piroschka van de Wouw
EMA green lights new Covid treatments

In a statement, the drug regulator said the medicine called Lagevrio – also known as molnupiravir or MK 4482 – “can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of developing severe Covid-19.

It said the treatment should be administered as soon as possible after Covid-19 is diagnosed and within five days of the start of symptoms. The medicine should be taken twice a day for a period of five days.

The EMA listed the potential side effects of the capsules, including mild or moderate diarrhea, nausea, dizziness and headache. The treatment is not recommended for pregnant women.

The watchdog announced earlier on Friday that it had begun reviewing Pfizer’s medicine Paxlovid for Covid-19 with the same goal “to support national authorities” who may decide on its early use prior to marketing authorization in light of rising cases and deaths in Europe.

On Friday, Austria announced it would enter a new nationwide lockdown from Monday and make vaccination mandatory, while Germany’s health authorities claimed the country had turned into “one big outbreak.”

Both Pfizer and Merck have requested approval for their coronavirus medicines from the US Food and Drug Administration, but it is unclear when it might be granted.

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Amid a surge in Covid-19 cases, Gibraltar has canceled official Christmas events and “strongly” discouraged people from hosting private gatherings for four weeks. Gibraltar’s entire eligible population is vaccinated.

The government of Gibraltar recently announced that “official Christmas parties, official receptions and similar gatherings” have been canceled, and advised the public to avoid social events and parties for the next four weeks. Outdoor spaces are recommended over indoor ones, touching and hugging is discouraged, and mask wearing is advised.

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Screenshot © YouTube / Tesco
Santa’s vaccine passport prompts supermarket boycott

“The drastic increase in the numbers of people testing positive for Covid-19 in recent days is a stark reminder that the virus is still very prevalent in our community and that it is the responsibility of us all to take every reasonable precaution to protect ourselves and our loved ones,” Health Minister Samantha Sacramento said. 

Gibraltar, a tiny British Overseas Territory sharing a land border with Spain, has seen an average of 56 Covid-19 cases per day over the last seven days, up from fewer than 10 per day in September. The rise in cases, described by the government as “exponential,” comes despite Gibraltar having the highest vaccination rate in the world.

More than 118% of Gibraltar’s population are fully vaccinated against Covid-19, with this figure stretching beyond 100% due to doses given to Spaniards who cross the border to work or visit the territory every day. Masks are still required in shops and on public transport. 

The initial vaccine campaign on the British outpost came to a conclusion in early spring 2021, with a large proportion of the population fully inoculated against Covid-19. It became one of the first places in Europe to reduce restrictions following a winter of lockdowns, in what was dubbed ‘Operation Freedom’.

Gibraltar is currently doling out booster doses to the over-40s, healthcare workers, and other “vulnerable groups,” and administering vaccines to children aged between five and 12.

Similarly well-vaccinated countries have also reported surges in Covid-19 infections recently. In Singapore, where 94% of the eligible population have been inoculated, cases and deaths soared to record highs at the end of October, and have since subsided slightly. In Ireland, where around 92% of the adult population is fully vaccinated, cases of Covid-19 and deaths from the virus have roughly doubled since August.

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Once you’ve reached optimal cat lady status, there comes a time in your life where you think it’s necessary to start massaging your cat’s head. Luckily, someone has already created a cat head massager, and it is most likely the most specific niche product you could think of. You can get it on Amazon or AliExpress.

Cat head massager.

If your cat didn’t love you before, rest assured he will love you now. Your cat will be so thankful for the head massage that he might even ignore you for less time throughout the day, and if you’re really lucky, your cat may even acknowledge your existence. …Or you can use it on yourself if you have a particularly small head.

Cat head massage.

Cat massage.

Feels good, man.

Feels good.

In case you feel like you should have this thing in your (and your cat’s) life, you can get it on Amazon or AliExpress.

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Behind the Headlines brings you expert perspectives on today’s headlines by telling you more than what happened, but also what it means.  You can also listen to The Cipher Brief’s Daily Open-Source Collection Podcast wherever you listen to podcasts.

Jack Devine, Former Acting Director, National Clandestine Service, CIA

Cipher Brief Expert Jack Devine, a 32-year CIA veteran. Devine served as both Acting Director and Associate Director of CIA’s operations from 1993-1995.  He is a founding partner and President of The Arkin Group, which specializes in international crisis management, strategic intelligence and investigative research. Devine is the author of Spymaster’s Prism: The Fight Against Russian Aggression.

Russia’s multi-pronged support of Myanmar is a microcosm of its strategy in Southeast Asia.

In the months since Myanmar’s February military coup, Russia and China have been the junta’s most powerful allies, but Russia has exploited regional instability to position itself as a third path between China and the West. While China was closer with the former Myanmar government than the military, it was also concerned about the government’s ties with the West and potential interference in its development efforts, particularly its Belt and Road Initiative. Russia, on the other hand, doesn’t depend on stability in Southeast Asia to the same degree as China and can instead take advantage of warring factions. Last month, on his first trip outside of the immediate region since February, Myanmar’s junta leader Min Aung Hlaing went to Moscow to meet with high-level Russian defense officials instead of heading to Beijing. Hlaing has reportedly visited Russia seven times within the past decade and previously stated that over 6,000 Myanmar officers have studied at Russian military academies. According to data from the Stockholm International Peace Research Institute (SIPRI), Russia was responsible for almost 40% of arms sales to Myanmar from 1999-2018, second only to China. SIPRI data further indicates that Russia has been Southeast Asia’s largest arms supplier over the past two decades, counting Vietnam and Laos as top customers. But Russia is offering the region more than arms and has promised Myanmar two million Covid-19 vaccines and assistance in the nation’s own vaccine production efforts. Russia has also been trying to expand free trade agreements between its Eurasian Economic Union (EAEU) and Southeast Asian countries, most recently getting Indonesia to sign on to the deal. Stepping even further into soft power efforts, last week Russia’s foreign minister met with his Bangladeshi counterpart and agreed to encourage Myanmar to engage in dialogue with Bangladesh on the Rohingya crisis.


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Leftist, former schoolteacher Pedro Castillo is declared President of a divided Peru, projected economic growth could play in his favor. 

Peru, like many of its neighbors, has been battling the triple and interwoven threat of Covid-19, social unrest, and severe economic downturn. But for the past several years Peru has also been challenged by sharp divisions between its executive and legislative powers. Last November, Peru’s unicameral legislature voted to impeach then-President Martín Vizcarra, citing mismanagement of the pandemic and corruption, in a move that outraged thousands. The June presidential elections were likewise fraught. Castillo’s right-wing rival Keiko Fujimori, who is also under investigation for corruption, alleged electoral fraud and the Peruvians initiated a six-week long investigation, eventually finding Castillo the rightful victor. The EU, U.S. and 14 electoral missions deemed the elections legitimate, and the U.S. called the election a “model of democracy” for the region. Castillo, who previously worked as an elementary school teacher and has never held public office, will be greeted by a political establishment that is almost entirely against him. Peruvian citizens are also deeply divided, and many urban elites reportedly moved their money overseas out of fear for Castillo’s economic policies. But Castillo’s Peru Libre party holds fewer than 40 of 130 seats in the legislature and Castillo has already recruited several moderate advisors. Further, he has backed away from talk of nationalizing Peru’s lucrative multinational mining, oil, gas, and hydrocarbon companies, instead pledging to raise taxes on mining firms. Prices of copper and gold, two of Peru’s most critical exports, remain high and Covid-related trade obstacles are expected to ease over the coming months. While it is uncertain how effective Castillo will be, or where he will ultimately fall on his policies, positive projections for Peru’s export-based economy will likely play in his favor.


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Enjin becomes first blockchain platform to gain acceptance into the United Nations Global Compact, signaling widespread range of corporate sustainability efforts.

On Tuesday, Enjin, an innovative blockchain technology company focused on non-fungible tokens (NFTs), became the first such company to join the United Nations Global Compact. Upon admission, Enjin stated that it hopes to use NFTs to promote sustainability and equality in line with the UN pact that encourages businesses and firms worldwide to adopt more environmentally friendly and socially responsible practices. NFTs have surged in popularity in the past two years, and during the first quarter of 2021 NFT sales reportedly exceeded US $2 billion. In essence, an NFT is a way to prove ownership of a unique virtual item. It’s a unit of data that’s stored on a blockchain, or digital ledger, that certifies exclusive ownership of digital files ranging from photos to sports trading cards. Enjin, which is headquartered in Singapore, has focused its NFT efforts on games and apps and is reportedly able to operate with a lower carbon footprint than Bitcoin due to a slimmed-down verification model that requires less energy. This week, the UN Global Compact not only included Enjin as a member, but gave the company its highest membership rank, sending a signal that it’s interested in promoting such an environmental effort by crypto and blockchain entrepreneurs. For its part, Enjin has stated that it wants to employ the technology in carbon capture companies, fighting climate change in the process. The Head of the UN AI and Robotics Center remarked that during the global struggle to recover from the pandemic we should take advantage of new technologies like AI and blockchain to better equip ourselves for the future.

Read more expert-driven national security insights, perspective and analysis in The Cipher Brief

 

The post Behind the Headlines: Russia in Myanmar, Peru’s New President and what Enjin means for the United Nations Global Compact appeared first on The Cipher Brief.

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The city council in Austria’s second-largest city, Graz, has elected a new mayor. Communist Party member Elke Kahr has become the first Communist leader of a major city in the country.

The 60-year-old politician, who has been working in the municipal government for more than 15 years and previously served as vice mayor of Graz, was elected as the new city leader on Wednesday. A member of the Austrian Communist Party (KPÖ, Kommunistische Partei Österreichs) for almost 30 years, she won the election with 28 of 46 votes. Kahr succeeded the previous long-standing mayor Siegfried Nagl of the center-right, liberal-conservative People’s Party.

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FILE PHOTO: A protester waves a EU flag outside the parliament building in Budapest, December 16, 2014
Brussels, we got a problem! 30 years after collapse of communism, Eastern Europe is losing its faith in Liberal Democracy

Who would have thought that the daughter of a locksmith, a Communist, would become mayor,” she said in her first speech following the vote.

Having acknowledged a number of issues to deal with in the city, especially during the Covid-19 pandemic, the new mayor highlighted a housing policy, pledging to put a stop to profit-driven construction in Ganz.

The Communists have also already formed a coalition with the Greens and the Social Democratic Party (SPÖ), and another precedent in European city governance was made – two women serving as mayor and deputy. Green leader Judith Schwentner was chosen as Graz’s vice mayor, with the new governing coalition saying they would support not only social, but also environmental changes, aiming to improve living standards especially for low-income groups. Providing a bicycle for every child in the city from the municipality is in their program.

However, not everyone in the local government is happy with the new Communist rule. A member of the right-wing Freedom Party of Austria (FPÖ), Alexis Pascuttini, described the choice as “unpleasant,” having accused the Graz Communists of empty catchphrases in their program and refusing to participate in what he described as “left-wing nonsense.” Kahr herself has been exposed to strong pressure to justify her party, being repeatedly asked about her position on “the crimes of communist parties around the world since 1917,” according to Austrian media.

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People around the world will need to get a jab against Covid-19 once a year, at least when it comes to the Pfizer vaccine, BioNTech’s CEO Ugur Sahin said in an interview on Sunday, as he praised the quality of its booster shot.

In an interview with Germany’s Bild newspaper on Sunday, Sahin said he considers the vaccine, co-developed by his company, to be “very effective.”

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© Getty Images / sasacvetkovic33
Drastic drop in Covid vaccine effectiveness – study

When asked whether people should be worried about the “breakthrough infections” – in which those vaccinated with the Pfizer-BioNTech vaccine still developed Covid-19 symptoms – he dismissed such concerns, saying that the jab offers a “90 percent protection” against cases that require intensive care in those aged over 60.

A “very high” level of protection against severe illness lasts for up to nine months, the BioNTech CEO maintained. He said this level starts decreasing “from the fourth month,” however. To maintain the protection, Sahin strongly pushed for booster shots, arguing that they would not just restore levels of antibodies but would potentially help “to break … chains of infection.”

He also encouraged doctors to be “as pragmatic as possible” when it comes to greenlighting vaccination and “not to send people home unvaccinated even though they could be vaccinated without any problems.”

In the future, people might need to get booster shots once a year, the BioNTech CEO believes. He said that he expects protection from a booster shot to “last longer” than the initial immunity one acquires after getting two doses of the vaccine.

“Subsequent … vaccinations may only be needed every year – just like [with] influenza,” he said. Currently, the German Federal Center for Health Education – an agency subordinated to the Health Ministry – recommends a booster shot six months after one gets the second dose of a vaccine. It also says that “booster vaccination makes sense after a minimum interval of about four months.”

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© AFP / MARTIN BERNETTI
FDA approves Covid booster shots for all US adults

Sahin’s interview comes days after it was revealed that Pfizer, BioNTech and Moderna are making a combined profit of $65,000 every minute – all thanks to their Covid-19 jabs. That is according to estimates made by the People’s Vaccine Alliance (PVA) – a coalition demanding wider access to vaccines.

The PVA estimated that the three companies are to earn a total of $34 billion in combined pre-tax profits this year alone, which roughly translates into more than $1,000 a second and $93.5 million a day.

PVA has slammed the three companies over their refusal to allow vaccine technology transfer despite receiving a combined $8 billion in public funding. Such a move could increase global supply and save millions of lives as well as drive down prices, the coalition said.

“Pfizer, BioNTech and Moderna have used their monopolies to prioritize the most profitable contracts with the richest governments, leaving low-income countries out in the cold,” said Maaza Seyoum of the African Alliance and People’s Vaccine Alliance Africa.

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Just three days after restrictions were announced for unvaccinated Austrians, a provincial governor is pressing for a nationwide lockdown of all residents as Covid-19 infections continue to hit record highs.

“If no national lockdown is ordered tomorrow, there will definitely have to be a lockdown of several weeks in Upper Austria, together with our neighboring province Salzburg as of next week,” Upper Austria Governor Thomas Stelzer told lawmakers on Thursday.

That will mean at least two of Austria’s nine provinces will be in full lockdown mode just days after the nation created a two-tier society by locking down approximately two million unvaccinated Austrians.

“We must raise the vaccination rate. It is shamefully low,” Chancellor Alexander Schallenberg said on Sunday, announcing that unvaccinated residents would only be allowed to leave their homes for “essential” purposes, such as to buy groceries or go to a doctor’s office.

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FILE PHOTO: Health care workers exchange a fast PCR test sample in a mobile laboratory truck, amid the coronavirus disease (COVID-19) outbreak, in Soelden, Austria, October 15, 2020. REUTERS/Leonhard Foeger
Lockdown-ready Austria has its PCR system tricked

Police are now doing random checks for proof of vaccination on Austrian streets. Those unvaccinated residents who are found to be in violation of the lockdown order face steep fines of up to €500. Those who refuse to go through a vaccination status check will have to pay about three times as much.

Stelzer and other Austrian governors are scheduled to meet with Schallenberg and Health Minister Wolfgang Mueckstein on Friday, when a full lockdown will likely be considered.

New Covid-19 cases in the country passed the 15,000 mark for the first time on Thursday, far surpassing 2020’s daily high of 9,586, set when no vaccines were available. Upper Austria and Salzburg have been hit the hardest, putting hospitals at risk of bed shortages. With some 66% of its population fully vaccinated, Austria lags behind other Western European countries in terms of the Covid-19 vaccination rate.

While Austria is the first to impose a lockdown on the unvaccinated, other EU countries – including Slovakia, the Czech Republic and Greece – have imposed increasingly tight restrictions on people who haven’t accepted a Covid vaccine.

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When you think the internet can’t get any more niche, it finds a way to get even more specific. We’re, of course, talking about an Instagram account @BagDogs that is solely dedicated to sharing people’s photos of dogs chilling in bags as they are being transported from point A to point B. Scroll down to see some of their best photos!

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

Dog in a bag.

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Hospitals in the Netherlands have begun delaying certain operations to free-up ICU beds during a record wave of Covid-19 infections, while an infectious diseases researcher has warned of an impending ‘Code Black’ in the sector.

The country set a daily national record for new Covid infections on Thursday, registering around 23,600 cases. It was the third day in a row of the figure topping 20,000.

To make more staff available for Covid wards, a number of operations, including those for cancer and heart patients, are being canceled from this week on, Dutch healthcare officials have said. Fewer than 200 beds remained available in Dutch ICUs as of Thursday, while Friday figures show almost half (47.8%) of occupied ICU beds were being used by Covid patients.

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FILE PHOTO. A woman wearing a protective mask walks past a store in Amsterdam, Netherlands.
Netherlands re-introduces facemasks & other restrictions as Covid-19 cases surge

“These are cancer patients that should actually be operated-on within six weeks of diagnosis, and that won’t be met in all cases. It’s also heart patients,” said a spokesperson for the National Coordination Center for Patient Distribution (LCPS).

Meanwhile, new calculations by an infectious disease modeller at Wageningen University & Research suggest that a so-called ‘Code Black’ in hospitals is looming. The emergency designation means that patient safety is at risk and, if declared, would mean many people with life-threatening illnesses cannot go to the ICU, while doctors have to prioritize who to treat.

According to recent estimates from the Dutch Healthcare Authority (NZa), up to 200,000 operations were not performed as a result of urgently needed Covid care since the start of the pandemic. On Thursday, the NZa revealed that almost a quarter of operating rooms across the country are not currently in use due to a combination of Covid patient pressures and rising staff absences due to illness.

It is not yet clear what impact the delayed care will have on public health. In December 2020, the Dutch National Institute for Public Health and the Environment (RIVM) calculated that an estimated 34,000 to 50,000 ‘healthy life years’ had been lost due to the first Covid-19 wave alone.

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