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Tuesday 12 September 2023

FDA greenlights updated mRNA Covid vaccines


The FDA on Monday cleared two updated mRNA Covid-19 shots from Pfizer-BioNTech and Moderna, paving the way for an early fall rollout. It will be the first updated shots offered to the public in a year and since the public health emergency ended in May.

The new shots target the XBB.1.5 subvariant of Omicron, following the FDA's June recommendation. Both companies said their shots generate substantial antibodies against the XBB subvariants of the virus, as well as the newer EG.5 and FL.1.5.1 subvariants, which now make up more than 30 percent of cases in the U.S.

Pfizer-BioNTech and Moderna said their updated shots provide additional neutralizing antibodies against BA.2.86, a variant the World Health Organization is monitoring because the variant's high number of mutations could mean it can evade existing immunity. The variant was first detected in Denmark in July and in the U.S. in August.

The FDA approved shots from Pfizer-BioNTech for those 12 years and older as a single shot rather than the two-dose regimen approved previously. It also approved Moderna's shot for those 18 and older as a single dose, when it had previously consisted of two doses.

The agency also updated authorizations for shots from both Moderna and Pfizer so that a child 5 years old and older can receive either shot in a single dose, as long as it has been two months since their previous shot. Children 6 months through 4 years old who have been previously vaccinated can receive one or two doses of an updated vaccine, depending on their last shot, and those who have never been vaccinated can receive three doses of the Pfizer-BioNTech shot, or two doses of the Moderna shot.

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

Novavax asked the FDA to authorize its updated shot earlier this summer, but has not yet received a decision from the FDA. The company said it has received shipments of the vaccine in the U.S. that are ready to go. If it receives authorization, it will be the only non-mRNA vaccine option available.

What's next: The CDC's Advisory Committee on Immunization Practices will meet on Tuesday to discuss endorsing and deciding who should receive the updated shots. The panel will also hear from all three vaccine manufacturers, as well as updates on current Covid spread and data on vaccine effectiveness.

Once the agency's director, Mandy Cohen, signs off on ACIP's recommendations for the two shots just approved, they have a clear path to reach the public. Makers of all the shots have said they're prepared to deliver shots in the coming weeks.



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Monday 11 September 2023

Biden admin takes its first big shot at Big Tech


The Biden administration’s push to check the power of the tech giants gets its first big test Tuesday in a Washington courtroom where the Department of Justice will kick off a case designed to curb Google’s dominance in online search.

The trial against the $1.7 trillion company will be “the most significant U.S. monopoly case in a generation,” said Bill Baer, a fellow with the Brookings Institution and former DOJ antitrust head under President Barack Obama.

The DOJ’s suit against Google claims the company has become the overwhelmingly most-used search engine not because of a superior product but because it illegally uses its money to box out its competitors.

With other federal investigations looming into Amazon, Apple, Ticketmaster and others, it could have broad implications for the government’s concerns that modern companies are using their money and power to forge new kinds of monopolies at the expense of competitors and customers.

The trial also marks a key moment for Jonathan Kanter, the attack-dog attorney who President Joe Biden installed as the head of the DOJ’s antitrust division and who helped build the case, initially filed under former President Donald Trump's administration. The DOJ is hoping to succeed where the Obama Administration took a pass in 2013 when enforcers considered evidence that Google was becoming a digital behemoth, and chose not to sue.

The case centers on a series of revenue-sharing agreements, worth tens of billions of dollars annually, that Google has with Apple, Mozilla, Samsung and others to be the default search engine on web browsers and mobile phones, as well as its control of the ads that populate search results. Google does not disclose the exact value of the deals. The DOJ says these contracts have hindered the ability of rivals to compete and deprived consumers of the benefits of high quality, innovative services that only competition can foster.

According to some estimates, including those cited in the DOJ’s lawsuit, Google controls about 90 percent of the search engine market in the U.S. and globally.

A court loss for Google could force major changes to its business arrangements and even the potential sale of key parts of the company. It would also put Google’s fellow internet giants on edge, as they face their own investigations and lawsuits.

A loss for the Biden administration could cause it to rethink its legal strategy in other pending tech cases. And while they wouldn’t necessarily pull back completely, enforcers could take a more conservative approach.


“How it goes has significance for how U.S. courts and enforcers will treat behavior by dominant companies that entrenches their monopoly power,” said Baer.

According to court filings, the DOJ is expected to argue that Google’s business moves have hurt internet users by restricting their choices: For example, had there been a more competitive search engine market, consumers could have a wider array of privacy protections. DuckDuckGo, a privacy-focused search engine whose selling point is that it doesn’t mine consumers’ data for ads, is a long-time Google antagonist.

Google argues in court filings that its agreements with suppliers and platforms are not exclusive and that the default setting can easily be changed to use rival search engines such as Microsoft’s Bing. It says that it competes vigorously to win those contracts and that it succeeds because it has the best product.

Spokespeople for the DOJ and Microsoft did not have a comment ahead of the trial.

The case will be decided in a non-jury trial by U.S. District Judge Amit Mehta, who was appointed by Obama in 2014.

Long road to a decision

Over the next eight to 10 weeks top executives from Google, Apple, Microsoft, Samsung and other companies will testify about benefits and drawbacks of Google’s outsized role in the internet — arguing over whether the company is an aggrieved innovator being punished for its success or has intentionally stifled competition for its own financial gain.

It will however likely take years before a winner is declared. The trial starting Tuesday is centered solely on whether Google broke the law, and Mehta is not expected to rule until the spring. A ruling against Google would result in a second trial to determine an appropriate remedy. After that would come appeals that could ultimately end up in the U.S. Supreme Court, potentially adding several more years of litigation.

During that time, Google will also face another trial, expected in 2024, in which the Justice Department is challenging its online advertising business. The DOJ is also investigating whether Google violated antitrust law with its market-leading mapping service.



In an interview last week, Google’s top lawyer, Kent Walker, said that the default setting for search engines does not ultimately determine Google’s success. “I think everyone will say that the default position is valuable, again that's why we pay for it. But people are not locked in, and if there was a better search engine, a better browser that came along tomorrow, people would switch quickly.”

Walker said Google is faced with competition from all sides in the search market, including from Amazon, where he says consumers are increasingly turning to for product search queries. “It’s frustrating, maybe it’s ironic, that we’re seeing this backward-looking case and really unprecedented, forward-looking innovation.”

Google points to Mozilla switching its default search engine from Google to Yahoo! and back to Google as evidence that its market-leading role stems from a superior product.

In an exchange in court earlier this year, Mehta asked Google whether the default spot is akin to a 200-meter head start in a 400-meter race. “There's certainly no factual dispute that the default is a 200-meter advantage,” Google lawyer John Schmidtlein responded. But Google began signing these agreements in 2002, long before it was the dominant search engine, Schmidtlein said. “Google was 350 meters behind in 2008 when it introduced Chrome after years and years of monopoly behavior by Microsoft on Internet Explorer. Google was 350 meters behind in a 400-meter race, and they came around and they surpassed them.”

Regardless of what happened in the past, DOJ maintains that antitrust laws place an obligation on Google to not abuse its dominant position. The default position enables the company to scale its business in a manner unavailable to its rivals, the government says. Being the default browser on so many devices generates a “feedback loop,” giving it access to more users, which then generates more data that’s used to further improve the product and, increasingly, its ability to retain customers.

The DOJ cites the failure of Neeva, a search engine founded by a former top Google executive that shut down earlier this year, as evidence of the inability of competitors to gain traction in the market.

“Two decades ago, Google became the darling of Silicon Valley as a scrappy start-up with an innovative way to search the emerging internet,” the Justice Department said in its lawsuit. “That Google is long gone.”

Google contends that when considered in the broader context of how consumers find information online, it has no monopoly, and argues there are “diminishing returns” to scale.

Looking ahead to the AI landscape

As the world moves to new computing platforms underpinned by artificial intelligence, the DOJ is expected to argue that its search dominance will give Google a leg up at its rivals' expense.

As the world’s primary search engine, Google is one of the few companies with access to the massive data sets needed for the large language models underpinning chatbots and other artificial intelligence tools. While Google points to OpenAI as a key example of the intense competition it faces, the DOJ is expected to argue that Google is one of only a few companies with a high chance of success in AI.


On Friday, Mehta rejected the DOJ’s arguments around a related emerging technology, voice assistants. The DOJ had said Google’s restrictive conduct extended to “emerging search access points, such as voice assistants,” but Mehta said the DOJ offered no evidence to support that.

Several dozen state attorneys general, which filed a similar lawsuit in December 2020, will also try their case alongside the DOJ. The states are also challenging Google’s default position and also separately argued that Google designs its search pages to discriminate against more specialized rivals like Yelp for local businesses, or Expedia for travel. Last month, however, Mehta threw out the latter argument, saying the AGs offered no evidence that Google’s conduct harmed the specialized search market.

While the DOJ did not bring similar allegations related to the specialized search market, it still intends to discuss at trial the impact of Google’s conduct on those companies.

A Microsoft reunion

The DOJ’s lawsuit leans heavily on its antitrust case against Microsoft from the late 1990s. There the government accused the software giant of monopolistic behavior in making Internet Explorer the default browser in its Windows operating system, using the dominance of Windows to crush potential competitors such as Netscape.

The government initially won that case in district court, including a ruling breaking up the company. That was reversed on appeal, and the case ultimately ended in a settlement where Microsoft agreed to not block rival software companies in its contracts with computer makers.

A number of state attorneys general objected to the settlement, saying it did not go far enough, but were overruled.

It’s a case that Google’s lawyers are well acquainted with. Walker was Netscape’s deputy general counsel from 1997 to 2001, while Google’s longtime outside counsel, Susan Creighton of the tech-focused law firm Wilson Sonsini, authored a prominent white paper outlining the antitrust case against Microsoft.

Schmidtlein, Google's lead trial lawyer from the Washington law firm Williams & Connolly, represented state AGs in their case against Microsoft, and Mark Popofsky, another outside lawyer for Google from the law firm Ropes & Gray, was on the DOJ team.

Kenneth Dintzer, the 30-year DOJ veteran leading the department at trial, also did early investigative work into Microsoft in the mid-1990s. Other current DOJ lawyers were involved in the Microsoft case as well.

The case remains a key legal precedent limiting how companies can leverage their dominance in one market to gain market share in a separate market. If Mehta follows that precedent from Microsoft, the DOJ believes it will prevail.

“I think the DOJ case asserts law and facts consistent with the Microsoft opinion from [the D.C. Circuit Court of Appeals] 22 years ago,” Baer said.

Palpable tension

Though the search case was initially filed during the Trump administration, current DOJ antitrust head Kanter has built a long legal career representing the company’s competitors, including Microsoft, and played a key role in shaping the search case first from outside the department.

Google has argued that Kanter should recuse himself, saying the DOJ’s current posture toward the company stems in large part from Kanter’s bias.

The DOJ, meanwhile, has said Google has sought to stymie its investigation and lawsuit at every turn. And while bare-knuckle tactics are common in every courtroom, the government says Google destroyed a great deal of evidence in the form of deleted internal instant messages and abused its legal privilege to withhold other documents. The trial will be peppered throughout with disputes over missing evidence, and Mehta could ultimately sanction the company if he finds it acted nefariously.



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Britain's Sunak hopes AI could be his legacy

The prime minister believes his drive for AI governance can leave a lasting impact on the world stage.

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Putin wants more land. The European Union is racing to get there first.

EU expansion is back on the agenda for Ursula von der Leyen but rapid growth is going to hurt.

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Aftershock rattles Morocco as rescuers seek survivors from quake that killed over 2,100


AMIZMIZ, Morocco — An aftershock rattled Moroccans on Sunday as they mourned victims of the nation’s strongest earthquake in more than a century and sought to rescue survivors while soldiers and aid workers raced to reach ruined mountain villages. The disaster killed more than 2,100 people — a number that is expected to rise.

The United Nations estimated that 300,000 people were affected by Friday night’s magnitude 6.8 quake and some Moroccans complained on social networks that the government wasn’t allowing more outside help. International aid crews were poised to deploy, but some grew frustrated waiting for the government to officially request assistance.

“We know there is a great urgency to save people and dig under the remains of buildings,” said Arnaud Fraisse, founder of Rescuers Without Borders, who had a team stuck in Paris waiting for the green light. “There are people dying under the rubble, and we cannot do anything to save them.”

Help was slow to arrive in Amizmiz, where a whole chunk of the town of orange and red sandstone brick homes carved into a mountainside appeared to be missing. A mosque’s minaret had collapsed.

“It’s a catastrophe,’’ said villager Salah Ancheu, 28. “We don’t know what the future is. The aid remains insufficient.”

Residents swept rubble off the main unpaved road into town and people cheered when trucks full of soldiers arrived. But they pleaded for more help.

“There aren’t ambulances, there aren’t police, at least for right now,” Ancheu said.

Those left homeless — or fearing more aftershocks — slept outside Saturday, in the streets of the ancient city of Marrakech or under makeshift canopies in hard-hit Atlas Mountain towns like Moulay Brahim. The worst destruction was in rural communities that are hard to reach because the roads that snake up the mountainous terrain were covered by fallen rocks.

Those areas were shaken anew Sunday by a magnitude 3.9 aftershock, according to the U.S. Geological Survey. It wasn’t immediately clear if it caused more damage or casualties, but it was likely strong enough to rattle nerves in areas where damage has left buildings unstable and residents feared aftershocks.

Friday’s earthquake toppled buildings not strong enough to withstand such a mighty temblor, trapping people in the rubble and sending others fleeing in terror. A total of 2,122 people were confirmed dead and at least 2,421 others were injured — 1,404 of them critically, the Interior Ministry reported.

Most of the dead — 1,351 — were in the Al Haouz district in the High Atlas Mountains, the ministry said.

Flags were lowered across Morocco, as King Mohammed VI ordered three days of national mourning starting Sunday. The army mobilized search and rescue teams, and the king ordered water, food rations and shelters to be sent to those who lost homes.

He also called for mosques to hold prayers Sunday for the victims, many of whom were buried Saturday amid the frenzy of rescue work nearby.

But Morocco has not made an international appeal for help like Turkey did in the hours following a massive quake earlier this year, according to aid groups.

Morocco’s Interior Ministry said Sunday that it was accepting international aid from Spain, Qatar, Britain and the United Arab Emirates. The Ministry said that Moroccan authorities have carefully assessed the needs on the ground, stressing that a lack of coordination would be counter-productive. The efforts will center on search and rescue.

But aid offers poured in from around the world, and the U.N. said it had a team in Morocco coordinating international support. About 100 teams made up of a total of 3,500 rescuers are registered with a U.N. platform and ready to deploy in Morocco when asked, Rescuers Without Borders said. Germany had a team of more than 50 rescuers waiting near Cologne-Bonn Airport but sent them home, news agency dpa reported.

A Spanish search-and-rescue team arrived in Marrakech and headed to the rural Talat N’Yaaqoub, according to Spain’s Emergency Military Unit. Foreign Minister José Manuel Albares said in a radio interview that Moroccan authorities asked for help. Another rescue team from Nice, France, also was on its way.

Officials in the Czech Republic earlier said the country was sending about 70 members of a rescue team trained in searching through rubble after receiving an official request from the Moroccan government. Czech Defense Minister Jana Cernochova said three military planes were prepared to transport the team.

In France, which has many ties to Morocco and said four of its citizens died in the quake, towns and cities have offered more than 2 million euros ($2.1 million) in aid. Popular performers are collecting donations.

The epicenter of Friday’s quake was near the town of Ighil in Al Haouz Province, about 70 kilometers (44 miles) south of Marrakech. The region is known for scenic villages and valleys tucked in the High Atlas Mountains.

Devastation gripped each town along the High Atlas’ steep and winding switchbacks, with homes folding in on themselves and people crying as boys and helmet-clad police carried the dead through the streets.

”I was asleep when the earthquake struck. I could not escape because the roof fell on me. I was trapped. I was saved by my neighbors who cleared the rubble with their bare hands,” said Fatna Bechar in Moulay Brahim. “Now, I am living with them in their house because mine was completely destroyed.”

There was little time for mourning as survivors tried to salvage anything from damaged homes.

Khadija Fairouje’s face was puffy from crying as she joined relatives and neighbors hauling possessions down rock-strewn streets. She had lost her daughter and three grandsons aged 4 to 11 when their home collapsed while they were sleeping less than 48 hours earlier.

“Nothing’s left. Everything fell,” said her sister, Hafida Fairouje.

The Mohammed V Foundation for Solidarity was coordinating help for about 15,000 families in Al Haouz province, including food, medical aid, emergency housing and blankets, the state news agency MAP quoted the organization’s head, Youssef Rabouli, as saying after he visited the region.

Rescuers backed by soldiers and police searched collapsed homes in the remote town of Adassil, near the epicenter. Military vehicles brought in bulldozers and other equipment to clear roads, MAP reported. Ambulances took dozens of wounded from the village of Tikht, population 800, to Mohammed VI University Hospital in Marrakech.

In Marrakech, large chunks were missing from a crenelated roof, and warped metal, crumbled concrete and dust were all that remained of a building cordoned off by police.

Tourists and residents lined up to give blood.

“I did not even think about it twice,” Jalila Guerina told The Associated Press, “especially in the conditions where people are dying, especially at this moment when they are needing help, any help.” She cited her duty as a Moroccan citizen.

The quake had a preliminary magnitude of 6.8 when it hit at 11:11 p.m., lasting several seconds, the USGS said. A magnitude 4.9 aftershock hit 19 minutes later, it said. The collision of the African and Eurasian tectonic plates occurred at a relatively shallow depth, which makes a quake more dangerous.

It was the strongest earthquake to hit the North African country in over 120 years, according to USGS records dating to 1900, but it was not the deadliest. In 1960, a magnitude 5.8 temblor struck near the city of Agadir, killing at least 12,000. That quake prompted Morocco to change construction rules, but many buildings, especially rural homes, are not built to withstand such tremors.

In 2004, a magnitude 6.4 earthquake near the Mediterranean coastal city of Al Hoceima left more than 600 dead.

Friday’s quake was felt as far away as Portugal and Algeria, according to the Portuguese Institute for Sea and Atmosphere and Algeria’s Civil Defense agency.



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Disgraced soccer chief Luis Rubiales resigns over World Cup kiss scandal

Journalist Piers Morgan landed an exclusive interview with Spain's departing federation boss.

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'Perfect storm' brewing in House, Colorado Republican says


There’s a “perfect storm” brewing in the House in the coming weeks, and it could pose a threat to Rep. Kevin McCarthy’s speakership, Rep. Ken Buck (R-Colo.) said Sunday.

“On the one hand, we've got to pass a continuing resolution," Buck said during an interview on MSNBC’s “Inside with Jen Psaki.” "We also have the impeachment issue. And we also have members of the House, led by my good friend, Chip Roy, who are concerned about policy issues. They want riders in the appropriations bills, amendments in the appropriations bills that guarantee some type of security on our Southern border.

“So you take those things put together, and Kevin McCarthy, the speaker, has made promises on each of those issues to different groups. And now it is all coming due at the same time,” Buck said.

McCarthy became House Speaker after eking out a victory on the 15th round of votes among House Republicans. One of the concessions the California Republican made to win the position — agreeing to allow a single member of his party to start a process ousting the speaker, known as a “motion to vacate” — has left him at the mercy of some of the more fringe members of his conference as they look to the House leadership to accomplish their goals.

Buck said Sunday the GOP’s focus should be on the issues like border security, crime and inflation — not, at least at this point, on impeaching Democratic President Joe Biden.

“If we start going down these paths that really bear no fruit — we are not going to get an impeachment through the Senate,” Buck said.

“The reality is that the impeachment process is one that is going on right now. The Judiciary Committee, the Oversight Committee, the Ways and Means Committee are all investigating. They're developing really good information about Hunter Biden,” Buck added, noting that “there is not a strong connection at this point between the evidence on Hunter Biden and any evidence connecting the president.”



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