Tag Archives: us federal departments and agencies

FBI finds no classified documents at Biden’s Delaware vacation home



CNN
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The FBI completed a search of President Joe Biden’s Rehoboth Beach, Delaware, home and no documents with classified markings were found, Biden’s personal attorney said Wednesday.

Bob Bauer, Biden’s attorney, did say the FBI took with them handwritten notes and some materials for further review. The search took three-and-a-half hours.

“The DOJ’s planned search of the President’s Rehoboth residences, conducted in coordination and cooperation with the President’s attorneys, has concluded,” Bauer said. “The search was conducted from 8:30 AM to noon.”

“No documents with classified markings were found,” he said.

Bauer said that like last month’s search of Biden’s home in Wilmington, Delaware, agents “took for further review some materials and handwritten notes that appear to relate to his time as Vice President.”

Bauer confirmed earlier in the morning that investigators were searching the home. The search was planned and had the “full support and cooperation” of Biden, Bauer said.

“Under DOJ’s standard procedures, in the interests of operational security and integrity, it sought to do this work without advance public notice, and we agreed to cooperate,” Bauer said. “The search today is a further step in a thorough and timely DOJ process we will continue to fully support and facilitate. We will have further information at the conclusion of today’s search.”

Reporters positioned in the coastal community observed black sport utility vehicles and sedans arriving to the home mid-morning.

Biden’s personal attorneys previously searched the Rehoboth home on January 11 and found no classified documents.

The FBI search in Rehoboth marks the third known occasion that federal agents have searched properties associated with Biden to look for classified material.

The FBI previously searched Biden’s home in Wilmington, Delaware, turning up what his lawyer described as multiple items containing classified material. That search occurred on January 20. Biden’s attorneys had previously found documents at the Wilmington home and suspended their search of a specific space where additional documents were found. It’s not clear whether the documents the FBI found were in that same space or elsewhere in the house.

The FBI also searched the Washington office of the Penn Biden Center in mid-November after Biden’s attorneys first discovered classified material in a locked closet at the think tank.

None of the searches, including Wednesday’s in Rehoboth, required a warrant, according to people familiar with the matter. Biden’s team has stressed they are cooperating with the Justice Department as its probe of the documents matter proceeds.

Biden purchased his home in Rehoboth after leaving the vice presidency. He and his wife occasionally spend weekends there, most recently from January 20 to 23.

The search comes on the day that the Justice Department announced special counsel Robert Hur officially began his job overseeing the investigation of Biden’s handling of classified documents. Hur takes over for US Attorney John Lausch who conducted an initial review that has since become a full blown criminal investigation.

Hur, who previously served as US attorney in Maryland, was nominated to that position by then-President Donald Trump in 2017. He served in the role until his resignation in 2021. In the job, Hur played a key role in a number of high-profile cases, including a children’s book scandal involving then-Baltimore Mayor Catherine Pugh that resulted in Pugh being sentenced to three years in prison.

He was unanimously confirmed by the Senate to the US attorney job in 2018, and at the time he received praise from both of Maryland’s Democratic senators, who expressed confidence in his ability to handle critical issues facing the state.

Prior to his time with the DOJ, Hur was a law clerk for Chief Justice William Rehnquist and also clerked for a federal appellate judge, Alex Kozinski.

This story has been updated with additional reporting.

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Hong Kong is criminalizing CBD as a ‘dangerous drug’ alongside heroin


Hong Kong
CNN
 — 

Two years ago, cannabidiol was booming in Hong Kong. The compound, known as CBD, was popping up in cafes, restaurants and stores, with businesses eager to join an exciting new market already well-established in countries around the world.

That all came to an end on Wednesday, when CBD was criminalized in the city and declared a “dangerous drug” on the same level as heroin and fentanyl.

CBD is a chemical found in hemp and marijuana plants. It’s non-psychoactive, meaning it won’t get you high; instead, CBD is often marketed for everything from helping to relieve pain and inflammation to reducing stress and anxiety.

It has surged in global popularity in recent years, with brands adding it to shampoos, drinks, body oils, gummy bears and dog treats. In the United States and Europe, you might find it sold in coffee shops and farmers’ markets, mom-and-pop and high-end department stores, and even drugstore chain CVS.

But last June, draft legislation banning CBD was introduced to Hong Kong lawmakers, and went into effect February 1.

Under the new legislation, possession and consumption of any amount of CBD is punishable by seven years in prison and a fine of 1 million Hong Kong dollars ($127,607). Manufacturing, importing or exporting CBD is punishable by life imprisonment.

Even travelers could face penalties, with the government warning people not to risk “buying these products or bringing them back to Hong Kong.”

The same penalties and conditions apply for cannabis, also known as marijuana.

The ban has forced CBD-focused businesses to close, while other brands have had to roll back or get rid of CBD products.

“It’s a shame because there’s a missed opportunity for sure,” said Luke Yardley, founder of Yardley Brothers Craft Brewery, which had previously sold four products containing CBD – a lager and three nonalcoholic drinks. “I think that anything that you can’t get intoxicated from, and helps you to relax, is probably a good thing.”

The health benefits and risks of CBD have long been debated. In the US, most CBD products are not regulated by the Food and Drug Administration (FDA), which means that people can purchase items off the shelf.

Some research has found that the compound can ease pain and may be useful for those who have trouble sleeping. The FDA has approved one drug with CBD to treat rare, severe forms of epilepsy.

But concerns have also been raised, with some experts saying there isn’t enough scientific research into how CBD works or its potential effects.

In January, the FDA announced CBD products will require a new regulatory pathway in the US, saying: “We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

In Hong Kong, which has strict cannabis laws, the government’s concern revolves around the possible presence of its sister compound THC (tetrahydrocannabinol) in CBD products. THC is also found in cannabis plants and is responsible for the “high.”

In the US and Europe, CBD products can carry up to 0.3% – a trace amount – of THC, but even that is not acceptable in Hong Kong. And while CBD products could avoid this trace amount by using a pure form of CBD, most manufacturers mix other compounds for higher potency.

From 2019 to early 2022, Hong Kong authorities launched nearly 120 “operations” seizing and testing CBD products from restaurants and shops to warehouses, Secretary for Security Tang Ping-keung said last year. He added that more than 3,800 products were found to contain THC, though did not give further detail on the proportion or percentage of THC in those products.

In a written response to questions raised in the Legislative Council, Tang suggested the government’s traditionally tough stance on THC should be applied to CBD “to protect public heath.”

“We have adopted ‘zero tolerance’ towards drugs and we understand that it is a matter of public concern,” he said. “Therefore, the government plans to control CBD.”

The Action Committee Against Narcotics, a group of representatives from “the fields of social work, education, medical and community service” that advises the government on anti-drug policy, said in a statement last November that it supported the CBD ban and the government’s goal of “a drug-free Hong Kong.”

Many businesses began bracing themselves for regulatory changes in 2022, ahead of the government’s official announcement this January.

Yardley Brothers Craft Brewery stopped making its CBD beverages late last year in anticipation of the ban, and all its leftover products had sold out by December, said Yardley.

He said the CBD drinks had been “very popular,” amounting to roughly 8% of the business, as they offered adults a nonalcoholic option to enjoy when out with friends. At some bars, regulars “come in every weekend for a glass of CBD lemonade,” he said.

Now “there’s less choice for consumers in Hong Kong. That’s not necessarily a step in the right direction,” he said.

Some companies have been forced to shut down completely.

Med Chef, a restaurant that opened in 2021, once boasted of offering Hong Kong’s “first full menu of CBD-infused cocktails, appetizers and entrees.” In a news release during its launch, the restaurant founder emphasized the health and wellness benefits of CBD.

But by early November 2022, it had closed its doors. “We have worked hard in the past to present CBD in its most acceptable form and integrate our food and beverage concepts,” the restaurant wrote in a farewell post on Instagram. “It’s a pity that things didn’t go the way we hoped. Under the latest policies of those in power, we ultimately aren’t able to continue forward with everyone.”

Hong Kong’s first CBD cafe, Found, had also made headlines when it opened in 2020. It sold a variety of CBD products including infused coffee and beers, oils to help sleep, powder to sprinkle into food and pet products to help ease stiff joints.

It closed at the end of September 2022, telling patrons on Instagram that their positive feedback had shown that “CBD could help to cope with the stresses of daily life.”

“Sadly, in spite of the demonstrable positive impact, it has now become apparent that the Hong Kong government intends to adopt new legislation to prohibit the sale and possession of CBD,” it wrote.

Yardley said the government’s concerns about THC were valid – but argued they could have implemented better regulations, such as requiring certifications or standards of safety around CBD samples.

“It’s quite an extreme response to just fully ban it,” he said.

And while the brewery will continue operating, with plans for alternative nonalcoholic beverages to fill the gap, Yardley hopes CBD will be back on the menu. “I hope for the future that it might become legal again,” he said.

This story has been updated to include details of the draft legislation and its introduction.



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EzriCare eye drops: CDC advises against use as it investigates dozens of infections and one death in 11 states



CNN
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The US Centers for Disease Control and Prevention is urging health care providers and consumers to stop using EzriCare Artificial Tears as it conducts an investigation into at least 50 infections in 11 states that have led to instances of permanent vision loss, hospitalization and one death.

Most of the people with these infections reported using artificial tears, and EzriCare was the most common brand, the agency says. These eye drops are preservative-free, meaning they don’t have ingredients to prevent bacterial growth.

Testing of open EzriCare bottles identified Pseudomonas aeruginosa bacteria that were resistant to carbapenem antibiotics as well as the antibiotics ceftazidime and cefepime. Testing of unopened bottles is ongoing, the CDC says.

“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the agency says.

New Jersey-based EzriCare says in a statement dated January 24 that it has not received any consumer complaints or adverse event reports.

“We have not been asked to conduct a recall. EzriCare does not manufacture the Lubricant Eye Drops,” the statement says.

“Nevertheless, and in an abundance of caution, EzriCare recommends that during this evolving situation you discontinue use of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns.”

Pseudomonas bacteria are common in the environment, such as in soil and water. Pseudomonas aeruginosa is usually spread in health care settings, the CDC says, and is increasingly difficult to treat because of antibiotic resistance. It caused more than 32,000 infections in hospitalized patients and about 2,700 deaths in the US in 2017.

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DOJ tells GOP lawmakers it will not hand over most Biden special counsel probe documents until investigation complete



CNN
 — 

The Justice Department told Republican Rep. Jim Jordan of Ohio on Monday that it will not provide most of the information he requested about the ongoing special counsel investigation into President Joe Biden’s handling of classified material until that probe is complete, according to a new letter obtained by CNN.

In the letter, DOJ reiterates that it will uphold its longstanding practice of withholding information that could endanger or compromise ongoing investigations, specifically citing regulations in special counsel probes.

Jordan, who chairs the House Judiciary Committee, has demanded access to a host of documents related to the Biden special counsel investigation.

“Disclosures to Congress about active investigations risk jeopardizing those investigations and creating the appearance that Congress may be exerting improper political pressure or attempting to influence Department decisions in certain cases. Judgments about whether and how to pursue a matter are, and must remain, the exclusive responsibility of the Department,” the DOJ letter states.

DOJ also states in the letter that “disclosing non-public information about ongoing investigations could violate statutory requirements or court orders, reveal roadmaps for our investigations, and interfere with the Department’s ability to gather facts, interview witnesses and bring criminal prosecutions where warranted.”

House Republicans have made clear they plan to examine the Justice Department’s handling of politically sensitive probes, including its role in the ongoing special counsel investigations related to the handling of classified material by Biden and former President Donald Trump.

Jordan has asked the department to produce documents related to the appointment of Robert Hur as special counsel in the Biden documents probe as well as the selection of Trump-appointed US Attorney John Lausch to lead the initial review of the case, in addition to a broad array of internal and external communications about the matter.

DOJ’s latest response raises the question of whether Jordan will now move to issue subpoenas for the documents in question, something he told CNN last week he would consider doing if the department refused to hand them over.

“We’ll see, but we’re definitely looking at asking for documents via subpoena,” he said. “But we don’t know whether that will happen yet.”

Jordan spokesperson Russell Dye responded to Monday’s letter by saying, “It’s concerning, to say the least, that the Department is more interested in playing politics than cooperating.”

In a letter sent to Jordan earlier this month, the DOJ also signaled it’s unlikely to share information about ongoing criminal investigations with the new GOP-controlled House but noted it would respond to the Judiciary Committee chairman’s request related to the Biden special counsel probe separately.

Together, both letters provide an early sign of the hurdles Jordan is likely to face, particularly as he tries to investigate the Justice Department and the FBI. They also underscore how the appointment of a special counsel has further complicated matters for Republican lawmakers seeking to launch their own probes into Biden’s handling of classified documents.

House Republicans have been especially eager to dig into the Justice Department’s ongoing probes, even authorizing a Judiciary subcommittee tasked with investigating the purported “weaponization” of the federal government, including “ongoing criminal investigations.”

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CNN Exclusive: Secretive process to select astronauts for NASA’s next moon mission

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CNN
 — 

Sometime this spring, NASA will make one of the biggest announcements in its history when it names the initial four-person crew for its flagship Artemis program to return astronauts to the moon for the first time in 50 years.

Scheduled to launch in 2024, Artemis II will be the program’s first crewed mission to orbit the moon, flying farther into space than any humans since the Apollo program and paving the way for the Artemis III crew to walk on the moon in 2025 — all aboard the most powerful rocket ever built and at a price tag that by then will approach $100 billion.

Yet, as publicized as the Artemis II mission is, the process of how its crew will be chosen is so secretive that it remains a mystery even for many on the inside. Other than announcing the astronauts’ nationalities — three Americans, one Canadian — NASA has said almost nothing publicly about who will be selected or how that decision will be made.

CNN spoke with nearly a dozen current and former NASA officials and astronauts to pull back the curtain on the secretive selection process. Based on those interviews, CNN not only gained exclusive insights into how the crew will be selected — it has also whittled down the list of candidates those insiders say are generating the most buzz at NASA.

At the top of everyone’s list for the first Artemis crew is Reid Wiseman, a 47-year-old decorated naval aviator and test pilot who was first selected to be a NASA astronaut in 2009. Wiseman stepped down as chief of the astronaut office in November, a prestigious job historically responsible for selecting the initial crew assignment for each mission, but which also comes with a big catch — the chief isn’t eligible to fly in space.

“Being chief is a crummy, lousy job,” former NASA astronaut Garrett Reisman told CNN. “No one wants it, especially now.”

While it may be a job that few astronauts want ahead of the Artemis crew assignments, it does come with one big advantage.

“Historically, the one benefit of being chief is that, when you did step down, you gave yourself the best flight assignment available at the time. That was kind of an acknowledged perk,” Reisman said. “You did this horrible job on our behalf. Thank you for doing that. Here’s your reward. You get to put yourself in the best seat around.”

Without question, the best open seat right now is on Artemis II — a high-pressure, high-visibility mission that will send four astronauts on a roughly 10-day mission around the moon and back.

INTERACTIVE: Trace the path Artemis I will take around the moon and back

Before stepping down as chief in November, just two days before the launch of Artemis I, the program’s first successful uncrewed test flight, Wiseman made another consequential move in August, when he reversed a previous NASA decision to select the Artemis crew from an initial core group of just 18 astronauts previously deemed the “Artemis Team.”

Instead, Wiseman expanded the group of candidates to all 41 active NASA astronauts.

“The way I look at it, any one of our active astronauts is eligible for an Artemis mission,” Wiseman said at the time. “We just want to assemble the right team for this mission.”

Determining the “right team” for a mission to space has always been a mysterious process, going all the way back to the 1950s. That’s when NASA was making its first flight assignments for its initial Mercury missions, made famous by Tom Wolfe’s book “The Right Stuff.”

Though the criteria may have changed, the process remains incredibly secretive. CNN has learned the decision for who gets to go to the moon will be made by three key people at NASA’s Johnson Space Center in Houston, where every US astronaut has lived and trained since 1961.

The first person in the decision process is the chief astronaut, a role currently filled on an acting basis by Wiseman’s deputy, Drew Feustel. Sources told CNN that the chief, whether it’s Feustel or someone else, will take their initial recommendations to the head of the Flight Operations Directorate, Norm Knight, and then on to the director of Johnson Space Center, Vanessa Wyche, who is responsible for signing off on the final four selections.

Cracking the code on how that decision is made is as complex as spaceflight itself.

“To this day, it’s a dark area,” former NASA astronaut Mike Mullane told CNN. “It’s terra incognita (unknown territory). Nobody knows! At least not in our era they didn’t.”

What is known is that NASA Administrator Bill Nelson, a former Democratic senator from Florida, will have no role in the process, something he confirmed for the first time to CNN earlier in January when he said that the space agency’s Washington leadership will “stay out of the selection” of the Artemis II crew.

“That is done by the people at the Johnson Space Center. They will make the decision,” Nelson told CNN. “I do not know if they’ve decided who the crew is, nor should I.”

The only thing set in stone is that the Artemis II crew will consist of three American astronauts and one Canadian, terms that were cemented in a 2020 treaty between the two countries. From the beginning, NASA has also emphasized the need for a program named after Apollo’s twin sister in Greek mythology, Artemis, to have a crew with a heavy mix of gender, racial and professional diversity.

NASA has a far more diverse pool of astronauts to choose from now than during the Mercury program, when all seven astronauts were White, male, military test pilots. More than a third of the Artemis generation’s 41 astronauts are women and 12 are people of color.

The Artemis generation of astronauts is also professionally diverse, with only 16 pilots in its ranks. The rest are “mission specialists” with expertise in biology, geography, oceanography, engineering and medicine.

Nearly a dozen current and former NASA officials and astronauts told CNN they anticipated multiple test pilots being named to the crew of Artemis II, since the mission marks the first crewed test flight to the moon since the Apollo program.

“Just having the courage to go in there and be the first ones and be cool about it, that does take a certain amount of skill and experience and maturity,” said Reisman, the former astronaut. “We’re going beyond Low Earth Orbit for the first time in a very long time, on only the second flight of this vehicle.”

If Wiseman, a White man, is selected, that means the other spots will almost certainly need to go to at least one woman and at least one person of color.

People familiar with the process tell CNN that along with Wiseman, there are a handful of other candidates atop the list. Among them is Victor Glover, a 46-year-old naval aviator who returned to Earth from his first spaceflight in 2021 after piloting the second crewed flight of SpaceX’s Crew Dragon spacecraft and spending nearly six months aboard the International Space Station. The veteran of four spacewalks earned a master’s in engineering while moonlighting as a test pilot.

Randy Bresnik, 55, is also a decorated naval aviator and test pilot who flew combat missions in support of Operation Iraqi Freedom. He has flown two missions to the International Space Station: one on the Space Shuttle, another on a Russian Soyuz spacecraft. Bresnik is often mentioned as a top contender for Artemis because, since 2018, he has overseen the astronaut office’s development and testing of all rockets and spacecrafts that will be used in the Artemis missions.

There are four women who people familiar with the process tell CNN are atop the list of likely candidates. Among them are Christina Koch and Jessica Meir, both of whom made history in 2019 when together they performed the first all-female spacewalk.

The 43-year-old Koch, a veteran of six spacewalks, also holds the record for the longest single spaceflight by a woman, with a total of 328 days in space. Koch, an electrical engineer, and Meir, a 45-year-old biologist, were both selected as mission specialists in NASA’s 2013 astronaut class after stints at remote scientific bases in polar regions. That experience of surviving in hostile climates and uncomfortable environments is critical for a crew who will be cramped inside a 17-foot-wide (5-meter-wide), gumdrop-shaped capsule for roughly 10 days.

“We pride ourselves on expeditionary behavior: being a good teammate, emptying the trash can when it’s full, cleaning out the dishwasher when your parents ask you. Those sorts of things,” Wiseman said in August. “That’s really what we’re looking for in those first Artemis missions. Technical expertise. Team player.”

Anne McClain is a decorated army pilot and West Point graduate who flew more than 200 combat missions in support of Operation Iraqi Freedom and went on to graduate from the US Naval Test Pilot School in 2013, the same year she was selected to be a NASA astronaut. After launching on a Russian Soyuz spacecraft in 2018, the 43-year-old spent more than 200 days in space at the International Space Station and served as lead spacewalker on two spacewalks.

Stephanie Wilson is the most senior astronaut on this list. The 56-year-old was selected to be an astronaut more than a quarter century ago in the class of 1996. Wilson served as a mission specialist on three Space Shuttle flights, including the first flight after the 2003 Columbia disaster, which killed seven astronauts.

The final seat on the Artemis II crew will be filled by a Canadian, and Jeremy Hansen is the most buzzed about astronaut with the Canadian Space Agency. Hansen was selected to be an astronaut almost 14 years ago, but he’s still waiting for his first flight assignment. The 47-year-old fighter pilot recently became the first Canadian to be put in charge of training for a new class of NASA astronauts.

All eight astronauts on CNN’s list of top contenders are highly qualified overachievers in the prime of their careers. But sometimes the deciding factor can come down to something frustratingly small.

“The problem is it can be influenced by trivial things, like what size spacesuit you wear. If there is only a medium and a large and you need the extra-large, you’re screwed. You’re not going to get assigned to the mission,” said Reisman, the former astronaut and veteran of three spacewalks. “It can be crazy, little things that dictate how it all comes out and it’s not always the most equitable or transparent process.”

Typically, NASA also strives for a professionally diverse crew with a healthy blend of rookies and veterans, aiming for a mix of military pilots and citizen scientists — doctors, engineers, astrophysicists, biologists and geologists — with a range of strengths.

“Not all astronauts are created equal when it comes to how good they do the job. Not all astronauts are equally as good at doing spacewalks. Not all astronauts are equally as good at doing robotics,” Reisman said. “The standard line is, if you’re qualified, you’re qualified. If you pass the test, then it shouldn’t matter. But when you have really tricky missions, it does matter, and you do want to put your best team forward.”

That is especially true for the crew of Artemis II, which will be riding on a rocket that’s only had one successful test flight.

As secretive as the crew selection process is for Artemis, it used to be even more confusing. That was especially true during the early days of the Space Shuttle program when, for the first and only time in NASA’s history, a non-astronaut had near total control over who flied and who stayed behind on Earth: George Abbey.

“George didn’t operate by committee any more than Josef Stalin had. His was the only voice that counted,” wrote Mullane, the retired astronaut, in his memoir, “Riding Rockets,” about the former director of the Johnson Space Center. “Everything about the most important aspect of our career — flight assignments — was as unknown to us as the dark matter of space was to astrophysicists.”

By the time former NASA astronaut Scott Kelly, who famously spent a year in space, was selected in 1996, the power had shifted back to the chief astronaut. Kelly described the flight assignment process as still “shrouded in mystery,” though he did recall a push toward more transparency by then-Chief of the Astronaut Office Bob Cabana, the current associate administrator of NASA.

“Bob put a big board in his office. He had all the shuttle flights lined up and certain people’s names would be penciled in next to them,” Kelly said. “Reid (Wiseman) did something similar. He was more of an open book. He would tell people what he was thinking.”

Now, Wiseman is on the other side, waiting along with every other active astronaut for the announcement of a lifetime, which the NASA administrator said would come “later in the spring.”

For those who don’t make the cut, Artemis is far from the only game in town. NASA astronauts are currently training and flying to the International Space Station for long-duration spaceflights on the SpaceX Crew Dragon and Russia’s Soyuz spacecraft. A third option, Boeing’s Starliner, is slated to fly astronauts for the first time this spring. The expectation is that every active astronaut will eventually be assigned to a flight. But only eight will get to fly to the moon on either Artemis II or Artemis III.

“This is a special and unique opportunity and, frankly, I’m going to be super jealous of whoever they pick,” Reisman said.

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States



CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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Wagner group: US introduces new sanctions targeting Russian mercenary group



CNN
 — 

The US Treasury Department on Thursday designated the Wagner Group, a Russian private mercenary organization heavily involved in the war in Ukraine, as a significant transnational criminal organization, and imposed a slew of sanctions on a transnational network that supports it.

The US Department of State concurrently announced a number of sanctions meant to “target a range of Wagner’s key infrastructure – including an aviation firm used by Wagner, a Wagner propaganda organization, and Wagner front companies,” according to US Secretary of State Antony Blinken.

“As Russia’s military has struggled on the battlefield, Putin has resorted to relying on the Wagner Group to continue his war of choice. The Wagner Group has also meddled and destabilized countries in Africa, committing widespread human rights abuses and extorting natural resources from their people,” the Treasury Department said in a press release.

In addition to the measures targeting the Wagner Group – which were previewed by the White House last week – both agencies announced sanctions against a wide group of individuals and companies tied to Russia’s war in Ukraine. They are the latest US punitive measures against the Kremlin and its proxies as Russian President Vladimir Putin’s war approaches its second year with no signs of abating.

“This action supports our goal to degrade Moscow’s capacity to wage war against Ukraine, to promote accountability for those responsible for Russia’s war of aggression and associated abuses, and to place further pressure on Russia’s defense sector,” Blinken said in a statement.

The Treasury Department announced sanctions on a number of individuals and companies tied to Moscow’s defense industrial complex, as well as Putin allies and their family members, and two people involved with Russia’s attempts to annex parts of Ukraine.

The State Department also announced sanctions on “three individuals for their roles as heads of the Russian Federal Penitentiary Service, which has been reported to facilitate the recruitment of Russian prisoners into the Wagner Group,” a Deputy Prime Minister who also serves as the Minister of Industry and Trade,” “the Chairman of the Election Commission of the Rostov Region,” a network tied to an already-sanctioned Russian oligarch, and a financier to Putin, according to Blinken.

In addition, the State Department announced it will take steps to impose visa restrictions “on 531 members of the Russian Federation military for actions that threaten or violate the sovereignty, territorial integrity, or political independence of Ukraine.”

National Security Council Coordinator for Strategic Communications John Kirby last week previewed the significant transnational criminal organization designation and forthcoming sanctions against the Wagner group, telling reporters Friday, “These actions recognize the transcontinental threat that Wagner poses, including through its ongoing pattern of serious criminal activity.”

Among the companies sanctioned by the Treasury Department for their ties to the Wagner Group and its leader, Yevgeniy Prigozhin, are Joint Stock Company Terra Tech, a “Russia-based technology firm that supplies space imagery acquired by commercially active satellites, as well as aerial images acquired by unmanned systems,” and a China-based entity “that has provided Terra Tech synthetic aperture radar satellite imagery orders over locations in Ukraine.”

“These images were gathered in order to enable Wagner combat operations in Ukraine,” the Treasury Department said.

In addition to sanctions related to the Wagner Group’s significant involvement in the war in Ukraine, the Treasury Department imposed sanctions for its illicit activities in the Central African Republic. The group was re-designated “for being responsible for or complicit in, or having engaged in, the targeting of women, children, or any civilians through the commission of acts of violence, or abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law in relation to the CAR.”

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FBI seizes website used by notorious ransomware gang



CNN
 — 

The FBI has seized the computer infrastructure used by a notorious ransomware gang which has extorted more than $100 million from hospitals, schools and other victims around the world, US officials announced Thursday.

FBI officials since July have had extraordinary access to the so-called Hive ransomware group’s computer networks, FBI Director Christopher Wray said at a news conference, allowing the bureau to pass computer “keys” to victims so that they could decrypt their systems and thwart $130 million in ransom payments.

As of November, Hive ransomware had been used to extort about $100 million from over 1,300 companies worldwide – many of them in health care, according to US officials.

The dark-web website on which Hive listed its victims displayed a message in Russian and English Thursday that it had been taken over “as part of a coordinated law enforcement action” against the group by the FBI, Secret Service and numerous European government agencies.

“Simply put, using lawful means, we hacked the hackers,” Deputy Attorney General Lisa Monaco told reporters.

The Hive ransomware has been particularly rampant in the health care sector. One ransomware attack using Hive malicious software, in August 2021, forced a hospital in the US Midwest to turn away patients as Covid-19 surged, Attorney General Merrick Garland said.

Other reported US victim organizations of Hive include a 314-bed hospital in Louisiana. The hospital said it thwarted a ransomware attack in October, but that the hackers still stole personal data on nearly 270,000 patients.

“Hive compromised the safety and health of patients in hospitals – who are among our most vulnerable population,” said Errol Weiss, chief security officer for the Health Information Sharing and Analysis Center, a cyber threat sharing group for big health care providers worldwide. “When hospitals are attacked and medical systems go down, people can die.”

Thursday’s announcement is the latest in a series of Justice Department efforts to crack down on overseas ransomware groups that lock up US companies’ computers, disrupt their operations and demand millions of dollars to unlock the systems. Justice officials have seized millions of dollars in ransomware payments and urged companies not to pay off the criminals.

The ransomware epidemic grew more urgent for US officials after Colonial Pipeline, the major pipeline operator for sending fuel to the East Coast, shut down for days in May 2021 due to a ransomware attack from a suspected Russian cybercriminal. The disruption led to long lines at gas stations in multiple states as people hoarded fuel.

While the ransomware economy remains lucrative, there are signs that the US and international law enforcement stings are making a dent in the hackers’ earnings. Ransomware revenue fell to about $457 million in 2022, down from $766 million in 2021, according to data from cryptocurrency-tracking firm Chainalysis.

Cybersecurity professionals welcomed the Hive takedown, but some worried that another group would soon fill the void left by Hive.

“The disruption of the Hive service won’t cause a serious drop in overall ransomware activity but it is a blow to a dangerous group that has endangered lives by attacking the healthcare system,” John Hultquist, a vice president at Google-owned cybersecurity firm Mandiant, told CNN.

“Unfortunately, the criminal marketplace at the heart of the ransomware problem ensures a Hive competitor will be standing by to offer a similar service in their absence, but they may think twice before allowing their ransomware to be used to target hospitals,” Hultquist said.

Wray said the FBI would continue to track the people behind Hive ransomware and try to arrest them. It was not immediately clear where those people were located. The Department of Health and Human Services has descried Hive as a “possibly Russian speaking” group.

This story has been updated with additional details.

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First on CNN: Classified documents found at Pence’s Indiana home


Washington
CNN
 — 

A lawyer for former Vice President Mike Pence discovered about a dozen documents marked as classified at Pence’s Indiana home last week, and he has turned those classified records over to the FBI, multiple sources familiar with the matter told CNN.

The FBI and the Justice Department’s National Security Division have launched a review of the documents and how they ended up in Pence’s house in Indiana.

The classified documents were discovered at Pence’s new home in Carmel, Indiana, by a lawyer for Pence in the wake of the revelations about classified material discovered in President Joe Biden’s private office and residence, the sources said. The discovery comes after Pence has repeatedly said he did not have any classified documents in his possession.

It is not yet clear what the documents are related to or their level of sensitivity or classification.

Pence’s team notified congressional leaders and relevant committees of the discovery on Tuesday.

Pence asked his lawyer to conduct the search of his home out of an abundance of caution, and the attorney began going through four boxes stored at Pence’s house last week, finding a small number of documents with classified markings, the sources said.

Pence’s lawyer immediately alerted the National Archives, the sources said. In turn, the Archives informed the Justice Department.

A lawyer for Pence told CNN that the FBI requested to pick up the documents with classified markings that evening, and Pence agreed. Agents from the FBI’s field office in Indianapolis picked up the documents from Pence’s home, the lawyer said.

On Monday, Pence’s legal team drove the boxes back to Washington, DC, and handed them over to the Archives to review the rest of the material for compliance with the Presidential Records Act.

In a letter to the National Archives obtained by CNN, Pence’s representative to the Archives Greg Jacob wrote that a “small number of documents bearing classified markings” were inadvertently boxed and transported to the vice president’s home.

“Vice President Pence was unaware of the existence of sensitive or classified documents at his personal residence,” Jacob wrote. “Vice President Pence understands the high importance of protecting sensitive and classified information and stands ready and willing to cooperate fully with the National Archives and any appropriate inquiry.”

The classified material was stored in boxes that first went to Pence’s temporary home in Virginia before they were moved to Indiana, according to the sources. The boxes were not in a secure area, but they were taped up and were not believed to have been opened since they were packed, according to Pence’s attorney. Once the classified documents were discovered, the sources said they were placed inside a safe located in the house.

Pence’s Washington, DC, advocacy group office was also searched, Pence’s lawyer said, and no classified material or other records covered by the Presidential Records Act was discovered.

The news about Pence come as special counsels investigate the handling of classified documents by both Biden and former President Donald Trump. The revelations also come amid speculation that Pence is readying for a run at the Republican nomination for president in 2024.

Since the FBI searched Trump’s home in Florida for classified material in August with a search warrant, Pence has said that he had not retained any classified material upon leaving office. “No, not to my knowledge,” he told The Associated Press in August.

In November, Pence was asked by ABC News at his Indiana home whether he had taken any classified documents from the White House.

“I did not,” Pence responded.

“Well, there’d be no reason to have classified documents, particularly if they were in an unprotected area,” Pence continued. “But I will tell you that I believe there had to be many better ways to resolve that issue than executing a search warrant at the personal residence of a former president of the United States.”

While Pence’s vice presidential office in general did a rigorous job while he was leaving office of sorting through and turning over any classified material and unclassified material covered by the Presidential Records Act, these classified documents appear to have inadvertently slipped through the process because most of the materials were packed up separately from the vice president’s residence, along with Pence’s personal papers, the sources told ClNN.

The vice president’s residence at the US Naval Observatory in Washington has a secure facility for handling classified material along with other security, and it would be common for classified documents to be there for the vice president to review.

Some of the boxes at Pence’s Indiana home were packed up from the vice president’s residence, while some came from the White House in the final days of the Trump administration, which included last-minute things that did not go through the process the rest of Pence’s documents did.

The discovery of classified documents in Pence’s residence marks the third time in recent history in which a president or vice president has inappropriately possessed classified material after leaving office. Both Biden and Trump are now being investigated by separate special counsels for their handling of classified materials.

Sources familiar with the process say Pence’s discovery of classified documents after the Trump and Biden controversies would suggest a more systemic problem related to classified material and the Presidential Records Act, which requires official records from the White House to be turned over to the National Archives at the end of an administration.

On Friday, the FBI searched Biden’s Wilmington residence for additional classified material, an unprecedented search of a sitting president’s home that turned up six additional items containing classified markings. The search was conducted after Biden’s lawyers discovered classified material in Wilmington following the initial discovery of classified documents at Biden’s private think office in November.

Biden’s attorneys say they are fully cooperating with the Justice Department, seeking to draw a distinction from the Trump investigation.

The FBI obtained a search warrant to search Trump’s Mar-a-Lago resort in August. Federal investigators took that step because they believed Trump had not turned over all classified material despite a subpoena and were concerned records at Mar-a-Lago were being moved around.

Last week, Pence told Larry Kudlow in a Fox Business interview that he received the President’s Daily Brief at the vice president’s residence.

“I’d rise early. I’d go to the safe where my military aide would place those classified materials. I’d pull them out, review them,” Pence said. “I’d receive a presentation to them and then, frankly, more often than not Larry, I would simply return them back to the file that I’d received them in. They went in commonly into what was called a burn bag that my military aide would gather and then destroy those classified materials—same goes in materials that I would receive at the White House.”

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FDA wants to simplify the use and updating of Covid-19 vaccines



CNN
 — 

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. That could include streamlining the vaccine composition, immunization schedules and periodic updates of Covid-19 vaccines.

The FDA said it expects to assess circulating strains of the virus that causes Covid-19 at least annually and decide in June which strains to select for the fall season, much like the process to update annual flu vaccines.

Moving forward, the agency said, most people may need only one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they have already received. Two doses may be needed for people who are very young and haven’t been exposed, or for the elderly or immune-compromised, according to the FDA’s briefing document for its vaccine advisers.

The agency is urging a shift toward only one vaccine composition, rather than a combination of monovalent vaccines, which are currently used for primary shots and target only one strain, and bivalent vaccines, which are currently used for booster doses and target more than one strain.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

The FDA’s plan was first reported by National Public Radio.

The agency’s independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, are scheduled to meet on Thursday to discuss the future of Covid-19 vaccine regimens, and will be asked to vote on whether they recommend parts of FDA’s plan.

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