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Thursday, December 31, 2020

MF Doom, Masked Rapper With Intricate Rhymes, Is Dead at 49 - The New York Times

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Daniel Dumile, the masked rapper who performed as MF Doom and built a lasting underground fan base with his offbeat wordplay and comic-book persona, died on Oct. 31, a statement from his family said on Thursday. He was 49.

The rapper’s record label, Rhymesayers, provided the statement, signed by Mr. Dumile’s wife, Jasmine. The label did not provide details on a cause of death or why the information was being shared two months later.

Over six solo albums released between 1999 and 2009 and five collaborative LPs (with Madlib and Danger Mouse, among others) between 2004 and 2018, Mr. Dumile honed a style that was intricate and imaginative, calling on both esoteric and lowbrow references as well as cartoonish imagery in lyrics that could be poignantly emotional.

Born in London and raised on Long Island, Mr. Dumile grew up steeped in early hip-hop influences. He debuted in 1989 on the 3rd Bass track “The Gas Face” with a standout cameo that helped him get a record deal for his own group, KMD, in which he rapped as Zev Love X. The act included his brother, Dingilizwe, who performed under the name DJ Subroc, and its first album, “Mr. Hood,” arrived in 1991 on the major label Elektra. During the recording of KMD’s second album, “Black Bastards,” Subroc was killed in a car accident, and the label later declined to release the record. Mr. Dumile went underground, vanishing from the entertainment business, but continuing to work on music privately while he raised his son.

He resurfaced in 1997 with the single “Dead Bent,” his first song under the name Metal Face Doom. (The persona was a nod to the Marvel villain Doctor Doom.) Around the time of the release of the album “Operation: Doomsday” in 1999, which featured a masked character on its cover, he began hiding his face in public, at first with a stocking mask, and later with the metal one that became his signature.

In a 2009 interview in The New Yorker, Mr. Dumile said the mask became necessary as he made the leap from the studio to the stage. “I wanted to get onstage and orate, without people thinking about the normal things people think about,” he said. “A visual always brings a first impression. But if there’s going to be a first impression I might as well use it to control the story. So why not do something like throw a mask on?”

Once an underground cult figure, Mr. Dumile’s albums in the mid-aughts launched him to greater fame. “Madvillainy,” which arrived in 2004 with the producer Madlib, was a breakthrough. “He delivers long, free-associative verses full of sideways leaps and unexpected twists,” the pop music critic Kelefa Sanneh wrote in The New York Times, reviewing a 2004 concert. “You think you know where he’s heading and what each sentence will mean when it ends. Then it bends.”

On “Raid,” a track from “Madvillainy,” he rhymes:

Trippin’, to date the Metal Fellow been rippin’ flows
Since New York plates was ghetto yellow
With broke blue writing, this is too exciting
Folks leave out the show feelin’ truly enlightened

Released in the same year, his album “MM .. FOOD" (an anagram of his stage name) included tracks like “Gumbo,” “Kon Queso” and “Kon Karne.” In rapping about the seemingly mundane topic of food with goofiness and wit, Mr. Dumile told Spin in 2004 that he was “showing respect for human life.”

“I’m more like a writer dude rather than a freestyler,” Mr. Dumile told The Chicago Tribune that same year. “I like to design my stuff, and I consider myself an author.”

Mr. Dumile rapped under different personas, and later became known for sending impostors out onstage to perform for fans; in his trademark metal mask, it was difficult to know the difference. The body doubles often disappointed fans but sparked viral moments online, like when an apparent MF Doom drop-in at a concert turned out to be the comedian Hannibal Buress.

Though he never reached mainstream superstardom, Mr. Dumile was widely admired by fellow rappers and producers, in addition to a loyal following of fans. He was “your favorite MC’s MC,” wrote Q-Tip from A Tribe Called Quest on Twitter. In a post on Instagram, El-P wrote, “thank you for keeping it weird and raw always. you inspired us all and always will.”

In 2017, Mr. Dumile announced on social media that his son, King Malachi Ezekiel Dumile, had died at 14. Information on survivors was not immediately available.

Caryn Ganz contributed reporting.

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January 01, 2021 at 06:08AM
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MF Doom, Masked Rapper With Intricate Rhymes, Is Dead at 49 - The New York Times

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College roundup: Armed Forces Bowl ends with brawl - pressherald.com

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Tulsa safety TieNeal Martin, center, and Mississippi State linebacker Aaron Brule, right, fight alongside teammates at the conclusion of the Armed Forces Bowl on Thursday in Fort Worth, Texas. Ian Maule/Tulsa World via AP

FORT WORTH, Texas — A bowl victory that increased Mississippi State’s win total this season to four and No. 22 Tulsa’s failed attempt to add another unlikely comeback to its impressive collection this season took a back seat to the melee that broke out Thursday shortly after the Armed Forces Bowl ended.

True freshman Will Rogers scored his first rushing touchdown of the season and had a 13-yard TD pass to lead Mississippi State past Tulsa, 28-26, in a game that was tense from the start.

Minutes after it ended, the teams became involved in a large brawl on the field, with players punching and kicking one another. Tulsa Coach Greg Montgomery said sophomore safety Kendarin Ray, who was helped off the field after being at the bottom of a dogpile during a scrum, was treated for “some sort of concussion.”

“I’m not sure what exactly caused that,” said Mississippi State Coach Mike Leach, who referred to the altercation as a “mosh pit.” “It was something before the game, too. We’ve never had any problem with that the entire season, so I can only guess without seeing the film.”

In a video posted from Mississippi State’s locker room, Malik Heath joked about kicking a Tulsa player in the facemask.

Jo’quavious Marks scored a rushing touchdown on the game’s first possession and Emmanuel Forbes returned an interception 90 yards for a touchdown for the Bulldogs (4-7), who finished the season with a second straight win in a game played at TCU’s Amon G. Carter Stadium in cold, rainy conditions.

LIBERTY BOWL: Reserve quarterback Austin Kendall threw a 20-yard touchdown pass to T.J. Simmons with 5:10 left and West Virginia held off Army 24-21 in Memphis, Tennessee.

Army (9-3) had a chance to tie it with 1:50 left, but Quinn Maretzki’s 39-yard field goal was wide left. Josh Chandler ended Army’s final possession with an interception, and led the Mountaineers (9-3) with 13 tackles.

Simmons also scored on a 5-yard pass from starting quarterback Jarret Doege.

Army quarterback Tyhier Tyler had three rushing touchdowns – from 1, 6, and 2 yards – to tie a Liberty Bowl record.

The Black Knights initially were scheduled to play in the Independence Bowl but seemed left out of the bowl lineup after that game was canceled. They got the opportunity to play in the Liberty Bowl after Tennessee (3-7) opted out because of COVID-19 cases.

ARIZONA BOWL: Antonio Phillips returned an early interception 53 yards for a touchdown, Drew Plitt accounted for two scores and Ball State beat No. 19 San Jose State 34-13 in Tucson, Arizona.

San Jose State (7-1, No. 22 CFP) had to play without its two coordinators and Mountain West Conference player of the year Cade Hall because of COVID-19 and other issues.

Ball State (7-1) took advantage, quick-hitting its way down the field on offense after Phillips’ interception for a 27-0 lead in the first quarter. The Mid-American champions bogged down in the second half but had four interceptions to win their first bowl game in 10 tries.

MEN’S BASKETBALL

(6) WISCONSIN 71, (21) MINNESOTA 59: Micah Potter had 18 points and 11 rebounds to lead the Badgers (9-2, 3-1 Big Ten) to a win over the Gophers (9-2, 2-2 Big Ten) in Madison, Wisconsin.

WOMEN’S BASKETBALL

(5) SOUTH CAROLINA 75, FLORIDA 59: Aliyah Boston had a career-high 28 points along with 16 rebounds, and the Gamecocks (6-1) opened Southeastern Conference play with their 13th consecutive win over the visiting Gators (7-2).

(14) MARYLAND 96, PENN STATE 82: Ashley Owusu scored a career-high 34 points and grabbed eight rebounds to lead the Terrapins (6-1, 2-0 Big Ten) to a road win over the Nittany Lions (3-3, 0-2).

NEBRASKA 65, (15) NORTHWESTERN 63: Sam Haiby made a game-winning putback just before the buzzer as the Cornhuskers (4-3, 2-2 Big Ten) beat the Wildcats (4-1, 2-1) in Lincoln, Nebraska.

(16) MICHIGAN 92, WISCONSIN 49: Leigha Brown scored 26 points as cruised the Wolverines (6-0, 1-0 Big Ten) cruised past the Badgers (3-3, 0-3) in Ann Arbor, Michigan.

(20) INDIANA 79, ILLINOIS 56: Mackenzie Holmes of Gorham scored 18 points, Grace Berger added 15 and the Hoosiers (6-2, 4-0 Big Ten) got their 11th straight win over the visiting Illini (2-4, 0-3).

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January 01, 2021 at 07:54AM
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College roundup: Armed Forces Bowl ends with brawl - pressherald.com

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India's love affair with classic British motorbikes - BBC News

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January 01, 2021 at 07:11AM
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India's love affair with classic British motorbikes - BBC News

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Connecticut Celebrates the New Year with First Day Hikes - CT.gov

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Press Releases

DEEP News Release Header

12/31/2020

Connecticut Celebrates the New Year with First Day Hikes on January 1 - Virtual and Self-Guided Hikes at 10 Parks and Forests Across the State

The Connecticut Department of Energy and Environmental Protection (DEEP)and its partners at the various State Parks and Forests Friends Groups are encouraging residents to get the New Year started off right by getting outside and safely partaking in a “First Day Hike,” at a state park or forest close to home.

Due to the COVID-19 pandemic, the format of this event has shifted from the usual in-person hikes and events to online, virtual and self-guided events with no specific timeframe. We ask all participating to wear a mask, practice safe social distancing, and meet in small groups composed of those within your household.

America’s State Parks First Day Hikes offer individuals and families an opportunity to begin the New Year rejuvenating and connecting with the outdoors by taking a healthy hike on January 1. First Day Hikes offer a great way to get outside, exercise, enjoy nature and welcome the New Year.

DEEP State Parks and Forests Friends Groups have put together an array of virtual and self-guided hikes and programs for those looking to participate, which average 1 to 2 miles or longer depending on the state park. See below for the list of Connecticut’s First Day Hikes, or view them on the DEEP website here.

“Connecticut is pleased to once again join in hosting First Day Hikes around the state, albeit in a slightly different fashion due to the COVID-19 pandemic,” DEEP Commissioner Katie Dykes said. “As they were in 2020, Connecticut’s state parks and forests will continue to be a respite for folks in 2021 who seek the mental and physical rejuvenation nature provides. “We hope you consider celebrating the New Year safely in the outdoors, whether it be a First Day Hike, or part of a resolution to engage more with nature over the course of the year.”

Each year more than 9 million visitors visit the 110 Connecticut State Parks and 32 State Forests across the state. Established in 1913, the mission of the Connecticut State Park System is to provide natural resource based public recreational and educational opportunities through a system of state park and forest recreation areas, environmental centers and nature centers which provide an understanding of, access to, and enjoyment of the state’s historic, cultural and natural resources.

In Connecticut, virtual and self-guided First Day Hikes and programs will be offered at 10 State Park and Forest locations as well as at several locations in the Litchfield area: 

 

1. Chatfield Hollow State Park

Visit: Friends of Chatfield Hollow Facebook page 

Contact: Cheryl Buckley ckbucks@sbcglobal.net 860-391-1919 

 

Information:  Event inviting families to toast the arrival of 2021 and more importantly bid adieu to 2020 with a personal walk/hike. When families complete the walk of their choosing, they will be asked if they would like their group to be part of collage (of WELCOME 2021) pictures to be posted on the site.  

2. Machimoodus State Park

Visit: Friends of Machimoodus-Sunrise Friends Facebook Page 

Contact: Tanya machsunfriends@gmail.com  

Information: Photo scavenger hunt. People will be able to print, download or simply view the list on their smart phone and participate at their own pace.  

3. Mansfield Hollow State Park

Visit: Friends of Mansfield Hollow Facebook page 

Contact: Ron Manizza. 860-428-3667 

Information: Virtual hikes with routes marked out and available using your smart phone with the app Ridewithgps 

4. Pachaug State Forest

Visit: Friends of Pachaug Forest Facebook page 

Contact: Ryan Snide, friendsofpachaugforest@gmail.com

Information: Will be hosting virtual hikes at several locations within Pachaug that participants can do at their leisure.  

5. Scantic River State Park  

Visit: American Heritage River Commission Facebook page 
Contact: Debbie Talamini, talamini@cox.net 

American Heritage River Commission 

Scantic River State Park 

East Windsor CT 

Information: Self-guided hikes. Please share photos of your First Day Hike 2021 to our AHRC Facebook page or tag us in your personal posts. Enjoy the State Park and stay safe out there! 

 

6. James L. Goodwin State Forest

Visit the following to register:   

https://www.ctwoodlands.org/CFPA-events/new-years-hike-seek-goodwin-state-forest

Information: Hosting a weekend long Hike & Seek event, where families/individuals register and get what is essentially a scavenger hunt checklist of nature-themed items to find throughout the trails and gardens (fire ponds, animal print, scratch marks on a tree, an invasive species, etc.). This event is on your own, socially-distant and safe. The event runs from Friday January 1, 2021 through Sunday January 3, 2021. If participants find a certain amount of the items they win a simple prize.  

7. Meigs Point Nature Center

Visit: Meigs Point Nature Center Facebook Page 

Contact: Russ Miller, Russell.Miller@ct.gov 

 

Information: Have you ever wondered what a state park looks like in the winter, what animals are still around or which ones come out in the winter? Visit the Meigs Point Nature Center Facebook page at 11:00 am on January 1stto join “Ranger Russ” for a live hike along the shore at Hammonasset Beach State Park.  

8. Topsmead State Forest

Visit: Friends of Topsmead State Forest Facebook Page 

Visit: Events link 

Contact: Jane Golding  860-480-9668  jane.golding54@gmail.com 

Information: Friends of Topsmead State Forest will stage their hikes at the main parking lot at Topsmead. 

*History hike led with a guide or printed information to tour/ inform interested hikers about the history and grounds of Topsmead. (the house is not open). 

*A songbird trail tour given by the Friend of Topsmead, Janet Blauvelt, who has established and maintained birdhouses at Topsmead. 

*A serenity and scenic walk out to the Birdblind/Wildlife viewing building which overlooks vistas and fields. There’s a bench there at Topsmeads’ Pollinator garden and shelter inside the viewing blind. 

Friends will be at the parking lot at 10:00 if any assistance is desired. 

 

9. Litchfield First Day Hiking Opportunities 

Contact: Dean Birdsall, Litchfield Land Trust Stewardship

The LLT trail maps link from our web site: https://www.litchfieldlandtrust.org/our-preserves.html 

LLT email: info@litchfieldlandtrust.org 

Information: Litchfield Land Trust (“LLT”) self-guided First Day Hikes

Suggested hiking experiences: 

 

New Year vistas 

Apple Hill Trail – White Memorial Conservation Center 

https://whitememorialcc.org/trails/ (Access to trail maps and trail descriptions). Self-guided hike. 

Prospect Mountain Preserve Trails - Litchfield Land Trust https://www.litchfieldlandtrust.org/  (Access to trail maps and trail descriptions). Self-guided hike. 

Scenic Serenity 

Bird Blind & Wildlife viewing - Friends of Topsmead https://www.friendsoftopsmead.org/  Friends will be at the parking lot at 10:00 if any assistance is desired. A songbird trail tour given by the Friend of Topsmead, Janet Blauvelt, who has established and maintained birdhouses at Topsmead. 

 

Boyd Woods Audubon Sanctuary – Litchfield Hills Audubon https://lhasct.org/www.lhasct.org/Boyd_Woods.html Marie Kennedy will be there at 9:00 am for those who would like a guide.  

Medicine Rock Trail - The Litchfield Land Trust  

https://www.litchfieldlandtrust.org/ (Access to trail maps and trail descriptions). Self-guided hike. 

Vineyard/River Trail Loop - White Memorial Conservation Center https://whitememorialcc.org/trails/ (Access to trail maps and trail descriptions). Self-guided hike. 

 

Local History 

Boyd Woods Audubon Sanctuary - https://lhasct.org/www.lhasct.org/Boyd_Woods.html Marie Kennedy will be there at 9:00 am for those who would like a guide.  

Ice House Ruins Trail - White Memorial Conservation Center https://whitememorialcc.org/trails/ (Access to trail maps and trail descriptions). Self-guided hike.     

Shepaug Crossing Trail – Litchfield Land Trust  

https://www.litchfieldlandtrust.org/  (Access to trail maps and trail descriptions). Self-guided hike. 

Topsmead Grounds – Friends of Topsmead                             

Visit: https://www.friendsoftopsmead.org/  

10. White Memorial Conservation Center

Visit: https://whitememorialcc.org/calendar/ 

Contact: Carrie Szwed, 860-567-0857 www.whitememorialcc.org 

 

Information: Self-guided hikes  

11. Gillette Castle State Park

Visit: Friends of Gillette Castle Facebook page and YouTube Channel: https://www.youtube.com/channel/UCrnlVQJXo8_6j7CFpyMJLmQ/videos?view_as=subscriber

Contact: Paul Schiller, info@gillettecastlefriends.org

 

Information: Videos series includes a tour of the castle, trail walks and other fun stories and features of the park. More information available at https://www.gillettecastlefriends.org/ 

 

12. Talcott Mountain State Park-Heublein Tower 

Visit: Friends of Heublein Tower Facebook page 

1) https://www.friendsofheubleintower.org/ 

2) Twitter: @heubleintower 

3) Instagram: @friendsofht 

Contact: Dan Hinman, dan@spiralx.com Jessica Hinman jhinman@friendsofheubleintower.org 

Twitter: @CTDEEPNews
Facebook: DEEP on Facebook

Contact

DEEP Communications  
DEEP.communications@ct.gov
860-424-3110

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December 31, 2020 at 11:56PM
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Connecticut Celebrates the New Year with First Day Hikes - CT.gov

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With limited surveillance of Covid-19 variant, it's déjà vu all over again - STAT

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As health officials in the United States announced a second and possibly a third person infected with a new, more transmissible strain of the SARS-CoV-2 virus, infectious diseases experts are feeling a sense of déjà vu all over again.

A little less than a year ago, the early response to the coronavirus crisis was stifled by an inability to scale up testing to detect the virus and curb its spread. Now, once again, it’s unclear how prevalent the new strain, which first surfaced in the U.K., might be in the U.S. Already a possible and a probable case have been detected in Colorado and one case has been reported in California. But it’s likely the variant’s spread hasn’t stopped there.

“It feels a lot like that time between Jan. 19 or so when we had that first case in the Seattle area and six weeks later, when all of a sudden, it looks like we’ve got community transmission in California and Seattle and who knows where else,” said Michael Worobey, a professor of evolutionary biology at the University of Arizona. “It does have that feeling.”

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Trevor Bedford, a computational biologist at Fred Hutchinson Cancer Research Institute, told STAT he doesn’t believe the new variant, which is called B.1.1.7, is widespread yet. There are 250 genetic sequences of SARS-2 viruses from December cases in the U.S. that have been logged into an international virus sharing database known as GISAID; there isn’t a B.1.1.7 among them, Bedford said. But he believes it may just be a matter of time.

“How I imagined this working is … very similar to back to January, February,” he said. “There are seeding events that have occurred throughout the country. Some have taken, some haven’t.… And you could imagine it should be more likely to be in places like New York and Boston with good travel connections to London, but it could have just by happenstance get picked up a bit elsewhere.”

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Worobey agreed the new variant is probably already spreading in a number of parts of the country, traveling under the radar because the U.S. is not doing enough sequencing of SARS-2 viruses.

“We’re a little behind the eight ball in terms of our genomic sequencing, both in terms of absolute numbers and the sort of delay between sampling and getting the sequences out there, compared to the U.K.,” Worobey said. He warned that if the U.S. doesn’t find the cases and slow spread it will likely see the same kind of rapid dissemination of the variant that the U.K. has seen.

The new variant sports an unusual number of mutations, including some that appear to change the virus’ behavior. It seems to be significantly more transmissible, increasing the rate at which infected people infect others.

There’s no evidence to date that the variant triggers more severe disease. But hospitals are straining to handle Covid patients as it is; more infections could lead to a higher death rate, because of diminished quality of care.

“The case fatality rate increases if health care systems get overwhelmed,” said Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center. “That’s just how it works.”

There are efforts afoot to try to figure out how widely the new variant is spreading — one of them led by Worobey’s laboratory. His team is trying to develop an assay that could be used to test for variant viruses in wastewater from community sewage systems. If the test works, he said, the lab will ship testing materials to other laboratories, test samples in their own lab, or share the recipe for making the primers and probes to get the test into wide use.

“I do think that wastewater is going to be the best way in the very near term to get a better handle rather than waiting for the odd lab like Colorado that comes across one of these in an individual patient sample,” Worobey said.

The Centers for Disease Control and Prevention is also stepping up efforts to increase the sequencing of SARS-2 viruses, officials said Wednesday.

Gregory Armstrong, who is leading the CDC team monitoring virus variants, said the national SARS-CoV-2 strain surveillance system, which was started in November, is scaling up to be able to handle 750 samples submitted by states for sequencing and study every week. The CDC is also working with national reference laboratories in the country, providing funding for sequencing on several times that many viruses. The hope is to get to about 3,500 a week, Armstrong noted.

He said experts at the CDC and elsewhere do not believe the mutations contained in B.1.1.7 will significantly undermine the protection generated by Covid vaccines in use or in production. “It may cause a small impact. But keep in mind it’s likely that the amount of immunity that is induced either by natural infection or vaccination is great enough that a slightly decreased [antibody] titer may not have any noticeable effect at all,” Armstrong said.

But Bedford said increased use of vaccine will put additional pressure on SARS-2 viruses to mutate to try to evade the protection the vaccine trigger.

“It’s even more of an argument to try to get to herd immunity faster and to drive transmission down through vaccination,” he said. “The faster we can get enough people vaccinated, the better we’d be at keeping this variant and other future mutants from spreading.”

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January 01, 2021 at 07:00AM
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With limited surveillance of Covid-19 variant, it's déjà vu all over again - STAT

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Minneapolis shooting: man dies in 'exchange of fire' with police - The Guardian

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Police in Minneapolis shot and killed a man in an exchange of gunfire during a traffic stop on the city’s south side on Wednesday night, authorities have said.

John Elder, a police spokesman, said the incident happened about 6.15pm while officers were carrying out a traffic stop with a man suspected of a felony.

Elder said the man was pronounced dead at the scene by medical personnel. A woman in the car was unhurt, Elder said. He declined to say whether police recovered a gun at the scene.

Elder said no officers were hurt. He said he did not know how many officers carried out the traffic stop. The officers’ body cameras were on.

Police chief Medaria Arradondo said witnesses said the man fired first. He promised to release the video from the police body cameras on Thursday.

“I want our communities to see that so they can see for themselves,” he said. Until then, Arradondo said, “Please allow me, the (state) investigators, allow us the time, let us get the evidence, get the facts, so we can process this.”

The state’s Bureau of Criminal Apprehension was called in to handle the investigation.

The shooting happened less than a mile from the street corner where George Floyd died in May after a Minneapolis officer pressed his knee on Floyd’s neck for minutes, even as Floyd pleaded that he couldn’t breathe. It sparked sometimes violent protest that spread around the country and turned Black Lives Matter into an international cause.

In the aftermath of the shooting on Wednesday night, videos posted on social media by a Star Tribune reporter showed a crowd of protesters chanting at police and officers in riot gear.

Minneapolis Police spokesman John Elder briefs community members and others about the shooting
Minneapolis Police spokesman John Elder briefs community members and others about the shooting Photograph: Jeff Wheeler/AP

Mayor Jacob Frey said in a statement late on Wednesday he was working with Arradondo for information on the shooting and pledged to get it out as quickly as possible in coordination with the state investigation.

“Events of this past year have marked some of the darkest days in our city,” Frey said. “We know a life has been cut short and that trust between communities of color and law enforcement is fragile ... We must all be committed to getting the facts, pursuing justice, and keeping the peace.”

In Minneapolis, Floyd’s death led to a push for radical change in the police department, long criticized by activists for what they called a brutal culture that resisted change. A push by some city council members to replace the department with a new public safety unit failed this summer.

Frey and Arradondo, who opposed doing away with the department, have offered several policy changes since Floyd’s death, including limiting the use of so-called no-knock warrants, revising use-of-force policies and requiring officers to report on their attempts to calm situations.

All four officers involved in Floyd’s death were fired and quickly charged in his death. They are scheduled for trial in March.

With the Associated Press

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December 31, 2020 at 09:02PM
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Minneapolis shooting: man dies in 'exchange of fire' with police - The Guardian

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Tom Brady surprises Bruce Arians with assistance of younger Buccaneers - Sporting News

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Tom Brady's reputation for coaching younger players in New England was spotty, at best. That's not the case with the Buccaneers, though, according to coach Bruce Arians.

"It's been a joy. It's been awesome," Arians said during a Wednesday morning appearance on NFL Network's "Good Morning Football." "I didn't know that Tom took so much time with young players and coached them. It's one thing for me to say 'When you're coming out of your break, your arms aren't pumping,' and they say 'Sure.' Then Tom says it, they go 'Oh, really?' And they do it."

While it usually felt more like outward speculation than total truth, Brady did spend lots of time with the Patriots honing in on his established receivers rather than rookies. Some criticized him later in his career for not participating in OTAs, which would've provided more opportunity for chemistry with new faces.

But in his first year in Tampa Bay, Brady has both played well and made a good impression on Arians. Statistically, Brady's thrown for 36 touchdowns, his highest total since 2015, while totaling 4,234 yards and completing 65.9 percent of his passes. Arians pointed out Wednesday that it's more than just the numbers, though.

"It's like, I appreciate you, brother," Arians said. "It's like having another coach on the field for sure."

MORE: NFL picks, predictions for Week 17

As far as young players go, the Buccaneers offense isn't filled with them. Much of Brady's work is with veteran wideouts Mike Evans, Chris Godwin and Antonio Brown, along with established tight ends Rob Gronkowski and Cameron Brate. But there are younger players, like Ronald Jones and Scotty Miller, who have had the best seasons of their short NFL careers working with Brady.

Of course, this is the part wher you can make a joke about every player on Tampa Bay being younger than the 43-year old Brady. Very true.

It'll all have a chance to pay off for Brady starting next week in the playoffs. Tampa Bay wants to win in Week 17 to secure the No. 5 seed in the NFC and a first-round matchup against the NFC East champion. Beyond that, Brady and the Buccaneers have a chance to be the first team to play in the Super Bowl in their home stadium. Super Bowl 55 will be played on Feb. 7 at Raymond James Stadium in Tampa.

Apparently, Brady will be happily bringing not just the veterans but the younger players right along with him. 

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December 31, 2020 at 09:52PM
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Tom Brady surprises Bruce Arians with assistance of younger Buccaneers - Sporting News

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'The little nonprofit that could': Water with Blessings purchases new HQ in Jeffersontown - Courier Journal

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December 31, 2020 at 06:41PM
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'The little nonprofit that could': Water with Blessings purchases new HQ in Jeffersontown - Courier Journal

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Britain braces for not-so-special relationship with Biden - POLITICO

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“When you wanted to get something done with Europe, you made the first or perhaps second call to London,” said Charles Kupchan, who served as a senior National Security Council European affairs official in both the Obama and Clinton administrations. In 2021, “you’re still going to call London, but that call will be lower down in the queue. Britain doesn’t have a seat at the table anymore,” thanks to Brexit, he said.

Other Democrats speak in wistful terms about a relationship Winston Churchill once described as “fraternal.” “London will still be a player” and “we will always look to the U.K. as an ally,” are common refrains. But it’s the power corridors of Brussels, Paris and Berlin, not No. 10 Downing St. and Whitehall, that increasingly command Washington’s attention.

While Democrats welcome Britain’s recent $22 billion defense spending increase, and plan close climate cooperation, “Biden is seeking to strengthen and renew ties with the EU, and Britain is not going to be a part of that,” said one person familiar with Biden’s thinking.

President Donald Trump had a sometimes rocky relationship with Johnson’s predecessor Theresa May, but his distrust of the EU and NATO meant London was always the White House’s preferred partner in Europe. In Johnson, a champion of Brexit, Trump saw a kindred spirit. London’s hoped-for dividend: a trade deal in 2021.

The Biden administration doesn’t plan to play along. “Boris Johnson needs a trade deal to show the domestic utility of Brexit,” the person familiar with the president-elect’s thinking said.

Biden’s team is promising only to review any trade deal chapters agreed with the Trump administration to ensure they are “in line with Biden priorities,” the person said, “taking domestic factors into account.”

“The first task is trying to get our house in order at home,” said James Clapper, director of National Intelligence under President Barack Obama. Based on his interactions with the Biden transition team, Clapper said, helping post-Brexit Britain “doesn't appear to me to be real high on their priority list right now.”

No trade deal before 2022

It’s not hard to see why: The sheer number of domestic challenges that will occupy Biden during his first 100 days will overshadow British efforts to secure a fast-track trade deal in that same timeframe.

“I’d say the best case scenario for a deal is 2022,” said Lewis Lukens, who served as U.S. deputy ambassador to the U.K. under Presidents Trump and Obama.

Kupchan agrees that London will have to wait until the second year of Biden’s team being in place, given the lack of a clear Democratic majority in the Senate and a wafer-thin margin in the House. “There’s an important conversation to be had on broader economic issues, but not on bilateral trade,” he said.

Politically, it would be “quite a big blow” for the U.K. if a trade deal can’t be secured quickly, said one former senior British diplomat. But in economic terms, it would hardly be noticed. The U.K. and U.S. were each other’s biggest investors in 2018 but the proposed deal would add only about $10 billion to the combined $23 trillion U.S. and U.K. GDP.

Some leading politicians from Britain’s ruling Conservative party think the deal is a transatlantic distraction. Tom Tugendhat, chair of the U.K. Parliament’s foreign affairs committee told POLITICO he thinks the U.K. should instead focus on getting the U.K. and U.S. to join the Trans-Pacific Partnership, an 11-country trade bloc including Japan, Canada and Australia, designed in part to counter China’s growing economic leverage.

The Obama administration helped negotiate an early version of that deal before President Trump withdrew from it. “We should be working with the U.S. on global regulatory reform, carbon pricing, and defending the rules-based system against China,” Tugendhat added, echoing what Biden’s transition team told POLITICO.

With the U.K. serving as G-7 president and hosting the U.N.’s annual climate conference in 2021, Democrats are keen to prioritize issues from Covid-19 to climate to global economic recovery, ahead of a trade deal.

The U.K. government isn’t ready to talk about “Plan B” for the deal, but a spokesperson acknowledged the challenge ahead: "securing a comprehensive deal that matches the depth of the U.K.-U.S. trading relationship is more important than meeting any particular deadline," the spokesperson said.

The timeline for a trade deal in 2021 is indeed daunting. USTR must notify Congress of a pending agreement before April 1 in order for it to be signed before congressional fast track authority expires on July 1. Further complicating matters, the last formal U.S.-U.K. negotiations ended October 30, meaning progress is limited to technical discussions during the transition. Meanwhile, political staffers at USTR have been blocking meetings throughout December between the Biden transition team and career officials, potentially hampering Biden’s ability to begin work immediately upon his inauguration.

To chime with Biden’s team, Britain is positioning a trade deal as an economic recovery tool. “This agreement would support both of our economies to build back better from Covid-19,” said a U.K. government spokesperson, who described the talks as being “at an advanced stage, with a significant proportion of legal text agreed.”

Several draft chapters of the deal are close to final, according to negotiation documents seen by POLITICO, including texts on small and medium-sized businesses, investment and digital services. But significant differences remain including on pharmaceutical regulation, textiles and intellectual property.

Johnson’s historic miscalculation

In the view of many Democrats, Johnson bet too heavily on Trump. “The [U.K.] government continued to believe Trump was going to do favors for them and that hasn’t panned out. The trade deal was going to happen in a matter of weeks, then months, and it’s now four years later and it hasn’t happened,” said a senior former American diplomat.

It was only after the U.S. Trade Representative published his trade deal wish list in 2018 that Johnson realized there would be no favors from Republicans. Having stacked his Cabinet with relatively inexperienced Brexit supporters, with marching orders to deliver Brexit above all else, Johnson’s team “doesn’t have the relationships they might need with a new Democratic administration,” the former diplomat said.

The U.K. government insists that’s an unfair reading of the situation. “From the outset, we have engaged with U.S. partners on a bipartisan basis — at the federal and state level,” a government spokesperson said. British diplomats also say they have long standing links with Katherine Tai, Biden’s pick for USTR.

That’s counted for little so far in the transition: Biden’s team is “hyper-disciplined” about not engaging with foreign officials before inauguration, according to both British officials and Democrats POLITICO spoke with.

Johnson and his allies may instead have to rely on President-elect Biden’s trademark capacity for not holding grudges.

So far, British officials are breathing a sigh of relief that Biden’s team isn’t publicly buying into the sharp, public criticisms former Obama administration officials have made about Johnson.

But privately, Democrats continue to take offense at Johnson’s often inflammatory rhetoric, including a racially charged description of President Barack Obama as America’s “part-Kenyan president” in 2016, raising the matter in discussions with a range of British officials. Biden himself described Johnson at a 2019 fundraiser as “a physical and emotional clone” of Trump.

Yet those close to Biden insist “it’s not helpful to over-personalize things,” according to a person familiar with his thinking. “You have perfect couples in the mold of Bill Clinton and Tony Blair, or Ronald Reagan and Margaret Thatcher, and then there’s pairings where the personalities don’t mesh but they make it work,” the person said, describing the likely Biden-Johnson relationship.

While “there’s not a lot of warmth,” a former American ambassador admitted, the pair’s differences “will be water under the bridge, frankly, because the U.S. wants the U.K. to thrive.”

Paris preferred over London

While President-elect Biden and his team respect Britain’s choice to leave the EU, Democrats nonetheless tend to view Brexit as a poorly executed policy.

Secretary of State-designee Antony Blinken has called Brexit a “total mess,” while Kupchan called it “an act of self-isolation that will inevitably diminish Britain’s weight in the world.”

They also lament that Britain’s departure from the EU will make it harder to influence the unwieldy 27-member club. Britain’s open economy often acted as a counterweight to the protectionist instincts of France and Germany. “The U.S. lost its most effective EU member,” said a former senior American diplomat. “Now life for the U.S. becomes more complicated. We have messier coalitions to deal with.”

Kupchan said Brexit merely accelerates a trend since the end of the Cold War, of Washington engaging more directly with Paris and Berlin. Paris has the edge because of its defense investments. “What will really irritate the U.K. is we will now return to engaging the EU as an essential partner, and it’s fair to see France as on the up,” said a former senior American diplomat. “France is the one that still aspires to be a global actor and has more ambition,” said Ellen Laipson, director of George Mason University’s Center for Security Policy Studies.

Senior Democrats back Biden’s wish to prioritize better relations with the EU. Sen. Chris Murphy (D-Conn.), a close Biden ally, wants a trade deal with the EU to take priority over the U.K. deal. Richard Neal (D-Mass.), chairman of the powerful House Ways and Means Committee has also urged the incoming administration to renew trade negotiations with the EU.

Biden will continue to follow the U.K.’s negotiations with the EU, particularly how peace arrangements in Northern Ireland are handled. “Folks are watching what’s happening, where that lands,” said a person familiar with the president-elect’s thinking.

While the Biden team welcomes the U.K. government’s Dec. 8 recommitment to uphold the Good Friday Agreement in full, that move doesn’t guarantee or speed up a bilateral trade deal, which remains a “separate discussion,” the person said.

In other words, Britain will have to earn its trade deal.

“I think the ball is really in the U.K.’s court,” said Lukens, the former ambassador. “Whether Boris and his team are capable of developing a worldview beyond Brexit remains to be seen.”

Nahal Toosi and Doug Palmer contributed reporting

The Link Lonk


December 31, 2020 at 12:00PM
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Britain braces for not-so-special relationship with Biden - POLITICO

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Justice Department Seeks Forfeiture of Third Commercial Property Purchased with Funds Misappropriated from PrivatBank in Ukraine - Department of Justice

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Today, the U.S. Department of Justice filed a civil forfeiture complaint in the U.S. District Court for the Southern District of Florida alleging that commercial real estate in Cleveland, Ohio, was acquired using funds misappropriated from PrivatBank in Ukraine as part of a multi-billion-dollar loan scheme. 

Deputy Assistant Attorney General Kevin Driscoll of the Justice Department’s Criminal Division, U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida, U.S. Attorney Justin E. Herdman for the Northern District of Ohio and Special Agent in Charge Eric B. Smith of the FBI’s Cleveland Field Office made the announcement.

In August 2020, two other civil forfeiture complaints were filed in the Southern District of Florida involving properties in Louisville, Kentucky and Dallas, Texas, in which it was alleged that those properties were also acquired using funds misappropriated from PrivatBank in Ukraine.  All three properties are alleged to be subject to forfeiture based on violations of federal money laundering statutes.

The three complaints allege that Ihor Kolomoisky and Gennadiy Boholiubov, who owned PrivatBank, one of the largest banks in Ukraine, embezzled and defrauded the bank of billions of dollars.  The two obtained fraudulent loans and lines of credit from approximately 2008 through 2016, when the scheme was uncovered, and the bank was nationalized by the National Bank of Ukraine.  The complaints allege that they laundered a portion of the criminal proceeds using an array of shell companies’ bank accounts, primarily at PrivatBank’s Cyprus branch, before they transferred the funds to the United States.  As alleged in the complaint, the loans were rarely repaid except with more fraudulently obtained loan proceeds.

As alleged in the complaints, in the United States, associates of Kolomoisky and Boholiubov, Mordechai Korf and Uriel Laber, operating out of offices in Miami, created a web of entities, usually under some variation of the name “Optima,” to further launder the misappropriated funds and invest them.  They purchased hundreds of millions of dollars in real estate and businesses across the country, including the properties subject to forfeiture: the office tower known as 55 Public Square in Cleveland, Ohio, the Louisville office tower known as PNC Plaza, and the Dallas office park known as the former CompuCom Headquarters.  The buildings have a combined value of more than $60 million.

A complaint is merely an allegation and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law. 

FBI’s Cleveland Division is investigating the case with support from FBI’s International Corruption Unit, IRS Criminal Investigation, and U.S. Customs and Border Protection.  International Unit Chief Mary K. Butler, Senior Trial Attorney Michael C. Olmsted, Trial Attorneys Shai D. Bronshtein and Peter Steciuk, and Law Clerk Robert Blaney of the Criminal Division’s Money Laundering and Asset Recovery Section and Assistant U.S. Attorney Adrienne Rosen of the U.S. Attorney’s Office for the Southern District of Florida are handling these cases.  The Justice Department’s Office of International Affairs has provided substantial assistance in the investigation.

The Kleptocracy Asset Recovery Initiative is led by a team of dedicated prosecutors in the Criminal Division’s Money Laundering and Asset Recovery Section, in partnership with federal law enforcement agencies, and often with U.S. Attorney’s Offices, to forfeit the proceeds of foreign official corruption and, where appropriate, to use those recovered assets to benefit the people harmed by these acts of corruption and abuse of office.  In 2015, the FBI formed International Corruption Squads across the country to address national and international implications of foreign corruption.  Individuals with information about possible proceeds of foreign corruption located in or laundered through the United States should contact federal law enforcement or send an email to kleptocracy@usdoj.gov (link sends e-mail) or https://tips.fbi.gov/.

The year 2020 marks the 150th anniversary of the Department of Justice.  Learn more about the history of our agency at www.Justice.gov/Celebrating150Years.

The Link Lonk


December 31, 2020 at 04:23AM
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Justice Department Seeks Forfeiture of Third Commercial Property Purchased with Funds Misappropriated from PrivatBank in Ukraine - Department of Justice

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This New Year’s Eve, Times Square Will Be Filled With Hope. But Not People. - The New York Times

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They remember when the wooden sawhorses used to control crowds would splinter against the crush of humanity; now interlocking aluminum barriers are used. They remember when corks popped from Champagne bottles caused some safety concerns; that is, until 9/11, after which restrictions cracked down on the free flow of people and booze.

They have seen the numbers steadily grow, the crowds stretching up to 59th Street and beyond. And the night’s mood, Chief Hughes said, “reflects what the city is going through in that year.”

This year it will be small, contained, muted. “A closed set,” he said. “A virtual event.”

Last year, when a million or so people showed up, those interlocking barriers stretched from 38th Street to 59th Street, and from Sixth Avenue to Eighth Avenue. This year, the barriers will run only from 41st to 49th Streets, and the few granted entrance to the stage area will be required to have tested negative for the virus.

Normally, several thousand officers work the night, a choice assignment because they get to interact with people from around the world in a setting of joy. This year, there will be an 80 percent reduction in the police complement, which still means many hundreds of officers working to keep people safe — and out.

“What’s going to happen at midnight?” Assistant Chief Hughes asked. “At midnight, everybody kisses. What are we going to do? Fist bump?”

The night’s touch of grace, though, is in the invitation to a few dozen frontline workers and their families. Among them was Ms. Erb, 44, a clinical research nurse who, for the last several months, has helped oversee trials for the Pfizer vaccine at the N.Y.U. Langone Vaccine Center.

The Link Lonk


December 31, 2020 at 06:39AM
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This New Year’s Eve, Times Square Will Be Filled With Hope. But Not People. - The New York Times

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Zdeno Chara leaves Boston Bruins after 14 seasons with team, signs with Washington Capitals - CBS Sports

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Zdeno Chara announced that after 14 seasons he is leaving the Boston Bruins and signing a one-year deal with the Washington Capitals. The 43-year-old defenseman said the team notified him that he was not in their future plans, leading to the latest breakup between a notable Boston sports athlete and his team.

Chara made the announcement in an Instagram video where he thanked the city of Boston and Bruins fans for the support during his tenure as a player, and later a team captain.

The defenseman joined the Bruins at 29 years old prior to the 2006-07 season. Chara would go on to play 1,023 games for Boston, scoring 148 goals, notching 333 assists and developing into one of the most dominant defensive forces in the league. He was a five-time finalist for the Norris Trophy, winning it in the 2008-09 season, and captained three Bruins teams to the Stanley Cup Final, winning it in the 2010-11 season. He leaves the franchise as the longest-tenured captain in the league.

Chara now joins a Washington team that has only sniffed the first round of the postseason over the last two seasons after exorcising the franchise's demons in 2017 to win the Stanley Cup. His contract is worth $795,000, according to the Caps.

"We are extremely pleased to have Zdeno join the Capitals organization," said senior vice president and general manager Brian MacLellan said in a press release. "We feel his experience and leadership will strengthen our blueline and our team."

The Link Lonk


December 31, 2020 at 06:00AM
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Zdeno Chara leaves Boston Bruins after 14 seasons with team, signs with Washington Capitals - CBS Sports

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Wednesday, December 30, 2020

Peloton tests its own exclusive music with three Elvis remixes - The Verge

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Peloton is now a place to debut music. The popular fitness startup, already known for its use of popular music during its classes, announced today that it’s debuting new Elvis remixes in its app that’ll be exclusive to the platform for a month. The company worked with Chromeo, Big Boi, and DJ Dillon Francis to create the remixes.

The songs premiere in the app today as part of an “ultimate remix collection,” which includes yoga, strength, core, and outdoor running classes. As part of a New Year’s promo, the company is also extending its 30-day free trial to two months.

A spokesperson says the idea behind starting with Elvis was to find a “new expression of the classic catalog in a contemporary way” — which to me reads as finding a way to make Elvis music something you’d actually want to hear when working out. Sony, however, owns the rights to the songs, and might choose to release the tracks more widely after the month-long exclusivity window expires.

Exclusive music makes sense for Peloton. The company already has its own hardware and video content, meant to keep users hooked and fend off competitors. If people want to use a Peloton bike or take a class from a Peloton instructor, they need to stay in the company’s ecosystem — and the same will now be true for these tracks, at least for the first month.

Peloton has worked to secure deals with musicians to include their tracks in classes. The company pays per music stream, similarly to companies like Spotify, and has signed deals with artists like Beyoncé to stream their music. Hyping up Peloton as a place to hear exclusive music for the first time could be a way to court new subscribers and keep current ones tuning in.

Update 12/30, 2:43PM ET: Peloton originally hyped in its press release that the company will have the exclusive rights to the three tracks and that it would be “the first time that any artist has created music just for Peloton classes.” But the company later said in an email to The Verge that the music will only be exclusive to Peloton for “an initial launch window”, and that Sony can publicly release all three tracks after that period.

The Link Lonk


December 30, 2020 at 11:00PM
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Peloton tests its own exclusive music with three Elvis remixes - The Verge

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Maintaining Safety with SARS-CoV-2 Vaccines | NEJM - nejm.org

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To date, the development of mRNA vaccines for the prevention of infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a success story, with no serious concerns identified in the ongoing phase 3 clinical trials.1 Minor local side effects such as pain, redness, and swelling have been observed more frequently with the vaccines than with placebo. Systemic symptoms such as fever, fatigue, headache, and muscle and joint pain have also been somewhat more common with the vaccines than with placebo, and most have occurred during the first 24 to 48 hours after vaccination.1 In the phase 1–3 clinical trials of the Pfizer–BioNTech and Moderna mRNA vaccines, potential participants with a history of an allergic reaction to any component of the vaccine were excluded. The Pfizer–BioNTech studies also excluded participants with a history of severe allergy associated with any vaccine (see the protocols of the two trials, available with the full text of the articles at NEJM.org, for full exclusion criteria).1,2 Hypersensitivity adverse events were equally represented in the placebo (normal saline) and vaccine groups in both trials.1

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom was the first to authorize emergency use of the Pfizer–BioNTech mRNA vaccine. On December 8, 2020, within 24 hours after the start of the U.K. mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine. On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer–BioNTech mRNA vaccine, and general vaccination of health care workers was started on Monday, December 14. On December 15, a 32-year-old female health care worker in Alaska who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine. The participants who had these initial three reported cases of anaphylaxis would not have been excluded on the basis of their histories from the mRNA vaccine clinical trials.1,2 Since the index case in Alaska, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported in the United States after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000, the known and stable incidence of anaphylaxis associated with other vaccines. The EUA for the Moderna mRNA vaccine was issued on December 18, and it is currently too soon to know whether a similar signal for anaphylaxis will be associated with that vaccine; however, at this time a small number of potential cases of anaphylaxis have been reported, including one case on December 24 in Boston in a health care worker with shellfish allergy who was carrying auto-injectable epinephrine.

In response to the two cases of anaphylaxis in the United Kingdom, the MHRA issued a pause on vaccination with the Pfizer–BioNTech SARS-CoV-2 mRNA vaccine, to exclude any person with a history of anaphylactic reaction to any food, drug, or vaccine. The Centers for Disease Control and Prevention (CDC) has issued advice pertaining to administration of either the first or the second dose of the Pfizer–BioNTech or Moderna mRNA vaccine, recommending exclusion of any person who has a history of a severe or immediate (within 4 hours) allergic reaction associated with any of the vaccine components, including polyethylene glycol (PEG) and PEG derivatives such as polysorbates.3

Anaphylaxis is a serious multisystem reaction with rapid onset and can lead to death by asphyxiation, cardiovascular collapse, and other complications.4 It requires prompt recognition and treatment with epinephrine to halt the rapid progression of life-threatening symptoms. The cause of anaphylactic reactions is the activation of mast cells through antigen binding and cross-linking of IgE; the symptoms result from the tissue response to the release of mediators such as histamine, proteases, prostaglandins, and leukotrienes and typically include flushing, hives, laryngeal edema, wheezing, nausea, vomiting, tachycardia, hypotension, and cardiovascular collapse. Patients become IgE-sensitized by previous exposure to antigens. Reactions that resemble the clinical signs and symptoms of anaphylaxis, previously known as anaphylactoid reactions, are now referred to as non-IgE–mediated reactions because they do not involve IgE. They manifest the same clinical features and response to epinephrine, but they occur by direct activation of mast cells and basophils, complement activation, or other pathways and can occur on first exposure. Tryptase is typically elevated in blood in IgE-mediated anaphylaxis and, to a lesser extent, in non–IgE-mediated mast-cell activation, a feature that identifies mast cells as the sources of inflammatory mediators. Prick and intradermal skin testing and analysis of blood samples for serum IgE are used to identify the specific drug culprit, although the tests lack 100% negative predictive value.5 The clinical manifestations of the two U.K. cases and the one U.S. case fit the description of anaphylaxis: they occurred within minutes after the injections, symptoms were typical, and all responded to epinephrine. The occurrence on first exposure is not typical of IgE-mediated reactions; however, preexisting sensitization to a component of the vaccine could account for this observation.4

Assessing Reactions to Vaccines.

SARS-CoV-2 mRNA vaccines are built on the same lipid-based nanoparticle carrier technology; however, the lipid component of the Pfizer-BioNTech vaccine differs from that of the Moderna vaccine. Operation Warp Speed has led to an unprecedented response to the study of the safety and effectiveness of new vaccine platforms never before used in humans and to the development of vaccines that have been authorized for use less than a year after the SARS-CoV-2 viral sequence was discovered. The next few months could see the authorization of several such vaccines, and inevitably, adverse drug events will be recognized in the coming months that were not seen in the studies conducted before emergency use authorization. Maintenance of vaccine safety requires a proactive approach to maintain public confidence and reduce vaccine hesitancy. This approach involves not only vigilance but also meticulous response, documentation, and characterization of these events to heighten recognition and allow definition of mechanisms and appropriate approaches to prediction, prevention, and treatment. A systematic approach to an adverse reaction to any vaccine requires clinical recognition and appropriate initial treatment, followed by a detailed history and causality assessment. Nonimmune immediate reactions such as vasovagal reactions are common and typically manifest with diaphoresis, nausea, vomiting, pallor, and bradycardia, in contrast to the flush, pruritus, urticaria, angioedema, tachycardia, and laryngeal edema seen with anaphylaxis. Post-reaction clinical assessment by an allergist–immunologist that includes skin testing for allergy to components of the vaccine can be helpful. Use of other laboratory information may aid in clinical and mechanistic assessment and guide future vaccine and drug safety as well as management, such as rechallenge with alternative vaccines if redosing is required. A useful resource for searching the excipients of drugs and vaccines is https://dailymed.nlm.nih.gov/dailymed/. A useful resource for excipients in licensed vaccines is https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-2.pdf.

Anaphylaxis is a treatable condition with no permanent effects. Nevertheless, news of these reactions has raised fear about the risks of a new vaccine in a community. These cases of anaphylaxis raise more questions than they answer; however, such safety signals are almost inevitable as we embark on vaccination of millions of people, and they highlight the need for a robust and proactive “safety roadmap” to define causal mechanisms, identify populations at risk for such reactions, and implement strategies that will facilitate management and prevention (Figure 1).6

We can be reassured that vaccine-associated anaphylaxis has been a rare event, at one case per million injections, for most known vaccines.6 Acute allergic reactions after vaccination might be caused by the vaccine antigen, residual nonhuman protein, or preservatives and stabilizers in the vaccine formulation, also known as excipients.6 Although local reactions may be commonly associated with the active antigen in the vaccine, IgE-mediated reactions or anaphylaxis have historically been more typically associated with the inactive components or products of the vaccine manufacturing process, such as egg, gelatin, or latex.6

The mRNA vaccines developed by Pfizer–BioNtech and Moderna use a lipid-based nanoparticle carrier system that prevents the rapid enzymatic degradation of mRNA and facilitates in vivo delivery.1,2,7 This lipid-based nanoparticle carrier system is further stabilized by a polyethylene glycol (PEG) 2000 lipid conjugate that provides a hydrophilic layer, prolonging half-life. Although the technology behind mRNA vaccines is not new, there are no licensed mRNA vaccines, and the Pfizer–BioNtech and Moderna vaccines are the first to receive an EUA. There is therefore no prior experience that informs the likelihood or explains the mechanism of allergic reactions associated with mRNA vaccines. It is possible that some populations are at higher risk for non–IgE-mediated mast-cell activation or complement activation related to either the lipid or the PEG-lipid component of the vaccine. By comparison, formulations such as pegylated liposomal doxorubicin are associated with infusion reactions in up to 40% of recipients; the reactions are presumed to be caused by complement activation that occurs on first infusion, without previous exposure to the drug, and they are attenuated with second and subsequent injections.8

SARS-CoV-2 Vaccines under Emergency Use Authorization (EUA) or in Late-Phase Studies.

PEG is a compound used as an excipient in medications and has been implicated as a rare, “hidden danger” cause of IgE-mediated reactions and recurrent anaphylaxis.9 The presence of lipid PEG 2000 in the mRNA vaccines has led to concern about the possibility that this component could be implicated in anaphylaxis. To date, no other vaccine that has PEG as an excipient has been in widespread use. The risk of sensitization appears to be higher with injectable drugs with higher-molecular-weight PEG; anaphylaxis associated with bowel preparations containing PEG 3350 to PEG 4000 has been noted in case reports.9,10 The reports include anaphylaxis after a patient was exposed to a PEG 3350 bowel preparation; anaphylaxis subsequently developed on the patient’s first exposure to a pegylated liposome microbubble, PEGLip 5000 perflutren echocardiography contrast (Definity), which is labeled with a warning about immediate hypersensitivity reactions.11 For drugs such as methylprednisolone acetate and injectable medroxyprogesterone that contain PEG 3350, it now appears that the PEG component is more likely than the active drug to be the cause of anaphylaxis.9,12 For patients with a history of an anaphylactic reaction to the SARS-CoV-2 Pfizer–BioNTech mRNA vaccine, the risk of anaphylaxis with the Moderna SARS-CoV-2 mRNA vaccine — whose delivery system is also based on PEG 2000, but with different respective lipid mixtures (see Table 1) — is unknown. The implications for future use of SARS-CoV-2 vaccines with an adenovirus carrier and protein subunit, which are commonly formulated with polysorbate 80, a nonionic surfactant and emulsifier that has a structure similar to PEG, are also currently unknown.6,13 According to the current CDC recommendations, all persons with a history of an anaphylactic reaction to any component of the mRNA SARS-Cov-2 vaccines should avoid these vaccines, and this recommendation would currently exclude patients with a history of immediate reactions associated with PEG. It would also currently exclude patients with a history of anaphylaxis after receiving either the BioNTech–Pfizer or the Moderna vaccine, who should avoid all PEG 2000–formulated mRNA vaccines, and all PEG and injectable polysorbate 80 products, until further investigations are performed and more information is available.

We are now entering a critical period during which we will move rapidly through phased vaccination of various priority subgroups of the population. In response to the cases of anaphylaxis associated with the Pfizer–BioNTech vaccine in the United Kingdom and now several cases of anaphylaxis in the United States, the CDC has recommended that only persons with a known allergy to any component of the vaccine be excluded from vaccination. A systematic approach to the existing hypersensitivity cases and any new ones will ensure that our strategy will maintain safety not only for this vaccine but for future mRNA and SARS-CoV-2 vaccines with shared or similar components (Figure 1 and Table 1).6

The next few months alone are likely to see at least five new vaccines on the U.S. market, with several more in development (Table 1).13 Maintaining public confidence to minimize vaccine hesitancy will be crucial.14,15 As in any post-EUA program, adverse events that were not identified in clinical trials are to be expected. In addition, populations that have been studied in clinical trials may not reflect a predisposition to adverse events that may exist in other populations.16 Regardless of the speed of development, some adverse events are to be expected with all drugs, vaccines, and medicinal products. Fortunately, immune-mediated adverse events are rare. Because we are now entering a period during which millions if not billions of people globally will be exposed to new vaccines over the next several months, we must be prepared to develop strategies to maximize effectiveness and safety at an individual and a population level. The development of systematic and evidence-based approaches to vaccination safety will also be crucial, and the approaches will intersect with our knowledge of vaccine effectiveness and the need for revaccination. When uncommon side effects that are prevalent in the general population are observed (e.g., the four cases of Bell’s palsy reported in the Pfizer–BioNTech vaccine trial group), the question whether they were truly vaccine-related remains to be determined.1

If a person has a reaction to one SARS-CoV-2 vaccine, what are the implications for the safety of vaccination with a different SARS-CoV-2 vaccine? Furthermore, what safety issues may preclude future vaccination altogether? Indeed, mRNA vaccines are a promising new technology, and demonstration of their safety is relevant to the development of vaccines against several other viruses of global importance and many cancers.7 For the immediate future, during a pandemic that is still increasing, it is critical that we focus on safe and efficient approaches to implementing mass vaccination. In the future, however, these new vaccines may mark the beginning of an era of personalized vaccinology in which we can tailor the safest and most effective vaccine on an individual and a population level.17 Moreover, postvaccination surveillance and documentation may present a challenge. On a public health level, the Vaccine Adverse Event Reporting System (VAERS; https://vaers.hhs.gov) is a national reporting system designed to detect early safety problems for licensed vaccines, but in the case of Covid-19 vaccines, the system will serve the same function after an EUA has been issued. On an individual level, a system that will keep track of the specific SARS-CoV-2 vaccine received and will provide a means to monitor potential long-term vaccine-related adverse events will be critical to individual safety and efficacy. V-safe (https://cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html) is a smartphone application designed to remind patients to obtain a second dose as needed and to track and manage Covid-19 vaccine–related side effects.

In the world of Covid-19 and vaccines, many questions remain. What are the correlates of protective immunity after natural infection or vaccination? How long will immunity last? Will widespread immunity limit the spread of the virus in the population? Which component of the vaccine is responsible for allergic reactions? Are some vaccines less likely than others to cause IgE- and non-IgE–mediated reactions? Careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety.

The Link Lonk


December 31, 2020 at 05:00AM
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Maintaining Safety with SARS-CoV-2 Vaccines | NEJM - nejm.org

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