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U.S. Food and Drug Administration approves Pfizer/BioNTech Covid-19 vaccine, cautions against use in younger children

The US Food and Drug Administration has fully approved the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older, and authorized it for people as young as 12. However the agency is warning against using the vaccine “off-label” in children younger than 12, saying it “would not be appropriate.” The Pfizer/BioNTech Covid-19 vaccine is not currently approved nor authorized for children younger than 12, and the appropriate dosage for this age group has yet to be determined.

‘Off-label’ refers to an approved product being used in a way or in a patient that it wasn’t necessarily approved for; it happens commonly with some drugs, such as when a chemotherapy approved for one type of cancer is used to treat a different type.

The FDA and the American Academy of Pediatrics (AAP) both strongly recommend that all eligible adolescents ages 12 to 17, be vaccinated as soon as possible, especially as the highly transmissible Delta coronavirus variant continues to circulate nationwide. As of last week, the AAP reported 180,000 new cases of Covid-19 among children and adolescents, according to the Academy. Currently approximately 8.5 million or 34% of all adolescents ages 12 to 17 are fully vaccinated against Covid-19.

Editorial credit: Daniel Chetroni / Shutterstock.com

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Defense secretary orders emergency use of 18 US commercial aircrafts to transport Afghan evacuees

On Sunday, defense Secretary Lloyd Austin ordered the emergency use of 18 U.S. commercial aircrafts to transport Afghan evacuees out of Kabul. The U.S. continues to evacuate Americans and Afghan people with special immigrant visas, a week since the Taliban entered Afghanistan’s capital city and Afghan President Ashraf Ghani fled. Seventeen thousand people have been taken out of Afghanistan in the past week; however, the scene at Hamid Karzai International Airport remains chaotic.

The Defense Department is acting under Stage I of the Civil Reserve Air Fleet (CRAF) and confirmed the commercial aircraft wouldn’t be flying in and out of Kabul.  Instead, officials say the planes will move evacuees “from bases in Germany, Qatar and Bahrain to ease overcrowding pressure and transport bottlenecks.”

Among the airlines who will provide commercial aircrafts are American Airlines, Atlas Air, Delta Air Lines and Omni Air, each of which will contribute three planes; Hawaiian Airlines, which will contribute two; and United Airlines, four.

Editorial credit: Edu Perez / Shutterstock.com

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Death Toll reaches 22 with dozens still missing in catastrophic Tennessee Flooding

The death toll has risen to 22 in catastrophic flooding in Middle Tennessee over the weekend. Twelve additional deaths were reported by the sheriff in Humphreys County on Sunday, adding to the 10 confirmed Saturday night. The number of missing is now estimated at 50, with the hardest-hit area being 40 miles west of Nashville.

Tennessee Gov. Bill Lee said during a Sunday evening press conference: “It is a devastating picture of loss and heartbreak in one of our Tennessee communities.”  The state of Tennessee activated its Emergency Operations Center as searchers continued to look for survivors on Sunday. At least 100 homes and 25 businesses had been searched as of 10 a.m. Sunday, while multiple bridges and roadways remained close in the area. More than 10,000 customers were without power.

Between 15 and 17 inches of rain was reported in 24 hours in areas around Dickson, Houston, Humphreys and Hickman counties. The flooding from the torrential rainfall trapped residents in their homes, closed highways and prompted multiple water rescues, where people took to their roofs and attics to escape the floodwaters. Homes were swept away and communities destroyed. The Tennessee National Guard has also deployed soldiers and airmen to the area in response to the flooding. Three helicopter aquatic rescue teams from the state, as well as swift water rescue teams from Nashville, were also sent to assist.

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Police identify suspect who surrendered after bomb threat near U.S. Capitol

A man was arrested Thursday after an hours-long standoff near the U.S. Capitol during which he claimed to have an explosive device. Police have identified the suspect as 49-year-old Floyd Ray Roseberry of Grover, North Carolina, and was described as having a history of supporting former President Donald Trump, who said “all Democrats need to step down.”

The U.S. Capitol Police wrote on Twitter that the incident on Thursday prompted multiple buildings in the area to be evacuated in what was labelled an “active bomb threat investigation.”  The USCP later said in a news release that no bomb was found in Roseberry’s truck but that he did possess suspected bomb-making material.  USCP Chief Tom Manger told reporters on Thursday that authorities couldn’t yet identify a motive, said that so far there is “no indication” Roseberry was acting with others. Manger revealed that Roseberry had been live-streaming from the scene and a half-hour Facebook video showed him inside a truck, holding a canister that he said was a bomb, speaking about a “revolution.” The video and Roseberry’s Facebook profile have since been removed. On Roseberry’s now-removed Facebook page, he frequently made pro-Trump posts and posted videos from Trump’s “Million MAGA March” on November 14.

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Tropical Storm Henri expected to strengthen into hurricane; potentially impacting northeast and New England coast

Tropical Storm Henri is forecast to become a hurricane by Friday. The National Hurricane Center (“NHC”) said Henri had maximum sustained winds of 65 mph and was moving west at 10 mph as of Thursday night.

Henri is expected to speed up before taking a turn toward north; the storm is now on a track to possibly make landfall somewhere along the New England coast as early as Sunday night, potentially affecting the northeast from Long Island, NY to Cape Cod, MA.  The NHC said:  “Henri is forecast to be near the northeast coast of the U.S. on Sunday and Monday, and the risks of storm surge, wind and rain impacts in portions of southern New England and eastern Long Island, [N.Y.], are increasing. Watches will likely be required for portions of this area early Friday.”

As of the National Hurricane Center’s latest complete update, Henri was about 800 miles south of Nantucket, Massachusetts, with maximum sustained winds near 70 mph and higher gusts expected to extend up to 90 miles from the center.  The storm is still expected to impact the coast, creating dangerous rip currents, rough surf and beach erosion.

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White House prepared to begin rolling out COVID booster shots by the week of Sept. 20

The nation’s top health officials announced Wednesday that the Biden administration is prepared to begin rolling out booster shots for many Americans the week of Sept. 20th. Citing data that show the effectiveness of Pfizer and Moderna vaccines against COVID-19 diminishes over time, U.S. Surgeon General Vivek Murthy said at a White House briefing: “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for COVID-19 boosters is now.” A final plan was still contingent upon the official sign-off by the U.S. Food and Drug Administration.

The recommendation will be that anyone who received Pfizer or Moderna vaccines should get a booster shot eight months after their second shot, with health care workers, nursing home residents and seniors first in line.  CDC Director Rochelle Walensky said at the briefing that Wednesday’s decision was largely based on data showing that vaccines are still working and are the best assurances against severe illness or death — but according to CDC data, key metric could also wane in a few months.  Walensky added: “Even though our vaccines are currently working well to prevent hospitalizations, we are seeing concerning evidence of waning vaccine effectiveness over time and against the delta variant. Given this body of evidence, we are concerned that the current strong protection against severe infection, hospitalization and death could decrease in the months ahead, especially among those who are at higher risk or who were vaccinated earlier during the phase of our vaccination rollout.”

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President Biden says U.S. is committed to getting all Americans out of Afghanistan, willing to extend August 31 deadline for total withdrawal

President Joe Biden said the U.S. is committed to getting every American out of Afghanistan, even if it means potentially extending the mission beyond his Aug. 31 deadline for a total withdrawal. In an interview with ABC News, anchor George Stephanopoulos asked Biden: “We’ve got like 10 to 15,000 Americans in the country right now. Right? And are you committed to making sure that the troops stay until every American who wants to be out is out?”  to which Biden replied, “Yes.”

The president did cautioned that his focus is on completing the mission by Aug. 31, but conceded to Stephanopoulos that the mission could take longer. Biden also told Stephanopoulos that in addition to the 10,000 to 15,000 Americans who need to be evacuated, there are between 50,000 and 65,000 Afghans and their families the U.S. also wants to get out. “The commitment holds to get everyone out that, in fact, we can get out and everyone who should come out. And that’s the objective. That’s what we’re doing now. That’s the path we’re on. And I think we’ll get there,” Biden said.

The Biden administration has come under fire for the chaotic situation in Afghanistan as control of the country quickly fell to the Taliban while the deadline for the final U.S. withdrawal approached.

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Taliban hold first press conference after evacuation flights restart from Kabul

As they held their first official news briefing on Tuesday since the seizure of Kabul, the Taliban said they wanted peaceful relations with other countries and would respect the rights of women within the framework of Islamic law. The Taliban suggesting a softer line then during their rule 20 years ago; during their 1996-2001 rule the Taliban stopped women from working and meted out punishments including public stoning. Girls were not allowed to go to school and women had to wear all-enveloping burqas to go out and then only when accompanied by a male relative. The U.N. Human Rights Council will hold a special session in Geneva next week to address “serious human rights concerns” after the Taliban takeover.

The Taliban press conference came as the United States and Western allies resumed evacuating diplomats and civilians the day after chaos at Kabul airport ensued. The State Department also said on Tuesday that Washington had completed a drawdown of embassy personnel from Kabul and remaining diplomats were assisting in the evacuation. U.S. President Joe Biden and British Prime Minister Boris Johnson said they had agreed to hold a virtual meeting of Group of Seven leaders next week to discuss a common strategy and approach to Afghanistan, hoping to assess how to respond to the situation.

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Texas Governor Greg Abbott tests positive for COVID-19

Texas Governor Greg Abbott tested positive for COVID-19 on Tuesday.  According to a statement from Abbott’s office, the Texas governor is fully vaccinated and had been tested for the virus daily before he tested positive.  His office added: “Governor Abbott is in constant communication with his staff, agency heads and government officials to ensure that state government continues to operate smoothly and efficiently.”

The governor’s office also said that Abbott is currently experiencing no symptoms but is receiving Regeneron’s monoclonal antibody treatment, and will isolate in the governor’s mansion where he will continue to be tested daily. The governor’s wife, first lady Cecilia Abbott, tested negative; and those who have been in close contact with Abbott have been notified of his COVID diagnosis. On Monday night, Abbott had tweeted a photo of himself speaking before a crowd of maskless guests at a Republican event in Collin County.

Abbott has been engaged in a battle with local school districts after he issued an executive order in May barring governmental entities, including public health authorities, from requiring face coverings and so-called vaccine passports. Texas is experiencing a COVID-19 surge as the state reported 20,123 new cases and 96 new deaths on Tuesday with 12,227 COVID-19 patients currently hospitalized.

http://rss.cnn.com/~r/rss/cnn_latest/~3/WIEIfRtPppY/index.html

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Tropical Storm Fred moves over land into Alabama after bringing heavy rain and flooding to Florida Panhandle

Tropical Storm Fred weakened slightly as it moved inland through the Florida Panhandle, the National Hurricane Center said in its 11 p.m. update. By Tuesday morning, Fred will have weakened to a tropical depression, a storm with a wind speed of 38 mph or less, the hurricane center said. However according to the hurricane center, Fred brought heavy rain and “a dangerous storm surge” to the Florida Panhandle.

Fred made landfall near Cape San Blas in the eastern Florida Panhandle, pounding the region with heavy rain and 65 mph winds, according to the National Hurricane Center. Fred brought 4 to 6 inches of rain to parts of Miami-Dade County, with the more southern areas of the county seeing as much as 9 inches. Areas of South Florida farther north saw 2 to 4 inches over the past seven days. As of 11 p.m. Monday, Fred was 10 miles east of Dothan, Ala., moving north-northeast at 12 mph. Fred is forecast to move from western Georgia on Tuesday across the Appalachian Mountains to West Virginia by Wednesday, the hurricane center said. Tropical-storm-force winds extended from Fred’s center up to 45 miles. There was also a chance that tornadoes could form on Florida’s west coast and the coastal Panhandle, forecasters said.

More than 20 Florida counties were under a state of emergency due to Tropical Storm Fred.