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FDA approves first RSV vaccine for at-risk adults in their 50s

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The Food and Drug Administration has approved giving GSK’s vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said Friday, making it the first shot greenlit for use in this age group to guard against RSV.

Global vaccine and drugmaker GSK asked the FDA in February to expand approval beyond adults 60 and older, citing data showing the immune response in adults vaccinated from this younger age group looked similar. Further trials are planned looking at adults between 18 and 49 years old, GSK said, with results expected in the second half of this year. 

Two other companies – Pfizer and Moderna – also manufacture RSV vaccines approved for adults 60 and older, and are testing their shots in younger adults. Pfizer told investors last month it was getting ready to submit “positive” data from studies of its own shot down to age 18.

GSK’s vaccine will next need to be recommended for adults between 50 and 59 years old by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Their backing, at upcoming meetings in June or October, would tee up insurance coverage.

Vaccinating adults in their 50s for RSV likely has a public health benefit, a work group within the CDC’s committee concluded last year ahead of the approval, though it is narrower than for older adults who are at higher risk from their age alone.

Under 60 years old, pre-existing medical issues play larger roles in the risk of RSV infections taking a dangerous turn. 

“A lot of disease comes because the virus is triggering your underlying medical conditions, whether it’s COPD, heart failure, etc. So the virus is more of a trigger for exacerbation,” said Dr. Phil Dormitzer, senior vice president and global head of vaccines research and development at GSK. 

Dormitzer said GSK had seen “relatively comparable” safety results from its vaccine in this group, compared to when it was given to those 60 and over. Some of the vaccine’s side effects did look to be a little stronger, likely as a result of better immune responses in this age group.

The CDC panel has also previously wrestled with rare but serious cases of a neurological disorder called Guillain-Barré syndrome seen after the use of the RSV shots. 

Around 1.5 cases of the syndrome per million doses given of GSK’s vaccine have been reported, the CDC said last week. The agency’s survey data has found that close to a quarter of adults ages 60 and older had received an RSV shot since they were approved last year.

GSK’s trials did not turn up any “concerning” trends of GBS cases in the 50 to 59 age group, Dormitzer said.

“The risk of GBS tends to go up, it’s another one of those risks that tends to go up, with age. But there’s nothing to indicate that there’s any particular risk of GBS,” he said.

The CDC panel is also expected to weigh the possibility of whether and when adults will need to start getting booster shots for RSV.
Dormitzer said GSK is planning on presenting more trial results to the CDC committee in June, looking at boosters spaced out as much as three years after an initial shot.

“This is a really key question. People originally anticipated it might have to be an every year immunization. But then we found the duration of protection actually lasts for more than one season, clearly,” he said.



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Tajikistan nationals with alleged ISIS ties removed in immigration proceedings, U.S. officials say

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When federal agents arrested eight Tajikistan nationals with alleged ties to the Islamic State terror group on immigration charges back in June, U.S. officials reasoned that coordinated raids in Los Angeles, New York and Philadelphia would prove the fastest way to disrupt a potential terrorist plot in its earliest stages. Four months later, after being detained in Immigration and Customs Enforcement (ICE) facilities, three of the men have already been returned to Tajikistan and Russia, U.S. officials tell CBS News, following removals by immigration court judges. 

Four more Tajik nationals – also held in ICE detention facilities – are awaiting removal flights to Central Asia, and U.S. officials anticipate they’ll be returned in the coming few weeks. Only one of the arrested men still awaits his legal proceeding, following a medical issue, though U.S. officials speaking on the condition of anonymity to discuss the sensitive proceedings indicated that he remains detained and is likely to face a similar outcome. 

The men face no additional charges – including terrorism-related offenses – with the decision to immediately arrest and remove them through deportation proceedings, rather than orchestrate a hard-fought terrorism trial in Article III courts, born out of a pressing short-term concern about public safety. 

Soon after the eight foreign nationals crossed into the United States, the FBI learned of the potential ties to the Islamic State, CBS News previously reported. The FBI identified early-stage terrorist plotting, triggering their immediate arrests, in part, through a wiretap after the individuals had already been vetted by U.S. Customs and Border Protection, law enforcement sources confirmed to CBS News in June. 

Several months later, their removals following immigration proceedings mark a departure from the post-9/11 intelligence-sharing architecture of the U.S. government. 

Now facing a more diverse migrant population at the U.S.-Mexico border, a new effort is underway by the Department of Homeland Security, Department of Justice and the Intelligence Community to normalize the direct sharing of classified information – including some marked top-secret – with U.S. immigration judges. 

The more routine intelligence sharing with immigration judges is aimed at allowing U.S. immigration courts to more regularly incorporate derogatory information into their decisions. The endeavor has led to the creation of more safes and sensitive compartmented information facilities – also known as SCIFs – to help facilitate the sharing of classified materials. Once considered a last resort for the department, Secretary Alejandro Mayorkas has sought to use immigration tools, in recent months, to mitigate and disrupt threat activity.

The immigration raids, back in June, underscore the spate of terrorism concerns from the U.S. government this year, as national security agencies point to a system now blinking red in the aftermath of the Oct. 7 attacks by Hamas on Israel, with emerging terrorism hot spots in Central Asia. 

A joint intelligence bulletin released this month, and obtained by CBS News, warns that foreign terrorist organizations have exploited the attack nearly one year ago and its aftermath to try to recruit radicalized followers, creating media that compares the October 7 and 9/11 attacks and encouraging “lone attackers to use simple tactics like firearms, knives, Molotov cocktails, and vehicle ramming against Western targets in retaliation for deaths in Gaza.”

In May, ICE arrested an Uzbek man in Baltimore with alleged ISIS ties after he had been living inside the U.S. for more than two years, NBC News first reported. 

In the past year, Tajik nationals have engaged in foiled terrorism plots in Russia, Iran and Turkey, as well as Europe, with several Tajik men arrested following March’s deadly attack on Crocus City Hall in Moscow that left at least 133 people dead and hundreds more injured. 

The attack has been linked to ISIS-K, or the Islamic State Khorasan Province, an off-shoot of ISIS that emerged in 2015, founded by disillusioned members of Pakistani militant groups, including Taliban fighters. In August 2021, during the U.S. military withdrawal from Afghanistan, ISIS-K launched a suicide attack in Kabul, killing 13 U.S. service members and at least 170 Afghan civilians. 

In a recent change to ICE policy, the agency now recurrently vets foreign nationals arriving from Tajikistan, Uzbekistan and other Central Asian countries, detaining them while they await removal proceedings or immigration hearings.

Only 0.007% of migrant arrivals are flagged by the FBI’s watchlist, and an even smaller number of those asylum seekers are ultimately removed. But with migrants arriving at the Southwest border from conflict zones in the Eastern Hemisphere, posing potential links to extremist or terrorist groups, the White House is now exploring ways to expedite the removal of asylum seekers viewed as a possible threat to the American public. 

“Encounters with migrants from Eastern Hemisphere countries—such as China, India, Russia, and western African countries—in FY 2024 have decreased slightly from about 10 to 9 percent of overall encounters, but remain a higher proportion of encounters than before FY 2023,” according to the Homeland Threat Assessment, a public intelligence document released earlier this month. 

A senior homeland security official told reporters in a briefing Wednesday, that the U.S. is engaged in an “ongoing effort to try to make sure that we can use every bit of available information that the U.S. government has classified and unclassified, and make sure that the best possible picture about a person seeking to enter the United States is available to frontline personnel who are encountering that person.”

Approximately 139 individuals flagged by the FBI’s terror watchlist have been encountered at the U.S.‑Mexico border through July of fiscal year 2024. That number decreased from 216 during the same timeframe in 2023. CBP encountered 283 watchlisted individuals at the U.S.-Canada border through July of fiscal year 2024, down from 375 encountered during the same timeframe in 2023.

“I think one of the features of the surge in migration over recent years is that our border personnel are encountering a much more diverse and global population of individuals trying to enter the United States or seeking to enter the United States,” a senior DHS official said. “So, at some point in the past, it might have been primarily a Western Hemisphere phenomenon. Now, our border personnel encounter individuals from around the world, from all parts of the world, to include conflict zones and other areas where individuals may have links or can support ties to extremist or terrorist organizations that we have long-standing concerns about.”

In April, FBI Director Christopher Wray warned that human smuggling operations at the southern border were trafficking in people with possible connections to terror groups.

“Looking back over my career in law enforcement, I’d be hard-pressed to think of a time when so many different threats to our public safety and national security were so elevated all at once, but that is the case as I sit here today,” Wray, told Congress in June, just days before most of the Tajik men were arrested.

The expedited return of three Tajiks to Central Asia required tremendous diplomatic communication, facilitated by the State Department, U.S. officials said.  

Returns to Central Asia routinely encounter operational and diplomatic hurdles, though regular channels for removal do exist. According to agency data, in 2023, ICE deported only four migrants to Tajikistan.

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Here Comes the Sun: Ralph Macchio and more

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Here Comes the Sun: Ralph Macchio and more – CBS News


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Actor Ralph Macchio sits down with Lee Cowan to discuss the sixth and final season of “Cobra Kai.” Then, Tracy Smith visits The Broad museum in Los Angeles to learn about Mickalene Thomas’ exhibition “All About Love.” “Here Comes the Sun” is a closer look at some of the people, places and things we bring you every week on “CBS Sunday Morning.”

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The Depraved Heart Murder – CBS News

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A surgeon is accused of drugging his girlfriend in order to control her. “48 Hours” contributor Nikki Battiste reports.

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