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FDA approves first self-administered flu vaccine spray
The Food and Drug Administration announced Friday it had broadened the approval of the FluMist nasal spray to become the first “self-administered” influenza vaccine — though a delay in the change means the vaccine will not be available to ship to homes until next year’s flu season at the earliest.
“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The FluMist vaccine, manufactured by AstraZeneca, had previously been approved back in 2003 to be given by health care providers similar to other flu shots. Now the vaccinemaker has approval to sell FluMist to adults for use at home on themselves or to administer to their children.
The FDA says patients will still need to get a prescription for the vaccine from a health care provider.
AstraZeneca says it plans to sell FluMist directly to patients through an online pharmacy. Adults will be able to complete a screening questionnaire to get the prescription, and then order shipments to their home.
There are also some limits to the kinds of people FluMist is recommended for. Since it uses a live but weakened version of the virus, some patients, like pregnant people or those who are severely immunocompromised, should not get this vaccine.
FluMist is less commonly used these days by pharmacies and doctors, in part due to fallout from a Centers for Disease Control and Prevention recommendation in 2016 against use of the spray over “poor or relatively lower effectiveness” compared to other vaccines.
AstraZeneca later redesigned the antigens in the vaccine, earning back the CDC’s recommendation starting in 2018.
Since then, the CDC says it has not had enough data for new official effectiveness estimates comparing FluMist to other flu vaccines, “because of limited use” in the U.S.
But AstraZeneca has cited data showing the shot has had “comparable” effectiveness in Europe versus more widely used shots.
AstraZeneca had initially told investors it hoped the FDA would broaden approval in time for this flu season, after the company submitted data last year showing that adults were able to correctly follow instructions to administer the vaccine spray on their own.
AstraZeneca did not comment when asked why the FDA’s approval decision came later than the company previously said it expected.
“We’re working diligently to bring this ‘first-of-its-kind’ innovative and convenient self-administrated flu vaccine to consumers and look forward to launching FluMist Home as soon as next flu season,” a spokesperson for the company said in a statement.
The spokesperson said AstraZeneca needed time to work with its partners to “ensure a seamless customer experience” for FluMist’s rollout for home use.
CBS News
Canada shuts down TikTok’s Canadian offices, but allows app to remain
Canada announced Wednesday it won’t block access to the popular video-sharing app TikTok but is ordering the dissolution of its Canadian business after a national security review of the Chinese company behind it.
Industry Minister François-Philippe Champagne said it is meant to address risks related to ByteDance Ltd.’s establishment of TikTok Technology Canada Inc.
“The government is not blocking Canadians’ access to the TikTok application or their ability to create content. The decision to use a social media application or platform is a personal choice,” Champagne said.
Champagne said it is important for Canadians to adopt good cybersecurity practices, including protecting their personal information.
He said the dissolution order was made in accordance with the Investment Canada Act, which allows for the review of foreign investments that may harm Canada’s national security. He said the decision was based on information and evidence collected over the course of the review and on the advice of Canada’s security and intelligence community and other government partners.
A TikTok spokesperson said in a statement that the shutdown of its Canadian offices will mean the loss of hundreds of local jobs.
“We will challenge this order in court,” the spokesperson said. “The TikTok platform will remain available for creators to find an audience, explore new interests and for businesses to thrive.”
TikTok is wildly popular with young people, but its Chinese ownership has raised fears that Beijing could use it to collect data on Western users or push pro-China narratives and misinformation. TikTok is owned by ByteDance, a Chinese company that moved its headquarters to Singapore in 2020.
TikTok faces intensifying scrutiny from Europe and America over security and data privacy. It comes as China and the West are locked in a wider tug of war over technology ranging from spy balloons to computer chips.
Canada previously banned TikTok from all government-issued mobile devices. TikTok has two offices in Canada, one in Toronto and one in Vancouver.
Michael Geist, Canada research chair in internet and e-commerce law at the University of Ottawa, said in a blog post that “banning the company rather than the app may actually make matters worse since the risks associated with the app will remain but the ability to hold the company accountable will be weakened.”
Canada’s move comes a day after the election in the United States of Donald Trump. In June, Trump joined TikTok, a platform he once tried to ban while in the White House. It has about 170 million users in the U.S.
Trump tried to ban TikTok through an executive order that said “the spread in the United States of mobile applications developed and owned” by Chinese companies was a national security threat. The courts blocked the action after TikTok sued.
Both the U.S. FBI and the Federal Communications Commission have warned that ByteDance could share user data such as browsing history, location and biometric identifiers with China’s government. TikTok said it has never done that and would not, if asked.
Trump said earlier this year that he still believes TikTok posed a national security risk, but was opposed to banning it.
U.S. President Joe Biden signed legislation in April that would force ByteDance to sell the app to a U.S. company within a year or face a national ban. It’s not clear whether that law will survive a legal challenge filed by TikTok or that ByteDance would agree to sell.
CBS News
Could prison companies get a boost from Trump’s immigration policies?
The Trump administration could be a boon for business for private prison companies in the U.S. if the president-elect delivers on his promise to crack down on illegal immigration.
CoreCivic and Geo Group, the two biggest private prison operators in the U.S., both contract with the U.S. Immigration and Customs Enforcement (ICE) to house detained, undocumented migrants. Their stocks soared Wednesday following Trump’s election win, with investors betting the companies will see increased profits from a tough-on-immigration administration.
CoreCivic, which closed at $13.50 a share on November 5, is trading at $22 a share, while Geo Group, which closed at $15 a share Tuesday, is currently trading at $23.75.
“Obviously, investors believe there is going to be a significant increase in opportunity for both of these firms under the Trump administration,” Noble Capital Markets analyst Joe Gomes told CBS MoneyWatch.
Geo Group executives acknowledged on the company’s third-quarter earnings call Thursday that it expects the incoming administration to enact stricter border security policies and that the company stands “ready to provide additional resources to help ICE meet future needs.”
CoreCivic executives also said they believe the election result will drive demand for its services.
ICE is biggest customer
During Trump’s first term in office, from 2017-2021, immigration detention expanded at record levels, according to an ACLU report. In 2019, ICE detained an average of over 50,000 people each day. At times, that number exceeded 56,000 — about 50% more than peak levels during the Obama administration, according to the report. During his first term in office, Trump expanded the federal government’s use of private prison companies to detain immigrants.
As of January 2020, 81% of people detained in ICE custody across the U.S. were held in facilities owned or managed by private prison corporations, according to the ACLU report.
In his second term, President-elect Trump promises a radical shift in policy at the U.S.-Mexico border from his predecessor. That includes a pledge to oversee the largest deportation operation in American history, which could bring significantly more business to CoreCivic and Geo Group.
For the first nine months of 2024, ICE accounted for 30% of each company’s revenue.
Both Geo Group and CoreCivic said they currently have excess capacity to accommodate a larger population of detainees. CoreCivic executives noted that they’re taking steps to prepare to activate additional capacity to meet ICE’s needs. That could include reconfiguring facilities to accommodate a bigger intake area, they noted.
“There is room for an uptick in occupancy from a capacity standpoint and both companies expect an ask from the Trump administration for more beds. The question is how much, and we just don’t know right now,” Wedbush Securities analyst Brian Violino told CBS MoneyWatch.
Monitoring
Geo Group also provides monitoring services for ICE under its Intensive Supervision Appearance Program (ISAP), a monitoring program using wearable technology that serves as an alternative to detention.
“If there is a finite number of beds and a significant number of people are detained, which Trump is discussing in his plans, there could be an increased usage in this alternative to detention,” Violino said.
Geo Group executives said they have the necessary technology and staffing resources to scale up the contract to more than several million participants, if necessary.
Funding from Congress
The degree to which ICE expands its contracts with the two largest private prison companies depends on how big of an increase in funding Congress authorizes. While Republicans won the Senate majority in Tuesday’s election, it remains to be seen which party will obtain control of the U.S. House of Representatives.
“That’s a big part of the story, and if it’s a Republican sweep, it will be easier for Trump to get funding from Congress to support this operation he’s looking to do,” Violino said.
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What’s next for Harris, Trump after the 2024 elections
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