Category: US

CNN
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Vaccine advisers to the US Food and Drug Administration narrowly voted Tuesday in favor of Pfizer’s RSV vaccine for adults over the age of 60, paving the way for approval of the first nation’s RSV vaccine, despite some safety concerns.

The committee members voted 7-4, with one abstention, that there is adequate data to support the safety and effectiveness of Pfizer’s vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus among older adults.

The FDA, which typically follows the independent committee’s recommendations, is scheduled to decide on approval of the vaccines by May, ahead of RSV’s typical winter surge. The US Centers for Disease Control and Prevention must then recommend the shot before it becomes available to the public.

Pending those steps, Pfizer’s vaccine – along with GSK’s candidate shot, which will be voted on by the FDA advisory committee on Wednesday – would be the first approved RSV vaccines for adults 60 or older.

RSV is a highly contagious virus that causes flu-like illness in people of all ages that increases in severity with age. It’s is responsible for an estimated 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older, according to the CDC.

The Pfizer vaccine was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing illness with three or more symptoms, according to an FDA briefing document.

Although a majority of the committee voted in favor of the vaccine, some members expressed concerns about the vaccine’s “important potential risk: of Guillain-Barre syndrome. Two adults among the 20,000 vaccine recipients in Pfizer’s Phase 3 clinical trial developed symptoms consistent with the rare neurological disorder within nine days of receiving the shot.

“It seems to me that one case is a red flag. Two cases is very concerning, and it’s concerning to me that Pfizer doesn’t think that there are any safety concerns,” said Dr. Marie Griffin, professor of health policy at Vanderbilt University Medical Center, who voted that the data demonstrated the vaccine was effective but not safe.

The FDA has recommended that Pfizer conduct a safety study for further evaluation of Guillain-Barre and other immune-mediated demyelinating conditions after potential vaccine approval, and the company has agreed.

Dr. Daniel Feikin, respiratory disease consultant, who voted that the vaccine was both safe and effective, said that post-marketing safety surveillance will be “critical.”

Some of the vaccine advisers wanted to see more data on effectiveness against hospitalization or death, especially among high-risk people such as older adults or those with other health conditions.

“I think the data does support the effectiveness of this vaccine. It’s just the population was underrepresented by people who could most benefit from the vaccine,” Griffin said.

The available safety and efficacy data from Pfizer’s clinical trial is from the first of two RSV seasons. Some of the experts said that the vote is premature and that they would like to see more data.

“I’m desperately eager to have a vaccine that works for RSV. This has been a terrible disease my whole career. I would love to see it. No doubt about it,” said Dr. Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City, who voted that the data demonstrated that the vaccine was safe but not effective.

Portnoy says that waiting for a second season of data would provide more robust numbers and complete analysis.

“It’s not an emergency use authorization. We can take the time to finish the studies and get the information we need before licensing this product going forward. So I remain a little bit skeptical, given the data that we have.”

CNN
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Russia’s Defense Ministry on Tuesday accused Ukraine of launching a spate of attempted drone strikes targeting infrastructure deep inside Russia, including near the capital, after a fire broke out at an oil depot and authorities abruptly closed airspace above the country’s second-largest city.

Moscow region Gov. Andrey Vorobyov claimed a Ukrainian drone had crashed near the village of Gubastovo southeast of the capital. The drone was apparently aimed at what he called “civilian infrastructure,” later confirmed to be a gas facility operated by state-owned company Gazprom.

The facility remained undamaged, state media reported, citing the region’s Energy Ministry.

State media later posted a photograph of what it said was the crashed device, which appeared to resemble a Ukrainian-made UJ-22 attack drone.

The UJ-22 is relatively small and versatile, able to fly through poor weather and to travel up to 500 miles (800 kilometers). It’s unclear where or when the photo of the crashed drone was taken.

The crash was allegedly one of several attempted strikes, with state media reporting a drone was shot down near the Belarus border and the defense ministry claiming two more strikes were thwarted through the use of drone-jamming technology in the Krasnodar and Adygea regions.

“Both drones lost control and deviated from their flight path,” the defense ministry said in a statement. “One UAV (unmanned aerial vehicle) fell in a field, and another UAV, deviating from the trajectory, did not harm the attacked civilian infrastructure facility.”

At least one drone appeared to have evaded Russian defenses, with footage posted on social media overnight and geolocated by CNN showing a fire at energy firm Rosneft’s oil depot in Tuapse, on Krasnodar’s Black Sea coast.

It’s unclear if the facility was the intended target, but Ukraine has previously targeted oil depots within Russian-controlled territory.

CNN is unable to independently confirm the claims for each alleged attack, and Ukraine did not immediately comment on the incident. Ukraine has previously declined to comment on attacks inside Russia.

Following the alleged attacks, Russia’s second-largest city of St. Petersburg closed its airspace Tuesday within a 200-kilometer (124-mile) radius, briefly banning incoming flights, according to state media.

Russian President Vladimir Putin had been briefed about the closures – but Kremlin spokesperson Dmitry Peskov had declined to discuss whether it was related to the “incidents in St. Petersburg and Tuapse,” state media reported.

Attacks targeting Russian infrastructure have focused attention on Ukraine’s efforts to develop longer-range combat drones.

In early December, Russia reported multiple attacks by Ukrainian drones targeting military infrastructure, including air bases that lie hundreds of miles inside Russian territory and beyond the reach of Ukraine’s declared arsenal of drones.

Around the same time, Ukraine’s state-owned weapons manufacturer Ukroboronprom indicated that it is close to finishing work on a new long-range drone – though there is no public indication that such a device has been readied for deployment or was involved in explosions inside Russia.

At the time, Ukraine’s Defense Ministry offered no comment on the strikes – though a presidential adviser tweeted a cryptic message hinting at the possibility Kyiv was indeed behind the December attacks.

“The Earth is round – discovery made by Galileo. Astronomy was not studied in Kremlin, giving preference to court astrologers. If it was, they would know: If something is launched into other countries’ airspace, sooner or later unknown flying objects will return to departure point,” he said at the time.

Paris/London
CNN
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The European Parliament on Tuesday banned TikTok from staff devices over cybersecurity concerns, meaning the Chinese video-sharing app is now barred in all three of the EU’s main institutions.

“In view of cybersecurity concerns, in particular regarding data protection and collection of data by third parties, the European Parliament has decided, in alignment with other institutions, to suspend as from 20 March 2023, the use of the TikTok mobile application on corporate devices,” it said in a statement.

The parliament also “strongly recommended” that its members and staff remove TikTok from their personal devices.

TikTok, which is owned by Beijing-based ByteDance, told CNN “it’s disappointing to see that other government bodies and institutions are banning TikTok on employee devices with no deliberation or evidence.”

“These bans are based on basic misinformation about our company, and we are readily available to meet with officials to set the record straight about our ownership structure and our commitment to privacy and data security. We share a common goal with governments that are concerned about user privacy, but these bans are misguided and do nothing to further privacy or security,” a spokesperson said in a statement.

“We appreciate that some governments have wisely chosen not to implement such bans due to a lack of evidence that there is any such need.”

Last week, the European Commission announced it was banning TikTok from official devices, citing cybersecurity concerns.

A senior EU official in the European Council told CNN that the General Secretariat of the Council, the body that assists the permanent representatives of the EU’s 27 countries based in Brussels, “is in the process of implementing measures similar to those taken by the Commission.”

“It will be uninstalling the application on corporate devices and requesting staff to uninstall it from personal mobile devices that have access to corporate services,” the official added. “The Secretariat continuously keeps its cybersecurity measures under review in close cooperation with the other EU institutions.”

The European Commission said last week their decision to ban TikTok applies only to devices overseen by the EU’s executive branch.

“This measure aims to protect the Commission against cybersecurity threats and actions which may be exploited for cyber-attacks against the corporate environment of the Commission,” it said in a statement.

A TikTok spokesperson told CNN in a statement at the time that it had contacted the commission to “set the record straight and explain how we protect the data of the 125 million people across the EU who come to TikTok every month.”

Previously, TikTok had disclosed to European users that China-based employees may access EU user data. The company also recently announced plans to open two new data centers in Europe.

TikTok is facing similar scrutiny across the Atlantic.

On Monday, the White House directed federal agencies to remove TikTok from all government-issued devices within 30 days, with few exceptions.

The move added to growing efforts by the United States to clampdown on the app amid renewed security concerns.

US officials have raised concerns that the Chinese government could pressure ByteDance to hand over information collected from users that could be used for intelligence or disinformation purposes. As CNN has previously reported, independent security experts have said that type of access is a possibility, though there has been no reported incident of such access to date.

Brooke Oberwetter, a TikTok spokesperson, called the ban “little more than political theater.”

“The ban of TikTok on federal devices passed in December without any deliberation, and unfortunately that approach has served as a blueprint for other world governments,” Oberwetter said in a statement.

“We hope that when it comes to addressing national security concerns about TikTok beyond government devices, Congress will explore solutions that won’t have the effect of censoring the voices of millions of Americans.”

China also hit back at the decision Tuesday, with a Foreign Ministry spokesperson accusing Washington of “generalizing the concept of national security” and “unreasonably suppressing enterprises of other countries.”

The Canadian government announced a similar ban on TikTok from official electronic devices on Monday.

Other nations may soon have to grapple with the same issue.

Asked whether Australia would soon follow the United States, European Union and Canada, Australian Treasurer Jim Chalmers said the country hadn’t yet been advised to restrict use of the app by government workers.

“We’ll take the advice of our national security agencies. That hasn’t been the advice to date,” Chalmers told Australia’s ABC broadcaster in an interview on Wednesday.

CNN
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The New College of Florida’s reshaped board of trustees voted Tuesday to abolish diversity, equity and inclusion programs at the school after a heated public comment session – events that follow Florida Gov. Ron DeSantis’ decision to move the college in a conservative direction.

Students and others expressed strenuous opposition to the new direction before the vote at the Sarasota institution, both at the meeting and at a rally.

“Shame on you!” a crowd including students, parents and alumni chanted toward the trustees as the public comment portion of the meeting closed before the board’s vote.

In January, DeSantis replaced six of the 13 members on the college’s board of trustees with conservative allies, including Christopher Rufo, who has fueled the fight against critical race theory and pushed to end diversity, equity and inclusion initiatives, known as DEI. The new board forced out the college’s president and appointed DeSantis ally Richard Corcoran as interim president.

Tuesday’s vote also came after DeSantis said last month that he intends to defund all DEI programs at state colleges and universities in Florida. These policies and programs are created to promote representation for people who have historically faced discrimination because of their race, ethnicity, disability, gender, religion or sexual orientation.

Dozens of parents, students and alumni spoke out against Florida’s conservative takeover of New College at Tuesday’s meeting.

Several speakers approached the microphone during the public comment session, most expressing outrage at DeSantis’ decision to handpick trustees who agree with his vision.

The college had offered an environment where members of the LGBTQ community can freely express themselves, students say. Student Sam Sharf said during public comments that the new leadership was launching a “hostile takeover” of the school and has neglected students’ concerns.

“Regardless of your attempts to suppress our educational freedom we will continue to learn the subjects that you want to ban,” Sharf said. “We reject the social inequalities that your ideology defends.”

At the meeting, Rufo said race shouldn’t be a consideration for the school. “It treats people differently on the basis of their skin color,” Rufo said.

The meeting came after hundreds of people rallied on campus Tuesday, holding signs with phrases such as “protect diversity, equity and inclusion” and “stand up for students.”

The school community has been up in arms for weeks, with many students saying they fear the college will no longer be a safe place for the LGBTQ community or other marginalized groups. Several protests have been held on campus since the leadership changes happened, including a walkout by students last week.

“A lot of us are hurting right now,” said third-year student Chai Leffler, who is studying Chinese and urban studies at the college.

Leffler said New College of Florida has always been a school that has encouraged “free academic thought.” Lawmakers, he said, are trying to strip away that freedom by telling students what they can and can’t study.

“I don’t think politicians should really be the ones making that decision,” Leffler told CNN. “And I really don’t think that’s an unpopular opinion.”

DeSantis’ office insists that the New College of Florida has seen declining enrollment and focuses too heavily on DEI, critical race theory and gender ideology.

Tuesday’s meeting followed the introduction of a bill in the Florida House that mirrors DeSantis’ ideas for an overhaul of higher education.

The bill, filed by a Republican lawmaker last week, would put board of trustee members in charge of faculty hiring; defund diversity, equity and inclusion programs; eliminate majors or minors related to critical race theory or gender studies; and authorize boards of trustees to review tenure of faculty.

The bill was praised by Rufo, who said on Twitter that it restores the “principle of colorblind equality in higher ed.” Rufo is a senior fellow and director of the initiative on critical race theory at the conservative Manhattan Institute.

“This would be the most ambitious reform to higher education in a half-century,” Rufo tweeted. “Gov. DeSantis is channeling the sentiment of the voters, who have demanded that taxpayer dollars stop subsidizing left-wing racialist ideology and partisan political activism. Democracy returns.”

Some students and advocates say they believe DeSantis has proposed sweeping changes to Florida’s colleges and universities for political gain because he is expected to run for president in 2024.

But they fear the lasting impacts could be Florida colleges struggling to retain students and recruit faculty.

People pursuing graduate degrees might opt for schools in other states that support academic freedom, Irene Mulvey, president of the American Association of University Professors, told CNN earlier this month.

“The consequences for students are enormous,” Mulvey said. “They are denied the opportunity to learn and grow, students are denied the opportunity to hear important perspectives. That’s the real tragedy.”