The Arlington County Board has given unanimous approval to Amazon’s plans to build a unique, helix-shaped tower as the centerpiece of its emerging second headquarters in northern Virginia
By MATTHEW BARAKAT Associated Press
23 April 2022, 19:48
• 2 min read
FALLS CHURCH, Va. — The Arlington County Board gave unanimous approval Saturday to Amazon’s plans to build a unique, helix-shaped tower as the centerpiece of its emerging second headquarters in northern Virginia.
Amazon announced the plans in February 2021 for the eye-catching, 350-foot tower to anchor the second phase of its redevelopment plans. The new office towers will support a second headquarters for Amazon that is expected to welcome more than 25,000 workers when it’s complete.
The helix is one of several office towers granted approval, but the helix stands out. The spiral design features a walkable ramp wrapping around the building with trees and greenery planted to resemble a mountain hike.
Amazon has said the building is designed to help people connect to nature, and the outdoor mountain climb will be open to the public on weekends.
Since then, the plans have gone through the famously thorough review process of Arlington County, including numerous public hearings. Earlier this month, the county planning commission voted 9-0 to support the project.
On Saturday, the County Board voted 5-0 to approve the plans. They also include park space and will accommodate a community high school, along with ground level retail.
Amazon has said it hopes to complete the project in 2025.
Because skyscrapers are banned in the District of Columbia, and the Amazon buildings will be among the tallest in Arlington County, from some vantage points the helix will dominate the region’s skyline like no building other than the Washington Monument.
Apple is reportedly paying more to employees amid a return-to-office request.
James Martin/CNET
Apple has again paid some of its engineers stock bonuses, this time with values of between $100,000 and $200,000, according to a report Friday.
It’s part of an effort to retain software and hardware engineers, with the shares vesting over several years, Bloomberg reported, citing unnamed sources. Apple didn’t immediately respond to a request for comment. It declined to comment to Bloomberg.
The news follows Apple reportedly issuing surprise stock bonuses to its “high performers” in December, across divisions including silicon design, virtual reality headsets, hardware and some software and operations groups. Those reported bonuses ranged from $50,000 to $180,000 in value.
Read also:Best iPhone for 2022: Which of Apple’s 8 Phones is Right for You?
Competition between tech giants to attract and retain talent is fierce in Silicon Valley, and the move also comes as Apple has set its return-to-office expectations, announced earlier this month after roughly two years of remote work amid the COVID-19 pandemic.
During the company’s annual shareholder meeting, Apple CEO Tim Cook said corporate employees will return to in-person work starting in April. Employees will be required to work from the office at least one day a week starting April 11 and at least three days a week by May 23.
“For many of you, I know that returning to the office represents a long-awaited milestone and a positive sign that we can engage more fully with the colleagues who play such an important role in our lives,” Cook reportedly said in a memo sent in early March. “For others, it may also be an unsettling change.”
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WINDSOR, Ontario/WASHINGTON, Feb 11 (Reuters) – A Canadian judge on Friday ordered an end to the four-day-long blockade of a key Canada-U.S. trade corridor by protesters opposing pandemic restrictions, and Prime Minister Justin Trudeau promised President Joe Biden quick action to end a crisis that has disrupted North America’s auto industry.
The order could lead to police in Windsor, Ontario, clearing truckers who have crowded dozens of vehicles near the Ambassador Bridge, North America’s busiest land border crossing and a choke point for Detroit’s carmakers.
Superior Court Justice Geoffrey Morawetz said his order would come into effect at 7 p.m. Eastern Time (0000 GMT) on Friday to give people some time to clear the area. Trudeau earlier told reporters that no action was off the table.
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An hour after the deadline, about 200 protesters, including children, milled around the entrance to the bridge, waving Canadian flags, while others set off fireworks.
Police, who started to gather in a parking lot a few blocks away from the protesters, began handing out pamphlets that outlined penalties under Ontario’s emergency order, which takes effect at midnight.
Companies have diverted cargo to stem losses amid production cuts by companies including Ford (F.N).
The judge on Friday approved the request by auto industry associations and Windsor city authorities hoping to end the protests.
Occupying access roads leading to the bridge on Friday, protesters voiced defiance and there was little sign of them backing down.
“Canada is supposed to be a free country,” said Liz Vallee, a protester from Chatham, Ontario. “When that freedom is threatened, we must stand up.”
Vallee said she and others would stay until all pandemic mandates are lifted.
The “Freedom Convoy” protests, started by Canadian truckers opposing a vaccinate-or-quarantine mandate for cross-border drivers, are also occupying areas outside government buildings in the capital city of Ottawa and have blocked two smaller U.S. crossings.
The protests have inspired similar convoys and plans in France, New Zealand, Australia and the United States, whose Department of Homeland Security is working to ensure that a “Freedom Convoy” event due in early March in Washington, D.C., “does not disrupt lawful trade.” read more
U.S. PRESSURE
Adding to earlier calls for action by U.S. officials and business leaders, Biden expressed concerns over auto plant closures and production slowdowns during a phone call with Trudeau, the White House said in a statement.
People erect a tent as truck drivers and supporters continue to block access to the Ambassador Bridge, which links Detroit and Windsor, in protest against coronavirus disease (COVID-19) vaccine mandates, in Windsor, Ontario, Canada February 10, 2022. REUTERS/ Carlos Osorio
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“The two leaders agreed that the actions of the individuals who are obstructing travel and commerce between our two countries are having significant direct impacts on citizens’ lives and livelihoods,” the statement said.
“The Prime Minister promised quick action in enforcing the law, and the President thanked him for the steps he and other Canadian authorities are taking to restore the open passage of bridges to the United States,” it added.
Trudeau told reporters that he agreed with Biden that the blockades cannot continue. “Everything is on the table because this unlawful activity has to end and it will end,” Trudeau said.
U.S.-Canada cross-border trade in vehicles and core parts totaled $51.5 billion in 2021, IHS Markit estimates.
Biden’s administration had urged Canada to use federal powers to ease the Ambassador Bridge blockade, a step Trudeau’s government has not taken. Trudeau said on Friday his government was not seriously contemplating calling in the military over the protests. read more
The leader of Ontario, where police have avoided using force to disperse protesters, sought to build pressure on Friday by threatening C$100,000 fines and up to a year in prison for non-compliance.
Announcing the penalties as part of emergency measures, Ontario Premier Doug Ford said they were needed to “make crystal clear it is illegal and punishable to block and impede the movement of goods, people and services along critical infrastructure.”
Windsor police issued a statement warning of arrests, but it was not clear if or when authorities would begin issuing fines or seeking jail sentences.
ECONOMIC LOSSES
With car production cuts mounting, Ford, the second-largest U.S. automaker, said on Friday it had temporarily halted work at its assembly plant in Ohio. General Motors and Toyota also announced new production cuts.
The stock of Canadian autoparts maker Magna International (MG.TO) fell 6.4% on Friday after it said it had seen an initial hit from the bridge’s closure. read more
Beyond auto sector losses, the three U.S.-Canada crossings obstructed account for 33% of Canada’s trade with the United States, valued at $616 million per day, Export Development Canada said.
The bridge’s shutdown could worsen the tight supply of new vehicles in the United States and contribute to the already fast-rising price of new vehicles, IHS Markit said in a Friday report. Even if the blockade ends, a return to normal will take several weeks as shortages cascade through the supply chain, IHS Markit said.
Governor Gretchen Whitmer of Michigan, home to nearly a fifth of U.S. car production, told CNN: “The Canadian government has to do whatever it takes to safely and swiftly resolve this.”
($1 = 1.2737 Canadian dollars)
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Reporting by Kayla Tarnowski and Trevor Hunnicutt; Additional reporting by Steven Scherer and Julie Gordon in Ottawa, Anna Mehler-Paperny in Toronto, Doina Chiacu and David Shepardson in Washington and Ismail Shakil, Kanishka Singh, and Shivansh Tiwary in Bengaluru; Writing by Rami Ayyub; Editing by Karishma Singh, Mark Porter, Grant McCool and William Mallard
Our Standards: The Thomson Reuters Trust Principles.
NEW YORK (WABC) — A New York Appellate Judge granted a stay in the state’s lawsuit over the COVID-19 face mask mandate, meaning it remains in place while case is appealed — and schools must enforce it.
New York State had quickly filed an appeal after a Supreme Court judge in Nassau Count ruled that the New York’s mask mandate couldn’t be enforced.
The mandate had been reinstituted over concerns about a winter surge of coronavirus cases.
Masks were optional Tuesday in many Nassau County school districts.
Wednesday, students and staff need to wear their masks that appellate judge judge issued a stay until a hearing later this week.
The issue isn’t the mask mandate itself but how it was implemented.
A judge in Nassau County saying the state health department does not have the authority to issue the statewide school mask mandate.
Before Monday’s ruling, Governor Kathy Hochul has already implied that the school mask mandate would be lifted once infection numbers went down.
But that wasn’t good enough for many.
“How can you have a mandate where you don’t know where it begins and you don’t know where it ends?” Blakeman said.
“I don’t want to keep any requirements for safety in place a day longer than necessary, but I will not do it a day before we can do it safely,” Governor Hochul said.
“It’s not invasive, it’s effective, and it is simple,” a parent said, “And our children do not appear to be complaining about it, mostly the parents are.”
The hearing is set for Friday at state appellate court.
ALSO READ | MTA officials address alarming rise in crime, promise more uniformed officers on platforms
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A lot of us here at XDA-Developers originally started browsing the forums for the first time when we were looking to root our Android devices. Back in those days, people often relied on “one-click root” methods: Apps or scripts containing payloads that target known privilege escalation vulnerabilities of the existing firmware to gain root access. With improvements and changes to encryption, permissions, and privacy-related handling, modern Android devices are relatively safe from such attack vectors, but there will always remain scope for exploits and vulnerabilities.
OnePlus might have cemented its name among the major Android OEMs, but its phones are no stranger to security flaws. This time, the company has left a rather interesting (read: worrying) vulnerability unpatched on the OnePlus Nord 2 since its release. Although exploiting the loophole requires physical access to the device, the attacker can effectively gain an unrestricted root shell before the user can even enter their credentials. Notably, the newly released Pac-Man edition of the Nord 2 is affected as well.
Background
Nowadays, when we talk about having root access on an Android smartphone, people usually think about patching the stock boot image with Magisk first and then flashing the patched image to the target device after bootloader unlocking. That way, the end-user can have supervised access to the “su” binary through a manager app. A couple of other experimental approaches exist, but they seldom gather as much mainstream usage.
When it comes to pre-production, though, the scenario is entirely different. While preparing the firmware of a device, the engineers need to have various logging parameters turned on, including root access. Even on a userdebug build, the Android Debug Bridge Daemon (adbd) runs as root, so that one can have privileged shell access for debugging purposes. When the firmware is ready for shipping, all these debugging parameters must be turned off before rolling it out.
But what happens if you forget to do so? We will see, as the official OxygenOS releases for the OnePlus Nord 2 comes with such a flaw.
OnePlus Nord 2 — Root Shell Vulnerability
Some OEMs like Samsung offer update package sideloading capability in their stock recovery on retail devices. In that case, the adbd binary runs with a significantly high privilege while sideloading, but it closes down itself as soon as the update process finishes up. Other than that, there is no ADB access permitted in an OEM-provided recovery environment.
OnePlus no longer allows users to flash an update ZIP package through its stock recovery via ADB sideload. Assuming that everything else is configured as it should, a regular OnePlus device’s recovery environment should be safe from attackers delivering any kind of payload using ADB. Unfortunately, not everything goes according to plan in the case of the OnePlus Nord 2.
As it turns out, anyone can spawn an Android debugging shell with root privilege inside the recovery environment of the OnePlus Nord 2. One of the critical debugging settings apparently made its way to the production builds, which leads to this glitch.
Exploiting the flaw on the OnePlus Nord 2
All you need to do is reboot the OnePlus Nord 2 to its recovery mode. An attacker can take the device and use a simple hardware button combo to force it to go to recovery mode. In fact, there is no need to reach the actual recovery menu, as the vulnerable section comes before that. Credit goes to XDA Senior Member AndroPlus for pointing out the existence of this glitch back in October 2021.
While the phone is turned off, press the volume down and the power buttons simultaneously until you see the OnePlus logo with a minuscule “RECOVERY MODE” banner at the bottom left corner of the screen.
Next, you should see the language selection screen. No need to move forward, as we can initiate ADB access right from here.
Now connect the phone to a PC (or Mac) using the USB cable. In case you’re using Windows, you can see a new Android USB debugging interface pops up in the Device Manager. You might also need to install a suitable Android USB driver before Windows can recognize the new device. Linux and macOS users, on the other hand, can use the lsusb command to detect the presence of the new hardware interface.
Considering you already have the latest version of ADB and Fastboot utilities installed on your PC/Mac, fire up a Command Prompt/PowerShell/Terminal instance and execute the following command:
adb devices
It should list the Nord 2 in recovery mode. This is also particularly interesting, as the standard ADB authorization prompt is not needed here. You may get a “device unauthorized” error, but wiping out the host PC’s existing ADB RSA key database and restarting the ADB server should eventually allow you to get it authorized.
Now instruct adbd to run as root:
adb root
This command might take a long time and you will probably get a timeout error. Nonetheless, now adbd should be running as root.
Finally, verify the privilege level of the shell using the following command:
adb shell whoami
The extent of the flaw
The potential abuses of this security vulnerability are frightening. With a successful attack on the OnePlus Nord 2, an attacker can dump every partition of the device. As a result, the entirety of the data partition — including files stored in the typically inaccessible private data directories of applications — is accessible to the attacker. In case the data partition came out as encrypted (because of the user set a PIN or password), the dump could still be useful for forensic analysis.
Not only that, you can push an executable to /data/local/tmp and run it from there. This is a classic attack vector, which can be useful for chainloading another exploit. Moreover, since you can now call the setprop utility as root to modify various prop values, you can technically hijack some of the privileged OEM-specific variables. Last but not least, even if you don’t have developer options unlocked, the phone will automatically prompt for USB debugging access after you invoke ADB in recovery and reboot to the regular Android environment, which means the vulnerability’s scope is not limited to just the recovery section only.
Note that you can’t install APK files using ADB in the recovery environment due to the fact that the Package Manager utility isn’t accessible there.
How to check if your OnePlus Nord 2 is affected? (Hint: It is)
As mentioned earlier, you can exploit this vulnerability on both the regular and the special Pac-Man edition of the OnePlus Nord 2. In a nutshell, if you enter a root shell (you’ll know when the shell symbol changes from $ to #), then you’ll know the flaw is present.
We have successfully gained root shell access on the latest public Indian and the European OxygenOS firmware for the device, which means every single OnePlus Nord 2 unit out there is vulnerable at the time of writing this article.
What’s next?
We will be following up on this matter as more information becomes available. OnePlus provided the following statement on the issue:
“We treat privacy and security very seriously. We are prioritizing this matter and we will share an update as soon as we have more information.”
While all of this seems scary, keep in mind that an attacker will still need to physically access the phone in order to gain root shell access. Until OnePlus rolls out an update that patches the vulnerability, try to keep your OnePlus Nord 2 away from strangers. While we have not come across any instances of malicious use, one cannot discount such possibility as the vulnerability has been in the wild for at least 2 months now.
The origin of the SARS-CoV-2 virus that causes COVID-19 remains unclear, but recent revelations reinforce the likelihood that the true source was a lab leak from the Wuhan Institute of Virology.
A letter from Lawrence Tabak, the National Institutes of Health’s principal deputy director, to Rep. James Comer of Kentucky confirms that the NIH funded research at the WIV during 2018–2019 that manipulated a bat coronavirus called WIV1. Researchers at the institute grafted spike proteins from other coronaviruses onto WIV1 to see if the modified virus was capable of binding in a mouse that possessed the ACE2 receptors found in humans — the same receptor to which SARS-CoV-2 binds. The modified virus reproduced more rapidly and made infected humanized mice sicker than the unmodified virus.
Starting in 2014, the NIH’s National Institute of Allergy and Infectious Diseases, headed by Anthony Fauci, funded the New York-based research nonprofit EcoHealth Alliance with annual grants through 2020 for “Understanding the Risk of Bat Coronavirus Emergence.”
Total funding was $3,748,715. More than $600,000 of that went to the Wuhan lab. Three other Chinese institutions received funding, as well. The principal investigator was EcoHealth Alliance President Peter Daszak, who, from the onset of the pandemic, has consistently campaigned in public and behind the scenes to convince people that SARS-CoV-2 did not come from the WIV but evolved naturally from animal-to-human transmission.
Lawrence Tabak, the National Institutes of Health’s principal deputy director, previously claimed that “bat coronaviruses had not been shown to infect humans,” in 2017.National Institutes of Health
Tabak’s letter asserts that the modified virus’ becoming more virulent “was an unexpected result” and not “something that the researchers set out to do” — an odd claim, considering that the whole point of manipulating the virus was to investigate things that could make it more virulent.
The 2018 research mentioned in Tabak’s letter is similar to earlier WIV research, funded in part by the NIH, that modified viruses related to SARS to see if they could infect human cells.
Publications of these studies in 2017 and 2016 were the subject of a contentious Senate hearing in which Republican Sen. Rand Paul of Kentucky pressed Fauci to admit that they constituted gain-of-function research, prompting Fauci’s denial and a statement that “NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology.”
EcoHealth Alliance President Peter Daszak (left) was instrumental at denying the Wuhan lab leak theory along with Dr. Anthony Fauci. Twitter
Many, but not all, virologists believe that the WIV experimentation qualifies as gain-of-function research.
Such research was originally defined as “any modification of a biological agent that confers new or enhanced activity.”
The National Science Advisory Board for Biosecurity proposed that only a narrower category, gain-of-function research of concern — research that could make a pathogen likely to spread and cause disease in humans — needs extra regulatory oversight.
Following laboratory biosafety incidents at government research facilities, the US paused funding on gain-of-function research with influenza and the SARS and MERS coronaviruses in 2014 to determine additional oversight. Researchers conducted the 2017 and 2016 studies discussed in the Senate while this pause was in effect.
In 2017, officials lifted the moratorium and replaced it with oversight guidelines for research using potential pandemic pathogens (PPP) — pathogens likely to be highly transmissible, capable of uncontrollable spread and able to cause significant morbidity or mortality in humans. A PPP resulting from the enhancement of the transmissibility or virulence of a pathogen is called an enhanced PPP (ePPP).
Tabak does not address whether the 2018 WIV experiments he cited in his letter were gain-of-function research. Instead, he maintains that NIH did not consider the WIV experiments so dangerous as to require special review and biosafety measures under the ePPP regulations adopted in 2017 “because these bat coronaviruses had not been shown to infect humans.”
But this is an unconvincing technicality. Other bat coronaviruses had already caused two deadly diseases, SARS and MERS, and other coronaviruses regularly circulate and infect humans to cause the common cold. It isn’t a stretch to think that a different coronavirus could become dangerous, too — particularly if used in an experiment designed to manipulate a virus that humans have never encountered to see if it could acquire the ability to infect humans.
After explaining why NIH didn’t review the proposal under its guidelines, Tabak’s letter claims that EcoHealth violated the terms of its grant stipulating that it had to report if its research increased the viral growth of a pathogen by tenfold — terms that NIH inserted “out of an abundance of caution and as an added layer of oversight.”
But the letter never explains why this stipulation was necessary.
This blame-shifting is not only unseemly but also may be untrue: EcoHealth maintains that it reported the results in its April 2018, Year Four report.
The main point of the letter seems to be that any deficiencies in NIH’s grant-review and oversight processes didn’t make a difference.
Tabak repeatedly assures Rep. Comer that the viruses being studied “were genetically very distant from SARS-CoV-2,” so they “are not and could not have become SARS-CoV-2.”
The Wuhan Institute of Virology received more than $3.5 million in federal funding since 2014.AFP via Getty Images
Whether this particular virus evolved into SARS-CoV-2 is beside the point: The WIV was engaged in this type of research, with US government support, and this makes it more, not less, likely that the COVID-19 pandemic is a manmade catastrophe.
Another WIV project, other than the specific one in the Tabak letter, could have created SARS-CoV-2.
Despite early attempts by the scientific community, with the aid of a credulous and politically motivated media, to downplay this possibility, the accumulating evidence suggests that the pandemic was more likely the result of laboratory creation and accidental release of SARS-CoV-2 than a product of natural viral evolution.
The first reported cases of COVID-19 occurred in Wuhan, China, the site of the WIV. In addition, both US intelligence sources and the State Department reported that several WIV researchers became ill and were hospitalized with COVID-19-like symptoms months prior to the Chinese government’s announcement of the first cases.
A Ecohealth Alliance research group examines fecal and bodily fluids from bat caves while looking into COVID-19’s origins in January 2020.ECOHEALTH ALLIANCE
In previous animal-to-human viral transmissions, such as the 2003 SARS outbreak in China, researchers ascertained intermediate animal hosts and serologic signs of infections in animal traders within months of the outbreaks. Despite intensive efforts over the past two years, no one has found a bat-source population, SARS-CoV-2 circulating in an intermediate species that functioned as a viral conduit between bats and humans, or evidence that SARS-CoV-2 was present anywhere else before it emerged in Wuhan.
Consider, too, the unique furin cleavage site between the S1 and S2 subunits of the SARS-CoV-2 spike protein. Furin is an enzyme expressed by human cells that separates the spike protein subunits at the cleavage site, enabling the virus to bind more efficiently to human cells and release its genetic material into them. It is an important reason that SARS-CoV-2 is so easily transmissible.
The furin cleavage site is found nowhere else in the entire genus of SARS-related betacoronaviruses. SARS-CoV-2 is the only one that has it. This fact alone suggests that it did not arise naturally in SARS-CoV-2. In addition, while other, more distant coronaviruses do have furin cleavage sites, the protein components (amino acids) in the SARS-CoV-2 furin cleavage site are coded for by a unique set of nucleotides in its RNA, not found in the other viruses, making natural recombination between the viruses unlikely.
Dr. Anthony Fauci insists the Wuhan Institute of Virology experimentation on coronaviruses was not gain-of-function research.AFP via Getty Images
It’s particularly concerning that in 2018 the EcoHealth Alliance reportedly submitted a proposal to the Defense Advanced Research Projects Agency (DARPA) to partner with the WIV in constructing SARS-related bat coronaviruses by inserting such cleavage sites into their spike proteins. DARPA rejected the proposal because it failed to address the risks of gain-of-function research. EcoHealth’s president, Daszak, did not dispute details of the reporting.
In other words: There are many indications that SARS-CoV-2 could have been created in a lab, specifically the Wuhan lab, which was conducting gain-of-function-type research with coronaviruses, some of it funded by the NIH.
While the particular experiments revealed in Tabak’s letter may not have created SARS-CoV-2, other research at the WIV, including research that EcoHealth sought to fund with US grants, could have done so.
It’s doubtful that we will ever discover the true origin of the SARS-CoV-2 virus, since the Chinese will never cooperate with a full and open investigation. It doesn’t help that, until recently, our own NIH stonewalled on questions about its funding of WIV research.
Rep. Rand Paul has called on Dr. Anthony Fauci to resign over denying his gain-of-function research at the Wuhan Institute of Virology.Greg Nash/UPI/Shutterstock
Considering the release of the recent NIH letter and the revelations about EcoHealth Alliance, it remains entirely possible that US taxpayers funded a project at the Wuhan lab that may have led to the COVID-19 pandemic.
Joel Zinberg, M.D., J.D., is a senior fellow at the Competitive Enterprise Institute and an associate clinical professor of surgery at the Icahn School of Medicine at Mount Sinai in Manhattan. Adapted with permission from City Journal.
More vaccine mandates may be imposed across the US once the Food and Drug Administration gives its final stamp of approval to COVID-19 shots, health experts have predicted.
The three vaccines on the market are currently being administered under an emergency use authorization but a full regulatory sign off could remove legal hurdles for businesses and government agencies that want to require shots for their customers and employees, NBC News reported.
“I think once the vaccines go through full FDA approval, everything should be on the table, and I think that everything will be on the table at the level of municipalities, states, employers, venues, government agencies,” Andy Slavitt, the Biden administration’s former COVID-19 response coordinator, told NBC News.
Once one or more of the vaccines are fully approved, Slavitt said he believes that federal agencies should begin to require the inoculation.
People seen protesting against mandatory vaccines on Broadway in Manhattan on June 27, 2021.MediaPunch/ShutterstockAnti-vaccine protesters gather outside Madison Square Garden in NYC ahead of a Foo Fighters’ show, which requires proof of vaccination to enter.REUTERS/Andrew Kelly
“I think every government agency ought to rethink what’s appropriate,” Slavitt said. “There are a number of people in surveys, by the way, who say precisely these words, ‘I’m not going to take it, unless it’s required.’”
Robert Field, a law and public health professor at Drexel University, noted that there had been no precedent for requiring shots still in the full-fledged regulatory review process.
“Employers are on shakier grounds because of the emergency use authorization,” Field told Reuters in December.
Full approval is the FDA’s strongest endorsement of a drug and typically requires six months of safety follow-up.
Pfizer and Moderna have applied for full approval of their two-dose vaccines, both of which secured emergency use authorization in December.
Pfizer has said that it anticipates a decision no later than January 2022, but the FDA is widely expected to finish its work reviewing the vaccine far sooner.
Kathleen Sebelius, health and human services secretary under President Barack Obama, said that the mandates could be the necessary push to get more Americans vaccinated as more contagious strains, such as the Delta variant, spread across the nation.
Security personnel ask customers for proof of vaccination as they enter City Winery Thursday, June 24, 2021, in New York.AP Photo/Frank Franklin II
“Shame on us if we sit here in July and don’t do something to increase the vaccination rates and then we can’t open schools or have a situation where, God forbid, the economy takes another hit because businesses have to shut back down,” she said.
Health experts says that once the major COVID-19 vaccines are fully approves, more mandates may come into place.AP
WASHINGTON — The United States could see a wave of Covid-19 vaccine mandates as soon as the Food and Drug Administration grants full approval to one or more of the shots, public health experts predicted.
The three vaccines authorized by the FDA for emergency use against the coronavirus have proven safe and effective under that expedited review process and in the real world, and doctors and the nation’s top public health officials have said there’s no need for anyone to wait to get inoculated.
But as the pace of vaccinations lags and concerns about the highly-contagious delta variant grow, the official regulatory signoff would remove a significant legal and public relations barrier for businesses and government agencies that want to require vaccinations for their employees and customers, former health officials from the Biden and the Obama administrations said.
“I think once the vaccines go through full FDA approval, everything should be on the table, and I think that everything will be on the table at the level of municipalities, states, employers, venues, government agencies,” said Andy Slavitt, who stepped down as President Joe Biden’s Covid response coordinator last month and remains in close contact with administration officials.
Many institutions, including colleges and universities, have long required certain immunizations. Still, the suggestion of Covid vaccine mandates, whether by local governments for school children or by businesses for their customers, has so far been met with sharp resistance — primarily from conservative lawmakers and activists.
At least 20 state legislatures have passed bills or are considering measures that would ban businesses and state and local governments from placing restrictions on unvaccinated people. Even so, some colleges, concert venues and employers have already started requiring Covid vaccinations.
But the expedited review process for Covid vaccines has been cited as a safety concern by some people yet to get vaccinated and as a legal hurdle for organizations that have hesitated to put a mandate in place.
Institutions that have put vaccine requirements in place have already faced lawsuits, with opponents arguing that the statute creating the emergency use authorization indicates people should have the option to refuse a treatment. One such lawsuit by health care workers at Houston Methodist was thrown out last month.
But with the new delta variant spreading and hospitals once again filling up, there is a renewed sense of urgency by public health officials to find ways to reach the nearly 1 in 3 eligible Americans who have yet to get their first dose. Pfizer, maker of the first vaccine authorized for emergency use in the United States, said Friday it expects the FDA to grant full approval by January 2022 at the latest. Acting FDA Commissioner Janet Woodcock has said a decision should come well before then.
Health officials said they believe vaccine requirements could be that last push for people who haven’t made getting vaccinated a priority or have been indifferent about needing it.
“Shame on us if we sit here in July and don’t do something to increase the vaccination rates and then we can’t open schools or have a situation where, God forbid, the economy takes another hit because businesses have to shut back down,” said Kathleen Sebelius, who served as health and human services secretary under President Barack Obama.
Biden’s administration has so far resisted any vaccine requirements, opting instead to offer incentives. But Slavitt said he expects that to change with full FDA approval.
He said he believes some federal agencies should then begin requiring vaccinations for their employees, including members of the military, health care workers at Veterans Affairs hospitals and nursing homes, and other federal workers in close contact with the public, like airport security screeners.
“I think every government agency ought to rethink what’s appropriate,” Slavitt said. “There are a number of people in surveys, by the way, who say precisely these words, ‘I’m not going to take it, unless it’s required.’”
White House press secretary Jen Psaki declined to say Friday whether the administration was considering making the vaccine a requirement for the military or the federal workforce. The federal government already requires members of the military to get certain vaccinations. Immigration applicants must also be vaccinated against a range of ailments.
It is unclear how much authority the Biden administration could have as far as requiring vaccinations beyond the federal workforce. No federal vaccination mandate has ever been tested in court and none has ever been issued for the general population. Instead, much of the power to require vaccinations has rested with state and local governments following a Supreme Court ruling in 1905 that upheld a city board of health law requiring all adults get vaccinated against smallpox.
Just a handful of major companies, businesses and venues have put in place any vaccine mandates so far. Delta Air Lines and United Airlines are among the few companies requiring new employees to get vaccinated, but the policy doesn’t apply to current employees.
Several other companies, like BlackRock, have said only vaccinated employees can return to the office but have yet to say what will happen with unvaccinated ones. Madison Square Garden and Yankee Stadium have both limited their events to vaccinated attendees, but many other venues have only encouraged guests to get vaccinated.
Even hospitals and nursing homes have been hesitant about making vaccines compulsory for employees. Among nursing home employees, the rate of vaccination is below that of the general population and in some states, including Florida and Georgia, the vaccination rate is under 50 percent for workers, according to data from the Centers for Medicare and Medicaid Services.
“I do think it is a responsibility of employers and others that have the ability to mandate it at their sites,” Zeke Emanuel, a health adviser in the Obama administration, said of requiring vaccines for health care workers. “It is not like it is easy, but this is a moment of leadership and sometimes when you are a leader, you have to do hard things.”
Hundreds of colleges have required students to be fully vaccinated against Covid before returning to campus, but it’s unclear how those mandates will be enforced and there has already been pushback, including lawsuits. A federal judge on Monday upheld Indiana University’s vaccine requirement. Most colleges already had vaccine requirements in place for other diseases.
Slavitt said one compromise employers could offer those who are firmly against getting vaccinated would be to requiring them to get tested several times a week.
Biden’s administration has been supportive of private companies putting vaccine requirements in place and his chief medical adviser, Dr. Anthony Fauci, said July 11 he believes there should be more vaccine mandates at the local level.
The Biden administration’s strategy has focused heavily on trying to make vaccinations more accessible, spreading information about the vaccines and warning about the risks of not getting the shots.
“We know that some employers, hospitals, health systems, colleges, universities and local leaders have chosen to take this step, and we expect others to do so as well,” Psaki said regarding vaccine requirements. “But our role we’re playing from here is continuing to go community by community, person to person, making sure we are meeting people where they are to get the vaccine out.”
Last week the White House turned to the pop star Olivia Rodrigo to try to reach younger people, who have the lowest vaccination rates. The surgeon general also released a report on the influence that misinformation on social media has had on vaccination efforts. Biden said Friday that those social media platforms, including Facebook, were “killing people” by allowing lies about the Covid vaccines to spread on their websites. Hewalked back the criticism Monday, saying those posting the false information were to blame.
The rate of vaccinations has fallen by half since June 1, when the administration declared a “month of action” to redouble efforts as the delta variant spread. By the end of last week, new cases had risen 70 percent over the past seven days with the bulk of infections in four states with relatively low vaccination rates, and the number of deaths had increased by 26 percent to 211 a day, according to the CDC.
“We’ve got a chance to really continue the progress, the incredible progress that’s been made since January,” Sebelius said. “But we also have some real warning signs across the world that we should pay close attention to.”
Pfizer and BioNTech announced Friday that the US Food and Drug Administration has granted priority review designation to the companies’ application for approval of their Covid-19 vaccine. The goal date for a decision from the FDA is January 2022, the companies said.
The typical priority review process allows six months, but FDA approval could come before the goal date.
Andy Slavitt, former White House senior adviser for the Covid-19 response, told CNN earlier this month that approval could happen in July, but acknowledged it’s a complex process.
“There’s a lot of moving pieces. It’s not as easy,” Slavitt told CNN’s Alisyn Camerota. “Hopefully in the next four to five weeks, and I think that will be very, very good news.”
Pfizer and BioNTech completed the rolling submission for the vaccine’s Biologics License Application for people ages 16 and older in May.
MALVERN, Pa., Feb. 23, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that on the recommendation of the European Medicines Agency (EMA), the European Commission has granted orphan medicinal product designation for OCU400 (AAV5-hNR2E3), for the treatment of both retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).
The prevalence of RP in Europe is estimated at approximately 165,000 patients and the prevalence of LCA in Europe is estimated at approximately 40,000 patients. Globally, the number of people suffering from RP and LCA is estimated to be around 2.0 million and 0.2 million, respectively.
“We believe the granting of this designation by the European Commission validates the potential of our modifier gene therapy platform to treat many inherited retinal diseases (IRDs). IRDs associated with RP and LCA diseases are caused by mutations in over 175 genes, and it is impractical to develop therapies that are specific to each gene. OCU400 has the remarkable potential to address a significant number of patients globally who are in desperate need of rescue from these blindness diseases and we are working diligently to move this program to clinic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.
“RP and LCA are chronically debilitating groups of IRDs characterized by severe impairment in visual functions starting as young as infancy, often progressing into night blindness and tunnel vision and eventually causing total blindness as early as the patient’s mid-40s. Since the existing approved therapy only addresses a small percentage of this population, there is an unmet need for new treatment options addressing a wider population of patients with IRDs,” said Dr. Mohamed Genead, Chair of Retina Scientific Advisory Board and Acting Chief Medical Officer of Ocugen.
Nuclear Hormone Receptors such as NR2E3 are important modulators of retinal development and function acting as “master genes” in the retina. NR2E3 is delivered to target cells in the retina using an adeno-associated viral (AAV) vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis, potentially stabilizing cells and rescuing photoreceptor degeneration. Preclinical results published in Nature Gene Therapy demonstrate the potency of modifier gene therapy to elicit broad-spectrum therapeutic benefits in early and advanced stages of RP including vision rescue in early and advanced stages of the disease.
Orphan medicinal product designation in Europe offers certain benefits to drug developers while they develop drugs intended for safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that impact fewer than 5 in 10,000 patients in the European Union. Benefits include protocol assistance, reduced regulatory fees, research grants, and 10 years of market exclusivity following regulatory approval.
About Retinitis Pigmentosa Retinitis pigmentosa is a clinically and genetically heterogeneous group of IRDs characterized by diffuse progressive dysfunction of predominantly rod photoreceptors, with subsequent degeneration of cone photoreceptors, and retinal pigment epithelium (RPE). Visual impairment usually manifests as night blindness and progressive visual field loss. Its prevalence is 1 in 3,000 to 1 in 5,000. RP may be seen in isolation (typical RP) or in association with systemic disease. Over 150 gene mutations have been associated with RP and this number represents only 60% of the RP population. The remaining 40% of RP patients cannot be genetically diagnosed, making it difficult to develop individual treatments.
About Leber Congenital Amaurosis Leber congenital amaurosis is a family of congenital retinal dystrophies that results in severe vision loss at an early age. Patients present usually with nystagmus, sluggish or near-absent pupillary responses, severely decreased visual acuity, photophobia and high hyperopia. It is the most severe retinal dystrophy causing blindness by the age of 1 year. This dystrophy is a genetically heterogeneous recessive disease affecting 1 in 30,000 to 1 in 81,000 subjects. Mutations in one of more than two dozen genes can cause LCA.
About OCU400 OCU400 is a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs. OCU400 is the first program that Ocugen is advancing based on its breakthrough modifier gene therapy platform developed by Dr. Neena Haider, Associate Professor of Ophthalmology at Harvard Medical School and Associate Scientist at the Schepens Eye Research Institute (SERI) of Massachusetts Eye and Ear. Ocugen obtained an exclusive worldwide license from SERI to develop and commercialize ophthalmology products based on specified nuclear hormone receptor genes, including NR2E3. Consisting of a functional copy of the nuclear hormone receptor gene NR2E3, OCU400 is delivered to target cells in the retina using an AAV vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis, stabilizing cells and potentially rescuing photoreceptors from degeneration.
About Ocugen, Inc. Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.
Ocugen Contact: Ocugen, Inc. Sanjay Subramanian Chief Financial Officer and Head of Corporate Development ir@ocugen.com
Media Contact: For Ocugen: LaVoieHealthScience Emmie Twombly etwombly@lavoiehealthscience.com +1 857-389-6042
