An uncommon experiment to forestall nursing residence workers members and residents from an infection with the coronavirus has succeeded, the drug maker Eli Lilly introduced on Thursday.
A drug containing monoclonal antibodies — laboratory-grown virus-fighters — prevented symptomatic infections in residents who had been uncovered to the virus, even the frail older people who find themselves most weak, in accordance with preliminary outcomes of a examine carried out in partnership with the Nationwide Institutes of Well being.
The researchers discovered an 80 p.c discount in infections amongst residents who bought the drug, in contrast with those that bought a placebo, and a 60 p.c discount among the many workers, outcomes that had been extremely statistically highly effective, Eli Lilly mentioned.
The information haven’t but been peer-reviewed or revealed. The corporate expects to current the findings at a future medical assembly and to publish them in a peer-reviewed journal, however didn’t say when.
The examine included 965 contributors at nursing houses: 666 workers members and 299 residents. (The corporate had hoped extra residents would take part, however it proved tough to enroll them; many had dementia, and others had been leery of getting an intravenous drug.)
There have been 4 deaths from Covid-19 amongst examine contributors. All had been amongst nursing residence residents who bought a placebo, not the drug.
The drug, bamlanivimab, already has an emergency use authorization from the Meals and Drug Administration that enables Eli Lilly to supply it to symptomatic sufferers early in the midst of their an infection.
However this examine requested if the drug might cease infections earlier than they began. It was an unusual experiment: In vehicles geared up with cell labs, medical workers sped to nursing houses the second a single an infection was detected there. As quickly as the employees arrived, they arrange momentary infusion facilities to manage the drug.
The analysis ended this weekend with an emergency assembly of the info security and monitoring board, an impartial group monitoring the incoming outcomes. The information had been sturdy and convincing sufficient to name a halt to the placebos.
Whereas the precise order of vaccine recipients could fluctuate by state, most will seemingly put medical employees and residents of long-term care services first. If you wish to perceive how this determination is getting made, this article will help.
Life will return to regular solely when society as an entire positive aspects sufficient safety in opposition to the coronavirus. As soon as international locations authorize a vaccine, they’ll solely have the ability to vaccinate a couple of p.c of their residents at most within the first couple months. The unvaccinated majority will nonetheless stay weak to getting contaminated. A rising variety of coronavirus vaccines are displaying sturdy safety in opposition to changing into sick. Nevertheless it’s additionally potential for folks to unfold the virus with out even figuring out they’re contaminated as a result of they expertise solely gentle signs or none in any respect. Scientists don’t but know if the vaccines additionally block the transmission of the coronavirus. So in the interim, even vaccinated folks might want to put on masks, keep away from indoor crowds, and so forth. As soon as sufficient folks get vaccinated, it’ll grow to be very tough for the coronavirus to search out weak folks to contaminate. Relying on how shortly we as a society obtain that objective, life would possibly begin approaching one thing like regular by the autumn 2021.
Sure, however not eternally. The 2 vaccines that can probably get licensed this month clearly shield folks from getting sick with Covid-19. However the medical trials that delivered these outcomes weren’t designed to find out whether or not vaccinated folks might nonetheless unfold the coronavirus with out growing signs. That continues to be a chance. We all know that people who find themselves naturally contaminated by the coronavirus can unfold it whereas they’re not experiencing any cough or different signs. Researchers shall be intensely finding out this query because the vaccines roll out. Within the meantime, even vaccinated folks might want to consider themselves as potential spreaders.
The Pfizer and BioNTech vaccine is delivered as a shot within the arm, like different typical vaccines. The injection gained’t be any completely different from ones you’ve gotten earlier than. Tens of 1000’s of individuals have already acquired the vaccines, and none of them have reported any severe well being issues. However a few of them have felt short-lived discomfort, together with aches and flu-like signs that sometimes final a day. It’s potential that individuals could have to plan to take a day without work work or college after the second shot. Whereas these experiences aren’t nice, they’re a very good signal: they’re the results of your individual immune system encountering the vaccine and mounting a potent response that can present long-lasting immunity.
No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, often known as mRNA, is finally destroyed by the physique. The mRNA is packaged in an oily bubble that may fuse to a cell, permitting the molecule to slide in. The cell makes use of the mRNA to make proteins from the coronavirus, which may stimulate the immune system. At any second, every of our cells could comprise tons of of 1000’s of mRNA molecules, which they produce in an effort to make proteins of their very own. As soon as these proteins are made, our cells then shred the mRNA with particular enzymes. The mRNA molecules our cells make can solely survive a matter of minutes. The mRNA in vaccines is engineered to resist the cell’s enzymes a bit longer, in order that the cells could make additional virus proteins and immediate a stronger immune response. However the mRNA can solely final for a couple of days at most earlier than they’re destroyed.
“My jaw dropped once I noticed the desk of outcomes,” mentioned Dr. Myron Cohen, a professor of medication on the College of North Carolina at Chapel Hill, and a principal investigator who helped design and implement the examine.
Though the examine has ended, Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer, mentioned the corporate would proceed to hurry to nursing houses in its examine community when an outbreak is detected. “Everybody will get the drug,” he mentioned.
Specialists who weren’t a part of the examine had been enthusiastic, however emphasised that they’d not but seen full information. “I see solely positives right here,” mentioned Dr. Ofer Levy, director of the precision vaccine program at Boston Youngsters’s Hospital. “This can be a win.”
Dr. Kathleen Neuzil, director of the Middle for Vaccine Improvement and International Well being on the College of Maryland, additionally was inspired.
“The mortality impact is outstanding,” she mentioned, including that the drug ought to be used extra broadly to forestall and deal with Covid-19, “notably in populations comparable to nursing residence residents, who’ve excessive mortality and will have suboptimal responses to vaccines.”
Vaccines, after all, additionally shield folks from an infection with the virus, and nursing residence workers and residents had been among the many first group prioritized for the pictures. However provides are insufficient, and lots of nursing residence employees, afraid of the vaccines, have declined to get them.
And following vaccination, it may take six weeks for the physique to provide sufficient antibodies for optimum safety, mentioned Dr. Srilatha Edupuganti, a vaccine researcher at Emory College in Atlanta and a examine investigator.
The monoclonal antibody remedy, she mentioned, can provide almost equal safety instantly, though it won’t final so long as the safety provided by a vaccine.
Eli Lilly plans to method the F.D.A. about an emergency use authorization to be used of the drug to forestall infections in frail older populations, particularly these in nursing houses or long-term care services, Dr. Skovronsky mentioned.
Biden Officials Now Expect Vulnerable Americans to Need Booster Shots
WASHINGTON — Biden administration health officials increasingly think that vulnerable populations will need booster shots even as research continues into how long the coronavirus vaccines remain effective.
Senior officials now say they expect that people who are 65 and older or who have compromised immune systems will most likely need a third shot from Pfizer-BioNTech or Moderna, two vaccines based on the same technology that have been used to inoculate the vast majority of Americans thus far. That is a sharp shift from just a few weeks ago, when the administration said it thought there was not enough evidence to back boosters yet.
On Thursday, a key official at the Centers for Disease Control and Prevention said the agency is exploring options to give patients with compromised immune systems third doses even before regulators broaden the emergency use authorization for coronavirus vaccines, a step that could come soon for the Pfizer vaccine.
Dr. Amanda Cohn, the chief medical officer of the C.D.C.’s immunizations division, told an advisory committee to the agency that officials were “actively looking into ways” to provide certain people access to booster shots “earlier than any potential change in regulatory decisions.”
“So stay tuned,” she added.
The growing consensus within the administration that at least some Americans will need a booster is tied in part to research suggesting that the Pfizer vaccine is less effective against the coronavirus after about six months. More than half of those fully vaccinated in the United States so far have received Pfizer’s vaccine, in two doses administered three weeks apart.
Pfizer’s continuing global study of its clinical trial participants shows that four to six months after the second dose, the vaccine’s effectiveness against symptomatic infection drops from a high of 95 percent to 84 percent, according to the company.
Data from the Israeli government, which has fully vaccinated more than half of its population with Pfizer doses since January, also points to a downward trend in effectiveness over time, although administration officials are viewing that data cautiously because of wide margins for error.
The most recent figures from the Israeli Ministry of Health, released late this week, suggested that Pfizer’s vaccine was just 39 percent effective in preventing infection in that country in late June and early July, compared to 95 percent from January to April.
The vaccine remained more than 90 percent effective in preventing severe disease, and nearly as effective in preventing hospitalization. Israel began offering a third Pfizer dose to citizens with severely weakened immune systems on July 12.
Dr. Anthony S. Fauci, who heads the infectious disease division of the National Institutes of Health, said he was surprised by the apparent steep falloff in the Pfizer vaccine’s effectiveness that the Israeli data seems to suggest. He said he wanted to compare it with data that the C.D.C. had been gathering from cohorts of thousands of people across the United States. “People are sort of raising their eyebrows a bit,” he said.
While other questions abound, senior administration officials said it appeared increasingly clear that the vaccines would not grant indefinite immunity against the virus, and that boosters might be necessary for at least some people perhaps nine months after their first shot. The administration has already purchased more than enough vaccine to deliver third doses of both Pfizer and Moderna, and has been quietly preparing to expand the distribution effort, should it become necessary.
With so little data yet public, many health officials and experts have spoken cautiously about booster shots. Dr. Paul A. Offit, a member of the Food and Drug Administration’s outside advisory committee of vaccine experts, said a rise in mild or moderate cases of Covid-19 among vaccinated people did not necessarily mean a booster was required.
“The goal of this vaccine is not to prevent mild or low, moderate infectious disease,” he said. “The goal is to prevent hospitalization to death. Right now this vaccine has held up to that.”
Prematurely dangling the prospect of a third dose could also work as a deterrent against vaccination, other health experts warn. If Americans think that immunity from the vaccines is short-lived, they said, they may be less likely to get their initial shot.
“We don’t want people to believe that when you’re talking about boosters, that means that the vaccines are not effective,” Dr. Fauci testified at a congressional hearing Tuesday. “They are highly effective.”
Among the vaccine manufacturers, Pfizer has been especially proactive in sharing its data with the government. But the administration was taken aback by the company’s public announcement this month that it planned to seek emergency authorization from the F.D.A. for a booster shot.
The company said that early data from its booster study showed the level of neutralizing antibodies among clinical trial participants who received a third dose six months after the second was five to 10 times as high as among two-dose recipients.
Fearful the American public would get the wrong message, the F.D.A. and the C.D.C. reacted with an unusual public statement saying, “Americans who have been fully vaccinated do not need a booster shot at this time.” They added, “We are prepared for booster doses if and when the science demonstrates that they are needed.”
Typically, the F.D.A. would authorize use of a booster, perhaps after a meeting of its outside advisory committee. Then the C.D.C., which has its own advisory committee, would need to formally recommend it, Dr. Offit said.
Understand the State of Vaccine Mandates in the U.S.
But if the F.D.A. fully licenses a vaccine, doctors would have vastly more leeway to prescribe a booster for their patients. Some health experts expect that Pfizer could receive that approval by this fall.
At the C.D.C. advisory panel’s meeting Thursday, Dr. Cohn, the medical officer for the vaccine division, suggested that it might be possible to offer booster shots to those with weakened immune systems through an investigational study or other avenues, without waiting for the F.D.A.
Dr. Camille Kotton, an infectious disease expert with Massachusetts General Hospital, told the panel that some patients, especially those who are more educated or “empowered to take care of their own health care,” are managing to get a third dose on their own, despite the lack of a green light from the government.
“Many have taken matters into their own hands,” she said. “I am concerned about them doing this kind of in an unsupervised fashion,” she said, while doctors’ hands are tied because of the lack of regulatory approval.
People with compromised immune systems make up 2.7 percent of the population, according to the C.D.C., and include those with cancer, organ or stem cell transplants or H.I.V., among other conditions.
At Tuesday’s hearing of the Senate’s health committee, several senators grilled administration health officials on how soon they would act on the question of boosters. Senator Mitt Romney, a Utah Republican, said he was unhappy that officials could not provide a better timetable.
Senator Richard M. Burr, a North Carolina Republican, noted that Israel was already offering some of its most vulnerable citizens a third shot. “Why aren’t we making the same decisions?” he asked.
Dr. Rochelle Walensky, the director of the C.D.C., testified that scientists were studying the vaccines’ efficacy in tens of thousands of people, including nursing home residents and more than 5,000 essential workers.
“Fortunately, we’re anticipating that this will wane and not plummet,” she said of their efficacy. “As we see that waning, we — that will be our time for action.”
Pfizer is expected to soon publicize its clinical trial research about waning immunity and the benefits of a booster shoot in articles in a peer-reviewed journal. Moderna has yet to release data on any booster studies, officials said.
Johnson & Johnson’s one-shot vaccine has so far played a minor role in the nation’s vaccination campaign. Clinical trial data on how that vaccine works with two shots is expected next month.
Noah Weiland contributed reporting.
Hole Blasted In Guntrader: UK Firearms Sales Website’s CRM Database Breached, 111K Users’ Info Spilled Online
Criminals have hacked into a Gumtree-style website used for buying and selling firearms, making off with a 111,000-entry database containing partial information from a CRM product used by gun shops across the UK. The Register reports: The Guntrader breach earlier this week saw the theft of a SQL database powering both the Guntrader.uk buy-and-sell website and its electronic gun shop register product, comprising about 111,000 users and dating between 2016 and 17 July this year. The database contains names, mobile phone numbers, email addresses, user geolocation data, and more including bcrypt-hashed passwords. It is a severe breach of privacy not only for Guntrader but for its users: members of the UK’s licensed firearms community. Guntrader spokesman Simon Baseley told The Register that Guntrader.uk had emailed all the users affected by the breach on July 21 and issued a further update yesterday.
Guntrader is roughly similar to Gumtree: users post ads along with their contact details on the website so potential purchasers can get in touch. Gun shops (known in the UK as “registered firearms dealers” or RFDs) can also use Guntrader’s integrated gun register product, which is advertised as offering “end-to-end encryption” and “daily backups”, making it (so Guntrader claims) “the most safe and secure gun register system on today’s market.” [British firearms laws say every transfer of a firearm (sale, drop-off for repair, gift, loan, and so on) must be recorded, with the vast majority of these also being mandatory to report to the police when they happen…]
The categories of data in the stolen database are: Latitude and longitude data; First name and last name; Police force that issued an RFD’s certificate; Phone numbers; Fax numbers; bcrypt-hashed passwords; Postcode; Postal addresses; and User’s IP addresses. Logs of payments were also included, with Coalfire’s Barratt explaining that while no credit card numbers were included, something that looks like a SHA-256 hashed string was included in the payment data tables. Other payment information was limited to prices for rifles and shotguns advertised through the site. The Register recommends you check if your data is included in the hack by visiting Have I Been Pwned. If you are affected and you used the same password on Guntrader that you used on other websites, you should change it as soon as possible.
Protest erupts at Myanmar’s Insein prison amid COVID outbreak | Military News
A protest has erupted at a prison in Myanmar’s commercial capital of Yangon against what activists said was a worsening COVID-19 outbreak at the jail, which is used to hold opponents of February’s military takeover.
The protest on Friday was one of the first of its kind since the February 1 coup in the Southeast Asian country, where people across the country demonstrate daily against military rule.
Protest chants in opposition to the military government could be heard from inside the colonial-era Insein Prison early on Friday in videos recorded from outside the prison and posted by local residents to Facebook.
“End the dictatorship! Our cause! Protest, protest! Start, start! Revolution! Must prevail!” the call-and-response chant went.
The Thailand-based activist group, Assistance Association for Political Prisoners (AAPP) said the protest began in the women’s detention block and had been supported by some prison staff members. Reuters could not immediately verify the report.
“A riot happened in the prison,” Myanmar Prison Department’s Deputy Director Chan Nyein Kyaw told state-run news outlet Myawaddy. “There was a negotiation and accepted the prisoners’ demands and requests.”
AAPP said the military had entered the prison compound earlier on Friday and confiscated staff weapons.
Prison spokesperson Zaw Zaw did not answer phone calls from Reuters seeking comment about the protest and the report that the military had intervened. He told local media the protest had been brought under control. Calls to military spokesperson Zaw Min Tun went unanswered.
Diplomats called for an end to the standoff.
“We urge the relevant authorities to resolve the situation peacefully and respect the basic right to proper healthcare for all those detained inside this and other prisons,” a group of diplomatic missions including Australia, Canada, the United Kingdom, the United States and nine European Union member states said in a joint statement posted on Facebook.
Earlier this month, Myanmar freed more than 2,000 detainees from the prison, among them journalists and others who the military said had been held on incitement charges for taking part in protests.
Myanmar’s military has struggled to impose order and a growing COVID-19 outbreak has added to the chaos. Myanmar registered more than 6,000 new COVID-19 infections on Thursday after reporting 286 deaths a day earlier, both record highs.
Medics and funeral services have said the real death toll is far higher, with crematoriums unable to keep pace, and the military has arrested several doctors treating COVID-19 patients independently.
“The protest reportedly began because prisoners have not been provided with medical care, and neither have prison staff been given protection from COVID-19,” the AAPP statement said.
Nyan Win, a senior adviser to overthrown leader Aung San Suu Kyi, died in hospital on Tuesday after becoming infected with COVID-19 in the prison.
UK ambassador replaced
In a separate development, Myanmar has appointed a new temporary head of its embassy in London, the UK’s foreign ministry said, replacing the previous ambassador who was removed after breaking ranks with the military government over the coup.
The selection of the new “charge d’affaires ad interim” did not require the consent of the British government, a foreign ministry spokesperson told Reuters, which first reported the move earlier on Friday.
More than 900 people opposing the military government have been killed by security forces since the coup, drawing international condemnation and sanctions including from the UK.
“The consent of the receiving State is not required,” the spokesperson said in a statement, citing the Vienna Convention on Diplomatic Relations. The statement did not name the new appointee.
A spokesperson for the military-controlled government in Myanmar did not respond to calls from Reuters seeking comment.
The Myanmar Accountability Project, a UK-based rights group, said the appointee for the London job was Htun Aung Kyaw, who served as a fighter pilot during a long army career.
A source familiar with the matter also said Htun Aung Kyaw was Myanmar’s new pick, but Reuters could not confirm that.
In a statement this week, the Myanmar Accountability Project urged the UK not to recognise the representative appointed by the military saying it would be “a gross double standard and a moral outrage”.
The former ambassador, Kyaw Zwar Minn, was locked out of the London embassy in April after calling for the release of detained civilian leader Aung San Suu Kyi.
Kyaw Zwar Minn remains in the UK and has urged the British government to refuse to recognise any envoys appointed by the military government and to send them back to Myanmar.
The UK has imposed sanctions on members of Myanmar’s military and some of its business interests following the coup, and has called for democracy to be restored.
The UK on Friday appointed a new ambassador to Myanmar, Pete Vowles, who previously worked in diplomatic and international development roles in Africa and Asia.
NSO Group CEO Says Law-Abiding Citizens Have ‘Nothing To Be Afraid Of’
The CEO of NSO Group, whose spyware tools have reportedly been used to target journalists and activists, says that people who aren’t criminals shouldn’t be afraid of being surveilled AppleInsider reports: Shalev Hulio, 39, recently spoke to Forbes after investigations indicated that NSO Group’s Pegasus spyware was used by authoritarian governments to hack and surveil the mobile devices of world leaders, high-profile journalists, and activists. NSO Group says that it sells its tools to governments to help them catch serious criminals like terrorists or gangsters. However, Hulio admitted that it can’t control what governments ultimately do with the tools. “We are selling our products to governments. We have no way to monitor what those governments do,” he said.
Hulio did note that NSO Group has mechanisms in place to detect when abuse happens so that the company can “shut them down.” He says that NSO Group has “done it before and will continue to do so. On the other hand, he said that NSO Group shouldn’t be responsible for government misuse. Additionally, Hulio said that the average smartphone has nothing to worry about. While NSO Group’s spyware can break into the latest iPhones running up-to-date software, often without any action from the user, it’s only aimed at criminals. “The people that are not criminals, not the Bin Ladens of the world — there’s nothing to be afraid of. They can absolutely trust on the security and privacy of their Google and Apple devices,” Hulio said.
The Activision Blizzard Harassment Suit Feels Painfully Familiar
Gaming behemoth Activision Blizzard is the latest game company to face scrutiny for allegedly fostering a culture of sexism. A California Department of Fair Employment and Housing suit filed Wednesday alleges rampant sexual harassment and discrimination against Activision Blizzard’s female employees. The suit’s spotlight on Activision Blizzard’s structures and systems are painfully similar to those exposed by lawsuits and exposés around Riot Games and Ubisoft from the last several years.
The games industry’s reckoning with workplace inequality has been underway for years. Leading companies have been slow, even reticent, to answer for their reportedly discriminatory cultures, in some cases architecting fortresses of asylum around their more problematic employees and systems. Activision Blizzard has the opportunity to set a different tone. As of now, it seems unlikely to.
The games industry is notoriously male-dominated, and has long had a reputation for hostility to women. The 29-page DFEH complaint follows a two-year investigation into Activision Blizzard—publisher of high-profile titles like Call of Duty, World of Warcraft, and Overwatch—and contains hair-raising allegations of misconduct, from harassment by top executives to so-called “cube crawls,” in which male employees would reportedly “drink copious amounts of alcohol as they ‘crawl’ their way through various cubicles in the office and often engage in inappropriate behavior toward female employees.” It describes a culture in which double standards prevented women from advancing and even remaining at the company; across the board, it says, women receive less pay than men for “substantially similar work.” The agency alleges that female employees receive a lower starting pay than men and are promoted more slowly. Only 24 percent of Activision Blizzard’s nearly 10,000 employees are women, and top leadership is almost entirely white and male.
In this “frat boy” culture, the complaint reads, men “proudly” came to work hungover, delegated responsibilities to women while they played games like Call of Duty, openly discussed sexual encounters, and even joked about rape. The complaint also alleges that employees and even executives sexually harassed female employees without repercussions. It states that a female employee who may have experienced sexual harassment at work—including an instance when coworkers at a party allegedly shared an intimate photo of her—later committed suicide. (In a statement, Activision Blizzard says, “We are sickened by the reprehensible conduct of the DFEH to drag into the complaint the tragic suicide of an employee whose passing has no bearing whatsoever on this case and with no regard for her grieving family.”)
“We value diversity and strive to foster a workplace that offers inclusivity for everyone,” an Activision Blizzard spokesperson said in a statement. “There is no place in our company or industry, or any industry, for sexual misconduct or harassment of any kind. We take every allegation seriously and investigate all claims. In cases related to misconduct, action was taken to address the issue.” The company says it has made an effort over the last several years to bolster diversity, including helping employees report violations, adding a confidential hotline, and instituting a team to investigate workers’ concerns. Activision Blizzard claims that the DFEH complaint includes “distorted, and in many cases false, descriptions of Blizzard’s past.”
The DFEH is asking for relief for compensatory and punitive damages, unpaid wages, and attorneys fees. Citing the ongoing investigation, the department declined to respond to WIRED’s request for comment.
The Activision Blizzard revelations echo those around Riot Games in 2018 and Ubisoft in 2020. Just as gaming culture at large has been slow to embrace women and minorities, gaming companies previously accused of fostering cultures of sexism have been slow to evolve.