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The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The group, in a 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days. The vaccine had already been authorization by officials in Canada and the UK.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Millions of shots would then ship to begin vaccinating health care workers and nursing home residents, but the Centers for Disease Control and Prevention will need to formally recommend the vaccine before health care officials can begin distributing the shots.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing the efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant to take the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush, and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.Widespread access to the general public is not expected until the spring. 4342
The city attorney is cracking down on independent living facilities that are posing a danger to their residents - and potentially neighbors.City Attorney Mara Elliott's office is investigating about two-dozen of these facilities and prosecuting the operators of six, the office announced Wednesday. The facilities, often inside single-family homes, are unregulated and unlicensed. They provide physically and mentally disabled persons a last chance to avoid homelessness. But Elliott said the operators often take advantage of residents. She said this came onto her radar after investigating a home last year. "It was a horrible situation where 11 individuals were essentially being held captive in this home and didn't have sanitary facilities," she said. "The shower facilities were covered in feces, they didn't have food they didn't have ventilation, they didn't have access to telephones."On Wednesday, Elliott's office announced charges against two more facilities, one on Parkbrook Lane in Skyline and another on Brandywood Street in North Bay Terraces. Operators and owners are charged with violations including vermin infestations, blocked exists, improper plumbing, and fire hazards. People who live near the Parkbrook Lane home described shouting in the middle of the night, verbal harassment, physical fighting and graffiti. "We moved because of it," said one neighbor, whose first name was Tammy. The home had trash and old mattresses on the property. The owner, Evelyn Louise Peters, said the issues identified were only one-time instances and the trash accumulated after the home was vacated. Sherry Lynn Bennett, who manages the home in North Bay Terraces, said the issues are being dealt with."The owners have been doing all the repairs, everything is done, everything's back to normal, we've done everything the city's said," Bennett said. Bennett and Peters are charged with 22 misdemeanor violations of the health, safety and municipal codes.There is no telling how many of these facilities exist in the county. In December, a man living in an El Cajon independent living home was beaten to death with a frying pan. El Cajon police had responded to calls at the home 78 times in the year leading up to the event. 2241
The coronavirus has ruined a lot of things, but Children's Hospital of Orange County, California, made sure that the virus didn't cancel prom.Choc Ball 2020 had everything, even a disco ball.“I will never forget asking our maintenance crew to help me hang some disco balls from our valet which has never happened before.” Kara Noskoff, a program coordinator for the Child Life department at Children's Hospital of Orange County, said.It's her job to normalize the hospital environment for kids of all ages. She helps throw the oncology ball, which is held every year, to recreate what teems might miss out on at school."It’s not like going to their school dance,” Noskoff said. “They’re in a room full of 200 plus people dancing and taking pictures and dressed up with the health care professionals that took care of them as well as their peers that all have the same scars.”Except it's 2020. And it almost didn't happen due to too many high-risk patients and too many high-risk exposures. But the staff at Children's Hospital decided happiness is important too.“Their mental health and growth and development is so important as well. I’m so proud of… our staff to see that bigger picture and push the boundaries a little bit and find a way to keep them safe but give them these things to look forward to,” Noskoff said.They turned what was supposed to be a huge party into a socially distanced, masked, drive thru experience complete with a theme. "Driving through the decades" had a photo booth, party favors, music and dancing. And it was everything that 17-year-old Veronica Larson could dream of.“There’s a bridge that crosses from the hospital into the employee parking and I looked up and all the nurses that had finished their shift were up in the bridge they were all cheering and clapping there was music playing,” Larson said.Cancer treatment is hard enough. Add in COVID-19 and its restrictions, and teens like Larson have struggled.“I would be considered immunocompromised so I’m being extra careful but there are safe ways like this oncology ball, but I am able to see my peers and that’s one of the reasons why it was so important to everyone being able to have that interaction in such a time of isolation,” Larson said.Back in 2015, Larson was an aspiring gymnast. She suffered a pulled hamstring that led to exhaustion and then a diagnosis of leukemia. She was only 12 years old. Now, she's in remission and building back her strength. And found her way back into gymnastics as a coach.“My hair is growing back. I’m trying to rock the short hair,” Larson said.The medical staff at CHOC is a huge part of Larson's life. After all, they helped her apply for college from her hospital bed. The soon to be freshman at UCLA wants to go into pediatric medicine and credits the children's hospital that gave her so much life with helping her find her future.“Obviously it’s an area I’ve been involved in and I think I can make a difference there and I’ve met incredible people and I would love to be a part of a team of such amazing people,” she said.Amazing people who all got to be together, even if from a distance for one night, created an evening that was just as magical for the staff as it was for the patients.“The night itself blew me away it was beyond anything I could have imagined,” Larson said.Proof that the coronavirus can't steal joy, happiness, or prom. 3390
The Department of Homeland Security formally requested that the Pentagon extend the deployment of active-duty troops on the southern border Friday, potentially extending their deployment 45 days beyond the original deadline of December 15."Given the ongoing threat at our Southern border -- today the Department of Homeland Security submitted a request for assistance to the Department of Defense to extend its support through January 31, 2019," Department of Homeland Security spokeswoman Katie Waldman told CNN in a statement."This request refines support to ensure it remains aligned with the current situation, the nature of the mission, and (Customs and Border Protection) operational requirements," she added.The Pentagon confirmed receipt of the request but said Secretary of Defense James Mattis had yet to sign off on it:"We have received the Request for Assistance from the Department of Homeland Security, it is with the Secretary (of Defense) for consideration."There are currently some 5,600 troops at the border, divided among Texas, California and Arizona.President Donald Trump sent the troops after spending the weeks leading up to the midterm elections decrying a procession of migrants that was still thousands of miles from the US border. Last week, Trump granted the troops new powers to aid in "crowd control, temporary detention and cursory search" while protecting Customs and Border Protection personnel from the migrants, should they engage in violence.Defense officials have suggested that some of the troops, primarily engineers involved in enhancing infrastructure at points of entry, could be drawn down in the relative near term as those tasks are completed.Two officials tell CNN that the number of trumps assigned to the mission is likely to drop to 4,000 as a result.Other functions, including helicopter support to help move Customs and Border Protection personnel to different areas along the border, are likely to continue.The deployment's extension means the Pentagon's initial cost estimate of million for the border deployment is likely to increase as that estimate was based on the mission ending on December 15. 2175
The digital news company Mic has laid off most of its staff, a spokesperson for the company confirmed.The layoffs were first reported Thursday by Recode. It is not yet clear exactly how many employees were affected. Mic declined to comment beyond confirming the Recode report.The company was founded in 2011, and for the past several years has branded itself as a news website geared toward millennials.Mic Publisher Cory Haik also resigned Thursday. In a note to staff that was obtained by CNN Business, Haik called journalism a "tough business.""Our business models are unsettled, and the macro forces at play are all going through their own states of unrest," she wrote. "If anyone tells you they have it figured out, a special plan to save us all, or that it's all due to a singular fault, know that is categorically false. Like the truth, it is indeed complicated."Mic was once a digital media darling, attracting around million in funding from investors. Its biggest backers included Lightspeed Venture Partners, Clark Jermoluk Founders Fund, WPP and WarnerMedia. (WarnerMedia owns CNN.)The company's staff swelled to more than 100 people by early 2016, according to The New York Times, which asked in an article published at the time: "What happens when millennials run the workplace?"But the climate is a tough one for digital media publishers right now. Ad revenue alone hasn't been enough to support these businesses, and Google and Facebook have substantial control over the ad market.Refinery29, HuffPost and Vocativ have all cut staff in the past year. So have CNN Digital, Vice and BuzzFeed.Mic laid off 25 employees in August 2017 as part of a pivot to video. Co-founder and CEO Chris Altchek told staff at the time that the shift was needed because "visual journalism already makes up 75% of the time that our audience spends" with the site.There were signs this year that the environment wasn't improving for Mic. Digiday reported in April that traffic to Mic's website had been plunging.The article also noted that Mic was very reliant on Facebook, citing statistics that showed views on the social media site fell to 11 million views in March compared to 192 million about a year earlier.Still, company executives pushed back on some reports that characterized the situation at Mic as particularly dire. When the Columbia Journalism Review reported in September that the company's board discussed a possible shutdown, Altchek called the report "categorically false."Emily Singer, a senior political reporter at Mic, tweeted Thursday that she was leaving the company."I'm so proud of what we've accomplished here," Singer wrote.Kerry Lauerman, Mic's executive news director, tweeted about the "gutting experience" Thursday."But only love for the extremely resilient and open-hearted team of Mic editors, producers, writers and shooters I had the great honor of working with," he added. "They performed brilliantly often under a cloud of uncertainty."Reached by phone, Lauerman declined to comment further, saying only that the team was packing up all of their things.Several other employees also tweeted news of their departures."I have so much to say, but most importantly the time I spent at @mic was the best of my career," wrote Managing Editor Colleen Curry. "I learned so, so much from brilliant people dedicated to keeping journalism alive."Mic is also in talks to sell at least part of the company to Bustle Digital Group, Recode reported Wednesday. A source with knowledge of the potential deal confirmed that report to CNN Business. 3572