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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 Democratic-controlled House has approved a wide-ranging defense policy bill, even as President Donald Trump renewed his threat to veto the bill unless lawmakers clamp down on social media companies he claims were biased against him during the election. Trump tweeted Tuesday he will veto “the very weak National Defense Authorization Act,″ or NDAA, unless it repeals so-called Section 230, a part of the communications code that shields Twitter, Facebook and other tech giants from content liability. Trump also wants Congress to strip out a provision of the defense bill that allows renaming of military bases that now honor Confederate leaders. The defense bill now goes to the Senate. 699

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

The Food and Drug Administration approved on Wednesday a treatment for the Ebola virus. This is the first FDA-approved treatment for Zaire ebolavirus infection in adults and kids.Zaire ebolavirus is one of four Ebola virus species that can cause potentially deadly infections. It is transmitted through direct contact with blood, tissue or body fluids of an infected person or wild animal.The treatment, Inmazeb, is a mixture of three monoclonal antibodies and was created by Regeneron Pharmaceuticals. The three antibodies work together to bind to the glycoprotein on the surface of the Ebola virus and block it from entry into the body’s cells.Inmazeb was tested in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-2019 through a partnership between the local government and the National Institutes of Health.A vaccine for Ebola virus was approved by the FDA in December 2019.Regeneron is also the company behind an experimental antibody cocktail that was given to President Donald Trump following his diagnosis of COVID-19, and which he said “cured” him. Trump was also prescribed the antiviral drug remdesivir and the steroid dexamethasone at the time.Regeneron’s COVID-19 treatment is a mix of two powerful antibodies that are believed to boost the immune response to the coronavirus. Early results seem promising, according to initial tests and a press release from the company.The company has submitted an application to the FDA to get emergency approval of their COVID-19 treatment. 1525

The Cincinnati-area airport took a child’s beloved stuffed animal for an impromptu tour, reaching many on social media, before uniting the toy Dalmatian with its family in Florida. Staff at the Cincinnati/Northern Kentucky International Airport were sending the toy back to Florida on Friday. Spokesperson Mindy Kershner says the airport’s Facebook posts about the missing plaything reached 1 million people. Airport employees found the toy left behind in the terminal and snapped photos of the lost traveler outfitted in a mask at the airport’s restaurants, on the runway and with a K9 team. 600

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