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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 FBI issued a warning on Wednesday alerting Americans to scammers using the coronavirus to solicit donations for fraudulent charities.Federal law enforcement officials say they have received reports that scammers are using the pandemic to steal money, personal information or both.The FBI says that often, the fraudsters will use the name of a real charity to conduct their scam. The FBI adds that criminals may spoof their caller ID number to make it appear the call originated from a legitimate charity.“Be careful,” the FBI said.The FBI offered the following advice to Americans:The best way to protect yourself is by doing your research. Here are some tips on how to avoid becoming a victim of a charity fraud:Do your homework when it comes to donations, whether you’re donating through charities, social media, or crowdfunding websites.Look for online reviews of charity organizations or use information from your state’s regulator of charities or from websites like the Better Business Bureau, give.org, charitynavigator.org, or charitywatch.org to check on the legitimacy of charitable organizations.Before donating, ask how much of the donation will go toward the program or cause you want to support. Every organization has administrative costs, and it’s important to understand those structures.Never pay by gift card or wire transfer. Credit cards are safer.After making a donation, be sure to review your financial accounts to ensure additional funds are not deducted or charged.Always do your research before clicking on links purporting to provide information on the virus, purchasing COVID-related products online, or providing your personal information in order to receive money or other benefits. 1724

The Democratic National Committee contacted the FBI on Tuesday after it detected what it believes was the beginning of a sophisticated attempt to hack into its voter database, a Democratic source tells CNN.The DNC was alerted in the early hours of Tuesday morning by a cloud service provider and a security research firm that a fake login page had been created in an attempt to gather usernames and passwords that would allow access to the party's database, the source said.The page was designed to look like the access page Democratic Party officials and campaigns across the country use to log into a service called Votebuilder, which hosts the database, the source said, adding the DNC believed it was designed to trick people into handing over their login details.The source said the DNC is investigating who may have been responsible for the attempted attack, but that it has no reason to believe its voter file was accessed or altered.The DNC's chief security officer Bob Lord, a former Yahoo! executive, briefed Democrats on the attempted attack at a meeting of the Association of State Democratic Committees in Chicago on Wednesday.CNN has reached out to the FBI for comment.Early Tuesday morning, Microsoft announced that parts of an operation linked to Russian military intelligence targeting the US Senate and conservative think tanks that advocated for tougher policies against Russia were thwarted last week.That disclosure, coming less than three months ahead of the 2018 midterms, demonstrated Russia's continued efforts to destabilize US institutions. The news also places additional pressure on President Donald Trump to take action, even though he downplayed Russia's involvement as recently as Monday.The-CNN-Wire 1740
The FBI's top liaison on Capitol Hill is out.Greg Brower, an FBI assistant director and head of the Office of Congressional Affairs, stepped down last Friday after a year on the job. In the role, Brower was on the receiving end of a pack of congressional probes into the law enforcement agency's conduct.The decision, a "tough" one he made of his own accord, Brower said, follows other high-level departures from the bureau as FBI Director Christopher Wray assembles his own team of close advisers."It was tough but I had an offer I couldn't refuse from a great law firm," Brower said in an interview Thursday. "It was very gratifying to be a part of that team. I could not be more proud of how people work and how committed they are to the mission."Brower was appointed to the position by then-FBI director James Comey in March of 2017 after serving as the bureau's deputy general counsel. He will join the lobbying and law firm Brownstein Hyatt Farber Schreck as a shareholder in the litigation department.The work in the legislative affairs office has heated up during Brower's tenure, as the fallout from Comey's firing by President Donald Trump has fanned a growing mistrust of the FBI among some lawmakers and spurred a round of congressional investigations.Not long before Brower's departure, the chairman of the House Judiciary Committee slapped the Justice Department with a subpoena for documents related to a trio of recent controversial decisions made by the FBI, including the move in 2016 to not charge Hillary Clinton after the probe of her email server and the internal recommendation by an FBI office to fire former FBI Deputy Director Andrew McCabe.In response, Wray said last week that the pace of document production for congressional inquiries at the bureau was "too slow" and doubled the number of FBI staff responsible for reviewing the records.On Thursday, Brower said he had worked with the FBI's Office of the General Counsel, which reviews the internal documents for release, before his departure to get a "a better plan in place" to respond to "an unprecedented wave of oversight requests.""That's all really on track," Brower said, adding that his decision to leave had nothing to do with the probes. "As the director mentioned, it's probably taking longer than it should, but the volume is just so unprecedented that we finally had to put more people on it."Brower's year atop the office saw big wins for the bureau on Capitol Hill, including a six-year extension of the controversial foreign surveillance program known as FISA Section 702 in January and the recent passage of the CLOUD Act, which makes it easier for the US to collect data stored overseas."I felt like the biggest things I set off to do in '17 were done and I felt less bad about leaving," he said.Brower is the fifth top adviser to the director to leave his position since Trump tapped Wray to replace Comey in June. 2943
The chairman of the Joint Chiefs of Staff has confirmed a report by The Associated Press that some of the service members who deployed to Washington, D.C., last month in response to civil unrest were issued bayonets. Army Gen. Mark A. Milley confirmed the information in a letter sent to two Democratic U.S. representatives last month. The Pentagon letter comes as the AP also reports that members of the 82nd Airborne who deployed to Washington were not trained in riot response. The soldiers were scheduled to learn riot control tactics once arriving. The soldiers were ultimately not used and were sent back to their home base. 638
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