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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 charges against one of the three men in connection to a viral video of a shark being dragged behind a boat from July 2017 have been dropped.A Hillsborough County (Florida) judge dropped two felony counts of aggravated animal cruelty (third-degree felony) against Spencer Heintz Tuesday morning.According to the judge, the state dropped the charges because no evidence showed that Heintz, 23, broke the law and because he agreed to testify as a witness.Heintz, 21-year-old Michael Wenzel and 28-year-old Robert Lee Benac were all charged after a four-month-long investigation into the graphic video of a shark being dragged behind a boat.At this time, it is unknown if the charges against Wenzel and Benac will also be dropped.Wentzel and Benac still face the following charges: 824

The General Services Administration, a government agency that assists incoming presidents with their transitions into the Oval Office, announced Monday that it has formally recognized President-elect Joe Biden’s victory in this month’s presidential election, according to a memo sent by the GSA.The announcement comes as the Trump campaign has been failing to gain traction in its legal battle against a number of states that Biden won.With the GSA’s decision, the White House will be required to provide intelligence briefings for Biden, along with classified government documents. The Biden team can also begin conducting background checks on potential hires before taking office on January 20, 2021.Last week, Biden said that the lack of a formal transition could have set the United States’ response to the coronavirus back.“I am optimistic but we should be further along,” Biden last week said during a virtual call with first responders. “One of the problem that we are having now is the failure of the administration to recognize (the results)."Since the Associated Press projected Biden as the winner of the election on Nov. 7, President Donald Trump and his campaign has made multiple claims that the election was stolen, and accusing election officials of fraud. So far, Trump’s campaign has not been able to substantiate any evidence of fraud in court, and has had a number of lawsuits dismissed.After past presidential elections, the apparent winner is given funding and access to documents to begin the transition.Biden pointed to the Presidential Transition Act of 1963, which says that government services and documents be made available to the “apparent” victor of the presidential election.While Trump did not concede on Monday, he said he is recommending his team to cooperate in the transition of power. "I want to thank Emily Murphy at GSA for her steadfast dedication and loyalty to our Country," Trump tweeted. "She has been harassed, threatened, and abused – and I do not want to see this happen to her, her family, or employees of GSA. Our case STRONGLY continues, we will keep up the good fight, and I believe we will prevail! Nevertheless, in the best interest of our Country, I am recommending that Emily and her team do what needs to be done with regard to initial protocols, and have told my team to do the same."GSA Administrator Emily Murphy said in letter that she had received threats, and that she was no coerced into delaying the announcement of an apparent winner."To be clear, I did not receive any direction to delay my determination," Murphy said in a letter to the Biden-Harris transition. "I did, however, receive threats online, by phone, and by mail directed at my safety, my family, my staff, and even my pets in an effort to coerce me into making this determination prematurely. Even in the face of thousands of threats, I always remained committed to upholding the law."Contrary to media reports and insinuations, my decision was not made out of fear or favoritism. Instead, I strongly believe that the statute requires that the GSA Administrator ascertain, not impose, the apparent president-elect. Unfortunately, the statute provides no procedures or standards for this process, so I looked to precedent from prior elections involving legal challenges and incomplete counts. GSA does not dictate the outcome of legal disputes and recounts, nor does it determine whether such proceedings are reasonable or justified. These are issues that the Constitution, federal laws, and state laws leave to the election certification process and decisions by courts of competent jurisdiction. I do not think that an agency charged with improving federal procurement and property management should place itself above the constitutionally-based election process. I strongly urge Congress to consider amendments to the Act."The Biden transition team welcomed the news on Monday. "Today’s decision is a needed step to begin tackling the challenges facing our nation, including getting the pandemic under control and our economy back on track," Biden- Harris transition executive director Yohannes Abraham said in a statement. "This final decision is a definitive administrative action to formally begin the transition process with federal agencies. In the days ahead, transition officials will begin meeting with federal officials to discuss the pandemic response, have a full accounting of our national security interests, and gain complete understanding of the Trump administration’s efforts to hollow out government agencies." 4568

The erratic stock market just made a serious comeback.Fears about slowing earnings growth sent the Dow careening 549 points lower on Tuesday before the index raced back to life.By the closing bell, the Dow was only down 126 points, or 0.5%.Similarly, the Nasdaq closed down 0.4%, erasing the vast majority of a 2.6% plunge. The index also climbed out of a technical correction, a 10% decline from prior highs.The S&P 500 suffered its fifth straight loss. But the broad index finished just modestly lower after touching its weakest point in nearly four months.Market veterans saw little reason for the dramatic recovery -- other than the fact that stocks had gotten to oversold levels."It was an impressive day. We reversed on very little news," said Art Hogan, chief market strategist at B. Riley FBR.Hogan pointed to how the rebound was led by two of the most beaten-down corners of the market: homebuilders and chip makers.Stocks sold off early on Tuesday after major US companies reported gloomy results and guidance. Disappointing numbers from Caterpillar and 3M reinforced ongoing concerns about how long blockbuster profits can last, especially given tariffs and rising costs."Investors are skittish about whether we've seen a peak in earnings," said Mark Luschini, chief market strategist at Janney Capital Management. "It's a schizophrenic market environment where things that didn't matter suddenly do."It's been a scary month for investors. The Dow and Nasdaq are on track for their worst months since January 2016."The market is fragile," said Rich Guerrini, CEO of PNC Investments. "But we're telling our investors to relax. We're in a correction. I think the market does have some legs left."The CNN Business Fear & Greed Index slipped further into "extreme fear." A month ago the gauge of market sentiment was flashing "extreme greed."Wall Street was also spooked by extreme turbulence in China, the epicenter of the trade war. The Shanghai Composite dropped 2.3% overnight. The sell-off wiped out a chunk of Monday's spike, the benchmark index's best day since March 2016. 2114

The first hearing in CNN and Jim Acosta's federal lawsuit against President Trump and several top White House aides lasted for two hours of tough questioning of both sides.At the conclusion of the hearing, Judge Timothy J. Kelly said he would announce his decision Thursday afternoon.CNN and Acosta are alleging that the White House's suspension of his press pass violates the First and Fifth Amendments.The hearing started around 3:40 p.m., Kelly began by probing CNN's arguments for the better part of an hour. Then he turned to questioning a lawyer representing the government.Lawyers for the network and Acosta asked for a temporary restraining order and a preliminary injunction that would restore his press pass right away, arguing that time is of the essence because his rights are violated every day his pass is suspended.Kelly opened the hearing by quizzing CNN attorney Theodore Boutrous on the network's First Amendment claim and asking how the President's history of attacks on CNN should be viewed in the context of the lawsuit.Boutrous rattled off examples of Trump's missives against CNN, including his claim that the network is an "enemy of the people."Kelly expressed skepticism that this proves the Acosta ban is "content-based discrimination," as CNN is alleging.Kelly said there is some evidence that Acosta's conduct -- not his content -- led the White House to suspend his press pass.But Boutrous disputed that and said there "never will there be more evidence of facial discrimination and animus against an individual reporter" than in this case.Kelly said "we've all seen the clip" of the White House press conference where Trump and Acosta had a combative exchange last week. Kelly said that Acosta "continued speaking after his time expired" and "wouldn't give up his microphone" -- points that the Trump administration made in its briefs earlier Wednesday.Under questioning from the judge, Boutrous cited Trump's words to Acosta from the press conference, and said, "'Rudeness' is really a code word for 'I don't like you being an aggressive reporter.'"Kelly peppered CNN's attorney with hypotheticals as he tried to determine what a lawful move by the White House, responding to Acosta's actions, would look like."Could they let him keep the pass but tell him he couldn't come to presidential press conferences?" Kelly asked.Boutrous contended that even a partial response like that would be a violation of Acosta's First Amendment rights.Boutrous called the White House's move to revoke Acosta's hard pass "the definition of arbitrariness and capriciousness.""What are the standards?" Boutrous asked. "Rudeness is not a standard. If it were no one could have gone to the press conference."Boutrous separately brought up evidence that hadn't been available when CNN filed its suit: A fundraising email that the Trump campaign sent Wednesday.The email touted the decision to revoke Acosta's credentials and attacked CNN for what it called its "liberal bias." Boutrous said that by grouping that all together in the same breath, the email made it clear that it was Acosta's coverage and not his conduct at a press conference that triggered the revocation of his press pass.Kelly asked CNN's lawyers to state the company's position regarding the original White House accusation that Acosta placed his hands a White House intern as she tried to grab his microphone away."It's absolutely false," Boutrous said.Boutrous also pointed out that Trump administration never mentioned that accusation against Acosta in the 28-page brief that Justice Department lawyers filed with the court earlier on Wednesday."They've abandoned that" claim, Boutrous said.In his first question in a back and forth with the government, Kelly asked Justice Department attorney James Burnham to clear up the government's shifting rationale for revoking Acosta's pass."Why don't you set me straight," Kelly said. "Let me know what was the reason and address this issue of whether the government's reason has changed over time.""There doesn't need to be a reason because there's no First Amendment protection and the President has broad discretion," Burnham said.Still, Burnham called the White House's stated reasonings "pretty consistent throughout," and walked through a series of statements that the administration has made — from Trump's first comments at the press conference to Sanders' tweets announcing the revocation to the official statement put out Tuesday after CNN filed its suit.Burnham said Sanders' claim that Acosta had inappropriately touched a White House intern was not a part of their legal argument."We're not relying on that here and I don't think the White House is relying on that here," Burnham said.Burnham said that it would be perfectly legal for the White House to revoke a journalist's credentials if it didn't agree with their reporting.He made the assertion under questioning from Kelly, who asked him to state the administration's position in this hypothetical situation.The judge asked if the White House could essentially tell any individual journalist, "we don't like your reporting, so we're pulling your hard pass." Burnham replied, "as a matter of law... yes."Pressed again by the judge on Sanders' claim that Acosta had inappropriately touched the intern, Burnham said "we don't have a position" on that."The one consistent explanation," Burnham said, "is disorder at the press conference."Burnham contended that revoking Acosta's hard pass was not "viewpoint discrimination" — part of a legal threshold for a First Amendment claim."A single journalist's attempt to monopolize a press conference is not a viewpoint and revoking a hard pass in response to that is not viewpoint discrimination," Burnham said.Kelly tried to press for details about how Acosta's pass came to be revoked, asking Burnham who made the actual decision.Burnham said he didn't have any information beyond what had been filed in court documents: that the revocation was first announced by Sanders on November 7 and then "ratified" by Trump the next day."Do you have any information to suggest that it was anyone other than Ms. Sanders that made the decision?" Kelly asked."No, not that I'm offering today. I'm not denying it but I don't know anything beyond what's been filed," Burnham said.Later, Burnham argued that revoking Acosta's press pass does not infringe on his First Amendment rights because he can still call White House staffers for interviews or "catch them on their way out" of the building."I think the harm to the network is very small," Burnham said."Their cameras are still in there," he added.Burnham said CNN had made an "odd First Amendment injury" claim and suggested that Acosta could do his job "just as effectively" watching the President's appearances piped into a studio on CNN."The President never has to speak to Mr. Acosta again," Burnham said. "The President never has to give an interview to Mr. Acosta. And the President never has to call on Mr. Acosta at a press conference.""To be in a room where he has no right to speak... this seems to me like an odd First Amendment injury that we're talking about," Burnham said.Boutrous, the CNN attorney, fired back on rebuttal."That's not how reporters break stories. It's simply a fundamental misconception of journalism," Boutrous said, adding how unscheduled gaggles and source meetings throughout the White House amounted to "invaluable access."In a legal filing by the Justice Department on Wednesday, the White House asserted that it has "broad discretion" to pick and choose which journalists are given a permanent pass to cover it.That position is a sharp break with decades of tradition. Historically both Republican and Democratic administrations have had a permissive approach to press access, providing credentials both to big news organizations like CNN and obscure and fringe outlets.Acosta's suspension -— which took effect one week ago — is an unprecedented step. Journalism advocates say it could have a chilling effect on news coverage.CNN and Acosta's lawsuit was filed on Tuesday morning, nearly one week after Acosta was banned.Before the hearing began, CNN's lawyers said the case hinges on Acosta and CNN's First Amendment rights; the shifting rationales behind the ban; and the administration's failure to follow the federal regulations that pertain to press passes, an alleged violation of Fifth Amendment rights. The lawsuit asserts that this ban is really about Trump's dislike of Acosta.The "reasonable inference from defendants' conduct is that they have revoked Acosta's credentials as a form of content- and viewpoint-based discrimination and in retaliation for plaintiffs' exercise of protected First Amendment activity," CNN's lawsuit alleges.In addition to the temporary restraining order and preliminary injunction that CNN is seeking at the hearing, CNN and Acosta are also seeking what's known as "permanent relief." The lawsuit asks the judge to determine that Trump's action was "unconstitutional, in violation of the First Amendment and the Due Process Clause of the Fifth Amendment." This could protect other reporters against similar actions in the future."If the press is not free to cover the news because its reporter is unjustly denied access, it is not free," former White House correspondent Sam Donaldson said in a declaration supporting CNN that was filed with the court on Tuesday. "And if denying access to a reporter an organization has chosen to represent it -- in effect asserting the president's right to take that choice away from a news organization and make it himself -- is permitted, then the press is not free."Ted Olson, a Republican heavyweight who successfully argued for George W. Bush in Bush v. Gore, is representing CNN, along with Boutrous — himself another prominent attorney — and the network's chief counsel, David Vigilante.Olson said Tuesday that while it was Acosta whose press pass was suspended this time, "this could happen to any journalist by any politician."He spoke forcefully against Trump's action. "The White House cannot get away with this," Olson said.Most of the country's major news organizations have sided with CNN through statements and plan to file friend-of-the-court briefs. 10291