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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 FDA wants to remind parents that infants under 1 year old can't have honey after four infants in Texas were hospitalized with botulism. Each of the infants had been given a pacifier containing honey, according to the Texas Department of State Health Services. Symptoms of infant botulism include difficulty breathing, constipation, poor feeding, general weakness, drooping eyelids and loss of head control. It can lead to death if left untreated. Botulism is a serious illness caused by a toxin that attacks the body’s nerves and can cause difficulty breathing, paralysis and even death. Honey may contain bacteria that produces the toxin in the intestine of babies that eat it.By the time children get to be 12 months old, they’ve developed enough other types of bacteria in their digestive tract to prevent the botulism bacteria from growing and producing the toxin. 910

The FBI seized recordings President Donald Trump's attorney made of his conversations with a lawyer representing two women who had alleged affairs with Trump, a source familiar with the matter tells CNN.The recordings could prove valuable to the government's criminal investigation of Michael Cohen. The President's personal attorney is under scrutiny in part for his role in seeking to suppress the alleged affair through a hush deal with porn star Stormy Daniels. The warrant sought information about that payment along with any information that connected Cohen with efforts to suppress disclosure of Trump's alleged affair with Playboy model Karen McDougal.The warrant for the raids also specified that Cohen was being investigated for bank fraud, wire fraud and campaign finance issues, CNN reported earlier this week.While Cohen has admitted to no wrongdoing, the intensity of the government's investigation will put significant pressure on one of the President's closest confidants. If Cohen chooses to cooperate rather than fight a potential case against him, then his knowledge about the President's activities could create serious problems for Trump as special counsel Robert Mueller continues his investigation.The source said Cohen recorded some calls he had with attorney Keith Davidson, who at the time represented both Daniels and McDougal. Davidson no longer represents either woman. Their deals to keep their stories about alleged affairs quiet are now the subject of litigation, with each seeking to be released from their agreements.Another source tells CNN that in at least one conversation between the two men, "Cohen was being unusually simplistic, like he had bullet points that he was reading from to try and make himself look good. He was trying to clarify the timeline of the agreements made with Davidson in his (Cohen's) favor.""Attorney Davidson never consented to any recordings of his conversations with Mr. Cohen. If they in fact do exist, Attorney Davidson will pursue all his legal rights under the law," Dave Wedge, a spokesman for Davidson, said. Recording phone conversations without the consent of both parties could be a legal issue if Davidson was in a state that has such laws, like California.Cohen's attorney and a spokesman for Cohen's attorney did not reply to requests for comment.Prosecutors are "going to be very excited at the prospect of having an independent means of corroborating what was said between the two parties," CNN legal analyst and former federal prosecutor Michael Zeldin said. "If all that stuff gets recorded, then they are in deep hurt because if it was just oral between them, it could be a conspiracy of liars but the tapes undermine that."Zeldin said a conversation between attorneys for different clients would most likely not be considered covered by attorney-client privilege.McDougal alleges in a lawsuit that Cohen has a cozy relationship with Davidson. She argues Davidson was part of a "broad effort to silence and intimidate her and others." Davidson denies that claim.In an exclusive interview with CNN last month, Davidson described several calls he had with Cohen about striking a deal for Daniels to keep her story quiet.Davidson also said he was contacted in recent weeks by Cohen, who encouraged him to go out and reveal what he knew about his clients and their agreements. Davidson said Cohen argued that the women had waived attorney-client privilege by going public with their stories."He suggested that it would be appropriate for me to go out into the media and spill my guts," Davidson said.There was no discussion of recordings during a court hearing on Friday to argue over Cohen's filing of a temporary restraining order that seeks to suppress the evidence gathered in the raid.The Davidson recordings may not be the only conversations the FBI gathered in the raid. Cohen often recorded telephone conversations both before and during the 2016 presidential campaign that also could have been scooped up in the FBI raid on his apartment, office and hotel room, sources told CNN.One source said Cohen played to Trump and some associates conversations that he had with political and media figures during the exploratory part of the campaign.The-CNN-Wire 4249

The Department of Justice issued a warning to the public not to fall for cards bearing the DOJ logo claiming exemption from state mask requirements amid the spread of COVID-19.“Inaccurate flyers or other postings have been circulating on the web and via social media channels regarding the use of face masks and the Americans with Disabilities Act (ADA) due to the COVID-19 pandemic,” the Department of Justice said. “Many of these notices included use of the Department of Justice seal and ADA phone number.”According to the Department of Justice, the ADA does not provide a blanket exemption to people with disabilities from complying with legitimate safety requirements necessary for safe operations.According to CDC guidance, only children under age 2, or anyone who has trouble breathing, is unconscious, incapacitated or otherwise unable to remove the mask without assistance are encouraged not to wear face coverings.This reminds me of when my friend and I got fake IDs in Times Square that just said “ID Card” and looked like someone had made them with a home laminator. pic.twitter.com/2a393OFkIs— The Hoarse Whisperer (@HoarseWisperer) June 25, 2020 1168

The first snowflakes flew into the lower 48 this week.A big winter storm blew through the higher elevations of western Montana and northern Idaho earlier this week, and now, a few of those snowflakes may fall in parts of western Wyoming and in the mountains of Utah and Colorado. 287