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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 driver who plowed down pedestrians and cyclists on a New York bike path is a "soldier of the caliphate," the ISIS terror group said on its weekly newspaper, without providing evidence to back up its claim.The attack Tuesday killed eight people and left more than a dozen others injured."One of the Islamic State soldiers in America attacked on Tuesday a number of crusaders on a street in New York City," the al-Naba newspaper reported Thursday.The terror group provided no evidence that ISIS had knowledge of the attack before it happened or it was involved in planning it. The article did not name the attacker.Suspect Sayfullo Habibullaevic Saipov has told authorities that he was inspired to carry out the attack after watching ISIS videos and closely followed the terror group's playbook for an attack.While ISIS did not claim direct responsibility for the attack, it described the attacker as one of its soldiers.Suspect's link to ISISThe 29-year-old Uzbek native was charged with providing material support to ISIS, violence and destruction of motor vehicles, said Joon H. Kim, acting US attorney for the Southern District of New York.Saipov drove a rental truck down a bike path in New York's Lower Manhattan, crashed into a school bus and then jumped out, brandishing imitation firearms, officials said. He was shot by New York police Officer Ryan Nash in the abdomen and taken into custody.He didn't enter a plea Wednesday to the federal terror charges.Saipov was so devoted to ISIS, he wanted to display the terror group's flag in his hospital room, documents show. He had about 90 videos and 3,800 images on a cell phone featuring ISIS propaganda, including video of a beheading, according to the complaint.This is the first time the terror group has put such a claim on its newspaper before releasing it on its media wing, Amaq news agency, which is its first point of publication for claims of responsibility.The wording of the ISIS statement -- not claiming the attack as an outright act of ISIS and saying the person carrying the attack is one of its "soldiers" -- mirrors ISIS' language in statements after an attack in France and the nightclub shooting in Orlando last year.No warning signsThose who crossed Saipov's path are trying to reconcile the man they met and the one they are now hearing about.When approached in the lobby of her Brooklyn apartment building, the suspect's mother-in-law said she was in shock."I don't know what happened," she said.Those who knew him in Tashkent, Uzbekistan, and in at least three states he bounced between since coming to America say they saw no warning signs of Saipov being radicalized."He was happy that he was here, he had a family here, and he was a truck driver and his business was really good," said Makhina Kadirova, a childhood friend.His neighbors described him as a quiet and said his family didn't socialize often.Trump calls for death penaltyOn Twitter, President Donald Trump said Saipov should be executed and added that he "would love" to send him to the Guantanamo Bay detention camp in Cuba."NYC terrorist was happy as he asked to hang ISIS flag in his hospital room. He killed 8 people, badly injured 12. SHOULD GET DEATH PENALTY!' the President tweeted Wednesday night.Presidents typically do not comment on pending criminal cases because their statements could be seen as influencing a potential jury pool.Concrete barriersThe Lower Manhattan bike path where the attack took place has reopened, CNN affiliate WPIX reported, as New York started installing concrete barriers to prevent similar terror incidentsThe work started Thursday as part of a statewide review of shared-use paths, according to the New York State Department of Transportation.A total of 57 barriers are being positioned diagonally along the path, leaving enough space for bicycles but not for larger vehicles, CNN affiliate WABC reported. But some local cyclists think the barriers are problematic."There's no way two bikes can pass each other there and the runners as well," New York City resident James Petty told WABC. "There's going to be accidents."Similar concrete barriers were placed in May after a man drove a car onto a crowded sidewalk in Times Square, killing a teenage woman and injuring at least 22 people. 4290
The Department of Labor reported Thursday that 1.5 million Americans filed initial claims for unemployment during the week ending June 20, bringing a 14-week total to about 46.5 million claims.Thursday's figures were down about 20,000 from last week's unemployment filings. It marked the third straight week where unemployment claims have hovered at about 1.5 million.Weekly claims for unemployment have been falling for about three straight months after peaking at about 6 million a week in late March. But weekly unemployment claims remain historically high.Prior to the pandemic, the record high for weekly unemployment claims came in 2006, when 665,000 people filed for unemployment. The Department of Labor has been tracking the statistics since 1967.Economists often use weekly unemployment claims as a reliable tool when predicting unemployment. However, some surveys indicate that initial weekly claims may be underestimating the amount of those unemployed.At least one survey from the Economic Policy Institute found that millions of Americans gave up trying to seek benefits or didn't even attempt to due to states' overwhelmed and antiquated unemployment systems.The economy has improved slightly since the virus first arrived in the U.S. earlier this year. Every state had begun the process of restarting its economy as of earlier this month.However, new cases of COVID-19 are currently on the rise in many states, with reports of new infections nearing record levels — re-igniting fears that more lockdown restrictions could be on the way. 1560
The FBI, Homeland Security’s Cybersecurity and Infrastructure Security Agency and the Director of National Intelligence issued a joint statement Wednesday night confirming an investigation is underway over a hack of government networks.Cybersecurity officials at Homeland Security ordered federal civilian agencies to immediately disconnect or power down affected SolarWinds Orion products from their network.Previously, officials said that the network was “compromised.”“The compromise of SolarWinds’ Orion Network Management Products poses unacceptable risks to the security of federal networks,” CISA Acting Director Brandon Wales said earlier this week. “Tonight’s directive is intended to mitigate potential compromises within federal civilian networks, and we urge all our partners—in the public and private sectors—to assess their exposure to this compromise and to secure their networks against any exploitation.”On Wednesday, SolarWinds acknowledged the cyberattack.“SolarWinds has been made aware of a cyberattack to our systems that inserted a vulnerability within our SolarWinds? Orion? Platform software builds for versions 2019.4 HF 5, 2020.2 with no hotfix installed, and 2020.2 HF 1, which, if present and activated, could potentially allow an attacker to compromise the server on which the Orion products run,” the company said. “We have been advised that this incident was likely the result of a highly sophisticated, targeted, and manual supply chain attack by an outside nation state, but we have not independently verified the identity of the attacker.”Federal officials said that the FBI is engaging with victims and is conducting an investigation. 1678
The former Minneapolis police officer charged with killing George Floyd and three other officers accused of aiding and abetting in his death are scheduled to appear in court on Monday.Derek Chauvin is facing a second-degree murder charge for pinning Floyd to the ground and pressing his knee down on his neck. Floyd pleaded that he couldn't breathe, but Chauvin continued to press down for nearly eight minutes, according to bystander video.Two autopsies were performed and both ruled the death a homicide, although there were differences in what caused Floyd's death.The three other officers, J. Alexander Kueng, Thomas Lane and Tou Thao, will also appear in court Monday. Keung, Lane and Thao will appear in person, while Chauvin will appear via video conference.Their appearances are scheduled to take place around midday on Monday. Hennepin County Judge Peter Cahill has ruled that cameras cannot be present in the courtroom for pretrial hearings, though it remains to be seen if cameras will be allowed in the courtroom during the trial itself.Floyd's death prompted worldwide protests against police brutality and systemic racism. 1144