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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 Department of Justice announced Thursday that 57 people have been arrested across the country for fraud related to the Paycheck Protection Program (PPP).In a press conference Thursday, officials with the Department of Justice said that the suspects attempted to steal millions of dollars of taxpayer money.The PPP was established in the CARES Act, a stimulus package signed into law in March amid the coronavirus pandemic. The funds were meant to be used by small businesses to keep their businesses afloat.Officials said some of those arrested used the funds to buy "flashy or expensive" luxury items for themselves, rather than use the funds for their businesses. The DOJ also described that some of the suspects were part of "coordinated criminal rings" meant to obtain the funds through fraud.While officials did not put a specific dollar amount on the amount of funds stolen, officials called the number "significant." The DOJ says that it was able to seize or freeze million in funds provided through the PPP.This story is breaking and will be updated. 1074
The freewheeling entrepreneur who built Tower Records into a global business and pioneered a new way to sell music has died at 92.Russ Solomon, who started selling records at his father's pharmacy in the 1950s, passed away on Sunday at his home near Sacramento, California.The founder of Tower Records died while watching the Academy Awards, his son Michael Solomon told the Sacramento Bee."He was giving his opinion of what someone was wearing that he thought was ugly, then asked [his wife] Patti to refill his whiskey," Michael Solomon told the newspaper.Solomon had passed away by the time his wife returned.The first Tower Records opened in Sacramento in 1960, and by 1968 the company had expanded to San Francisco. Its iconic yellow and red signs would later be seen as far away as London and Tokyo.Fans flocked to the stores, attracted by a relaxed atmosphere where it was easy to bond with other music aficionados. Solomon did not have a dress code for employees, who mixed easily with customers."If you came into town, you went into Tower Records," Bruce Springsteen said in a documentary about the company called "All Things Must Pass."Solomon told Billboard Magazine in 2015 that his favorite regular was Elton John."He probably was the best customer we ever had," Solomon said of the pop star. "He was in one of our stores every week, literally, wherever he was -- in L.A., in Atlanta when he lived in Atlanta, and in New York."The chain thrived on massive demand for physical music -- first records and then CDs. Solomon built sprawling mega stores where fans could find everything from pop hits to obscure albums.But the retailer was soon undermined by dramatic changes in the music industry.The rise of music sharing sites such as Napster put it under pressure, and the company's debt ballooned. Tower declared bankruptcy in 2004, and was liquidated in 2006."The banks said 'we don't need a visionary,'" Solomon lamented in "All Things Must Pass," which was directed by Colin Hanks."When we met Russ," Hanks told Billboard in 2015, "it took less than a second to realize this guy is a great character and one of the most humble people I had ever met." 2180
The classified ads website Backpage.com has been seized by federal law enforcement agencies, according to a banner that popped up on the site Friday.The banner says, "backpage.com and affiliated websites have been seized as part of an enforcement action" by the FBI, US Postal Inspection Service and the IRS Criminal Investigation Division.Lawmakers on Capitol Hill and advocacy groups have long called for an investigation into Backpage.com for allegedly facilitating prostitution and sex trafficking.A spokesperson for the Justice Department confirmed to CNN that the website has been seized and that additional information would be made available Friday evening. However, a judge decided that the federal case should remain sealed on Friday night. No other additional information was provided.A two-year Senate investigation into online sex trafficking found that found that Backpage.com knowingly aided criminal sex trafficking of women and young girls, simply scrubbing terms from ads such as "Lolita," "teenage," "rape," "amber alert," and publishing them on its site. After the investigation was published in January 2017, Backpage.com shut down its adult ads section.The company has been targeted with several lawsuits over the years, but has been largely protected by Section 230 of the 1996 Communications Decency Act, a legal protection that gives a broad layer of immunity to online companies from being held liable for user-generated content. Companies are supposed to act in good faith to protect users, but critics argue the law can be used as a shield. The law, however, does not, protect sites from federal liability against criminal law, like child-pornography laws.Last month, however, the Senate approved bipartisan legislation called the Stop Enabling Sex Traffickers Act. The legislation would create an exception to Section 230, which would pave the way for victims of sex trafficking to hold websites accountable for facilitating abuse.Two days after the Senate approval, Backpage competitor Craigslist removed its personal ads section.The-CNN-Wire 2080
The first round of the NFL Draft got underway Thursday evening and Oklahoma quarterback Baker Mayfield was selected as the first overall draft pick by the Cleveland Browns. Mayfield will likely take over as Cleveland's starting quarterback in the fall after the Browns finished the 2017 season with a winless 0-16 record. Mayfield was a three-year starter at Oklahoma after starting one season for Texas Tech. He threw for 131 touchdowns over his four collegiate years, which is fourth all time in NCAA Division I history. According to most NFL Draft experts, five college quarterbacks will likely be selected in the first round on Thursday. The group includes USC's Sam Darnold, Oklahoma's Baker Mayfield, Wyoming's Josh Allen, UCLA's Josh Rosen and Louisville's Lamar Jackson. 807