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The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.___AP Medical Writer Lauran Neergaard contributed to this report.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5644

The family of Pfc. Vanessa Guillen, an Army soldier who was allegedly killed by a fellow soldier and his girlfriend, met with President Donald Trump on Thursday.Guillen's family began the day with a morning march on the National Mall in support of a military-focus sexual harassment bill bearing her name. The family and their attorney later met with the President at the White House.The event was closed to the press."It hit me very hard," Trump said later Tuesday about meeting with Guillen's family, according to CBS News. "We didn't want this to be swept under the rug."Guillen was last seen on April 22 at Fort Hood, Texas, where she had been stationed. On June 30, Guillen's dismembered remains were found on the banks of a nearby river.Hours later, a suspect in the case, Spc. Aaron Robinson died by suicide during a standoff with police. Robinson's girlfriend, Cecily Ann Aguilar, was later charged with assisting in hiding Guillen's body. Aguilar has pleaded not guilty.Guillen's family maintains that she had been sexually harassed by Robinson and others prior to her disappearance. They claim she did not report the abuse to her superior officers because she feared retribution.While an investigation into sexual harassment against Guillen remains open, the Army has not yet confirmed the family's claims. According to ABC News, the Army has confirmed that Guillen may have been harassed, but it was not of a sexual nature.The bill for which Guillen's family was marching, the #IAmVanessaGuillen Bill, would allow military members to file harassment claims with third-party agencies instead of within their chain of command."We will not accept anything less than justice for Vanessa," Attorney Natalie Khawam said, according to KPRC-TV in Houston. "When someone volunteers to serve our country, they deserve to be treated with dignity and respect by their fellow service members. This bill will help us provide the protection and respect to others that was denied to Vanessa." 1995

The Department of Justice announced Wednesday the indictment of two fighters affiliated to the Islamic State group who are alleged to have killed American journalists and aid workers.El Shafee Elsheikh and Alexanda Kotey were previously in U.S. military custody in Iraq and have been transported to Virginia to face trial.Elsheikh and Kotey, both of the United Kingdom, are two of the four ISIS fighters nicknamed "The Beatles" by intelligence officers because of their British accents. They've been linked to the killings of aid workers Peter Kassig and Kayla Mueller and journalists Steven Sotloff and James Foley.“These charges are the product of many years of hard work in pursuit of justice for our citizens slain by ISIS. Although we cannot bring them back, we can and will seek justice on behalf of their memories,” Attorney General William Barr said in a statement. “My message to other terrorists around the world is this — if you harm Americans, you will face American arms on the battlefield, and if you survive that ordeal, you will face American law in our courtrooms with the prospect of many years in an American prison. Either way, you will never live in peace — you will be pursued to the ends of the earth until justice is done.”Barr was not present at Wednesday's press conference as he is currently self-isolating amid a COVID-19 outbreak in the Trump administration. 1395

The digital news company Mic has laid off most of its staff, a spokesperson for the company confirmed.The layoffs were first reported Thursday by Recode. It is not yet clear exactly how many employees were affected. Mic declined to comment beyond confirming the Recode report.The company was founded in 2011, and for the past several years has branded itself as a news website geared toward millennials.Mic Publisher Cory Haik also resigned Thursday. In a note to staff that was obtained by CNN Business, Haik called journalism a "tough business.""Our business models are unsettled, and the macro forces at play are all going through their own states of unrest," she wrote. "If anyone tells you they have it figured out, a special plan to save us all, or that it's all due to a singular fault, know that is categorically false. Like the truth, it is indeed complicated."Mic was once a digital media darling, attracting around million in funding from investors. Its biggest backers included Lightspeed Venture Partners, Clark Jermoluk Founders Fund, WPP and WarnerMedia. (WarnerMedia owns CNN.)The company's staff swelled to more than 100 people by early 2016, according to The New York Times, which asked in an article published at the time: "What happens when millennials run the workplace?"But the climate is a tough one for digital media publishers right now. Ad revenue alone hasn't been enough to support these businesses, and Google and Facebook have substantial control over the ad market.Refinery29, HuffPost and Vocativ have all cut staff in the past year. So have CNN Digital, Vice and BuzzFeed.Mic laid off 25 employees in August 2017 as part of a pivot to video. Co-founder and CEO Chris Altchek told staff at the time that the shift was needed because "visual journalism already makes up 75% of the time that our audience spends" with the site.There were signs this year that the environment wasn't improving for Mic. Digiday reported in April that traffic to Mic's website had been plunging.The article also noted that Mic was very reliant on Facebook, citing statistics that showed views on the social media site fell to 11 million views in March compared to 192 million about a year earlier.Still, company executives pushed back on some reports that characterized the situation at Mic as particularly dire. When the Columbia Journalism Review reported in September that the company's board discussed a possible shutdown, Altchek called the report "categorically false."Emily Singer, a senior political reporter at Mic, tweeted Thursday that she was leaving the company."I'm so proud of what we've accomplished here," Singer wrote.Kerry Lauerman, Mic's executive news director, tweeted about the "gutting experience" Thursday."But only love for the extremely resilient and open-hearted team of Mic editors, producers, writers and shooters I had the great honor of working with," he added. "They performed brilliantly often under a cloud of uncertainty."Reached by phone, Lauerman declined to comment further, saying only that the team was packing up all of their things.Several other employees also tweeted news of their departures."I have so much to say, but most importantly the time I spent at @mic was the best of my career," wrote Managing Editor Colleen Curry. "I learned so, so much from brilliant people dedicated to keeping journalism alive."Mic is also in talks to sell at least part of the company to Bustle Digital Group, Recode reported Wednesday. A source with knowledge of the potential deal confirmed that report to CNN Business. 3572

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

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