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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 Broadway League, the trade association that regulates theater performances in New York City, said Monday that all Broadway shows would be canceled through the end of 2020 due to the coronavirus pandemic.The group says that those who have purchased tickets to shows before Jan. 3, 2021 will automatically receive an email detailing refund and exchange information."Every single member of our community is eager to get back to work sharing stories that inspire our audience through the transformative power of a shared live experience," Thomas Schumacher, the Broadway League's Chairman of the Board, said in a statement released Monday. "The safety of our cast, crew, orchestra and audience is our highest priority and we look forward to returning to our stages only when it’s safe to do so. One thing is for sure, when we return we will be stronger and more needed than ever.”“Our membership is working closely with the theatrical unions and in concert with key experts and some of the greatest minds inside and outside of the industry to explore protocols for all aspects of reopening. We are focused on identifying and implementing necessary measures that will enable us to resume performances safely for Broadway audiences and employees,” Charlotte St. Martin, the president of the Broadway League, said in a statement. “We are determined to bring back the people who rely on this industry for their livelihood, and to welcome back all those who love this vital part of New York City, as soon as it is safe to do so. "Broadway performances in New York shut down on March 12, the day before President Donald Trump declared the pandemic a national emergency. Last month, the Broadway League said it was canceling all performances through Sept. 6. 1759

The Cameron Peak Fire is now the largest wildfire in Colorado's history. It grew overnight and is now 164,140 acres, but it remains 56% contained and no injuries have been reported.The fire became the largest in Colorado history Wednesday evening. It took only 48 days for the Cameron Peak Fire to surpass the 139,007-acre Pine Gulch Fire as the largest in recorded state history, and also blew past the 137,760-acre Hayman Fire in 2002.In a Thursday morning update, Operations Section Chief Paul Demerico of Rocky Mountain Team 1 said they are expecting a challenging few days ahead."But we have beefed up and feel like we have adequate resources to do what we can, especially when it comes to structure protection," he said.Several areas near the fire are under mandatory or voluntary evacuations as a result of the blaze. Highway 34 was also temporarily shut down in both directions between Loveland and Estes Park to help with evacuations, but has reopened.In addition, the Canyon Lakes Ranger District of the Roosevelt National Forest closed Thursday morning. This closure includes recreation sites — including all campgrounds — trails and Forest Service Roads.View the mandatory evacuations in the map below, or go here for the full list of evacuations and closures.Demerico said the western side of fire is almost all contained, but the fire was able to run east all the way to County Road 27 thanks to the wind, terrain and dry fuels.The main objective for the next day or so is to keep the fire south of 44H Buckhorn Road and west of County Road 27, he said.Winds will continue to be a problem over the next few days, Demerico said. Structure protection resources are scattered around Storm Mountain, Cedar Park, Glen Haven and Estes Park.The gusts also prevent fire officials from flying aircraft to help fight the blaze from the air.Larimer County residents may see periods of moderate to heavy smoke in their neighborhoods Thursday, according to the Colorado Air Quality Summary. The smoke may impact Fort Collins and Loveland as well.The National Weather Service said smoke from both the Cameron Peak Fire and the new East Troublesome Fire in Grand County will move toward Denver Thursday afternoon.The state's 10 largest wildfires in history, ranked by acreage, are:1. Cameron Peak Fire (2020): 164,140 acres2. Pine Gulch Fire (2020): 139,007 acres3. Hayman Fire (2002): 137,760 acres4. Spring Fire (2018): 108,045 acres5. High Park Fire (2012): 87,284 acres6. Missionary Ridge Fire (2002): 72,962 acres7. 416 Fire (2018): 54,000 acres8. Bridger Fire (2008): 45,800 acres9. Last Chance Fire (2012): 45,000 acres10. Bear Springs/Callie Marie fires (2011): 44,662 acresNote: The Rocky Mountain Area Coordination Center said the West Fork Complex fire, which burned a total of 109,632 acres in 2013, is not included on this list since it involved three separate fires.This story was originally published by Stephanie Butzer at KMGH. 2951

The Cleveland Cavaliers announced today that Kevin Love will not be playing in Game 7 on Sunday against the Boston Celtics.The decision came after Love knocked heads with Celtics rookie Jayson Tatum during the first quarter of last night's game. The team said Love was evaluated before their flight to Boston and is experiencing concussion-like symptoms. He has since been placed in the league's concussion protocol.  435

The bull market turns 3,453 days old on Wednesday. It's the longest period of uninterrupted gains in American history.The remarkable run began on March 9, 2009, in the ashes of the Great Recession and the scariest financial crisis since the 1930s. The slow-but-steady economic recovery, coupled with unprecedented aid from the Federal Reserve, catapulted the Dow from around 6,500 to nearly 26,000 today. The S&P 500 has quadrupled from its 2009 low of 666. And market darlings like Netflix and Amazon have skyrocketed much further.The bull market narrowly survived countless panic attacks from crisis-scarred investors along the way. There was the downgrade of America's credit rating in 2011, the feared collapse of the euro, China's alarming economic slowdown and the dramatic crash in oil prices.Yet each scare failed to derail the steady rise of the economy and corporate profits that has underpinned Wall Street's record-breaking run. There were close calls, but the S&P 500 never dropped 20%, the trigger for a new bear market. 1050

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