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The CDC could take over handling COVID-19 data coming in from states and medical facilities again, according to media reports.This week, during a briefing on a visit to Arkansas, Dr. Deborah Birx said the CDC is working "to build a revolutionary new data system so it can be moved back to the CDC" for tracking COVID-19 treatment, patients and PPE needs, according to the Wall Street Journal.The CDC’s National Healthcare Safety Network site had been tracking COVID-19 cases and data since the pandemic started.Then, abruptly in mid-July, hospitals and states were asked to stop using it and send their information directly to Health and Human Services, and a new database created by private contractor TeleTracking.The request was initially made in an effort to cut down on duplicate requests and minimize the reporting burden on hospitals and facilities.However, many hospitals, state officials and journalists noted the numbers in the new system seemed incomplete and the database was slow to update.The CDC is reportedly working with the U.S. Digital Service, according to the WSJ, an agency set up during the Obama administration to help improve HealthCare.gov, the marketplace for insurance plans that are part of the Affordable Care Act.There was no timeline mentioned as part of Dr. Birx’s comments, according to NPR. 1333

The Don Cesar is a world-famous hotel, where guests expect to have a safe and enjoyable experience, but Stacey Wagers’ birthday dinner there turned into a nightmare. We allege that Don Cesar’s restaurant served her a dangerous chemical that caused extreme pain and injury. As a young woman and mother, she will possibly experience pain and discomfort for the rest of her life. We believe this was entirely preventable had the restaurant not acted recklessly, and we will fight to hold them accountable and make sure it never happens to another guest. 558

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 first day of October might seem like an odd time to talk about summer camp, but one business has found a way to keep its operation running overtime during the COVID-19 pandemic.Camp Sea Gull is located on a remote part of the North Carolina shore. Typically, it accommodates thousands of campers a year. But once COVID-19 hit, that changed and put the camp in a precarious position along with so many other businesses.“It was really difficult,” said camp director Allison Simmons.Simmons said the camp was able to open this summer but only with a fraction of its normal participants. So, to try to attract more people, she had the idea of opening the bunks to families who wanted a change of scenery as they work or learn from home.“To me, this is giving a lot of our parents and students some hope in breaking up the monotony of whenever their school started,” said Simmons.The reservations allow families to stay at Camp Sea Gull for up to seven days, and Simmons, along with other administrators, came up with five different activity programs for families.The camp installed high-speed WiFi throughout its buildings so parents and their kids could access it during working hours, while it worked to offer activities afterward.A normal day might include opportunities to fish, sail, canoe, and play games from 3 p.m. to sundown.“[Before coming to camp] my kids were all sitting in their rooms by themselves for 6 or 8 hours a day in front of a screen, and that’s just not normal for kids,” said Stan Coerr.Coerr says he has been coming to Camp Sea Gull for 40 years--first as a camper, then as a counselor, and now as a dad who wants to plan a getaway with his three sons ages 20, 16, and 14.“I told my boys [the pandemic] won’t be the worst thing you go through but it will probably be the weirdest,” said Coerr. “And as much as I can get them out and doing things as a family, which is kind of rare these days, I will definitely take that opportunity.”Coerr says the four of them stay in the same bunk and have each claimed a portion of it for their work. Since being at camp for a few days now he says he has noticed his sons are more attentive to their schoolwork and bicker less.It has also allowed Simmons’ business to flourish. She says camp can now stay open past August, when it would end during a normal season.She says 75 percent of the people who have signed up are new clients as well. 2412

The Force is with the Hollywood Walk of Fame.Legendary actor Mark Hamill will be honored Thursday with the 2,630th star on Tinsel Town's iconic sidewalk. Hamill's "Star Wars" co-star Harrison Ford and director George Lucas will help unveil the star during the ceremony.Of course, in addition to his role in the "Star Wars" saga, the California native has encompassed all aspects of the entertainment world, including Broadway, voice-over roles, and television.The ceremony can be viewed live online:Fans will undoubtedly recognize Hamill's memorable turn as "The Joker" throughout various Batman shows, movies, and media. He's also played notable roles in the films "Corvette Summer," "The Big Red One," "Slipstream," "Kingsman: The Secret Service" and the upcoming "Brisby Bear."On Broadway, Hamill flexed his acting reach in productions of "The Elephant Man," "Amadeus," "The Nerd," and "Six Dance Lessons in Six Weeks."Hamill had some fun with TV host Jimmy Kimmel Wednesday on "Jimmy Kimmel: Live," where he cleared a little room from his place on the Walk of Fame."Well, I just picked out my spot for the star. I'm getting it ready for tomorrow," Hamill, with a jackhammer in hand, tells Kimmel before the camera pans down to reveal Kimmel's own star demolished. "Hey Jimmy I got an idea, why don't you put your star in front of Hooters?"However, Hamill's work extends past entertainment. The actor has been involved with charitable work with NAI (USC Neighborhood Academic Initiative), the Make-A-Wish Foundation, and Feeding America.  1579

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