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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 economy is humming. Americans are eager to spend on clothes, toys and home decor.Just not at JCPenney.Leaderless, billion in debt and with a stock price below , the besieged retailer faces an uncertain fate after posting its latest round of dismal earnings."They're in a leaky boat that eventually will sink," said Mark Cohen, the director of retail studies at the Columbia Business School and a former CEO of Sears Canada and other department stores. "The prognosis for the future is not happiness."Penney finds itself weighed down by years of errors, failed CEOs and muddled attempts to establish a clear identity with shoppers. 652

The Florida Senate on Monday passed Senate Bill 7026, The Marjory Stoneman Douglas High School Public Safety Act — a bill that raises the minimum purchasing age for a firearm to 21 and sets a program that allows for armed librarians, coaches and counselors.The bill now moves to the Florida House. It's not immediately clear when the House will take up the measure.The legislation works to address the issues presented by the Feb. 14 shooting at Marjory Stoneman Douglas High School in Parkland, including firearm and school safety, and community mental health resources. The bill includes the following provisions:Mental HealthIn the area of mental health the legislation makes significant changes to keep firearms out of the hands of those suffering from mental illness: 800

The counting is over. Now, the recounting begins.More than three days after the polls closed in Florida, the secretary of state announced on Saturday afternoon that the razor-thin races for governor, senator and agriculture commissioner will be reviewed in a series of recounts.According to unofficial results filed by the counties, Republican Gov. Rick Scott leads incumbent Democratic Sen. Bill Nelson by more than 12,500 votes, or about .15%. The spread in the governor's race is larger, with Republican former Rep. Ron DeSantis ahead of Democratic Tallahassee Mayor Andrew Gillum by nearly 34,000 votes, for a lead of .41%. In the narrowest contest, Democratic agriculture commissioner Nikki Fried's advantage stands at 5,326 votes — just .06% — over Republican Matt Caldwell.With the margins in all three contests at under .5%, the votes will now be recounted by machine. That process must be finished by Thursday at 3 pm ET. Races within .25% will then go to a hand recount of overvotes and undervotes. An overvote means a voter selected more than the allotted options on the ballot; an undervote means a vote selected fewer than the available choices or, in these races, none. The Senate race and the contest for agriculture commissioner both currently both fall within .25%.The Senate race and the contest for agriculture commissioner both currently both fall within .25%.In a statement after the unofficial count was made public, Scott's campaign called on Nelson to opt out of a recount, which is his option under state law."It's time for Senator Nelson to accept reality and spare the state of the Florida the time, expense and discord of a recount," said Scott spokesman Chris Hartline.While the politicians tweeted and activists kicked off new protests this weekend, demonstrators on the streets outside the Broward County Supervisor of Elections office on Friday targeted Snipes, chanting "lock her up" and "fake votes don't count" as she and others worked inside trying to finish the initial vote count. "Make America Great Again" and "Trump 2020" signs and hats were also visible as a group carrying signs supporting Scott and DeSantis were met by another backing the Democrats, as nose-to-nose screaming matches nearly escalated into physical altercations.Scott escalated already rising tensions across the state on Thursday night, when in a news conference he took a page from President Donald Trump and, without citing any evidence, accused "left-wing activists in Broward County" of trying to steal the election for Nelson. The county, in deep-blue portion of South Florida, is notoriously slow in counting its votes and as its tally mounted, Scott's lead had predictably diminished. In a series of tweets on Friday, Trump picked up the thread and accused the Democrats of attempting "Election Theft in Broward and Palm Beach Counties."But Scott's request for an investigation into election-related fraud did not go far. On Friday, the Florida Department of Law Enforcement said it was told by the Department of State, which is run by a Republican Scott-appointee, that they had received "no allegation of criminal activity." Still, Scott's campaign issued an ominous-sounding statement on Saturday morning "encouraging every Florida Sheriff to watch for any violations and take appropriate action."Meanwhile, Nelson's campaign filed suit against the state over its process for validating vote-by-mail ballots.Democratic lawyer Marc Elias, who is running the Nelson recount effort, argued that Florida's signature matching process put an undue onus on the "untrained opinions" of poll workers, which led to a "complete lack of uniformity" in how the ballots were being judged."This serves as an outright disenfranchisement and burden on the right to vote," Elias told reporters on a call Friday.South Carolina Sen. Lindsey Graham has also injected himself into the fight, alleging on Thursday and Friday -- like Scott and the President, with no proof -- that there are "shenanigans going on in Broward and Palm Beach" before suggesting that a sinister cabal of liberals from Washington was at work trying to rig the election. In fact, out-of-state lawyers from both parties, including a handful who had significant roles 18 years ago, have been flocking to Florida ahead of the recount.Leading a call for Scott's campaign on Saturday, Graham touted Scott's legal team and again skewered Broward and Palm Beach election officials for their lack of transparency."Rick has a good team of lawyers," Graham said. "Lawyers are not going to decide this race, the voters will. I support every valid vote being counted. But I also support the rule of law when it comes to voting."Around the state on Friday, allegations and rumors of misplaced or lost votes fueled simmering anger and confusion as the campaigns, lawyers, operatives and freelance rabble-rousers girded themselves for a re-run of the pitched partisan combat that took over the state during the 2000 presidential recount.Outside a mail distribution center in Miami-Dade County, a group of activists with images they said showed undelivered ballots inside tried and failed to get a meeting with a supervisor. Later in the day, a spokeswoman for the U.S. Postal Service said it was "researching the matter to verify that all ballots have been handled in accordance to USPS service standards."Detailed updates on the state of the race had been hard to come by ahead of Sunday's noon reporting deadline, leading Scott to successfully sue top election officials in Broward and Palm Beach Counties for information on the total votes cast and how many of them had been canvassed.In Broward, Supervisor of Elections Brenda Snipes turned over information to Scott and his team for review late Friday. But before midnight, the campaign pushed out a new press release claiming Snipes had not fully complied with the court order "because she refuses to confirm whether or not additional ballots exist that must be counted."Adding to Broward County's troubles, a CNN analysis of votes cast there suggests that ballot design could be responsible for a substantial difference in the number of votes cast between the race for governor and the race for senator in Florida. 6239

The chemotherapy dripped through a catheter in his chest. Cancer patient Robert Goodman had burned through his paid sick days while undergoing surgery and chemotherapy for colon cancer.The Florida public school teacher figured he needed at least 20 additional sick days to deal with more chemotherapy, days he just didn't have. So on July 23, right there in a room at Tomsich Health and Medical Center of Palm Beach County, Goodman took a selfie, posted it on Facebook and appealed for help.Within four days he had enough sick days to cover an entire semester."I couldn't believe it happened so fast," Goodman, 56, told CNN.Teachers, staff members, administrators and even lunchroom workers who pay into the Florida retirement system transferred 75 sick days to Goodman."Educators all over the country were reaching out to me to donate their sick days, even professors over at Florida Atlantic University," he said. "I felt guilty because I knew there were people who had it much worse than me." 1003