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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 Department of Labor reported Thursday that 1.5 million Americans filed initial claims for unemployment during the week ending June 20, bringing a 14-week total to about 46.5 million claims.Thursday's figures were down about 20,000 from last week's unemployment filings. It marked the third straight week where unemployment claims have hovered at about 1.5 million.Weekly claims for unemployment have been falling for about three straight months after peaking at about 6 million a week in late March. But weekly unemployment claims remain historically high.Prior to the pandemic, the record high for weekly unemployment claims came in 2006, when 665,000 people filed for unemployment. The Department of Labor has been tracking the statistics since 1967.Economists often use weekly unemployment claims as a reliable tool when predicting unemployment. However, some surveys indicate that initial weekly claims may be underestimating the amount of those unemployed.At least one survey from the Economic Policy Institute found that millions of Americans gave up trying to seek benefits or didn't even attempt to due to states' overwhelmed and antiquated unemployment systems.The economy has improved slightly since the virus first arrived in the U.S. earlier this year. Every state had begun the process of restarting its economy as of earlier this month.However, new cases of COVID-19 are currently on the rise in many states, with reports of new infections nearing record levels — re-igniting fears that more lockdown restrictions could be on the way. 1560

The COVID-19 pandemic has given a new perspective to many people across the world. For some women, it's made them consider whether the career they've chosen is the right one.A new survey by AllBright Collective, a membership-based club created by women that aims to provide inspiration, career coaching, networking and more for women around the world, shows many women are ready for a change."And so what we wanted to do was, rather than just guess what people were thinking, we wanted to do this global survey to really try and understand how women were thinking about their careers when we emerge," said Anna Jones, the CEO of AllBright Collective. "And we were actually very pleasantly surprised."Jones says AllBright surveyed 800 members during the pandemic, and 61% of them said they were going to be pivoting in their career."Now, that may mean pivoting to a different industry or different job, or it may be pivoting within the organization they're working in. But we were very pleasantly surprised that it was quite positive and women were very keen to kind of grab this time as an opportunity and make their ambitions a reality," Jones said.The survey also showed 25% of women were already in the process of changing their careers."I think we've all gotten used to working in a different way," Jones said. "We're all sitting on Zoom and connecting digitally in a way that we could never have imagined. I think for many women who wanted to work more flexibly, they're proving that they can."Elizabeth Middleton, a former teacher and mom of four, isn't surprised by the survey's results. She, too, is in the middle of a career change, starting her own business, Forward Function Health."It's been a major life shift," Middleton said. "I knew — and it wasn't just because of this pandemic, fortunately — before the pandemic, I was making this shift. But the pandemic just confirmed that it's the best for my family and self, and I think the pandemic has woken everybody up. It woke me up."Middleton is nearly finished with her courses relating to nutrition and wellness counseling and is thrilled to find a career that fills her soul."We launch fully in 2021. However, I've had already quite a few people on board with needs with this coronavirus," Middleton said. "I'm looking forward to helping people.""I also think that maybe it's just that we've had a bit of time," Jones said. "Admittedly, people have been juggling a lot. Juggling their households, chores and household responsibilities and their work but I think we've all had a little bit more time to think about, Well what would we like to do?"AllBright is hoping to continue working with its members who need additional support to make their new career moves — taking newfound time at home and turning a business idea into a reality. 2809

The cast and crew of "Parks and Rec" are reuniting for a political cause.Amy Poehler and other stars of the show will participate in a virtual town hall on Thursday to raise money for the Democratic Party of Wisconsin.Series creator Michael Schur is also slated to make an appearance.The event is scheduled to begin at 8 p.m. CT, and anyone who donates money will be able to participate in a Q&A at 8:30 p.m., the group stated on its website.In April, the cast came together to raise money for Feeding America. 522

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

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