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The first full slate of preseason games kicked off Thursday night, bringing NFL players back into the field for more football and more protests.Several players took a knee, raised fists or did not take to the field while the National Anthem was played before a dozen preseason games began across the country.The Miami Herald reported that Dolphins wide receiver Kenny Stills, along with wide receiver Albert Wilson, knelt during the anthem before a home game against Tampa Bay.WTVJ Miami reported that Dolphins defensive end Robert Quinn raised his fist during the song. 578
The coronavirus pandemic has had a big impact on businesses of all kinds, restaurants and retailers alike are closing permanently and others are doing what they can to financially survive.That also means it could be a good time for consumers looking for specific items to save some money.The website rather-be-shopping.com compiled a list of 13 items that have become cheaper during the pandemic.Items like clothing for the whole family. Retailers like Macy’s, Stein Mart, Ann Taylor, and many more are closing anywhere from several stores to most of them. That could mean deep discounts during liquidation sales.Those looking for a home or want to refinance will find low mortgage rates right now. Mortgage rates have hit an all-time low.Gas is about 50 cents cheaper nationally than it was in the summer of 2019. Maybe it’s time for a road trip or long drive and save on fuel prices.That also contributes to low shipping costs. Many online sites are offering no or low shipping costs right now.In time for school to start, technology is cheaper and many places are offering discounts on laptops and electronic devices and headphones that can be used for at-home learning. There are also 16 states with "no sales tax" weekends to encourage shopping. 1259
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 experimental COVID-19 vaccine in the U.S. is on track to begin a huge study next month to prove if it really can fend off the coronavirus, while hard-hit Brazil is testing a different shot from China.Where to do crucial, late-stage testing and how many volunteers are needed to roll up their sleeves are big worries for health officials as the virus spread starts tapering off in parts of the world.Moderna Inc. said Thursday the vaccine it is developing with the National Institutes of Health will be tested in 30,000 people in the U.S. Some will get the real shot and some a dummy shot, as scientists carefully compare which group winds up with the most infections.With far fewer COVID-19 cases in China, Sinovac Biotech turned to Brazil, the epicenter of Latin America’s outbreak, for at least part of its final testing. The government of S?o Paulo announced Thursday that Sinovac will ship enough of its experimental vaccine to test in 9,000 Brazilians starting next month.If it works, “with this vaccine we will be able to immunize millions of Brazilians,” said S?o Paulo′s Gov. Joao Doria.Worldwide, about a dozen COVID-19 potential vaccines are in early stages of testing. The NIH expects to help several additional shots move into those final, large-scale studies this summer, including one made by Oxford University that’s also being tested in a few thousand volunteers in Brazil.There’s no guarantee any of the experimental shots will pan out.But if all goes well, “there will be potential to get answers” on which vaccines work by the end of the year, Dr. John Mascola, who directs NIH’s vaccine research center, told a meeting of the National Academy of Medicine on Wednesday.Vaccines train the body to recognize a virus and fight back, and specialists say it’s vital to test shots made in different ways — to increase the odds that at least one kind will work.Sinovac’s vaccine is made by growing the coronavirus in a lab and then killing it. So-called “whole inactivated” vaccines are tried-and-true, used for decades to make shots against polio, flu and other diseases — giving the body a sneak peek at the germ itself — but growing the virus is difficult and requires lab precautions.The vaccine made by the NIH and Moderna contains no actual virus. Those shots contain the genetic code for the aptly named “spike” protein that coats the surface of the coronavirus. The body’s cells use that code to make some harmless spike protein that the immune system reacts to, ready if it later encounters the real thing. The so-called mRNA vaccine is easier to make, but it’s a new and unproven technology.Neither company has yet published results of how their shots fared in smaller, earlier-stage studies, designed to check for serious side effects and how well people’s immune systems respond to different doses.Even before proof that any potential vaccine will work, companies and governments are beginning to stockpile millions of doses so they can be ready to start vaccinating as soon as answers arrive.In the U.S., a program called “Operation Warp Speed” aims to have 300 million doses on hand by January. Under Brazil’s agreement with Sinovac, the Instituto Butantan will learn to produce the Chinese shot.___AP journalist Marcelo Silva de Sousa 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. 3499
The engine came roaring back to life, despite the vehicle being partially burned and melted. And though their car may not look pretty, Christina Lopez and her husband concluded the fire-damaged Honda Civic was safe enough to drive.Lopez said she was anxious to have her car so she could drive to work and take her 18-month-old son to day care. Her husband's car was lost in the fire.A locksmith had to make a new key because the previous one was lost, along with everything else they owned, inside their now-destroyed home. 531