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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 Defense Department has temporarily grounded all of its 245 F-35 fighter jets for inspection of a potentially faulty engine part in the wake of last month's crash in South Carolina.Initial data from the ongoing investigation into the September 28 crash indicates a fuel tube may have been faulty. In response, all US military F-35s will be inspected as well as F-35s operated by US allies."If suspect fuel tubes are installed, the part will be removed and replaced. If known good fuel tubes are already installed, then those aircraft will be returned to flight status," the Defense Department said in a statement.Inspections are expected to be completed within the next two days, the statement said, and a defense official told CNN some aircraft have already been returned to flight status.The initial assessment is the faulty tube may be on older models of the aircraft, but all are being inspected. 911

The coronavirus is shaking up America’s liquor laws.At least 33 states and the District of Columbia are temporarily allowing cocktails to-go during the pandemic. Only two — Florida and Mississippi — allowed them on a limited basis before coronavirus struck, according to the Distilled Spirits Council of the United States.Struggling restaurants say it’s a lifeline, letting them rehire bartenders, pay rent and reestablish relationships with customers. But others want states to slow down, saying the decades-old laws help ensure public safety.Julia Momose closed Kumiko, her Japanese-style cocktail bar in Chicago, on March 16. The next day, Illinois allowed bars and restaurants to start selling unopened bottles of beer, wine and liquor, but mixed drinks were excluded.Momose spent the next three months collecting petition signatures and pressing lawmakers to allow carryout cocktails. It worked. On June 17, she poured her first to-go drink: a Seaflower, made with gin, vermouth, Japanese citrus fruit and fermented chili paste. A carryout bottle, which serves two, costs .Momose has been able to hire back four of her furloughed employees. A group she co-founded, Cocktails for Hope, is now helping restaurants buy glass bottles in bulk for carryout.“Part of getting cocktails to go approved was embracing the fact that this isn’t going to fix everything, but it is going to fix something,” Momose said. “All these little things that we do will keep us open and keep our staff employed.”U.S. liquor laws — many of which date to the end of Prohibition in 1933 —are a confusing jumble that vary by state, city and county.Carryout cocktail regulations — which were passed starting in March — only deepen that confusion. Lawmakers approved carryout cocktails in some states; governors approved them in others. Nevada passed no statewide measure, but individual cities like Las Vegas and Reno allow them. In Pennsylvania, only restaurants and bars that lost 25% of average monthly total sales can sell cocktails to go.Most carryout cocktail regulations require customers to buy food with their mixed drinks. Lids or seals are generally required, but some states say drinks also need to be transported in the trunk. Marbet Lewis, a founding partner at Spiritus Law in Miami who specializes in the alcohol industry, says IDs should be checked — online or in person — by restaurants and bars as well as by delivery drivers.Some states, like Arizona, allow third party delivery companies like DoorDash to deliver cocktails; Kansas only allows delivery within a 50-foot radius.The laws also have different sunset dates. Alabama is only allowing carryout cocktails through Sept. 15, while Colorado and Massachusetts have extended them into next year. Michigan is allowing them through 2025.Last month, Iowa became the first state to permanently allow carryout and delivery of cocktails. Lawmakers in Ohio and Oklahoma are considering a similar measure, and the governors of Texas and Florida have expressed support for the change.There is overwhelming public support for making cocktails to go permanent, says Mike Whatley, vice president of state and local affairs for the National Restaurant Association. Between 75% and 80% of respondents have said they support carryout cocktails in numerous state polls, Whatley said.U.S. restaurants and bars have lost an estimated 5 billion since March due to lockdowns and social distancing requirements, the association said. In a May survey of 3,800 restaurants, the association found that 78% of operators who were selling alcohol to go had brought back laid-off employees, compared to 62% of operators overall.But some are urging states not to be too hasty. Mothers Against Drunk Driving worries that permanent carryout cocktails will lead to an increase in drunken driving unless laws make clear that the drinks can’t be consumed until the buyer is in a safe location.The U.S. government hasn’t released preliminary drunk driving data for 2020. But Jonathan Adkins, the executive director of the Governors Highway Safety Association, said there’s no anecdotal evidence that drunk driving has spiked during the pandemic.Patrick Maroney, a former liquor control officer in Colorado who is now a consultant, said carryout beer and wine — which was allowed in around 15 states prior to the pandemic — are different from cocktails because the containers are sealed by the manufacturer and the alcohol content is lower. Cocktails are mixed at the bar, so the alcohol content can vary and they may not be properly sealed, he said.Maroney said states need to make sure police and health officials are consulted before changing laws that have worked for decades. He noted that California reported a spike in reports of alcohol delivery to minors in April.“Are law enforcement officials worried about an ‘open air’ type atmosphere?” he said. “Is the law restricted to at-home consumption? How do they enforce it?”Maroney received funding from the Center for Alcohol Policy — which is funded by beer wholesalers — for a recent research paper raising concerns about carryout cocktails.Even before the coronavirus hit, there was a push to modernize alcohol laws to reflect the growing popularity of food delivery, Lewis said. She thinks lawmakers will have a hard time reinstating bans on carryout cocktails once the pandemic eases.“Once you get the genie out of the bottle and there hasn’t been a problem, how do you get it back in?” she said.Still, restaurant and bar owners say they’re not worried that patrons will get so used to carryout that they’ll stop going out even after the coronavirus has passed.“I think that people are social. People enjoy the bar experience and like being waited on,” said Dave Kwiatkowski, who owns the Sugar House cocktail bar in Detroit, which closed March 15 but was able to reopen July 10 for carryout service.Kwiatkowski normally employs a staff of 16. For now, it’s just him at the door and a bartender making drinks.“It’s enough to pay the electricity and the insurance, and it’s nice to give at least a couple of people some jobs,” he said.Kwiatkowski does wonder how he’ll handle carryout demand once the pandemic has ended and there’s a crowd in the bar on a Saturday night. But that will be a good problem to have, he said. He wants carryout cocktails to be permanently legalized.“I think this is probably going to change how we do business forever,” he said. 6446
The FBI has fired Peter Strzok, an agent who was removed from the Russia probe last year for sending text messages disparaging President Donald Trump, Strzok's lawyer said Monday.Aitan Goelman, Strzok's attorney, said FBI Deputy Director David Bowdich ordered the agent's termination on Friday. Goelman said that the deputy director's decision comes after the head of the office that normally handles disciplinary actions decided Strzok should instead face a demotion and 60-day suspension."The decision to fire Special Agent Strzok is not only a departure from typical Bureau practice, but also contradicts (FBI) Director (Christopher) Wray's testimony to Congress and his assurances that the FBI intended to follow its regular process in this and all personnel matters," Goelman said in his statement.The FBI declined to comment on Goelman's assertions.Strzok played a lead role in the investigation into Hillary Clinton's private email server and was involved in the FBI's recommendation that no criminal charges be filed against the former secretary of state. He later helped oversee the beginnings of the probe into Russian meddling in the 2016 election, and his involvement in both investigations has been seized on by Republicans as evidence of anti-Trump bias in the bureau and those investigating potential coordination between the Trump campaign and Moscow.The President tweeted about the firing Monday afternoon, calling Strzok a "total fraud" and repeated his claim that there was no collusion nor that he obstructed justice."Agent Peter Strzok was just fired from the FBI - finally. The list of bad players in the FBI & DOJ gets longer & longer. Based on the fact that Strzok was in charge of the Witch Hunt, will it be dropped? It is a total Hoax. No Collusion, No Obstruction - I just fight back!" Trump wrote, adding in another tweet, "Just fired Agent Strzok, formerly of the FBI, was in charge of the Crooked Hillary Clinton sham investigation. It was a total fraud on the American public and should be properly redone!"Because Strzok, who is 48, was fired before his 50th birthday, he potentially stands to lose a portion of his pension benefits.His firing was earlier reported by The Washington Post. 2236
The coronavirus pandemic is forcing school districts that choose to reopen for in-person learning to do so with precautions.While many school corporations have posed ideas for protocols, not all have decided on a final plan.In the animation above, we imagine what a day at school might look like, using ideas from districts around the United States. 357
来源:资阳报