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The Duchess of Cambridge, wife of Britain's Prince William, has given birth to a son, the royal family announced Monday. The baby weighs 8lbs 7oz (3.8 kilograms).The duchess, the former Kate Middleton, gave birth at 11a.m. local time at St. Mary's Hospital, Paddington, London."The Queen, The Duke of Edinburgh, The Prince of Wales, The Duchess of Cornwall, Prince Harry and members of both families have been informed and are delighted with the news," Kensington Palace said in a statement."Her Royal Highness and her child are both doing well." 554

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 cremated remains of notorious cult leader Charles Manson were scattered on a California hillside following a Christian funeral on Saturday, nearly four months after his death.The burial came one week after Manson's grandson, Jason Freeman, won the right to his grandfather's body after a court battle that began shortly after Manson's death on November 19.The family "acted like ninjas" to keep the funeral in Porterville, California, from gaining attention, Freeman said.About 20 people attended, he said, describing them as his grandfather's best friends from before and during Manson's 46-year incarceration.Among them was Sandra Good, a member of the original "Manson Family." Good was not part of the grisly two day killing spree that terrorized the nation in 1968. But she remained a follower and extolled Manson's environmental directive known as Air, Trees, Water, Animals (ATWA).Manson's body was dressed in an orange ATWA T-shirt for the funeral. His remains were cremated after the service.Also attending was Afton Burton, who was briefly Manson's fiancée in 2014. She was 53 years younger than Manson.Freeman battled two other men with Manson connections for the right to dispose of the remains -- Michael Brunner, who claimed to be Manson's son and Michael Channels, a long time Manson friend and memorabilia collector. Freeman invited both to the funeral. Neither showed up.During the court fight, both Freeman and a probate attorney talked about Manson's body being kept "on ice" by the Kern County Coroner. However, Freeman told CNN that the funeral home told him they "had a mess on our hands," and that there was "gross neglect to the corpse." Freeman said it was clear to him that his grandfather had not been properly stored.But Stephen Wells, a spokesman for the Kern County Sheriff's department, said that Manson's body "wasn't treated any differently than any other body" being stored by the coroner's office. Wells said it was kept refrigerated, and that "after four months it would have the standard decomposition."Freeman is a devout Christian, and had a local pastor from Porterville lead the service.Also at the service was a documentary camera crew working with Freeman on a film about his father -- Charles Manson Jr., who committed suicide when Jason was a boy.While the fight over Manson's remains is over, the court battle for his estate -- including personal items as well as music rights -- is still being fought in court. Freeman, Brunner, Channels and Matthew Robert Lentz, who also claims to be Manson's son, all head to probate court in Los Angeles again on Friday."It was great for everybody to come together for the first time," said Freeman's wife, Audrey, who accompanied him to the funeral. "It was a gift to us."  2775

The Environmental Protection Agency is widely expected to announce plans to change the definition of which waters in the United States are protected under the Clean Water Act on Tuesday -- a change President Donald Trump has been working toward since the beginning of his presidency.The EPA released a statement saying it would make a major water policy announcement on Tuesday.The announcement is expected to be a policy shift from former President Barack Obama's 2015 Waters of the United States regulation. Obama's rule changed the definition of which bodies of water the federal government had authority over to include streams and wetlands so that the government could ensure that those waterways remained pollution-free. It altered the definition from the initial one established by the EPA and Army Corps of Engineers in the 1980s.Obama's regulation was created under the Clean Water Act, which regulates discharges of pollutants into waters in the US. Under the Clean Water Act, it's illegal to discharge pollutants from a source into "navigable waters," according to the EPA. 1092

The Broward County Sheriff's deputy who was assigned to be the school resource officer at Stoneman Douglas High School during last week's massacre that left 17 dead resigned this morning after being suspended without pay, Sheriff Scott Israel announced on Thursday. Israel said that Deputy Scot Peterson was outside of the building during the time of the shooting. According to Israel, video evidence suggested that Peterson remained outside for four minutes. The entire mass shooting lasted an estimated six minutes, Israel said.Related story: Parkland shooter Nikolas Cruz recorded during 911 call in Palm Beach County 648

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