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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 death of a 22-year-old African-American man shortly after a struggle with police last week has been ruled a homicide, authorities in Jefferson Parish, Louisiana said Monday.Keeven Robinson, of Metairie, died last Thursday, following a police chase and an altercation with narcotics detectives from the Jefferson Parish Sheriff's Office, located outside of New Orleans, according to authorities.An initial autopsy found significant traumatic injuries to the soft tissue of Robinson's neck, said Jefferson Parish Coroner Dr. Gerry Cvitanovich, who cautioned that the results from the autopsy, which was conducted Saturday, are preliminary and more tests need to be conducted.Cvitanovich said the findings are consistent with compressional asphyxia, which will likely be cause of death at the end of the process.The four detectives involved in the incident are white, said Sheriff Joseph P. Lopinto, who declined to release their names at this point."I understand ... this investigation will be under a microscope, understand it fully," Lopinto told reporters.Gaylor Spiller, president of the West Jefferson Parish NAACP branch, said Robinson's family is also seeking a second independent autopsy."I like the fact that Sheriff Lopinto stepped up to plate, and he's doing his part," Spiller said, according CNN affiliate WDSU. "He knows that the NAACP will be on his trail."Robinson was being investigated by narcotics detectives early Thursday, Lt. Jason Rivarde, spokesman for Jefferson Parish Sheriff's Office, told CNN.Undercover detectives assigned to the case tracked Robinson down at a local gas station and tried to arrest him, according to Rivarde. But Robinson jumped back in his vehicle and led police on a chase after spotting them, Rivarde said.The suspect rammed several police cars before crashing his vehicle, according to Rivarde.Robinson took off on foot, jumping several fences before deputies caught him in a backyard of a nearby residential neighborhood, Rivarde said.Rivarde says a struggle ensued with deputies who eventually handcuffed Robinson. Once handcuffed, detectives noticed Robinson was not breathing, Rivarde said. Detectives administered life saving techniques before Robinson was taken to a local hospital where he died, Rivarde said.The agency is not equipped with body cameras or dash cameras, according to Rivarde."They were in a struggle," Lopinto said. "They used force." He added that the officers admitted to using force during the arrest.But the sheriff said he's "not coming to the conclusion that this was a chokehold."Lopinto said he contacted the Louisiana State Police on Saturday after he was told of the initial findings, and asked them to assist in the investigation.The sheriff said he has "every faith" in his officers to do their job well."I know they have the expertise because this is what they do every day, but I also understand that an independent set of eyes is something that's appropriate in a case like this," he said.The four detectives involved in the arrest were read their rights and have given statements, Lopinto said.They are being reassigned to administrative duty pending the outcome of the investigation, the sheriff's said.The FBI's Civil Rights Task force is also looking into the matter after he contacted them Saturday, the sheriff said.The actions of the coroner's office were largely praised Monday by Robinson's family.Hester Hilliard, an attorney for Robinson's family, thanked the coroner's office "for their professionalism and their transparency.""Today is just as hard as Thursday for this family. They're grieving, and today they had to find out that Keeven lost his life at the hands of another," she said, according DSU. "And that's very, very hard for them.""Now, it's time for us to move on to making funeral arrangements for a 22-year-old that should not have died," she said.In an interview with CNN, Hilliard said she is hoping "to see the same justice for Keeven as with any other individual who has died at the hands of someone other than the police.""We are hoping for a thorough investigation, an arrest and prosecution of those that caused his death unjustifiably," she said. 4201

The freewheeling entrepreneur who built Tower Records into a global business and pioneered a new way to sell music has died at 92.Russ Solomon, who started selling records at his father's pharmacy in the 1950s, passed away on Sunday at his home near Sacramento, California.The founder of Tower Records died while watching the Academy Awards, his son Michael Solomon told the Sacramento Bee."He was giving his opinion of what someone was wearing that he thought was ugly, then asked [his wife] Patti to refill his whiskey," Michael Solomon told the newspaper.Solomon had passed away by the time his wife returned.The first Tower Records opened in Sacramento in 1960, and by 1968 the company had expanded to San Francisco. Its iconic yellow and red signs would later be seen as far away as London and Tokyo.Fans flocked to the stores, attracted by a relaxed atmosphere where it was easy to bond with other music aficionados. Solomon did not have a dress code for employees, who mixed easily with customers."If you came into town, you went into Tower Records," Bruce Springsteen said in a documentary about the company called "All Things Must Pass."Solomon told Billboard Magazine in 2015 that his favorite regular was Elton John."He probably was the best customer we ever had," Solomon said of the pop star. "He was in one of our stores every week, literally, wherever he was -- in L.A., in Atlanta when he lived in Atlanta, and in New York."The chain thrived on massive demand for physical music -- first records and then CDs. Solomon built sprawling mega stores where fans could find everything from pop hits to obscure albums.But the retailer was soon undermined by dramatic changes in the music industry.The rise of music sharing sites such as Napster put it under pressure, and the company's debt ballooned. Tower declared bankruptcy in 2004, and was liquidated in 2006."The banks said 'we don't need a visionary,'" Solomon lamented in "All Things Must Pass," which was directed by Colin Hanks."When we met Russ," Hanks told Billboard in 2015, "it took less than a second to realize this guy is a great character and one of the most humble people I had ever met."  2180

The Florida Panthers have hired Brett Peterson as an assistant general manager, making him the first Black executive to hold that position in the NHL. "I'm very excited for this opportunity with the Panthers and with Bill's growing front office team," said Peterson in a press release. "It's a special day for myself and my family and I can't wait to get to work."Peterson's hiring comes days after the nearby Miami Marlins hired Kim Ng as the first female GM in Major League Baseball. The NHL has been working to increase minority participation in front offices and on coaching staffs. Peterson has a background as a player agent just like GM Bill Zito and fellow assistant Paul Krepelka. The 39-year-old was previously vice president of hockey for Wasserman Media Group and has been an NHLPA certified agent since 2009.Peterson also played professional hockey and made it up as far as the American Hockey League level. He also played at Boston College and won a National Championship with them in 2001. 1012

The Franklin Park Zoo announced its newest member of their family: a baby boy gorilla.On Tuesday, the zoo said the baby, who is the first male baby gorilla born at the zoo, was delivered via Cesarean section by veterinarians and physicians.The Zoo New England, which operates Franklin Park Zoo, said in a press release that Kiki needed the procedure after noticing that western lowland gorilla mom Kiki was experiencing vaginal bleeding days before her due date."The veterinary team at Zoo New England became concerned that she may have placenta previa, a condition where the placenta lies over the entrance to the cervix, blocking the path for delivery of the baby," zoo officials said in the release.After conducting an ultrasound on Kiki, which confirmed she had placenta previa, the zoo's veterinary team and Brigham and Women's Hospital and Cummings School of Veterinary Medicine at Tufts University specialists performed a C-section.And after a quick and smooth surgery, Kiki gave birth to a 6-pound baby boy. 1023