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The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___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. 6274

The video streaming service Netflix has been indicted by a grand jury in Texas over the film “Cuties,” alleging the company used “lewd” images."Cuties" is a French film that follows the story of an 11-year-old Senegalese immigrant in France who rebels against her family's Muslim traditions and joins a free-spirited dance crew.The film, directed by Ma?mouna Doucouré and originally called “Mignonnes”, won a directing award at Sundance Film Festival earlier this year.A Tyler County, Texas grand jury moved to return an indictment against Netflix last month, according to multiple media reports.The complaint alleges Netflix knowingly promoted visual material which “depicts the lewd exhibition of the genitals or public area of a clothed or partially clothed child who was younger than 18 years of age at the time the visual material was created, which appeals to the prurient interest in sex, and has no serious, literary, artistic, political, or scientific value.”In response, Netflix stated “‘Cuties’ is a social commentary against the sexualization of young children,” according to a statement in Deadline. “This charge is without merit and we stand by the film.”Netflix was reportedly served a summons October 1.Earlier this summer Netflix was forced to apologize for what they called “inappropriate art work” used to promote the movie on their service.The main image Netflix originally used shows the four lead actresses, all girls, wearing black and turquoise dance outfits revealing their stomachs and most of their legs, while posed mid-dance.The images used in France for the film show the girls walking down the street holding shopping bags.The film is recommended for 16+, according to Netflix. The image and description for the film have been updated in Netflix.The poster sparked outrage online, and with some comparing the poster to pedophilia. In the days following the release of the artwork, thousands had signed a Change.org petition calling for the film to be removed from Netflix. The film is now available on the service.Doucouré said the film is based in part on her own childhood experiences, and those of girls growing up today.“This is most of all an uncompromising portrait of an 11-year-old girl plunged in a world that imposes a series of dictates on her.” She said in an interview with Cineuropa.She continued that it is important to not judge these girls, but to understand them, listen to them and give them a voice. 2458

The suspect in the Pittsburgh synagogue massacre faces 44 federal charges -- most of them death penalty offenses -- in the slaying of 11 worshippers during last weekend's Shabbat services, according to a grand jury filing released Wednesday.Included are 11 counts each of obstruction of free exercise of religious belief resulting in death and use of a firearm to commit murder during a crime of violence.Thirty-two of the charges are punishable by death, according to the indictment.The suspected gunman, Robert Bowers, is accused of targeting the Saturday morning services at the Tree of Life synagogue after making anti-Semitic posts online. 652

The suspect in the shooting deaths of two people at Central Michigan University is in custody, police reported early Saturday. Police spent most of Friday searching for a 19-year-old person of interest after two people were shot and killed on the campus of Central Michigan University on Friday. Scripps station WXYZ in Detroit is reporting that the victims are the suspect's parents.James Eric Davis Jr. is the suspect in the deaths of his parents James Davis Sr. and his wife, Diva Davis. Davis Sr. is a part-time police officer in Illinois in Chicago. Police later confirmed the identities of the victims.  652

The woman involved in the domestic violence charge against NFL linebacker Reuben Foster said the Washington Redskins' decision to pick him up just days after his arrest felt like "a slap in the face.""I just couldn't believe somebody picked him up in less than -- how many hours?" Foster's ex-girlfriend, Elissa Ennis, said Thursday on ABC's Good Morning America, or GMA. "Like, I was shocked."The interview came more than a week after Foster, 24, then a linebacker for the San Francisco 49ers, was arrested and charged with one count of first-degree misdemeanor domestic violence in Tampa, Florida. Ennis, 28, reported that Foster pushed and slapped her during an encounter on November 24 at a hotel, police said.Ennis' attorney, Adante Pointer, released photos of Ennis' injuries after the assault."After having endured this relationship and then watching her name be tarnished in the press and then watching this person, from her perspective, go unpunished, she wanted to make sure that her side of the story got out," Pointer said.Ennis told GMA it was the third time an incident like this one had happened, including a February case in Los Gatos, California, that resulted in a criminal charge against Foster that was later dismissed and another occasion in October when "neighbors called the police."CNN reached out Thursday to Foster for comment. He has not commented publicly since the November arrest.The 49ers released Foster the morning after the latest incident. Days later, the Redskins picked him up on waivers.The NFL said Foster has been placed on the commissioner's exempt list, which means he cannot practice or play with the team as the league reviews his arrest.Still, the move to immediately hire a player twice arrested for domestic violence sparked widespread outrage for a league that has struggled to deal with several players committing violence against women. Another NFL player, Kansas City Chiefs running back Kareem Hunt, was released last week after video showed him pushing and kicking a woman in a Cleveland hotel.  2061

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