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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 winds were so strong on July 26 in Redding, California, authorities say they uprooted trees, ripped roofs off houses and downed power lines.The fast-moving Carr Fire took three family members from Ed Bledsoe that day -- his wife and two great-grandchildren."The tornado was hovering over the house," Amanda Woodley, Bledsoe's granddaughter, told CNN. "It was just a tornado fire over the house."Bledsoe had left the house earlier to go to the doctor's office, and was on the phone with his family members as the flames closed in. They believed they were safe from the fire and knew nothing of the approaching hellscape that was like nothing any of them had ever seen before.He said his son drove toward the flames in the hope of rescuing his family members. "My son said the grass wasn't on fire, the trees were getting sucked up in the air and burning," Bledsoe told CNN. "He said when he opened his doors, the leaves hit him like somebody was slapping him. He said it was sucking his breath out, and he got back in his car and tried to get out."Bledsoe was on the phone with his wife and great-grandchildren until the very end."It sucked the roof off the house and the walls fell out and the roof went right down on them," he said.The Carr Fire, now the sixth most destructive fire in California history, has consumed 121,000 acres and killed six people.Dr. Craig Clements of San Jose State University's Fire Weather Research Laboratory said there have been few observed firenadoes of this magnitude before. He says the conditions have to be perfect for something like this to occur.Firenadoes are formed from a fire's intense heat, causing the air to heat up quickly and rise rapidly. That, combined with surface winds that are obviously quite strong, creates a vortex similar to a dust devil.Clements says aside from the potentially damaging winds, a firenado like this can even pull fire in different directions.At 3:27 p.m. that day, the National Weather service sent out a statement noting that "radar indicates strong rotation located within the intense fire activity of the Carr Fire." They warned of possible wind gusts up to 50 mph."The wind went from zero wind to 40 to 60 mph winds within 15 minutes," Justin Sanchez told CNN. He said his house was consumed by the firenado. "(There was) a loud disturbing deep growling noise as it spun around in a spiral. It seemed the outside was moving around so slowly, with two-foot sized pieces of debris floating in it."Sanchez says when he and his family were about a mile and a half from his home, they looked back and could see their neighborhood consumed by it. 2631

The White House, after a day of uncertainty, confirmed Wednesday that deputy national security adviser Mira Ricardel is leaving her position.She will remain in the administration.In a statement, press secretary Sarah Sanders said, "Mira Ricardel will continue to support the President as she departs the White House to transition to a new role within the Administration. The President is grateful for Ms. Ricardel's continued service to the American people and her steadfast pursuit of his national security priorities."Sources said the President told advisers Tuesday that he had decided to fire her.The decision comes a day after first lady Melania Trump's office issued a surprising statement calling for Ricardel to leave the White House. 750

The Weinstein Company, the studio co-founded by disgraced movie mogul Harvey Weinstein, has filed for bankruptcy and torn up legal contracts that kept sexual harassment victims from speaking out.The company said late Monday that it will release victims of, and witnesses to, Weinstein's alleged misconduct from any non-disclosure agreements."Effective immediately, those 'agreements' end," the company said in a statement. "No one should be afraid to speak out or coerced to stay quiet," it added.The Weinstein Company was crippled by the sexual harassment and assault allegations first made against Weinstein last year.Now the studio has reached a deal with the private equity firm Lantern Capital Partners. Lantern is looking to acquire Weinstein Co. through the bankruptcy process.The initial bankruptcy paperwork was filed on Monday night."While we had hoped to reach a sale out of court, the Board is pleased to have a plan for maximizing the value of its assets, preserving as many jobs as possible and pursuing justice for any victims," Bob Weinstein, Harvey Weinstein's brother and chairman of the company, said in a statement provided to CNNMoney.Other bidders could come forward and try to top Lantern's bid for the Weinstein Co. assets.The filing estimates the Weinstein Co. businesses are valued between 0 million and billion.New York Attorney General Eric T. Schneiderman had been pushing for this outcome for several months."This is a watershed moment for efforts to address the corrosive effects of sexual misconduct in the workplace," Schneiderman said Monday night. "The Weinstein Company's agreement to release victims of and witnesses to sexual misconduct from non-disclosure agreements -- which my office has sought throughout this investigation and litigation -- will finally enable voices that have for too long been muzzled to be heard."To date, dozens of women have accused Weinstein of abuse, following reports in the New York Times and the New Yorker last year about his treatment of women, including some of those with whom he's worked. Weinstein has been accused of rape, assault and other forms of sexual misconduct.He sought treatment after the allegations were made public. Through a representative he has repeatedly denied allegations of "non-consensual sex."Monday night's press release from the company said Weinstein Co. "regrets that it cannot undo the damage Harvey Weinstein caused, but hopes that today's events will mark a new beginning."The bankruptcy filing came after a deal to sell the studio's assets fell apart earlier this month.An investment group led by Maria Contreras-Sweet, the former head of the U.S. Small Business Administration, had been close to acquiring all of the company's assets for 0 million but negotiations fell apart at the last minute.Schneiderman's office had been helping to mediate the deal talks.Schneiderman's civil suit against Weinstein Co., Bob Weinstein, and Harvey Weinstein remains active and the investigation is ongoing, his office said Monday.The bankruptcy was announced on the same day New York Gov. Andrew Cuomo directed Schneiderman to review the Manhattan district attorney's handling of a 2015 sexual abuse case involving Weinstein.This week's New York magazine features a story questioning why D.A. Cyrus Vance Jr. hasn't prosecuted Weinstein.Time's Up, the female-led organization formed in the aftermath of the Weinstein scandal, responded to the story by calling for a probe into Vance and his office "to determine the facts related to the decision not to prosecute Harvey Weinstein for sexual abuse crimes against one of his accusers, Ambra Battilana."Back in October, The New Yorker?released an audio recording of Weinstein speaking with young model Ambra Battilana Gutierrez as part of a 2015 sting operation. The NYPD set up the sting after Gutierrez told authorities that Weinstein groped her the day before.In the recording, Weinstein makes potentially incriminating comments to Gutierrez, but he was not arrested or charged with a crime at the time.After the tape's release, the New York Police Department and the Manhattan DA's office traded public finger-pointing. But on Monday, Vance and the NYPD released a joint statement reiterating their shared commitment to investigate and prosecute sexual assault cases.Vance has also faced criticism for accepting a ,000 donation from David Boies, an attorney who has represented Weinstein, in August 2015, according to campaign financial disclosure forms from the New York State Board of Elections.Vance's office said Monday that "our investigation of Mr. Weinstein is active and ongoing."That response didn't seem to satisfy Cuomo. He answered Time's Up's call and referred the matter to Schneiderman's office, instructing the A.G. to review Vance's handling of the Battilana case "in a way that does not interfere with the current investigation..."Schneiderman welcomed the opportunity, saying, "We are committed to pursuing a full, fair, and independent review of this matter."The-CNN-Wire 5076

The swarm happening now south of the Salton Sea, near Westmoreland is over 30 km south of the end of the San Andreas. It is in the Brawley seismic zone, a common source of swarms. So far largest is M4.4. Too far from the San Andreas to change the probability of a quake on it.— Dr. Lucy Jones (@DrLucyJones) September 30, 2020 340