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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 walk to school turned terrifying for a Rochester, Michigan teen who says he was shot at after he stopped to ask for directions.Fourteen-year-old Brennan Walker missed the bus and tried to walk to school, but got lost after he couldn't remember the route.The freshman wasn't hit, as the shot missed him as he ran away.The situation began when Walker's alarm didn't go off. After missing his bus, he thought he could walk the roughly 4 miles to school.Once he became lost, he stopped at a home and knocked."I knocked on her door a few times and she came down yelling at me before I could say anything and she thought I was trying to break into her house," he said. "I was trying to explain to her that I wanted to get directions to go to my school. I told her no, I go to Rochester High I’m just looking for directions to Rochester High."Walker and his mother, Lisa, say the security video from the home shows the woman then yelled for her husband."The man of the house came down, pretty much just grabbed the shotgun to shoot at my son," says Lisa Walker."I saw it. I saw him holding it like this through the window and I guess I put my hand up, I don’t really remember, and I started to run," Brennan Walker says. "I looked back behind me I saw him aiming at me and I turned back. I turned back and I heard the gunshot. And I tried to run faster."The man has been taken into police custody."If someone is running from your house and chase them outside and shoot at them, you’re going to have criminal charges coming from us," Oakland County Sheriff Michael Bouchard said.Both Walker and his mother believe race was a factor in the incident."After watching the video and hearing the wife say 'why did these people choose my house' I knew it was racially motivated. I don't know what other these people she could possible have been talking about. He was by himself," Lisa Walker said."I didn’t want to believe that that type of stuff could happen here," said Brennan, who said he is just trying to process the shock of what happened."I don't, I don't know how you process getting shot at for asking for directions," he says. 2159

The South Carolina Education Lottery reported on its website early Wednesday morning that one winning ticket was sold in its state.Mega Millions announced the win in a statement early Wednesday."The moment we've been waiting for finally arrived, and we couldn't be more excited," said Gordon Medenica, lead director of the Mega Millions Group and Director of Maryland Lottery and Gaming. "This is truly a historic occasion. We're so happy for the winner, and we know the South Carolina Education Lottery can't wait to meet the lucky ticket holder."The Mega Millions jackpot on Tuesday reached .573 billion, the game's largest-ever grand prize but not quite the nation's biggest prize of all time. A Powerball prize in 2016 was for .586 billion. The winning numbers on Tuesday were:28-70-5-62-65 and the Mega Ball was 5.Had a winning ticket not been sold on Tuesday, Friday's jackpot would have reached billion. Winning Tuesday's entire jackpot means either taking the .6 billion winnings in annuity payments spread over 29 years, or taking the lump sum of 3 million.  1112

The student shot at a North Carolina high school Monday morning has died, police say.The shooting occurred in a Butler High School hallway and stemmed from a fight between the victim and the suspect, said Stason Tyrrell, Patrol Commander for the Matthews Police Department.The suspected shooter, also a student, is in custody, Tyrrell said.No one else was injured.Parents were able to pick up their children, but classes resumed in the afternoon for students wishing to stay, said Yaviri Escalera, spokeswoman for Charlotte-Mecklenberg Schools.Matthews is located about 22 miles southeast of Charlotte.The-CNN-Wire 622

The US Supreme Court has ruled in favor of Black Lives Matter protest organizer Deray Mckesson.A Louisiana police officer had sued to hold Mckesson accountable for injuries the officer sustained in 2016 when he was hit by a heavy object.Mckesson didn't throw the object.The person who did is still unidentified.A lower court ruling had allowed the suit to move forward.Critics said the decision would dismantle the Civil Rights era precedent safeguarding the first amendment right to protest.The Supreme Court's decision wiped away the earlier ruling, sending the case back to the lower courts to further review Louisiana law.The justices ruled the case needed more guidance from state courts before important constitutional questions are considered. 758