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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 Susan B. Anthony Museum has something to say about President Trump’s recent decision to pardon the suffragette.“Objection! Mr. President, Susan B. Anthony must decline your offer of a pardon today,” the museum’s President and CEO Deborah Hughes posted online.President Donald Trump announced Tuesday that he would sign a pardon for Susan B. Anthony on the 100th anniversary of the ratification of the 19th Amendment.Anthony voted in a presidential election in 1872. She was arrested about a week later and eventually convicted of "knowingly, wrongfully, and unlawfully" voting without the right to do so. She was fined 0. 636

The stock market continued a September slide Monday, with the Dow Jones Industrial Average falling about 800 points at one point. The S&P 500 sank 1.2%, though a last-hour recovery helped it more than halve its loss from earlier in the day.The Dow Jones Industrial Average fell 509.72, or 1.8%, to 27,147.70 after coming back from an earlier 942 point slide. The Nasdaq composite slipped 14.48, or 0.1%, to 10,778.80 after recovering from a 2.5% drop.Monday’s downward movement was seen across many sectors, and market watchers point to multiple reasons.Multiple media outlets are reporting about documents indicating major banks around the world potentially ignored red flags and allowed millions to be transferred by questionable companies or individuals. Stock prices for banks, including JP Morgan Chase, fell on Monday. Many are worried about a spike in coronavirus cases and potential new “waves” of the virus; the United Kingdom announced they are seeing a sharp increase in cases.The recent death of Supreme Court Justice Ruth Bader Ginsburg and subsequent announcement a replacement could come soon means congress will be focused on hearings and the nomination process, and potentially not focused on any federal coronavirus relief aid, according to Marketplace.org.Without federal relief, economic experts have warned of a longer recovery. The Federal Reserve last week said the future of the U.S. economy remained uncertain.Over the weekend, China announced a new regulatory body that could blacklist foreign companies that put China’s national security at risk. NPR says this group could target U.S. tech companies operating in China, like Apple, Cisco, and others.Monday’s slide comes after a few weeks of stock market losses. September is historically the worst month for stocks, according to the Associated Press.“The market has been poised to just pull back, take a breather,” said Quincy Krosby, chief market strategist at Prudential Financial. “Raising capital is prudent during a month that is known statistically, historically for being difficult for the market.” 2095

The San Francisco 49ers released linebacker Reuben Foster on Sunday morning, hours after he was arrested on a domestic violence charge at a Tampa, Florida, hotel.Foster, 24, was arrested after Tampa Police officers responded to the Grand Hyatt hotel shortly after 9 p.m. Saturday, according to a release from the City of Tampa. The former first-round NFL draft pick was charged with one count of first-degree misdemeanor domestic violence and booked into the Hillsborough County Jail, the release says.Police said Foster's 28-year-old female companion reported that he "slapped her phone out of her hand, pushed her in the chest area, and slapped her with an open hand on the right side of her face."Officers observed a one-inch scratch on the woman's left collarbone, the release states. Investigating officers learned that Foster and the woman had lived together in the past and were in an on-again, off-again relationship over the past three years, the release says.The 49ers released Foster just hours before their scheduled game against the Tampa Bay Buccaneers.It was unclear Sunday morning whether Foster has retained an attorney.A college star at Alabama, Foster was the 31st overall pick in last year's NFL draft but has had several arrests since.He was charged with felony domestic violence in April for allegedly attacking his girflriend in February at their home, leaving her bruised and with a ruptured eardrum, the Santa Clara County District Attorney said. The charges were dismissed after the victim recanted her story, although the Santa Clara DA's office said the evidence demonstrated he "seriously hurt his girlfriend."The NFL had suspended him without pay for the first two games of this season in relation to a weapons offense and a misdemeanor drug offense which were resolved earlier this year, the 49ers said in a statement on its website."I accept the League's decision and am sorry that my mistakes have hurt my team," Foster said in July when the suspension was announced. "I have a responsibility to the 49ers, our fans and our community, and I am committed to learning from this situation and making better choices in the future. The support I have received over the last five months has been humbling, and I do not take it for granted."49ers General Manager John Lynch said at the time that they supported the league's decision to suspend Foster and hoped he had learned his lesson."Although we are disappointed that Reuben will not be with our team for the first two games of the season, we will continue to work with him on making better decisions and eliminating unnecessary distractions," Lynch said. "We are encouraged to see Reuben take responsibility for his mistakes, and hopeful that he has learned from them as well."In his two seasons with the 49ers Foster played in 16 games and recorded 84 tackles. 2850

The summer of 2020 has been one marred by civil unrest in the U.S. Since the death of George Floyd at the hands of police on Memorial Day weekend, thousands of protests have taken place across the country calling for police reform and an end to systemic racism.While some of those protests have resulted in burned buildings and looted businesses, a non-profit group reports that the overwhelming majority of Black Lives Matter protests in 2020 have been peaceful.According to a report from the Armed Conflict Location and Event Data Project (ACLED), there were nearly 8,000 demonstrations linked to the Black Lives Matter movement between May 26 and Aug. 22 — 93% of which were peaceful.The ACLED, which sources information via reports from the media, reports from government and non-government agencies as well as targeted social media reports, says that Black Lives Matter protests took place in more than 2,000 locations — including in all 50 states — between late May and August. Most places that saw protests that devolved into riots also saw several other peaceful demonstrations.The organization also notes that in places where riots were widespread, like Portland, that the vandalism was limited to the span of a few square blocks.The ACLED's findings contradict the findings of pollsters, who report that as many as 42% of Americans believe most Black Lives Matter activists are "trying to incite violence or destroy property." The ACLED believes that disparity comes from "biased media framing" stemming from "disproportionate coverage of violent demonstrations."And while BLM demonstrations have been largely peaceful, the ACLED reports that local governments have disproportionately responded with force. About 1 in 10 BLM protests were met with government intervention — a 6% increase when comparing government intervention in all other demonstrations. In half of those interventions, police used tear gas, rubber bullets, pepper spray or batons while attempting to force protesters to disperse.While not the case in every violent protest, the ACLED reports that some riots were instigated by "agents provocateurs," or outside infiltrators. For example, a man with an umbrella who committed early acts of vandalism in Minneapolis has since been linked to Hells Angels.The Black Lives Matter protests have also sparked a conversation about statues dedicated to Confederate leaders or those with colonialist or slave-owning pasts. The ACLED found 38 instances in which protesters toppled such statues, though local governments across the country have peacefully removed dozens of similar monuments on their own.The ACLED aggregates data from political conflicts around the world. According to the group's webpage, the non-profit organization receives some funding from the State Department. 2810