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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 City of Columbus took down a Christopher Columbus statue from in front of City of Hall on Wednesday, removing what Mayor Andrew Ginther called a symbol of “patriarchy, oppression and divisiveness.”Ginther announced the decision to remove the statue on June 18."That does not represent our great city, and we will no longer live in the shadow of our ugly past,” Ginther said. “Now is the right time to replace this statue with artwork that demonstrates our enduring fight to end racism and celebrate the themes of diversity and inclusion.”The statue, which was a gift from the people of Genoa, Italy, in 1955, will be placed in safekeeping at a secure city facility. The city asked the Columbus Art Commission to launch a community-driven process that embraces diversity. This process would determine how to best replace the statue while evaluating other monuments and art installations on their diversity and inclusiveness.The Arts Commission will also help determine the final disposition for the statue, working with the community to determine, in the proper context, if it should be displayed elsewhere to help future generations understand the ongoing conversations about racism and why leaders ultimately decided on its removal.“By replacing the statue, we are removing one more barrier to meaningful and lasting change to end systemic racism,” said Ginther. “Its removal will allow us to remain focused on critical police reforms and increasing equity in housing, health outcomes, education and employment.”This story originally reported by Kaylyn Hlavaty on news5cleveland.com. 1597

The daughters of the late singer-songwriter Oscar Brown Jr. said Monday that President Donald Trump is twisting the lyrics of their father's song titled, "The Snake" for politics."Oscar Brown Jr.'s words are being stolen to promote his hate message and intolerance," Africa Brown told CNN's Don Lemon on "CNN Tonight." "And it's absolutely wrong."The song tells the story of a woman who takes in a frozen snake she finds on her way to work. After the snake is nursed back to health, it bites the woman and kills her.  530

The Democratic National Committee is eyeing eight American cities for its 2020 Democratic National Convention, a party official tells CNN.The DNC sent requests for proposals to a host of cities and received responses from eight: Atlanta; Birmingham, Alabama; Denver; Houston; Miami Beach; Milwaukee; New York; and San Francisco."The DNC sent the original letters of interest to a broad list of cities that have traditionally been able to meet the preliminary requirements for serving as a host," the official said. "We expect the entire selection process to play out over the next year."The site of the convention often serves as either a symbolic representation of where the party hopes to perform well in the presidential run or an area that represents certain values the party is looking to project.The official also said the party will consider event facilities in each city, transportation options and hotel accommodations.The Republican National Committee plans to announce its 2020 convention site by the end of summer, committee leaders told members earlier this month.The Republicans have kept quiet about the cities they are considering. But Trump campaign manager Brad Parscale has signaled interest in his hometown of San Antonio, and The Charlotte Observer reported that Charlotte, North Carolina, had presented a bid to the RNC.The Democrats held their 2016 convention in Philadelphia. While the selection is considered an honor and a boon for business, it is also regularly a logistical nightmare.Some of the cities being considered by the Democrats would be repeat hosts, including New York, which has hosted five times, most recently in 1992.Atlanta hosted in 1988, Denver hosted in 1908 and 2008, Houston hosted in 1928, Miami Beach hosted in 1972 and San Francisco hosted in 1920 and 1984. 1826

The former police officer who knelt on the neck of George Floyd prior to Floyd's death in May has been released on bail, according to WCCO-TV and The Washington Post.Bail in his case had been set at .25 million, or million with conditions, according to WCCO. NBC News reports that Chauvin's release was conditional.Chauvin has been charged with second-degree murder, third-degree murder and manslaughter in connection with Floyd's death.Three other former police officers — J. Alexander Kueng, Thomas Lane and Tou Thao — face charges of aiding and abetting murder and manslaughter.Floyd's death sparked nationwide protests against systemic racism and police brutality across the country throughout the summer.Ben Crump, a civil rights attorney who has been working with the Floyd statement, decried Chauvin's release. ”Derek Chauvin’s release on bond is a painful reminder to George Floyd’s family that we are still far from achieving justice for George," Crump said in a statement. "The system of due process worked for Chauvin and afforded him his freedom while he awaits trial. In contrast, George Floyd was denied due process, when his life was ended over a bill. There was no charge, no arrest, no hearing, no bail. Just execution. Although George Floyd was denied justice in life, we will not rest until he is afforded full justice in death. The civil litigation team looks forward to our day in court.” 1426

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