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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 Geminid meteor shower peaks this week, so hope for clear skies that will let you see a beautiful show of green fireballs on Thursday and Friday. This will be the last -- and strongest -- meteor shower of the year, according to NASA.This phenomenon was first recorded in 1862 and causes a show each December.In the hours before sunrise Friday, the most meteors will be visible in the North American sky, peaking about 7:30 a.m. ET, predicts Sky & Telescope. To see when they will peak in your part of the world, check here.But the morning isn't your only chance. On Thursday and Friday, keep an eye on the sky a few hours after sunset -- just keep the moon at your back.Although the Geminid shower is known for its "shooting stars," the number of meteors visible depends on the time and how dark it is. There will be fewer of them earlier in the evening, but the shower should hit a maximum of about 100 per hour around 2 a.m., NASA said. For those in the suburbs, expect about 30 to 40 per hour. And if you're in a city like New York, San Francisco or Atlanta, you probably won't see anything.Early evening meteors may be longer, with dramatic streaks that last several seconds. Later on, the meteors will present quicker streaks or leave trails of smoke that appear to glow.The asteroid 3200 Phaethon is responsible for this meteor shower, which is unusual because comets usually create meteor showers with icy debris. Scientists have debated the very nature of what Phaethon is. The closely tracked near-Earth asteroid has been likened to comets, so it's been called a "rock comet."Phaethon was discovered in October 1983 and named after the Greek myth about the son of Helios, the sun god, because it closely approaches our sun.Phaethon orbits the sun closer than any other asteroid and takes 1.4 years to orbit it. The asteroid heats to about 1,300 degrees Fahrenheit on closest approach to the sun, which causes it to shed dusty debris.These particles cause the meteor shower when they plunge into Earth's atmosphere at 22 miles per second, vaporizing in the streaks we call "shooting stars."If you live in an urban area, you may want to drive to a place that isn't littered with city lights that will obstruct your view. If you're able to find an area unaffected by light pollution, meteors could be visible every couple of minutes from 10 p.m. until dawn.Find an open area with a wide view of the sky, and don't forget to bundle up. Make sure you have a chair or blanket so you can look straight up. And give your eyes about 20 to 30 minutes to adjust to the darkness -- without looking at your phone -- so meteors are easier to spot.While you're keeping an eye out for the meteor shower, you might see a small, foggy green patch in the sky, NASA said. That will be Comet 46P/Wirtanen, which is making its closest approach to Earth -- within 7 million miles -- for the next 20 years. And it will be visible to the naked eye. The comet is expected to come closest to Earth and peak Sunday. 3007

The coronavirus pandemic is forcing school districts that choose to reopen for in-person learning to do so with precautions.While many school corporations have posed ideas for protocols, not all have decided on a final plan.In the animation above, we imagine what a day at school might look like, using ideas from districts around the United States. 357

The Emmy Awards will be held live, and socially distanced, Sunday night to celebrate excellence in the television industry. It will be the first big Hollywood event broadcasted live amid the pandemic.Jimmy Kimmel will host from the Staples Center in Los Angeles. Other celebrities taking part include Morgan Freeman, Lin-Manuel Miranda, D-Nice, Patrick Stewart, Jason Bateman, Laverne Cox, Abbi Jacobson, RuPaul and Oprah Winfrey.Rather than using taped segments or elements like other awards shows this year, the Emmys will be using 130 cameras in 20 cities in ten countries to achieve a live show.Some of the nominees will be participating from home, surrounded by friends and family.Show producers are not expecting things to go smoothly, telling CNN Kimmel will be available throughout the night to “jump in as soon as anything goes wrong," producer Reginald Hudlin said.And what will Kimmel do? “If something happens technically, I will be touching upon all the skills I’ve acquired over the course of my life. I know one magic trick. I can kind of juggle. I guess I could draw caricatures of the crew,” Kimmel told The Hollywood Reporter.The 72nd Emmy Awards will air Sunday at 8 p.m. ET on ABC. 1209

The Dow Jones Industrial Average closed at a record high Monday, erasing the last of its pandemic losses, after a second drug company announced encouraging progress on developing a coronavirus vaccine. The Dow Jones closed at 29,950, topping the previous record set back in February. The Dow Jones has completed a long comeback after losing nearly 35% of its value over the course of six weeks during the onset of the coronavirus pandemic. While the Dow rallied at the end of spring and start of summer, the markets were sluggish in their recovery until the start of November. The S&P 500 added to the record high it reached last Friday. The Dow rose 1.6% and the S&P 500 added 1.2% after Moderna said its COVID-19 vaccine appears to be 94.5% effective, according to preliminary data. It comes just a week after Pfizer and BioNTech gave similarly encouraging numbers about their own vaccine candidate. Stocks of companies that would benefit the most from the economy climbing out of its recession led the way higher. 1032

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