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The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256

The caddies for Graeme McDowell and Brooks Koepka have tested positive for the coronavirus. And now both major champions have decided to withdraw from the Travelers Championship. Both say they are withdrawing to protect the rest of the field.McDowell says it feels like the snowball is getting bigger.On Tuesday, the PGA Tour announced that Cameron Champ withdrew after testing positive for the deadly virus. 416

The Danish government said they plan to kill 15 million minks after the animals spread a coronavirus mutation to humans.In a press release, Prime Minister Mette Frederiksen said that a mutation of the virus has already spread from the infected minks to 12 people in North Jutland.Frederiksen added that the virus could spread to other countries and "carry the risk that the upcoming vaccine will not work as it should.""Denmark has a responsibility to our population," Frederiksen said in the news release. "With the mutation that has now been established, we now also have a greater responsibility for the rest of the world. A mutated virus risks being spread from Denmark to other countries. Therefore, we must take the situation on the Danish mink farms extremely seriously." 786

The campaign ads are airing every set of commercials on the major television networks right now: Election Day 2018 is here on Tuesday.How many seats are open in the House of Representatives? What is the minimum age a member of the House must be?Take our quiz to see how much you know about the United States' leadership and its duties. If you can't see it below, click here. 382

The coronavirus pandemic pumped up bicycle sales to the point that buyers confronted the first bicycle shortage in the U.S. since the 1970s. In tandem with that sales surge, bicycle theft has soared in a number of U.S. cities.As you might expect, the rise in bike ownership and theft has prompted more Americans to ponder insurance coverage for bicycles. That’s a particularly valid concern, since more than 2 million bikes are stolen each year in North America, according to Project 529. Pedal along as we examine the numerous spokes of bicycle insurance.How Are Bicycles Insured?Bicycles are covered under the personal property section of a standard homeowners or renters insurance policy. An insurer will reimburse you, minus your deductible, if you file a claim when your bike is stolen or when it’s damaged in a fire or other disaster that’s covered by your policy.Furthermore, homeowners and renters policies offer financial protection (under liability insurance) if you injure somebody or damage someone else’s property when you’re riding your bike.If your bike is damaged because you fall off or you collide with a tree, pedestrian or curb, it won’t be covered by your homeowners or renters insurance unless you add it separately to your policy. This is known as “scheduling” an individual item.If you’re riding your bike and are injured in a crash with a vehicle, your auto insurance policy would generally cover your medical bills under either personal injury protection or medical payments coverage, assuming you have one of those.Snejina Zacharia, founder and CEO of insurance marketplace Insurify, further notes that homeowners or renters insurance usually doesn’t cover a bike (or any of your possessions, for that matter) if it’s damaged or destroyed in a flood, earthquake or landslide.What Kind of Coverage Do I Need if I Own an Expensive Bike?The Insurance Information Institute suggests that if you own an expensive bike, you should ask about an add-on to homeowners or renters insurance known as an endorsement to boost your coverage. You also can explore a standalone bike insurance policy.Bike insurance policies usually provide broader and deeper coverage than homeowners or renters insurance policies do. For example, Markel’s bike insurance can cover things like crash damage, roadside assistance, spare parts and replacement-bike rentals, whereas a typical homeowners or renters insurance does not.Markel and another bike insurer, Velosurance, say their annual premiums start at 0. Markel’s average bike insurance policy costs 0 to 0 a year.Trusted Choice, a network of independent insurance agents, says you should look into standalone bike insurance if:You spent a lot of money on your bike. An everyday bike might cost roughly 0 to 0, while a specialty bike might go for more than ,000.You frequently ride off-road, potentially placing you and your bike at greater risk for harm.You compete at cycling events.You own a bike that’s been specially designed, upgraded or modified.You lack homeowners or renters insurance.You don’t have health insurance to cover injuries you might suffer in a cycling crash.Should You File a Claim if Your Bike Is Stolen or Damaged?If your bike is worth 0 but your homeowners or renters policy carries a 0 deductible, Zacharia recommends against filing a claim.“Not only will a claim increase your monthly premiums, but you won’t be getting anything in return. Essentially, it’s a lose-lose situation,” she says.If your bike is worth more than the deductible, calculate your potential claim check amount. If it’s small, it still probably isn’t worth filing a claim and risking a rate increase in the future that could cost you more over time.“It’s really about the balance between the cost of replacement and the increased cost on your monthly premiums. Some people might also say the hassle of making a claim is an additional downside,” says Zacharia.“Remember that your deductible matters,” Zacharia adds. “If your bicycle is worth 0 but your deductible is set at ,000, you’ll be paying out of pocket to replace it. It’s up to you where you set a deductible level. Just be prepared for the bill.”Registering Your BikeOne way to discourage bike theft—or at least have a better chance of getting your stolen bike back—is to engrave a serial number on it and register the number with the local police department. For example, New York City offers a bicycle registration program. 4472