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The Food and Drug Administration issued an emergency use authorization on Tuesday to a rapid at-home coronavirus test, the first of its kind to receive such an approval.The Lucira COVID-19 All-In-One Test Kit tests can be administered at home via nasal swab. Within 30 minutes, a test display will light up to give the patient’s results. The FDA says that those who receive a negative COVID-19 test but display symptoms should continue to quarantine as a negative test does not preclude someone from having the virus.Those ages 14 and over can self-administer the test at home. Juveniles must have the test administered by a health care professional.“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”Previously, the only at-home tests for the coronavirus required samples to be sent to a lab, which meant the time to get results was significantly delayed. 1342

The FBI raid on President Donald Trump's personal attorney Michael Cohen sought information that included payments allegedly made to keep women silent about affairs with Trump more than a decade ago.A source familiar with the matter told CNN Tuesday that a focus of the raid was to seek records on the deal set up between ex-Playboy Playmate Karen McDougal and a company that reportedly paid her amid the 2016 presidential campaign cycle to keep her account from publication. 483

The driver of a rental truck drove down a busy bicycle path in New York near the World Trade Center, killing eight people and injuring about a dozen others in what officials said was an "act of terror."After crashing the truck into a school bus, the suspect exited the vehicle while displaying imitation firearms and was shot in the abdomen by a police officer, according to the NYPD.The suspect, a 29-year-old man, is in police custody and was taken to a hospital for treatment, officials said. 503

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 flu vaccine may have an important benefit beyond protecting against influenza: It may also prevent heart attacks, especially in those at high risk, experts say."It's been a long time that people have recognized that association with flu season and development of a heart attack," said Dr. Kevin Schwartz, an infectious disease physician at Public Health Ontario.When it comes to preventing heart attacks in people with cardiovascular problems, experts have put getting the flu vaccine on par with long-term measures such as quitting smoking or taking one's medication for high blood pressure.  610