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The current spike in COVID-19 cases is stressing the testing system across the country.As the virus spreads at unprecedented rates, more Americans are seeking COVID-19 tests. But in recent days, companies that make the tests and the supplies needed for them are struggling to keep up with demand."Those companies were operating on an allocation basis, and that just means that basically everything they make is going out the door," said Kelly Wroblewski, the Director of Infectious Disease Programs at the Association of Public Health Laboratories. "There is no reserve, so there's an increased demand in a lab for testing. There's no more reagent to be had, so to meet that demand, that lab has to use a different manufacturer's test."Wroblewski adds that along with issues in getting supplies, officials are also short on human resources — there is only so much lab capacity and only so many trained people to conduct the tests.The American Clinical Laboratory Association says the surge in demand for testing means some labs could reach or exceed their current testing capacities soon — meaning it could take longer for patients to get PCR test results back.Wroblewski says that it can take currently take anywhere from 24 hours to a week to get PCR test results back.With antigen tests, patients can get results back in less than 30 minutes. There is currently enough of a supply for antigen tests, but not all facilities offer them.Both lab groups stress that COVID-19 testing is important, but patients should be strategic."There's been a lot of emphasis put on testing, but testing is only one piece of the puzzle," Wroblewski said. "It gives you some information, and if you're not going to do anything with that information — whether it be targeted closures. whether it be staying home and isolating — we're not going to stop the spread of disease."As far as getting more tests, it's going to take a while. Wroblewski says it could take up to six months or more to increase production capacity significantly. Labs don't expect to see a ramp-up in supplies until early 2021. 2090
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 data firm that misused Facebook user data and had ties to President Donald Trump's 2016 election campaign is closing.The SCL Group, a British affiliate of Cambridge Analytica, will also shut down, the Wall Street Journal reports.WSJ says "a person familiar with the matter" said the company is losing clients and has mounting legal fees as a result of the Facebook issue.Cambridge Analytica issued a news release on Wednesday announcing it is ceasing operations in the U.K. and U.S."Parallel bankruptcy proceedings will soon be commenced on behalf of Cambridge Analytica LLC and the certain of the Company's U.S. affiliates in the United States Bankruptcy Court for the Southern District of New York," the release states.In his keynote address at the F8 summit on Tuesday, Facebook CEO Mark Zuckerberg addressed ongoing data privacy scandals, including election meddling issues and fake news problems. He said the company must keep a sense of optimism as it tackles the issues.Facebook announced it will soon launch a new privacy feature that will allow users to clear their browsing history of Facebook, including what websites they have visited and what they click on. 1212
The FBI held an unforeseen news conference on Wednesday to say that Iran and Russia have been leading a misinformation campaign ahead of this year’s election.Although the sudden nature of Wednesday’s news conference made the announcement seem urgent, intelligence community officials have been warning of interference by Iran, China and Russia for months.Director of National Intelligence John Ratcliffe said that the countries obtained voter registration information, and then used that data to direct misinformation toward voters. Ratcliffe, along with FBI Director Christopher Wray, would not take any questions.Voter registration information is generally public information. Information like voters’ names, addresses and voting history are generally available nationwide. It is unclear if Iran and Russia received information that is publicly available."We have already seen Iran sending spoofed emails designed to intimidate voters,” Ratcliffe said.Ratcliffe claimed that the emails worked to hurt Trump's campaign, but House Democrat Ted Lieu, a member of the Intelligence Committee, questioned how the emails were intended to hurt Trump's campaign. 1164
The Daily Mail released leaked footage of the fatal Memorial Day arrest of George Floyd, who died while in the custody of Minneapolis Police.The Daily Mail did not indicate how it received the leaked body worn camera videos of the arrest. Prosecutors told CNN they are working to find the source of the leak. Several media outlets have sued prosecutors in order to gain access to the body-worn camera footage from the officers."The prosecution team is not the source of the leak. We will continue to take the strictest precautions to ensure a fair trial," Minnesota Attorney General Keith Ellison said.The Daily Mail said the footage was taken from the body cameras of Thomas Lane and Alex Kueng. Lane and Kueng along with Derek Chauvin and Tou Thao were fired as officers and criminally charged for Floyd’s death. Chauvin is facing the most serious charges, which include second-degree murder. The other three former officers are being charged with aiding and abetting a second degree murder. Chauvin was the officer that held a knee to Floyd’s neck for several minutes, leading to his death.The footage shows officers pointing weapons at Floyd in order to get him to exit his vehicle and put up his hands. The video then shows Floyd pleading with officers not to shoot him.“I'm not going to shoot you,” Lane says.The footage showed Floyd in an apparent struggle with officers as officers repeatedly asked Floyd to sit.As Chauvin laid on Floyd’s neck, Floyd could be heard telling officers, “Tell my kids I love them. I'm dead.”To view the full video, click here. 1572
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