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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 Cambridge Analytica?scandal has thrust Facebook privacy settings into the national conversation after the political firm used the personal data of about 50 million people without their consent.Now, Mozilla is helping Firefox users keep their Facebook data secure so they won't be exploited in the future.The company has introduced a Firefox extension that it says will make it much harder for Facebook to track which websites you browse.Facebook has developed a network of trackers that tell the social media site which of its users are visiting certain webpages, like online retailers. Facebook will then use that information to serve its users ads based on what products they've been viewing.Mozilla says its Facebook Container extension will make it much more difficult to track which websites you visit, and keep your browsing information private.Mozilla admits the extension isn't perfect. In a blog post, the company said that the extension would not have prevented user information from being abused in the Cambridge Analytica scandal. It also says that Facebook Container would not work well on sites which require you to use Facebook information to log in.But Mozilla says the simple step of downloading the extension is giving power back to internet users. "Troves of data are being collected on your behavior on the internet, and so giving users a choice to limit what they share in a way that is under their control is important," the company wrote.To download Facebook container, first download the free Mozilla Firefox browser if you're not already using it. Then, all you need to do is click this link and add the extension.Alex Hider is a writer for the E.W. Scripps National Desk. Follow him on Twitter @alexhider. 1763
The first person known to be cured of HIV infection, Timothy Ray Brown, has died. He was 54.Brown was long known as “the Berlin patient” for where his historic treatment took place.He died Tuesday at his home in Palm Springs, California, according to his partner.The cause was a return of the cancer that originally prompted the unusual bone marrow and cell transplants Brown received in 2007 and 2008, which for years seemed to have eliminated both his leukemia and HIV, the virus that causes AIDS.His case inspired more research toward a cure, something that many scientists had thought impossible until his example proved that it was. 645
The good news is Americans are getting COVID-19 test results back, on average, a day faster than they were over the summer. The troubling news, according to experts, is that it is still taking three days on average for Americans to find out their COVID-19 status and this is not quick enough to help with contact tracing and quarantine efforts to slow the spread.Researchers from several universities, including Harvard, Northeastern, Northwestern and Rutgers universities, have been collecting data and conducting surveys for months since the beginning of the coronavirus pandemic.“Prompt test results constitute the foundation of a successful COVID-19 containment strategy,” researchers state at the beginning of their paper.Data now shows, of the participants who got a test for the coronavirus in late September, the average wait time was 2.7 days.In early August, the group announced their survey data showed the average wait time nationwide was 4.1 days. More than 30 percent of participants reported, at the time, they didn’t get test results back until four days or longer.The percentage of people getting results within 24 hours is also increasing; the September survey showed 37 percent of people getting results back in one day, compared to 23 percent over the summer.“Rapid turnaround of testing for COVID-19 infection is essential to containing the pandemic. Ideally, test results would be available the same day. Our findings indicate that the United States is not currently performing testing with nearly enough speed,” researchers said.Disparities still exist for Americans who are Black or Hispanic. Although wait times are shorter for these groups as well compared to summer numbers, they are still, on average, a day or more longer than white test takers.In the latest survey, Black Americans reported waiting an average of 4.4 days for results, and Hispanics reported waiting 4.1 days. By comparison, white and Asian Americans reported wait times of 3.5 and 3.6 days on average, respectively.Also troubling for trying to control the spread of the coronavirus, the data shows how many of those who tested positive had some sort of conversation about contact tracing.“Only 56% of respondents who received a positive COVID-19 test say that they were contacted for the purpose of contact tracing,” the survey found.The survey talked to more than 52,000 people across all 50 states and the District of Columbia. 2434
The Department of Labor reported Thursday that 1.5 million Americans filed initial claims for unemployment during the week ending June 20, bringing a 14-week total to about 46.5 million claims.Thursday's figures were down about 20,000 from last week's unemployment filings. It marked the third straight week where unemployment claims have hovered at about 1.5 million.Weekly claims for unemployment have been falling for about three straight months after peaking at about 6 million a week in late March. But weekly unemployment claims remain historically high.Prior to the pandemic, the record high for weekly unemployment claims came in 2006, when 665,000 people filed for unemployment. The Department of Labor has been tracking the statistics since 1967.Economists often use weekly unemployment claims as a reliable tool when predicting unemployment. However, some surveys indicate that initial weekly claims may be underestimating the amount of those unemployed.At least one survey from the Economic Policy Institute found that millions of Americans gave up trying to seek benefits or didn't even attempt to due to states' overwhelmed and antiquated unemployment systems.The economy has improved slightly since the virus first arrived in the U.S. earlier this year. Every state had begun the process of restarting its economy as of earlier this month.However, new cases of COVID-19 are currently on the rise in many states, with reports of new infections nearing record levels — re-igniting fears that more lockdown restrictions could be on the way. 1560