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As questions arise over when a coronavirus vaccine should be granted FDA approval, the leaders of several major pharmaceutical companies announced they have signed a pledge not to rush the development of a vaccine.The companies, AstraZeneca, BioNTech, GlaxoSmithKline, Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, released a joint statement on Tuesday confirming the pledge.The pledge includes the following points:Always make the safety and well-being of vaccinated individuals our top priority.Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.There has been pressure on both the FDA and manufactures to develop and approve a vaccine for the coronavirus. There have been more than 190,000 coronavirus-related deaths in the US since March, and the economic impact of the virus has cost millions of jobs.While most developed countries have not had the same public health pain as the US, the economic impact of the virus has been felt worldwide. The International Monetary Fund estimates a nearly 5% loss in global GDP in 2020.In Russia, the country claimed to begin distributing a coronavirus vaccine despite US-based vaccine candidates likely being months away from being able to demonstrate efficacy.The pressure domestically has also ratcheted up as President Donald Trump has suggested a vaccine could be ready by this fall’s presidential election."We're going to have a vaccine very soon... maybe even before a very special date, you know what date I'm talking about,” Trump said on Monday.In late August, the CDC told states to begin to prepare distributing a vaccine by Nov. 1. But Surgeon General Jerome Adams said that just because states will be ready to help distribute a vaccine on Nov. 1 does not mean a vaccine will be ready by then."We've always said that we're hopeful for a vaccine by the end of this year or the beginning of next year,” Adams told Good Morning America."We want to make sure states are available to distribute it," he added.The companies signing on the pledge said that the FDA has strict protocols for vaccine candidates. A typical vaccine trial takes one to three years, but the companies believe only a safe and effective vaccine will be granted approval.“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the companies wrote in the pledge. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.” 3296

At Allan Hancock College’s Fire Academy, Battalion 146 recently went through some intense rescue scenarios.“Help a brother out. Come on,” shouted an instructor.The person responsible for training the future firefighters is academy coordinator Andy Densmore, who has been in this industry for almost four decades and is retiring at the end of this year.“There’s nothing you can do about it,” he said. “We have to make the change.”Changes due to COVID-19.Since the pandemic hit, academy class sizes have been cut by a third, cadets are screened before they enter the facilities, they socially distance themselves once they’re in and wear masks when they’re not in face pieces.“The nice part is we asked these kids for their commitment the first day that we meet them and we said, ‘there’s only one variable in this entire program and it’s you,’” Densmore said.As Densmore’s career comes to a close during this crisis, Camila Schafer, class president of Battalion 146, is just starting hers.“Whether it’s a pandemic, it’s a fire, it’s a surf rescue, we’ll answer that call,” she said.Schafer says instructors can control all aspects of a cadet’s day while on campus but once they leave the academy, however, cadets are committed to an individual responsibility.“On weekends, we’re studying. we’re hitting the books,” she said. “We’re making sure that we’re not out there putting our battalion in jeopardy and possibly getting this virus.”Employment of firefighters is projected to grow faster than the average for all occupations across the country, according to the Bureau of Labor Statistcs.While this fire academy is training with new challenges, Densmore believes smaller class sizes could make cadets like Schafer better prepared than firefighters of the past.“We don’t graduate mediocre,” he said. “Our standards are really, really high. And we exceed what the state requires." 1888

Attorney General William Barr said Wednesday that a controversial Trump administration initiative had netted nearly 1,500 arrests with federal agents' assistance in nine U.S. cities.Speaking from Kansas City, Barr claimed that "Operation Legend" has been successful in combatting rising rates of violent crime across the country.Operation Legend — named in memory of 4-year-old LeGend Taliferrom, who was shot to death in Kansas City earlier this year — was launched in the city in early July. Officials with the Kansas City police department say the murder rate in the city has dropped in the month since federal agents arrived.Among those arrested in connection with the program was a suspect charged with LeGend's murder. The boy's mother attended Wednesday's press conference and thanked Barr for his assistance in LeGend's case.Since its launch in Kansas City, Operation Legend has spread to Chicago, Albuquerque, Cleveland, Detroit, Milwaukee, St. Louis, Memphis and Indianapolis.However, the initiative remains controversial with local leaders. In late July, the mayors of 13 large cities penned an open letter to Barr, Acting Homeland Security Sec. Chad Wolfe and other Trump administration officials, saying they did not wish for federal agents to patrol their streets.Earlier this year, the Trump administration sent federal agents to Portland, Oregon, in an attempt to quell months-long protests in the city. The arrival of federal agents caused tensions between protesters and federal agents to rise, resulting in several clashes.Last month, Barr claimed that Operation Legend had resulted in the arrests of 200 violent criminals within two weeks. According to the Kansas City Star, Barr was, in fact, citing arrest figures that dated back to December 2019, and included joint arrests between state officials and the FBI. 1841

At least 2.4 million more Americans were impacted by an Equifax data breach that happened last year, though those customers had less data stolen.The Associated Press reported the newly announced customers had only their names and a partial driver's license number stolen. The original data breach involved 145.5 million Americans who had their Social Security numbers impacted.In the driver's license theft, the attackers were unable to get the state where the license was issued and the dates of issuance and expiration. 529

As states across the country grapple with an increase in coronavirus cases and a huge demand for tests, many businesses are looking for other ways to get more mileage out of their supply chain.Like with anything else, supply and demand is a constant struggle. In this unprecedented era, the demand for things like coronavirus tests is so large that public health departments don't have a choice but to figure out ways to make our supplies last. Several states are examining pooled testing. California's Public Health Department says it's to "better leverage testing resources."Pooling is something that blood banks have used for decades to keep their blood supply safe. Dr. Claudia Cohn is the Chief Medical Officer of the AABB, formerly known as the American Association of Blood Banks.“If you have 100 people that need to be tested and if you test each of them, you’ll do 100 tests. If you find that your test is sensitive enough that you can pool together 20 samples at the same time, instead of having 100 tests, you can have five pools of 20,” Dr. Cohn said.Now, if one of those five pools is positive, then Dr. Cohn says, "You’ll need to break it out and test each of those separately. So, let’s say you have one positive person in a pool of 100 people, you either do 100 tests and find one positive or you do five pools of 20, four of those pools will be negative, so you’ve done 4 pools and covered 80 people."The test works by taking a tiny sample from each person who was tested.“When you take a swab from everyone’s nose, you isolate the DNA from that swab,” Dr. Cohn said about the PCR test, which is generally a nose swab. “It’s not a lot, it’s a small amount but it’s enough. Because these tests are very, very sensitive.”Those tests are so sensitive, and they have to be, that pooling can really only work if the test can handle, as in detect, multiple samples at once. The FDA mandates that.“The FDA is quite demanding as they should be in terms of making sure tests work well and are safe,” Dr. Cohn said.And Dr. Cohn says, pooling wouldn't work in an area where there's a large outbreak, which means a large number of people would test positive regardless of pooling. In the blood world, this strategy has been perfected.“You are taking 100 samples and taking a drop from each sample and putting it together,” Dr. Cohn said. “You are testing every single person who comes through. In the blood world safety is before everything."Blood banks test for HIV, Hepatitis C and B and well as COVID-19 antibodies, according to the American Red Cross. And, as this pandemic moves through our communities, Dr. Cohn says our blood supply needs to remain strong.“After that initial spike, it went down again and that was okay because elective surgery had been canceled, so the demand for blood had gone down as well so for a while we were at a good balance of demand and supply. But then elective surgeries opened up and hospitals went back to full service and we’re in a shortage again,” Dr. Cohn said. 3017