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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

As the pandemic has left millions unemployed or with reduced incomes, the demand at food pantries has soared in 2020.While there is relief coming for millions of Americans, Feeding America, a consortium of 200 food banks and 60,000 pantries nationwide, say that the stimulus signed by President Donald Trump last night was merely a “down payment.”Pantries across the US saw a 60% rise in demand in 2020, according to Feeding America.“As our country continues to weather a once-in-a-generation public health and economic emergency, the bipartisan agreement is an important down payment to help provide the food assistance our neighbors need, but further action will also be necessary in the coming months,” said Kate Leone, chief government relations officer for Feeding America.The legislation includes 0 million for the Emergency Food Assistance Program, but Leone cautions that more could be needed in the future.“The bipartisan legislation will provide much-needed short-term relief,” Leone said. “As 2020 ends, we know the need for food assistance will continue. While this legislation is a welcome step forward, the government will need to take further action to ensure that our neighbors do not slip further into crisis in the coming months. We strongly support the nutrition provisions in this bill and believe they are a critical step toward ensuring people have the food they need to learn, succeed, and thrive.”Before the pandemic began, 1 in 9 Americans were considered “food insecure,” which means those families were at risk at going hungry. That number has since increased to 1 in 6. 1608

Automakers are racing to develop driverless cars, putting increasingly complex technology on the road despite concerns from safety experts and the National Transportation Safety Board about a lack of regulations.Unlike rules for the design of a seatbelt or airbag, the federal guidelines for automated vehicle systems are voluntary. The U.S. Department of Transportation says keeping rules at a minimum will speed up the introduction of life-saving technology, a goal made all the more urgent as traffic deaths climbed again last year to 37,461, with 94 percent of those caused by human error.That lack of mandatory rules for self-driving cars has given automakers and technology companies the green light to police themselves, said Jackie Gillan, president of Advocates for Highway and Auto Safety. The group is calling for the government to issue mandatory safety standards for driverless cars.“Before we introduce this technology we need to have some assurance and accountability by the industry that this technology is not going to kill or injure consumers,” Gillan said.The National Transportation Safety Board makes recommendations after investigating major transportation incidents. The board recently called on DOT to issue new safety rules after its investigation of a May 2016 fatal crash of a Tesla Model S operating on autopilot near Williston, Fla. The Tesla slammed into a tractor-trailer, its cameras and automatic emergency braking system failing to spot the blank side of the truck against the white sky.It was the first known deadly wreck of a car driving with that level of automated sophistication. The NTSB said the driver relied too heavily on the car’s traffic-aware cruise control system and autosteering feature, but also blamed Tesla’s autopilot for allowing the driver to not interact with the car for prolonged periods of time.Investigators found the driver had his hands on the wheel for only 25 seconds during the 37 minutes the car was on autopilot. After the crash, Tesla updated its software that requires drivers touch the wheel every so often when the car is driving itself to ensure a human is paying attention to the road. Now if a driver repeatedly fails to touch the wheel, he or she will “strike out” and cause the car to slow down and stop in its lane with its hazard lights on, disabling autopilot for the remainder of the trip. 2378

As the world waits for deliveries of Pfizer’s coronavirus vaccine, the pharmaceutical company is having to adjust their target after hitting supply chain obstacles, according to the Wall Street Journal.“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman told the WSJ.Pfizer and partner BioNTech SE had hoped to ship out 100 million doses of their vaccine by the end of the year, that has now reportedly been cut to estimates of about 50 million.Two doses are needed for each person to be vaccinated.Pfizer did not elaborate on where the raw material shortfalls happened. They did say some raw materials in early production earlier this year did not meet their standards and they had to fix the issue.After the WSJ’s report, Pfizer’s stock price dropped and the S&P 500 fell slightly.The United Kingdom has granted emergency use of the Pfizer vaccine, and is expected to start administering doses soon. The FDA in the U.S. is considering a similar authorization, which could come later in December.As part of Operation Warp Speed, the U.S. Government has purchased 100 million doses of Pfizer’s vaccine, with an option to buy more.Roughly 20 million of those doses were expected by the end of the year once the FDA granted emergency use authorization. No word on how Pfizer’s shipping delays could impact this number.Pfizer says their production lines in the U.S. and Europe are complete and they are “confident” they will supply the targeted number of doses in early 2021. 1524

Attorney Michael Avenatti has been placed under arrest on suspicion of felony domestic violence and was booked early Wednesday evening.Los Angeles Police Department officer Jeff Lee said the domestic violence report was taken on Tuesday in West Los Angeles and the arrest was made Wednesday."We can confirm that today LAPD Detectives arrested Michael Avenatti on suspicion of domestic violence. This is an ongoing investigation and we will provide more details as they become available," the LAPD Twitter account posted Wednesday.In a statement, Avenatti called the allegations "completely bogus.""I wish to thank the hard working men and woman of the LAPD for their professionalism they were only doing their jobs in light of the completely bogus allegations against me," he said. "I have never been physically abusive in my life nor was I last night. Any accusations to the contrary are fabricated and meant to do harm to my reputation. I look forward to being fully exonerated."Avenatti posted ,000 bail and left police custody Wednesday evening. He told reporters waiting outside the station, "I have never struck a woman. I never will strike a woman.""I am confident I will be fully exonerated," he added.The alleged domestic assault incident was first reported by TMZ.Avenatti emerged this year as a regular antagonist of President Donald Trump, beginning with his legal representation of Stormy Daniels and his frequent media appearances. For months, he has publicly flirted with a potential bid for the Democratic presidential nomination to challenge Trump in 2020.The alleged domestic violence incident could dash Avenatti's prospects as a potential insurgent Democratic candidate and clash with the image he has presented of himself as an advocate for women, including Daniels in her clash with Trump and an accuser against recently confirmed Justice Brett Kavanaugh.The Vermont Democratic Party canceled Avenatti's appearances for Friday and Saturday following his arrest, and it will refund all ticket sales, said Christopher Di Mezzo, the party's communications director.The decision to cancel the events was made "almost immediately after the news broke," he said.The allegation would also mark another legal issue for the California attorney, whose firm settled a case with the IRS in July and was ordered?last month to pay a multimillion-dollar judgment over debt to a former law partner.Following his representation of Julie Swetnick for her allegations against Kavanaugh, Senate Judiciary Chairman Chuck Grassley said in October that he was referring Avenatti and Swetnick to the Justice Department. Avenatti said at the time that the referral was "baseless." Several Democrats said in the wake of Kavanaugh's confirmation that Avenatti and Swetnick's involvement damaged their efforts?to prevent Kavanaugh's confirmation -- a charge Avenatti denied. 2914