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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 funeral for Aretha Franklin will be held August 31 in Detroit, according to the singer's publicist, Gwendolyn Quinn.The service, for family and friends, will be held at 10 a.m. ET that day at Greater Grace Temple.Public viewings will be held August 28 and 29 from 9 a.m. to 9 p.m. at the Charles H. Wright Museum of African American History in Detroit, Quinn said.Franklin will be entombed at Woodlawn Cemetery in Detroit.The legendary soul singer died Thursday from advanced pancreatic cancer. She was 76. 518
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 doors to Interior Secretary Ryan Zinke's office are getting a nearly 9,000 upgrade.The Interior Department confirmed the project Thursday, saying it is both necessary to replace old doors that are in "disrepair" and attributing the high cost to the historical nature of the building.News of the 8,670 contract comes as several agencies are facing scrutiny over excessive spending. Last month, Housing and Urban Development Secretary Ben Carson withdrew an order for pricey dining room furniture, including a ,000 table. Zinke is also under fire for questionable travel habits.Zinke was unaware of the expense for the doors, Interior spokeswoman Heather Swift said, saying the project was driven by "career facilities and security officials" as part of a decade-long modernization of the 1930s building."The secretary was not aware of this contract but agrees that this is a lot of money for demo, install, materials, and labor," Swift said in a statement. "Between regulations that require historic preservation and outdated government procurement rules, the costs for everything from pencils to printing to doors is astronomical. This is a perfect example of why the secretary believes we need to reform procurement processes."The new doors will be made of fiberglass. The previous sets of doors have been damaged for years, according to an Interior official, to the point where wind and water come into the office during inclement weather, which in turn damaged the historic hardwood floors. Damage has caused bottom panels to fall out and be "replaced with cardboard and duct tape," the official said.The Associated Press previously reported on the door contract Thursday."What a waste. Just think how many dining sets you could have bought or private jets you could have chartered with that money," Rep. Adam Schiff, D-California, joked on Twitter. 1898
The Department of Veteran's Affairs (VA) is facing a huge undertaking as COVID-19 vaccines roll out to the general public.More than 418,000 healthcare workers and 10 million patients will eventually get the COVID-19 vaccine through the VA.The department received 73,000 doses of Pfizer's COVID-19 vaccine this week, and residents and staff at long term communities run by the department are first in line to be inoculated.There are about 17,500 veterans living in VA long-term care facilities across the country, and several thousand more work in those centers.The vaccine could not have arrived sooner for those staff members and patients."I know a lot of VA medical centers are going through COVID surges right now, alongside with their communities," said Dr. Jane Kim, the Chief Consultant for Preventive Medicine at the VA.Most vaccines are mandatory for military members. For now, the COVID-19 vaccine is still voluntary. That's likely due to the limited supply of the vaccine and because it's only under Emergency Use Authorization right now.Still, veteran doctors want to reassure their patients."I got the vaccine yesterday," Kim said. "I had a sore arm yesterday, but my arm feels good today. I feel fine today. I would recommend this vaccine to my family and also my patients when it's available for them and it's their turn."More than 5,500 veteran patients and 87 VA staff members have died of COVID-19 since the start of the pandemic. That doesn't include state-run veteran's homes.The VA is not responsible for providing COVID-19 vaccines to those state-run veteran's homes. 1596