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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 death of another Fort Hood soldier is under investigation after he was found unresponsive at a nearby lake.On Friday, July 17 at 12:07 a.m., deputy’s with the Bell County Sheriff’s Department were dispatched to the area of the Stillhouse Hollow Lake Dam after fishermen in a boat located what they believed to be a body in the water at the base of the dam.Upon arrival, deputy’s found the body 26-year-old Pvt. Mejhor Morta was located in the vicinity of Stillhouse Hollow Lake — located about 15 miles east of the Army base.An autopsy was ordered by Justice of the Peace Garland Potvin.A preliminary autopsy shows the cause of death to be consistent with drowning, but at this time, a full autopsy report has not been completed or released by the Medical Examiner’s Office in Dallas, Texas.Morta's body was found just weeks after officials found the dismembered remains of Pfc. Vanessa Guillen — a soldier stationed on Fort Hood who went missing in April. Officials have not said that the two cases are linked.Morta was from Pensacola, Florida, and entered the Army in September 2019, as a Bradley Fighting Vehicle mechanic. He has been assigned to 1st Battalion, 5th Cavalry Regiment, 2nd Armored Brigade Combat Team, 1st Cavalry Division, since May 2020.Friends of Morta say his family is from the Philippines."I reached out to his sister today and they are currently in the Philippines," said Hunter Proffitt, a friend of Morta. "He literally came over here, he joined the U.S. Army to help move his family over here. He wanted to move his family. He wanted to make a better life for himself and then we find out that this happens."The Bell County Sheriff’s Department continues their investigation and no other information is available for release at this time.This story was originally published by Sydney Isenberg on KXXV in Waco, Texas. 1856
The Duchess of Cambridge, wife of Britain's Prince William, has given birth to a son, the royal family announced Monday. The baby weighs 8lbs 7oz (3.8 kilograms).The duchess, the former Kate Middleton, gave birth at 11a.m. local time at St. Mary's Hospital, Paddington, London."The Queen, The Duke of Edinburgh, The Prince of Wales, The Duchess of Cornwall, Prince Harry and members of both families have been informed and are delighted with the news," Kensington Palace said in a statement."Her Royal Highness and her child are both doing well." 554
The family of a 14-year-old Arizona boy with autism is demanding accountability after a Buckeye, Arizona police officer mistook the child for a drug user and detained him.On July 18, the boy, Connor Leibel, was forced to the ground by the officer and suffered multiple scrapes to his back, arm and face.The entire incident was captured on body camera, which was obtained by Scripps station ABC15. Watch the full raw video in the player above. Buckeye police officials did not immediately respond to requests for comment early Monday. In a statement by the Leibels' attorney, the family said they anguished over what happened and are demanding the city implement better training for its officers. “It’s astonishing that even after an internal investigation, the Buckeye Police Department claims it did absolutely nothing wrong,” the statement said. 861
The COVID-19 pandemic has hit people of color particularly hard, and one new study says that may be because of racial disparities in treating high blood pressure.According to the American Heart Association's Scientific Sessions, one-third of disparities in treatment may be the result of racial inequalities in prescribing or increasing the dosage of new medications used in treating high blood pressure.The study found that blood pressure control rates are lower in Black patients compared to other racial groups. Black patients also had more missed opportunities for treatment and missed more clinic appointments."A doctor might think a patient is less likely less able to afford medications, and because of that, they choose to not prescribe a certain medication," said Dr. Valy Fontil, an assistant professor of medicine at UCSF and one of the researchers involved in the study. "Or, they might know this person doesn't have transportation to the clinic, and so sometimes it might even be well-intentioned."Fontil says more standardized treatment protocols would help eliminate the disparities and prevent missed opportunities to get someone the medication they need."Sometimes people present, and the main thing that they're there for is not for the blood pressure," he said. "So, the clinician just sort of kind of might ignore the blood pressure. So automating these sort of standardized treatments would tell the clinician that they — even if the patient's not here for blood pressure — you have to address it in some way."Previous studies have also shown Black patients have more apprehension about why someone is giving them more medication. Fontil says one solution is having the patient be part of the treatment decision making.Fontil adds that the increasing number of virtual visits for blood pressure issues could make the racial disparities even worse. 1876