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FDA grants “emergency use authorization” for UAB-developed drug to treat COVID-19

Eddie Burkhalter

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The U.S. Food and Drug Administration on Friday issued an “emergency use authorization” for the drug remdesivir to treat COVID-19 patients, a fast-tracked approval of a drug that early clinical trial results show can speed recovery.  

In a letter Friday to Gilead Sciences, the California-based drug-maker that owns the rights to the drug, the FDA wrote that based on a review of early results of a clinical trial by the National Institute of Allergy and Infectious Diseases (NIAID), and another study by Glead itself, “it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19.” 

The FDA’s emergency use authorization states that the drug can be used in children and adults who are confirmed or suspected CODID-19 cases, who have severe illnesses, low oxygen levels or who are on ventilators.

The NIAID on Wednesday released early results of a worldwide clinical trial, which showed that in a sample of 400 of the overall 1,063 coronavirus patients enrolled in the study, those who received remdesivir, rather than a placebo, recovered 31 percent faster. 

The drug was developed with the help of the University of Alabama at Birmingham, which was also selected as one of the sites in the clinical trial. UAB enrolled 16 COVID-19 patients in the clinical trial. 

“It’s 31 percent effective over a placebo, which doesn’t sound fantastic, but it is likely going to be saving lives, and it gives the researchers direction on how to target this virus and come up with even better therapies,” said Dr. Paul Goepfert, professor of medicine in the UAB Division of Infectious Diseases and principal investigator in UAB’s clinical trial of the drug, speaking on Wednesday. 

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According to the FDA’s approval letter to Gilead, the U.S. government will control distribution. 

“Gilead will supply remdesivir to authorized distributors , or directly to a U.S. government agency, who will distribute to hospitals and other healthcare facilities as directed by the U.S. Government, in collaboration with state and local government authorities, as needed,” the letter reads. 

For 400 of those enrolled in NIAID’s clinical trial, 10 days of treatments with the drug reduced the average hospitalization days time for COVID-19 patients from 15 days to 11. 

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Dr. Nathan Erdmann, an infectious disease specialist at UAB who oversaw UAB’s patient enrollment in the clinical trial, said during a video conference Wednesday that a handful of the 16 patients are still being treated at UAB, and those of them who were receiving a placebo could soon begin receiving remdesivir instead.

Eddie Burkhalter is a reporter at the Alabama Political Reporter. You can email him at [email protected] or reach him via Twitter.

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Education

Exposure notification app for college students launches pilot phase

Micah Danney

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Screen captures of the GuideSafe application. (UAB)

College students across Alabama and anyone with a .edu email address are being invited to participate in an anonymous Exposure Notification System app for iPhone and Android users. The app launched in a closed pilot phase on Monday that will allow up to 10,000 downloads for each phone type.

The app is part of the GuideSafe platform, a suite of tools designed to help people reduce the spread of the novel coronavirus. It features a tool called HealthCheck, which allows users to report COVID-19 symptoms, and another called Event Passport, which uses an algorithm to assess whether a person is safe to attend a gathering of 10 or more people or not based on the responses they log in HealthCheck. 

The GuideSafe platform encompasses the Stay Safe Together and Testing for Alabama initiatives. Participation is voluntary and designed to protect users’ privacy while anonymously alerting each user to potential exposure to someone who has tested positive in the last 14 days. The exposure notification system assigns random numbers to each user to keep them anonymous to each other and to the system.

The app will be made available for mass public download later this month after the pilot phase ends and the app’s performance is assessed.

GuideSafe is the largest-scale testing initiative for higher education in the nation. It uses exposure notification technology developed jointly by Google and Apple.

Alabama is one of the first states to launch the technology, which is part of the state’s program for safe entry to campuses of higher education. Gov. Kay Ivey allocated more than $30 million in Coronavirus Aid, Relief and Economic Security (CARES) Act funding for the plan.

The pilot app was built by the University of Alabama at Birmingham and Birmingham-based MotionMobs, in partnership with the Alabama Department of Public Health.

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“We have worked extremely hard to leverage research and innovation, community service, patient care and education to make a positive difference in this pandemic,” said UAB President Ray L. Watts. “This new app – using Google- and Apple-led technology and created by UAB faculty, staff and MotionMobs for the people of Alabama – is a necessary tool in our effort to return to college campuses safely this fall.”

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Education

Governor announces $100 million internet voucher program for students

The governor has allocated for the program $100 million of the state’s $435 million in federal CARES act funds to help the state safeguard schools amid the growing spread of COVID-19. 

Eddie Burkhalter

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(STOCK PHOTO)

Gov. Kay Ivey on Friday announced a program to increase internet access for K-12 students for distance learning as the start of the new school year approaches. 

The project, called Alabama Broadband Connectivity (ABC) for Students, will provide vouchers for families of students who are eligible for free and reduced lunches “or other income criteria,” according to a press release from Ivey’s office. The vouchers will pay for equipment and services for high-speed internet from the fall through Dec. 31. 

Ivey has allocated for the program $100 million of the state’s $435 million in federal CARES act funds to help the state safeguard schools amid the growing spread of COVID-19. 

The funds will be used to expand internet access by providing “equipment and service for broadband, wireless hot spots, satellite, fixed wireless, DSL, and cellular-on-wheels,” according to Ivey’s office. 

“Despite the upheavals in our lives during the past few months and at least into the near future, children must be able to continue their classroom instruction,” Ivey said in a statement. “This funding will expand internet access to allow more students to access distance learning while creating smaller classes in schools that provide those options and will also ensure their safety during the pandemic. While I respect those districts that have elected to use remote learning, I fear that a slide will come by keeping our kids at home. These funds will bridge the gap until all students can get back into the classroom as soon as possible.”

Families with children who receive free or reduced school lunch are to receive a mailed letter in August, and a website to assist Alabamians with questions as the program nears its launch can be found here.

“Once again, we are appreciative of the leadership and resources provided by Governor Ivey during this unprecedented time in our country’s history. More than ever before, the immediate need for broadband infrastructure, devices, and connectivity are an integral part of providing Alabama students with a quality education,” said Eric Mackey, Alabama superintendent of education, in a statement. “A huge part of evening the playing field to provide greater equity in educational services will come from closing the digital divide between varying Alabama communities. We still have a lot of work to do, but because of the resources provided by Gov. Ivey, we can head into what we know will be a challenging school year with greater optimism.”  

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The funds are to be administered by the Alabama Department of Economic and Community Affairs, which has partnered with Maryland-based CTC Technology & Energy for the project. 

“We have learned in the past several months that internet connectivity is a necessity for everything from education to healthcare and working remotely. I am pleased that Alabama is going to enter into this private-public partnership to make internet access available to those low-income households who cannot currently afford it. Economic status should not be a determining factor in receiving quality education, and it should not bar anyone from the ability to access vital online services,” said Sen. Del Marsh, president pro tem of the State Senate, in a statement. “Although this is only a temporary solution, I am confident that it will be a bridge to a time when fiber is put in the ground and access to the internet and devices will become standard across Alabama.”

According to Ivey’s office, the plan was drafted with the input from the Broadband Working Group, a group Ivey announced the creation of on June 25, which is composed of legislators and industry experts who are to provide to guidance on the state’s spending of $1.9 billion in CARES Act funds. 

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“I appreciate the opportunity to be a part of Governor Ivey’s working group to utilize federal funds in the CARES Act to provide broadband access to all Alabama students regardless of income. I think Governor Ivey has a good plan,” said Rep. Randall Shedd, a member of the working group and a leader of the Rural Caucus. 

Mackey said last week that approximately half of the state’s K-12 students will begin school by learning virtually for a period of time. A lack of internet connectivity in many homes is a major concern for school administrators who face the challenge of providing education to students when new coronavirus cases, hospitalizations and deaths continue to increase in Alabama. 

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Education

Jones urges USDA to extend waiver program for school meals amid COVID-19

Eddie Burkhalter

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(STOCK PHOTO)

Unless the U.S. Department of Agriculture extends a waiver program, set to expire at the start of school, thousands of Alabama’s schoolchildren without transportation to school and who are learning remotely could miss out on school meals.  

U.S. Sen. Doug Jones, D-Alabama, and dozens of other senators on Wednesday urged the USDA to extend vouchers that provide critical meals to children during the COVID-19 pandemic. 

“The COVID-19 pandemic has forced schools around the country to close their buildings and shift instruction to online and distance-learning models,” the senators wrote in a letter to USDA. “For many children, school breakfast and lunch may be the only healthy and regular meals they receive.”

The economic crisis caused by the COVID-19 pandemic has cost millions of parents their jobs, the senators wrote, and millions more students will be dependent on school-provided meals. 

“School meal program directors must begin procuring food, equipment, and supplies and placing orders now in preparation for the upcoming school year,” the letter continues. 

The waivers have allowed students to receive free meals when learning remotely, and the meals could be delivered to areas when transportation wasn’t available for students. 

State Superintendent Eric Mackey during a press briefing hosted by Jones on July 24 said “we do not anticipate that waiver being extended by the United States Department of Agriculture.” 

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Mackey said those waivers allowed for the delivery of meals to students who couldn’t come to school to pick the food up, and it allowed for the serving of bulk items, such as milk by the gallon. That all goes away if the USDA does not extend the waivers, he said. 

“Essentially, they will have to come to school to get the meals,” Mackey said. 

Mackey said last week that about half of the state’s K-12 students will be learning remotely for a period of time once school begins.

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The senators are urging the USDA to extend those waivers to help ensure low-income students can get school-provided meals throughout the upcoming school year. The senators also called on the USDA to reimburse schools for the transportation costs for delivering meals to low-income students.  

“While many school meal programs are managing these costs for the time-being, they cannot continue absorbing them for the foreseeable future. We ask that the USDA make additional funds available to schools to assist with the cost of delivering meals to low-income students until regular school operations are restored,” the letter continues. 

Senators in the letter asked the USDA to extend the following waivers: 

  • Unexpected School Closures Waiver 
  • Afterschool Activity Waiver
  • Fresh Fruit and Vegetable Program Parent Pick-Up Waiver
  • Waiver of Child Nutrition Monitoring
  • Waiver of Food Management Company Contract Duration Requirements
  • Waiver of Local School Wellness Assessments
  • Area Eligibility Waiver
  • Summer Food Service Program (SFSP) and Seamless Summer Option (SSO) Waivers

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Health

Nearly 20 Alabamians per day died from COVID-19 in July

The state is entering August and pending schools reopening with 48,346 actively infected people living in the state — not counting the thousands or even tens of thousands who are infected and have not yet been diagnosed.

Brandon Moseley

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(STOCK PHOTO)

The Alabama Department of Public Health reported Friday that another 15 Alabamians had died by the last day of the month, raising the number of confirmed COVID-19 deaths in the state to 1,531. July was by far the worst month of the pandemic in Alabama — with 605 Alabamians dying from the virus.

The high death toll in July translates into a rate of 19.52 deaths per day over the course of the month. At least 299 of the 605 deaths in July occurred in the last two weeks of the month — a rate of 21.36 deaths per day.

The state of Alabama entered the month with 37,536 diagnosed cases of coronavirus combined for March through June. Many of those cases had long since recovered. A largely apathetic public ignored all the warnings and insisted on parties, barbecues and vacations, often without masks, radically worsening the conditions on the ground in Alabama.

Another 47,742 cases of the novel strain of the coronavirus, SARS-CoV-2, were confirmed by the state department of health in July alone — more than doubled the number of cases diagnosed in the month of June, when 19,584 coronavirus cases were diagnosed in Alabama.

Nearly 56 percent of Alabama’s known cases were diagnosed just in July. Hundreds of them have died. 35,501 Alabamians, mostly from the previous months, have recovered from their ordeal, but most of Alabama’s cases are still considered active infections.

As of Aug. 1, Alabama has the seventh-highest per capita infection rate in the country — with 1,822 cases per 100,000 people, according to the New York Times. When limited to cases in the last seven days, Alabama has the sixth-highest rate in the country — at 239 cases per 100,000 people in the last seven days.

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The state is entering August and pending schools reopening with 48,346 actively infected people living in the state — not counting the thousands or even tens of thousands who are infected and have not yet been diagnosed.

The state also set a new record for COVID-19 hospitalizations on Thursday at 1,642. Intensive care beds continue to be in high demand as hundreds fill hospitals.

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While testing has increased, the percentage of tests that return positive rose dramatically through the month of July. On July 1, roughly 12.37 percent of tests were positive, based on 7-day averages of daily case and test increases. By July 31, that number rose to nearly 22 percent. Experts say that percentage — known as the positivity rate or percent positive — should be below 5 percent or many cases are going undetected and not enough tests are available.

On July 31, the Department of Public Health said “overwhelmed” labs and limited testing supplies are delaying testing results with most people taking at least a week to get their results back. Experts say test results that take that long are nearly worthless.

There are growing fears in business and government circles that the surging coronavirus cases could jeopardize what originally appeared to be an economic recovery. Already the Southeastern Conference, which includes the University of Alabama and Auburn University, has announced that it is moving the start of their college football season back three weeks from Sept. 5 to Sept. 26 to allow more time to assess the situation and plan for how they will play in the midst of the pandemic.

Alabama Gov. Kay Ivey and State Health Officer Dr. Scott Harris have extended the public health emergency to the end of August. The order to wear a mask or cloth face covering has similarly been extended to August 31.

Congress is debating passing another coronavirus relief package but Capitol Hill is bitterly divided on how large this latest package should be. Meanwhile, there were another 1.5 million new unemployment claims filed last week.

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