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Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.
Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.
The two coronavirus vaccines are among several candidates in final-stage testing, the last step before seeking regulatory approval.
The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S.
Such temporary halts of drug and vaccine testing are relatively common: In research involving thousands of participants, some are likely to fall ill. Pausing a study allows researchers to investigate whether an illness is a side effect or a coincidence.
Testing of the AstraZeneca vaccine, developed with Oxford University, has already resumed in the United Kingdom, Brazil, South Africa and Japan.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement.
AstraZeneca’s study involves 30,000 people in the U.S., with some getting the vaccine and others a dummy shot.
Testing was stopped after one British participant developed severe neurological symptoms consistent with a rare inflammation of the spinal cord called transverse myelitis. AstraZeneca testing had also been paused earlier in the summer.
Johnson & Johnson said it’s preparing to resume recruitment soon for its U.S. vaccine study. In a statement, the company didn’t disclose the nature of the volunteer’s illness but said a thorough evaluation “found no evidence that the vaccine candidate caused the event.”
The company added that it’s in talks with other regulators around the world to resume testing in their countries.
Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
By Robin Foster and E.J. Mundell
SATURDAY, Oct. 24, 2020 (HealthDay News) — The United States broke a bleak record on Friday, logging the highest daily number of new coronavirus cases since the pandemic began.
The tally of over 80,000 new infections eclipses the previous record of 76,533 new cases set on July 17, during a surge in cases across the Sun Belt, the Washington Post reported.
The country could soon be facing its worst stretch of the pandemic, with some hospitals in the West and Midwest already overwhelmed and death counts beginning to rise, the Post reported.
This latest spike in cases is far more widespread than the waves that hit America in the spring and summer. The geographic spread of this latest surge makes it more dangerous, with experts warning it could lead to dire shortages of medical staff and supplies, the Post said. Already, hospitals are reporting shortfalls of basic drugs needed to treat COVID-19 infections.
COVID-19 hospitalizations increased in 38 states over the past week. The number of deaths nationally has crested above 1,000 in recent days, the Post reported.
In July, just four states accounted for more than 40,000 cases: Arizona, California, Florida and Texas, according to a Post analysis. On Friday, 11 states accounted for that same lion’s share of cases.
“One key way we got through previous waves was by moving health care workers around. That’s just not possible when the virus is surging everywhere,” Eleanor Murray, an epidemiologist at Boston University, told the Post. And no one knows how high this wave will crest before peaking, she added.
“We are starting this wave much higher than either of the previous waves,” she explained. “And it will simply keep going up until people and officials decide to do something about it.”
The Midwest and Rocky Mountains are struggling to contain major outbreaks, while new hot spots are emerging in other parts of the country, The New York Times reported. Kentucky announced more than 1,470 cases on Thursday, the biggest one-day jump ever in that state. And Colorado reported more than 1,300 cases, setting another single-day record, the Times said. In Chicago, a nightly curfew started on Friday, after officials reported an average of 645 new cases a day this past week, the newspaper said.
Things are likely to get worse. The country has not even hit the stretch of holidays and cold weather that is coming. More interactions could mean more transmission during celebrations of Halloween, Thanksgiving, Christmas and the New Year. The winter’s cold, dry air will also help the virus stay stable longer, just as people start to spend more time indoors where ventilation may be poor.
Remdesivir gets full FDA approval to treat COVID-19
Remdesivir’s full approval Thursday by the U.S. Food and Drug Administration comes after the agency granted it emergency use authorization last spring. It is given intravenously to hospitalized patients.
California-based Gilead Sciences Inc. is selling the drug under the brand name Veklury.
By Steven Reinberg, HealthDay Reporter
SATURDAY, Oct. 24, 2020 (HealthDay News) — Sexual assault is common in America, with an attack occurring every 73 seconds. But having supportive care at the emergency department and afterwards can help heal the trauma, Penn State doctors say.
One in five women is raped during their lifetime, yet only 25% report it, according to the National Sexual Violence Resource Center. The closer the relationship is between the victim and the offender, the more likely it won’t be reported, says the U.S. Department of Justice. Even when attackers aren’t known, more than half the victims do not report their assaults.
“It’s a very traumatic event,” said Debbie Medley, an assistant nurse manager in the emergency department at Penn State Health Medical Center. “It takes quite a bit of emotional strength for somebody to decide that they want to report it and seek help,” she added in a Penn State news release.
If you are in immediate danger, you should call 911 to request assistance, Medley said. “But there are ways to report the assault other than just picking up the phone and calling 911 or your local police department,” she noted.
The Rape, Abuse and Incest National Network’s national hotline can connect you with trained staff from a local sexual assault service. Victims of sexual assault can also go directly to any local emergency room for treatment.
Medley stressed that in the emergency room it’s important to provide patients with as much control as possible during the forensic exam.
“Among the equipment in our dedicated exam room, we have a clicker that enables the patient to take their own photograph, should they agree to have photographs taken during the exam,” Medley said.
Sexual assault examiners should know the state’s regulations and required documentation and how to report the assault to the police — if that’s what the victim wants.
“Even though the assault will be documented by us, it doesn’t mean that a report must be filed with the police,” Medley said. Pennsylvania law, for example, allows victims to have the sexual assault evidence kit collected and tested anonymously — without their name attached to it, she added.
“They can have that reassurance that they’ll get the medical treatment they need, when they need it. They’ll get connected to support services to help them navigate the emotional trauma of their assault. And they’ll have the peace of mind that while they might not want to report the crime yet, we have the evidence kit if they ever change their mind,” Medley said.
Copyright © 2020 HealthDay. All rights reserved.
Health News of Saturday, 24 October 2020
The Food and Drugs Authority (FDA) has asked traditional medicine practitioners to use only medical devices approved by the Authority in their health institutions for operations.
Martin Kusi, the Northern Regional Head of FDA, who gave the advice said for his outfit to ensure public safety, practitioners must ensure that samples of all the devices, imported or manufactured in Ghana must be accessed by the FDA.
He gave the advice when his office organized a one-day training in partnership with Ghana Health Service, Ghana Federation of Traditional Medicine Practitioners Association, Traditional Medicine Practice Council, on October 24, 2020, in Tamale.
A statement from the FDA, copied to the Ghana News Agency said the training had representatives from the Ghana Police Service and the Ghana Pharmacy Council.
Mr. Kusi, also entreated herbal medicine practitioners to ensure that every medicine produced for the treatment of any disease is approved by the Authority before being administered.
He admonished practitioners to take advantage of the current favorable conditions in product registration to fast-track the approval of their herbal products.
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Scientists are closing in on a long-sought goal _ a blood test to screen people for possible signs of Alzheimer’s disease and other forms of dementia. Half a dozen research groups gave new results at a conference on these experimental tests. (July 15)
An artificial intelligence program analyzing language predicted whether people with no memory or thinking problems would develop Alzheimer’s disease later in life, researchers said.
The study performed by IBM and funded by drug giant Pfizer found a computerized model analyzing language patterns accurately predicted up to 74% of participants diagnosed with Alzheimer’s disease later in life. The study appeared Thursday in the journal EClinicalMedicine.
The study is the latest in an emerging research field focusing on early detection of Alzheimer’s disease, the memory-robbing disease that afflicts about 5.8 million Americans.
Many researchers are working to develop and study blood tests to detect Alzheimer’s disease before memory and thinking problems occur. Blood tests can potentially be more precise than memory and thinking tests now used to diagnose the disease. The tests also could be a less-expensive way to conduct clinical studies.
IBM officials say their study of language patterns show another possible tool for early detection of Alzheimer’s disease and other forms of dementia.
Ajay Royyuru, IBM’s vice president of healthcare and life sciences research, said IBM’s research efforts to track language shows the potential for a non-invasive test that “presents a better window for targeted interventions.”
The study analyzed more than 700 written samples from 270 participants in the decades-old Framingham Heart Study, which has collected detailed medical histories, physical exams and labs test from thousands of participants. Study participants were shown a cookie-theft picture and asked to write a description of the image.
The samples were collected when study participants showed no signs of memory loss. The study predicted Alzheimer’s disease an average of 7.6 years before participants were diagnosed.
Based on written samples from 80 participants, the study more accurately predicted Alzheimer’s than other methods such as evaluating a genetic susceptibility gene, demographics or psychological tests, the study said.
Risk factors found in language can include repeating questions, stories and statements, the study said. The study also cited agraphia, or loss of the ability to write, which can lead to errors or less complex language.
Royyuru said tracking language patterns over time could be done as part of a routine physical or behavioral health exam. Doctors might track collect a baseline of a patient’s language skills as a young adult and update the test every 5 years, he said.
“That is not in normal clinical practice today,” Royyuru said. “The technology allows us to think about this as something that would be possible.”
More: Is this Alzheimer’s drug a breakthrough for millions? Company unveils mixed results
More: Study: Blood test for Alzheimer’s detects signs 20 years before memory, thinking falter
More: Is this drug the most promising development on Alzheimer’s in recent history?
Dr. Oscar Lopez is a professor of neurology and
Turning clinicians into coaches so they can show up for their clients and earn six-figure incomes is what keeps Debbie Cherry motivated. She’s the perfect person to do it, because it’s a journey she’s walked herself.
Like many clinicians, Cherry started off trading time for dollars with one-on-one counseling sessions, but the need to make a bigger impact and start to reclaim some family time led her to launch Relationship Remedies, a couples-counseling program. The process of creating and marketing that program helped Cherry identify some of the gaps that stop many clinicians from growing their businesses successfully.…
Only nine jurisdictions are improving. Just five jurisdictions are at a plateau.
Forty-two states and territories are in an upward trajectory of new COVID-19 cases, while only nine jurisdictions are improving, according to an internal Health and Human Services memo obtained by ABC News.
Just five jurisdictions are at a plateau.
There were 5,530 deaths recorded from Oct. 16 to Oct. 22, marking a 15.1% increase in new deaths compared with the previous week, according to the memo.
The national test-positivity rate increased from 5.1% to 5.9% in week-to-week comparisons.
Across the country, 24% of hospitals have more than 80% of their ICU beds filled. That number was 17 to 18% during the summertime peak.
In Florida, new cases are up 30% among high school students compared to two weeks ago, and up 42% among young adults ages 18 to 24, the memo said.
In Kentucky, new deaths have been increasing over the last two weeks. Kentucky reported its second-highest daily fatality count on Wednesday, the memo said.
The state is preparing its surge capacity as hospitalizations rise.
Mississippi reported a 26.2% increase in cases over the last week, according to HHS.
COVID-19 related hospitalizations in Mississippi are up 24% since last week, with COVID-19 ICU hospitalizations up 7%.
The Mississippi Band of Choctaw Indians, who primarily live in Neshoba County, are disproportionately affected by the virus. The tribe reported 22 new cases this past week with
PARIS (Reuters) – France will have to live with the coronavirus at least until next summer, President Emmanuel Macron said on Friday.
Macron, who was speaking during a visit to a hospital in Pointoise, near Paris, said there were no plans at this stage to reduce curfews aimed at preventing the virus spreading but that curfews could even be extended.
“When I listen to scientists I see that projections are for at best until next Summer,” he said, adding it was too early to say if France was headed towards new full or partial lockdowns.
The coronavirus is spreading through France faster than at the peak of the first wave in spring, a government scientific advisor said earlier on Friday.
France reported 41,622 new COVID-19 cases on Thursday, a new daily record, and will break through the 1,000,000 cumulative tally on Friday – a grim milestone for the government as it and other European capitals battle to keep their economies open.
France has announced plans to extend a curfew to 38 more administrative departments from midnight on Friday. In all, two thirds of the country’s 67 million population will be confined indoors each night from 9 p.m. to 6 a.m. until early December.
(Reporting by Dominique Vidalon; Editing by Kevin Liffey and Chizu Nomiyama)
The Ronald McDonald Care Mobile, in partnership with Nevada Health Centers and Ronald McDonald House Charities, will offer oral health care to children up to age 21 and to pregnant women at three locations in Carson City Oct. 27-29.
The RMCM offers the same services provided in a brick and mortar dental facility and is staffed with a dentist, dental assistants and office assistants.
COVID precautions will be in place. Preventive dental services will be provided in addition to emergency restorative care. Call 800-787-2568 to schedule an appointment.
Services will be provided at the following times:
- 7:30 a.m. to 5 p.m. Oct. 27 at Empire Elementary School, 1260 Monte Rosa Drive
- 7:30 a.m. to 5:30 p.m. Oct. 28 at Empire Elementary School, 1260 Monte Rosa Drive
- 7:30 a.m. to noon Oct. 29 at McDonald’s, 3095 S. Carson St.
Nevada Health Centers accepts most dental insurance plans, Medicaid and Nevada Check-up.