Here are some of the share-worthy stories from Georgia Patches to talk about tonight:
30 Test Positive For COVID At Buckhead Nursing Home
Nearly 30 people are sick after another outbreak of COVID-19 at a Buckhead nursing home. Seven residents died at the William Breman Jewish Home in an earlier outbreak.
DeKalb School Closes Food Distribution After Positive COVID Test
A DeKalb County school will no longer be able to distribute food to students. Someone has tested positive for COVID-19.
Trump Commutes Former Atlanta Teacher’s Prison Sentence
President Trump commuted the prison sentence of a former Atlanta teacher convicted in an $8 million food stamp scheme.
Church Donates 16K Books, $15K To Fulton County Kids In Need
North Point Community Church surprised Fulton County Schools staff this week by donating 16,000 children’s books and $15,000 in funding to support underserved students in the county, including those in need of social services and emergency funds.
Donate Blankets, Towels To Roswell Animals In Need
Keep Roswell Beautiful and the Roswell Recycling Center are partnering to collect gently used blankets and towels for donation to the local Humane Society.
Contribute your own content to Patch by signing up for an account and clicking the “Post on Patch” button at the top right of the site.
Also Worth a Look Today
Fire Damages Roswell Apartment Complex, Dozens Displaced
GA Coronavirus: State Posts Highest Positive Numbers In A Month
WOW House: A Touch Of Frank Lloyd Wright In East Cobb, $894,900
WOW House: Classic ’50s Feel, 21st Century Construction, $849,900
Atlanta Kidnapping Suspect Possibly Linked To Sandy Springs Case
Best Hiking Trails In Alpharetta To See The Fall Colors
Best Hiking Trails In Canton To See The Fall Colors
Best Hiking Trails In Cumming To See The Fall Colors
Best Hiking Trails In Johns Creek To See The Fall Colors
Best Hiking Trails In Roswell To See The Fall Colors
Best Hiking Trails In Sandy Springs To See The Fall Colors
Best Hiking Trails In Woodstock To See The Fall Colors
Alpharetta Streetlights To Get A Major Upgrade
Visit A Pumpkin Patch Near Loganville And Grayson While You Can
Visit A Dacula-Area Pumpkin Patch Before It’s Too Late
Visit A Norcross-Area Pumpkin Patch Before It’s Too Late
Visit A Lilburn-Area Pumpkin Patch Before It’s Too Late
Visit A Snellville-Area Pumpkin Patch Before It’s Too Late
Visit A Gwinnett-Area Pumpkin Patch Before It’s Too Late
Visit A Duluth-Area Pumpkin Patch Before It’s Too Late
Visit A Buford-Area Pumpkin Patch Before It’s Too Late
Visit A Lawrenceville-Area Pumpkin Patch Before It’s Too Late
Visit An East Cobb-Area Pumpkin Patch Before It’s Too Late
Visit A Pumpkin Patch Near Dallas And Hiram Before It’s Too Late
Visit A Cartersville-Area Pumpkin Patch Before It’s Too Late
Visit A Douglasville-Area Pumpkin Patch Before It’s Too Late
Johns Creek PD To Host Drug Take-Back Event Saturday
Roswell Police Department To Host Drug Take-Back Event Saturday
Rural Areas Hardest Hit In Third Surge; WHO Fights Misinformation
Senate Panel Advances Amy
And then, finally, we’ve been working with the manufacturers around the quality of their manufacturing, the consistency of it. So that if a vaccine were to be authorized or approved, we could immediately know that quality manufacturing is in place. And again, that process normally takes months.
The last thing to mention is that there’s been manufacturing done at risk, meaning that companies have started manufacturing their vaccines [before the trials are complete], so that if an authorization or approval occurs, the vaccine is ready to go. And as you can see, this really shrinks the development time. But all the steps necessary to ensure safety and efficacy have taken place. And of course, that’s the next thing that we need to see — the data from the phase 3 clinical trials — before any consideration of authorization or approval takes place.
What happens after you see this data? Can you talk about the approval process and what the FDA will be looking for in the phase 3 trial results?
We have made every attempt to be transparent about this, and will continue to do so, so that all Americans understand what we’re doing from a regulatory point of view.
These phase 3 clinical trials are large trials with 30,000 or more participants, and they compare the active vaccine with a placebo to determine whether an infection occurs in a person participating in the trial — because what you’re looking for is a vaccine to prevent infection [with the coronavirus, SARS-CoV-2]. That’s the effectiveness side of things, and in our guidance for vaccine manufacturers [posted to the FDA’s website in June], we were very clear about the criteria: We said the floor for effectiveness would be 50 percent. [This means that the vaccine should be effective at preventing a coronavirus infection or decreasing its severity in at least 50 percent of vaccine recipients. For comparison, the influenza vaccine is between 40 percent and 60 percent effective.]
We also said that safety would be of the utmost importance to us, and on the safety side of things, we’re looking for side effects. Most recently in our guidance for emergency use authorization, we said that we need to see at least two months of follow-up for 50 percent of the participants after they get the final dose of the vaccine. Looking back at other vaccines, our scientists determined that two-month window was when the overwhelming majority of side effects would be seen.
What’s the difference between standard FDA approval and an emergency use authorization when it comes to a vaccine?
When the developers of the vaccine are in their clinical trials, they determine when their data are mature, and there’s an independent board, called a data safety monitoring board, that helps the manufacturers look at the data and determine whether they reached specified criteria. Then, they’ll apply to the FDA for either emergency use authorization (EUA) or a biological license application (BLA), which is the typical process for vaccine approval. Normally, it
Europe Daily Coronavirus Cases Double in 10 Days, Reports 200,000 Daily Cases for the First Time | World News
By Anurag Maan and Shaina Ahluwalia
(Reuters) – Europe’s reported coronavirus cases more than doubled in 10 days, crossing 200,000 daily infections for the first time on Thursday, according to a Reuters tally, with many Southern European countries reporting their highest single-day cases this week.
Europe reported 100,000 daily cases for the first time on Oct. 12.
Europe has so far reported about 7.8 million total coronavirus cases and about 247,000 deaths, according to a Reuters tally.
European countries like Italy, Austria, Croatia, Slovenia and Bosnia reported their highest single-day coronavirus cases on Thursday.
Europe as a region is reporting more daily cases than India, Brazil and the United States combined. The increase is partly explained by far more testing than was done in the first wave of the pandemic.
The global coronavirus tally stands at about 41.4 million cases and about 1.1 million deaths.
According to a Reuters tally, Wednesday saw the highest total of infections reported in a single day across the world, at 422,835.
As of now, Europe accounts for nearly 19% of global cases and about 22% of global deaths, according to Reuters tally.
In Western Europe, France, which is reporting the highest seven-day average of new cases in Europe with 25,480 infections per day, reported an all-time high of 41,622 new confirmed COVID-19 cases on Thursday, according to French health authorities.
To slow the spread of infection, France’s Prime Minister Jean Castex on Thursday announced widening of a coronavirus curfew to more than two thirds of its population.
Another Western European country Netherlands reported more than 9,000 in 24 hours, a new record, data released by the National Institute for Public Health (RIVM) on Thursday showed.
Germany, which reported more than 10,000 daily cases for the first time on Thursday, extended travel warnings for Switzerland, Ireland, Poland, most of Austria and Italian regions including Rome.
Hospitals across Europe remain under strain. Even though the it remains well below levels at the peak of the crisis six months ago in the region, COVID-19 hospital admissions and occupancy are going up again.
A World Health Organization (WHO) expert said on Monday said Europe and North America should follow the example of Asian states by persevering with anti-COVID measures and quarantining anyone who comes into contact with infected people,.
(Reporting by Anurag Maan and Shaina Ahluwalia in Bengaluru; Editing by David Gregorio)
Copyright 2020 Thomson Reuters.
HELENA, Mont. — Montana Gov. Steve Bullock says the state health department is pursuing legal action against several businesses in northwestern Montana for not following a mask mandate and other restrictions meant to prevent the spread of the coronavirus.
The announcement came Thursday as the state reported 932 newly confirmed coronavirus cases. That was far above the previous one-day high of 734.… Read More
BERLIN, Vt. (AP) — Advocates for a program that uses federal coronavirus relief money to distribute free restaurant-made meals intended for people in need during the pandemic and to help those eateries stay afloat are calling for the program to be funded past mid-December.
The statewide Everyone Eats program offers restaurants financial support to cook healthy meals for the community, said Sue Minter, executive director of Capstone Community Action on Thursday.… Read More
This story was published in partnership with The 19th, a nonprofit, nonpartisan newsroom reporting on gender, politics and policy.
A top pediatric hospital has agreed to stop performing certain types of genital surgeries on intersex children if they are too young to meaningfully consent— a decision that activists say could be a watershed moment for intersex rights.
A spokesperson for Boston Children’s Hospital told The 19th that it “will not perform clitoroplasty or vaginoplasty in patients who are too young to participate in a meaningful discussion of the implications of these surgeries, unless anatomical differences threaten the physical health of the child.” The decision came from the hospital’s behavioral health, endocrinology and urology program.
Each year, about 1.7 percent of people are born intersex, or people with sexual or reproductive anatomy that doesn’t neatly align into a binary of male or female. Some people develop those anatomical traits in adolescence or childhood, while others are born with them.
Boston Children’s Hospital says it will no longer perform certain intersex surgeries on children too young to consent, unless their health is in danger. (Photo: AP File Photo)
For decades, the standard medical protocol was to use surgery and hormonal therapy to try to change intersex children’s physical appearance. Clitoroplasties, the surgical creation of a clitoris (which can involve reducing its size), and vaginoplasty, which involves constructing a vagina, are two such surgeries. Activists have been protesting these practices for decades, and — though legal worldwide — they have been condemned by the United Nations, Amnesty International and Human Rights Watch.
Boston Children’s decision could reflect a turning point, activists said. It comes on the heels of a similar move by the Ann and Robert H. Lurie Children’s Hospital of Chicago, which announced in July it would suspend such intersex surgeries.
“One hospital was cool, but people might be like, ‘Oh, that’s an anomaly.’ Now that there are two hospitals, people in the community are going to feel more ability to pressure their hospitals to do the same,” said Pidgeon Pagonis, co-founder of the Intersex Justice Project.
Advocates are pushing for similar changes in other major cities, including New York, Seattle, Philadelphia, Los Angeles and Oklahoma City, Pagonis said. Both New York City Human Rights Commissioner Carmelyn Malalis and its former health commissioner Oxiris Barbot have also spoken out against performing intersex surgeries in children.
Still, Boston Children’s change isn’t exhaustive. The hospital has not indicated it will drop other intersex surgeries, including gonadectomies, which constitute the removal of certain reproductive glands, or phalloplasties, which enlarge penises.
“Vaginoplasties and cliteroctomies are very destructive, and it’s very welcome news,” Pagonis said. “But it means there’s still more work to do.”
There are a host of physical consequences to intersex surgeries: loss of sexual sensation, incontinence, fertility problems and pain during intercourse are just a few. And beyond physical consequences, intersex surgeries can have lifelong pyschological impact.
There are cases when surgery
HUNTSVILLE, Ala. (WAFF) – The parents of a two-year-old said their child was left in crippling agony after a trip to the dentist office earlier this week.
What was expected to be a routine cleaning ended with a child hospitalized and the parents taking legal action.
Two-year-old Chance had his first cleaning when the hygienist told his parents he had decay on his front teeth. They were told four silver crowns were needed to prevent future problems.
The parents agreed but said what happened in the exam room was something they never expected.
“His mouth had completely swollen up,” said Monica Roberson. “There was so much bruising, I took him to the emergency room directly after leaving there.”
Chance Roberson is on the mend, but his parents are still looking for an explanation. “They got mid-way through the process and said they can’t do any more and left them as they were because they filed them down too far.”
Monica and Donavyn took their two-year-old son to see a dentist at Children’s Dentistry of Huntsville. They were told Chance needed four caps for his four front teeth.
“The nurse kept saying, I don’t understand we don’t normally do procedures on children this small,” said Donavyn Larry. “It is not our specialty. I kept thinking why are you doing it then?”
Unaware to the parents, Chance also needed a root canal due to tooth decay. “The whole process was just uncomfortable for everybody. You could tell it was kind of a panic situation when they realize they couldn’t do anything,” said Roberson.
A family member posted photos following the procedure on social media where they were shared more than one-thousand times. The family also hired attorney Will League to represent them.
He told us, “This case falls under the Alabama Medical Liability Act. The applicable standard of care requires proof, through expert testimony, that no reasonable dentist would have done what this dentist did. The standard of care also requires the physician or dentist to fully explain the procedure along with its risks and benefits to the patient and obtain consent to proceed.”
We reached out to Children’s Dentistry of Huntsville. The office manager told me no one in the office would be available to comment due to the ongoing legal action.
I also reached out to the UAB Dentistry School and other pediatric dentists in the area, but no one felt comfortable commenting on the situation without first reviewing patient records.
A dentist who did not want to go on camera said root canals are one of the most common treatments performed on baby teeth. The procedure is typically performed on a tooth that has been infected, usually a result of tooth decay.
“I know you need to have some of the teeth grind down when you put a cap in but nothing to that severity. No, I wasn’t aware of
The US just topped 1,100 coronavirus deaths a day. One state is getting National Guard help, and others keep breaking records
You know Covid-19 is out of control when health officials are so overwhelmed, they can’t notify close contacts who may be infected.
That’s what’s happening in North Dakota, one of 31 states suffering more new Covid-19 cases this past week compared to the previous week.
Contact tracing is crucial to finding possible carriers of coronavirus, so they can quarantine and break the chain of infection.
But a “sharp increase” in new cases has engulfed contact tracers, leading to delays and “a backlog of positive cases that have yet to be assigned to a case investigator,” the North Dakota Department of Health said this week.
“Close contacts will no longer be contacted by public health officials; instead, positive individuals will be instructed to self-notify their close contacts and direct them to the NDDoH website, where landing pages will be created … explaining the recommended and required actions for both positive patients and close contacts.”
The North Dakota National Guard has shifted 50 soldiers from contacting close contacts to notifying people who have tested positive, the state health department said.
‘No safe period of time’ to be maskless with someone outside your bubble
Nationwide, all Americans need to double down on safety measures now that the definition of “close contacts” has expanded.
The Centers for Disease Control and Prevention just broadened “close contacts” to include anyone you may have had brief contact with, within 6 feet, during a combined 15 minutes over the course of a day. (Previously, the CDC defined close contacts as anyone you had close encounters with for at least 15 minutes straight.)
“It reiterates the importance of everybody wearing a mask,” said Dr. Ashish Jha, dean of the Brown University School of Public Health.
Jha and other health experts say there’s nothing magical about 15 minutes, and that the public shouldn’t assume spending less time with people without masks is safe.
“There is no safe period of time to be with somebody who’s not part of your bubble if both of you are not wearing masks,” he said.
“It’s really critical that people wear masks if you’re going to be with somebody for any period of time, even if it’s less than 15 minutes.”
The new CDC guidance came after researchers discovered even brief exposures (less than 15 minutes each) with an infected person nearby can silently spread coronavirus.
“A mask can protect other people from the virus-containing particles exhaled by someone who has COVID-19. As many as half of all people who have COVID-19 don’t show symptoms, so it’s critical to wear a mask because you could be carrying the virus and not know it,” the CDC said.
Video: Iowa doctor warns “the virus is absolutely winning right now” (CNN)
EAST BRUNSWICK, NJ — An entire department in the East Brunswick school district administration building will quarantine after a staff member tested positive for COVID-19. Superintendent Victor Valeski informed the school community on Thursday.
No information was provided on the department asked to quarantine.
This is the first positive case within the administration building. The case was reported to the district on Wednesday evening. The individual, along with the department will quarantine for 14 days.
“Because of our preplanning, the entire department can work remotely, and district operations will not be impacted,” said Valeski.
Meanwhile, a high school student is quarantining as a “close contact” to a positive COVID case outside of school.
The Centers for Disease Control on Wednesday revised their definition of a “close contact”.
Now, a “close contact” occurs if a person spends a total of 15 minutes within six feet of an infected person over the course of a 24-hour period, starting two days before the onset of illness.
This change was made after a study in Vermont outlined how a correctional officer contracted COVID after multiple brief exposures to COVID-positive individuals over the course of an eight-hour shift.
Valeski said the school district is applying the new CDC guidance standards across all schools.
“Beyond testing and wearing masks, rapid communication reinforces our defense against the spread of COVID within our school community,” Valeski said.
Meanwhile, the district is planning to combine hybrid learning groups in secondary schools, come Nov. 17.
Read More Here: East Brunswick Schools To Combine Hybrid Learning Groups
However, these plans will be put on hold if the school district reports an increase in positive COVID cases among the school population, and in case of any person-to -person transmission within the school communities, two weeks before Nov. 17.
Thank you for reading. Have a correction or news tip? Email [email protected]
Get breaking news alerts on your phone with our app. Download here. Sign up to get Patch emails so you don’t miss out on local and statewide news.
This article originally appeared on the East Brunswick Patch
U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV.
The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.
It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.
Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.
The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.
“We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement.
The drug is either approved or has temporary authorization in about 50 countries, he noted.
Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial.
Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.
So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.