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AstraZeneca announced Monday that its COVID-19 vaccine offered good safety for all adults in a long-awaited U.S. trial, raising expectations that the results would help restore public trust in the beleaguered vaccine in other countries while also bringing it closer to approval for use in the United States.
The vaccine, according to AstraZeneca, was 79 percent successful in preventing symptomatic COVID-19 outbreaks, even in older adults, and none of the study participants who were vaccinated were hospitalized or developed serious disease. The company also stated that its experts found no safety issues with the vaccine, including no increased risk of unusual blood clots that have been reported in Europe.
The results back up AstraZeneca’s previous studies in the United Kingdom and other countries, and they add to real-world proof that the shots are successful as they become more commonly used. However, public trust in the vaccine has been shaken by doubts about how data from previous studies are reported, as well as questions about its effectiveness in older adults and a recent clotting scare.
AstraZeneca said it will seek clearance in the United States “in the coming weeks,” putting it on track to arrive at the same time as three other vaccines already in use — from Pfizer, Moderna, and Johnson & Johnson — are expected to see a significant increase in supply.
AstraZeneca’s interim results are based on 141 COVID-19 cases in the 30,000-person trial, but officials refused to say how many were in study volunteers who received the vaccine and how many were in those who received dummy shots during a news conference on Monday. The vaccine was given to two-thirds of the volunteers.
“These findings corroborate previous findings,” said Ann Falsey, a trial co-leader from the University of Rochester School of Medicine. “It’s exciting to see similar effectiveness outcomes for the first time in people over 65.”
Until deciding whether to approve emergency use, a Food and Drug Administration advisory committee will debate the facts behind the shots in public. AstraZeneca executive vice president Ruud Dobber said that if the FDA approves the vaccine, the company would immediately supply 30 million doses, followed by another 20 million within the first month.
The AstraZeneca vaccine, which has been approved in over 70 countries, is a cornerstone of the United Nations-backed COVAX project, which aims to get COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries’ efforts to speed up their sluggish vaccine rollouts. The shot’s significance in the global plan to end the pandemic makes any questions about it all the more alarming.
The new data, according to Stephen Evans of the London School of Hygiene & Tropical Medicine, could help to alleviate vaccine concerns.
“These findings will primarily benefit the rest of the world, where confidence in the AZ (AstraZeneca) vaccine has been eroded, largely as a result of political and media commentary,” he said.
The findings were reassuring, but more information were needed to back up AstraZeneca’s argument that the vaccine was fully successful at preventing serious disease and hospitalization, according to Dr. Paul Hunter, a professor of medicine at the University of East Anglia.
”It would be interesting to know how many severe cases occurred in the control group and what the confidence intervals are for this 100% figure,” Hunter, who was not involved in the study, said. “However, this should give people more hope that the vaccine is doing its job.”
Scientists hoped that the study from the United States would clear up some of the uncertainty about how successful the shots are, especially in older people. Previous research suggested the vaccine was effective in younger populations, but there was no solid evidence that it was effective in those over 65, who are often the COVID-19’s most vulnerable victims.
The vaccine was first approved in the United Kingdom based on preliminary findings from studies performed in the United Kingdom, Brazil, and South Africa, which indicated that the shots were around 70% successful. However, those findings were tainted by a manufacturing error that resulted in some participants receiving only a half-dose in their first shot — an oversight that the researchers failed to acknowledge right away.
More concerns followed, including how well the vaccine protected older adults and how long they could wait before receiving the second dose. Some European countries, such as Germany, France, and Belgium, initially refused to give the shot to older people, only to reverse their decisions after new evidence suggested that it provided protection to seniors.
In the United States, too, AstraZeneca’s vaccine production was rocky. Last fall, the FDA put a six-week hold on the company’s research as irritated regulators requested information about some neurologic complaints identified in the United Kingdom; eventually, there was no proof that the vaccine was to blame.
More than a dozen nations, mainly in Europe, briefly stopped use of the AstraZeneca vaccine last week after news that it was related to unusual blood clots, despite international health agencies insisting that the vaccine’s benefits outweighed the risks. The European Medicines Agency announced on Thursday that, while the vaccine did not increase the overall risk of blood clots, it could not rule out the possibility that it was linked to two extremely rare types of clots. It was proposed that the vaccine’s leaflet contain a warning about these events.
It’s not uncommon for such uncommon issues to arise when vaccines are carried out, as trials usually include tens of thousands of patients, and some issues are only discovered after the shot has been administered to millions of people.
On Friday, France, Germany, Italy, and other countries resumed using the vaccine, with senior politicians rolling up their sleeves to demonstrate the vaccine’s safety.
The AstraZeneca vaccine is a “viral vector” vaccine, according to scientists. The vaccines are made with a virus that infects chimps and is completely safe. It acts as a Trojan horse, carrying the genetic material of the coronavirus’s spike protein into the body, which then produces a harmless protein. This prepares the immune system to fight the real virus when it appears.
COVID-19 vaccines are produced by two other firms, Johnson & Johnson and CanSino Biologics of China, using the same technology but different cold viruses.
MADISON COUNTY, Mo. – Located about 90 miles south of St. Louis, Fredericktown appeared to have sustained the worst of the damage from the strongest tornado to hit the region Sunday evening.
A National Weather Service survey team reported at least an EF-3 tornado hit the area, pending further investigation. The Enhanced Fujita Scale goes from 0-5, with 0 being the weakest.
EF-3 tornados have wind speeds of up to 165 miles per hour.
The view of widespread damage on the outskirts of town from Bommarito Automotive Group SkyFox was staggering. Up close, the views on the ground were heartbreaking.
A home just behind 72 West Motors RV/Camper sales off of Highway 72 had its roof torn off. Five people were inside hoping to make it out alive. Fortunately, they did.
“As soon as I said, ‘I think we need to go downstairs,’ it felt like a bomb going off behind me, which was the roof getting ripped off and falling in and all the attic insulation blinding everybody,” said A.J. Smith, standing outside the roofless house. “As this was happening, I ran into my dad’s room. I shook him real quick. He jumped up. I just scooped him up like a little baby and ran downstairs.”
They huddled near a basement support beam, he said.
The entire fleet of 50 new campers at 72 West Motors was damaged or destroyed; campers worth $40,000 to $100,000 or more.
Across the highway and nearby fields, the Black River Electrical Cooperative was also wiped out, along with a couple more homes and businesses.
Most of Black River’s repair trucks were idled awaiting a damage assessment, Monday, as opposed to be used to restore customers’ power.
“We’re used to that (role) but not this (being a tornado victim),” a spokesman said.
Enough trucks remained in service and/or were brought in from the other providers to have power restored to about 5,000 of 6,400 customers who lost service as of 3:00 p.m. Monday, he said.
No one was hurt.
No one was hurt at 72 West Motors either.
“I’ve never been through it. I’ve seen this stuff on TV. I’ve always felt bad for the families. I never thought I’d be one of them,” said Gary Stephens, owner of 72 West Motors. “I know what it feels like to be one of them and it’s not a very good feeling. “There’s always a bright side you know. I’ve got so many friends that’s come by here, so many people, customers drove plum from Springfield. Nobody got hurt. All my family is good and all my workers. My workers mean a lot to me.”
Homes and businesses within the Fredericktown city limits suffered very little damage but most were without power.
They are on the municipal power grid and not Black River’s.
It could be days before everyone’s power is restored, according to authorities.
Missouri State Highway Patrol Lt. Michael Lynch said as of late Monday night there was no curfew set in place for Fredericktown. He said it is not safe for people to be out on the roadways at night if they don’t have to, because there is still debris in on roadways.
Lynch added that authorities have rolling street closures to allow linemen and crews room to work while they restore power.
“The fact that nobody was hurt, best-case scenario for a bad situation, we had no reported injuries, from that we had one reported afterwards and it was relatively minor considering everything,” he said.
Lynch said there was one report of a minor hand injury after, but he believes it was an injury from cleaning up or being in the rubble.
Meanwhile, the National Weather Service is still looking for damage. They are asking the public to tweet pictures of it to them with the hashtags #mowx #ilwx. They are using the images to ask people if they would like to participate in a damage survey.
LINN COUNTY, Mo. – An EF-2 tornado was on the ground for more than 30 miles Sunday in north-central Missouri that hit a propane supplier and left some without a home.
Linn County Emergency Management Director Shelby Creed said the tornado was on the ground as it traveled across the entire county for 31 miles.
“I really wasn’t sure how bad it was until we got out there today and did some preliminary damage assessments and actually got to see how bad it was,” Creed said Monday.
The tornado touched down around 4:30 p.m. after residents in Linn County were on high alert for severe weather.
“We then paged out the effective fire departments to activate the storm spotters, then set off the sirens for the effective towns in Linn County,” Creed said.
The National Weather Service spent Monday surveying the damage before confirming it was an EF-2 tornado that hit Purdin, the north-central part of the county. A propane business known as MO Energy Propane was hit, throwing the office building off its foundation. The 120-mile per hour winds tossed empty propane tanks around. On Monday, the property was covered in shingles, wood pieces, parts of the steel structure, and office supplies.
Along Missouri Route 5 across from the propane business, the tree line was covered in debris like shed siding, installation, and other objects. A home on Expo Lane, about a mile southwest of the propane business, was ripped apart; the entire roof, garage, and shed were gone. Family members of the homeowners said the couple was down in the basement when the tornado hit.
“There was quite a bit of damage,” Creed said. “I’m really surprised we did not get more calls. There’s quite a bit of damage to houses, some trees, outside buildings, and power lines.”
The tornado traveled for more than 30 miles before stopping at the county line. Creed said the county is still assessing all the damage.
“It’s a pretty rural area where the storm went through so in the rural areas, everybody kind of takes care of themselves and their neighbors so they really did not call 911 or the admin line,” Creed said.
By Monday afternoon, friends, family, and neighbors came together to pick up the pieces.
“Make sure you have a plan, you have a bag or a tote ready in case you do need to seek shelter and know where you can seek shelter,” Creed said.
Once complete, the county hopes to pass the damage assessment off to the State’s Emergency Management Agency (SEMA) to see if state aid is needed.
Owners of the propane business did not want to go on camera but said luckily the tanks on the property were empty.
Fortunately, no was in Linn County was hurt from Sunday’s storms. Creed said the American Red Cross is in the county assessing damage but those who lost their home or have damage are staying with family and friends.
“There are community members that are very helping to their neighbors in Linn County,” Creed said. “It makes it a lot easier.”
What if you had a voice in your head — a voice that never stopped its cascade of negative thoughts?
That’s the premise of “Violet,” Justine Bateman’s writing-directing debut arriving Friday in theaters with Olivia Munn (“The Newsroom,” “The Predator”) as Violet, a successful Hollywood executive plagued by inner demons only she can hear.
“I think Violet is going through a lot of the same things that a lot of us are going through,” Munn, 41, said in a Zoom interview.
“At least for me, I can say that I have my whole life struggled with negative thoughts that make for fear-based decisions. In this film we call that ‘the voice.’
“And this film is really a map to your real self and shutting down that voice, shutting down those fear-based thoughts and decisions.”
As “Violet” unfolds, we see writing on the screen and hear a continuous stream of negativity with Justin Theroux’s voice.
In contrast, we see how Violet rules at her job, lunches with friends, bonds with her roommate (Luke Bracey, “Little Fires Everywhere”). She seems serene, confident, happy even.
“A big part of what we see happen with Violet,” Munn said, “is she’s trying to figure out what’s really her issue with these negative thoughts. Is she something better than that? Does she have a lot more self-love for herself than it may appear?
“Because when you actually hear those thoughts audibly and you hear Justin — that’s a big reason why Justine wanted to use a voice that was not even close to my voice. Because that voice is oftentimes something that feels like another person inside of you.
“So, it’s the erosion of what can happen when you appear one way, and you’re struggling with so much self-doubt and self-hate on the other side.”
It’s not a gender-based condition; it’s not something that afflicts only women. But how to silence that poisonous stream of invective? Therapy?
“I don’t think it’s something that is just cured overnight,” Munn offered. “The biggest thing is realizing that so many people can feel the same things.
“That is what’s been really amazing with this film: seeing the response from people who have seen the film and realizing that they relate to this, too. They relate to Justine’s words and that voice and understanding.
“That’s been really amazing to witness. And for Justine as well. To be like, Wow! there are some people who feel this way, or at least can recognize it. That has made me feel like, ‘Okay, I’m not one of the only ones who struggle with this.’ ”
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