Simone Biles withdraws from gymnastics team competition early, US comes in 2nd

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(TOKYO) — The U.S. won silver in the gymnastics team competition at the Tokyo Olympics after Simone Biles left competition early following a rare stumble on vault Tuesday.

She did not compete in the rest of the competition for the team event.

USA Gymnastics said in a statement, “Simone has withdrawn from the team final competition due to a medical issue. She will be assessed daily to determine medical clearance for future competitions.”

NBC had reported earlier that her coach said she withdrew due to a “mental issue.” Details were not immediately clear.

All eyes were on Biles to see if she would attempt a Yurchenko double pike on vault. Instead, as the Americans opened competition on vault, Biles bailed in the middle of her Amanar attempt, bringing down the difficulty level of her vault.

Rather than 2.5 twists, she only did 1.5, resulting in a score of 13.766 — remarkably low for Biles’ standard.

After that vault, Biles spoke with her coach and a trainer. She left the competition floor and returned as her teammates were preparing for uneven bars. She went on to stand by her team, wearing sweats and cheering them on for the rest of the event.

The U.S. women’s gymnastics team was competing in the team finals at the Tokyo Olympics on Tuesday, seeking to bring home the gold for the third time in a row.

The athletes from Russia came out on top, beating the Americans’ cumulative score by more than three points.

This was one of the strongest gymnastics teams the world has seen, led by all-time great Biles and uneven bars phenom Sunisa Lee. The team was rounded out by Jordan Chiles, who’s powerful on floor, and Grace McCallum.

During qualifiers for the final this past weekend, the Americans were surpassed by athletes from Russia competing under the Russian Olympic Committee (ROC).

“I truly do feel like I have the weight of the world on my shoulders at times,” Biles posted on Instagram after the qualifying event. “I know I brush it off and make it seem like pressure doesn’t affect me but damn sometimes it’s hard hahaha! The olympics is no joke!”

The U.S. has medaled in every women’s gymnastics team event at the Olympics since 1992. That included three golds, two silvers and two bronzes.

In the team event, three athletes from a four-person team compete on each apparatus. For the women, this includes balance beam, uneven bars, vault and floor.

The U.S. men’s gymnastics team came in fifth at their final Monday.

Both individual American men and women will have more opportunities for medals as the all-around and apparatus finals take place later in the Games. While Biles had qualified for those individual events, it remains to be determined if she will be able to compete.

For more Olympics coverage, see: https://abcnews.go.com/Sports/Olympics

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Simone Biles ends competition early in gymnastics team at Tokyo Olympics

Ezra Shaw/Getty Images

(TOKYO) — Simone Biles left competition early at the Tokyo Olympics team competition Tuesday after a rare stumble on vault, NBC announced and the International Gymnastics Federation wrote on Twitter.

She will not be competing in the rest of the competition for the team event.

USA Gymnastics said in a statement, “Simone has withdrawn from the team final competition due to a medical issue. She will be assessed daily to determine medical clearance for future competitions.”

NBC had reported earlier that her coach said she withdrew due to a “mental issue.” Details were not immediately clear.

All eyes were on Biles to see if she would attempt a Yurchenko double pike on vault. Instead, as the Americans opened competition on vault, Biles bailed in the middle of her Amanar attempt, bringing down the difficulty level of her vault.

Rather than 2.5 twists, she only did 1.5, resulting in a score of 13.766 — remarkably low for Biles’ standard. The Americans ended that first rotation, out of four, about a point lower than the athletes from Russia.

After that vault, Biles spoke with her coach and a trainer. She left the competition floor and returned as her teammates were preparing for uneven bars. She has since stood by her team, wearing sweats and cheering them on.

The U.S. women’s gymnastics team is competing in the team finals at the Tokyo Olympics on Tuesday, seeking to bring home the gold for the third time in a row.

This is one of the strongest gymnastics teams the world has seen, led by all-time great Biles and uneven bars phenom Sunisa Lee. The team is rounded out by Jordan Chiles, who’s powerful on floor, and Grace McCallum.

During qualifiers for the final this past weekend, the Americans were surpassed by athletes from Russia competing under the Russian Olympic Committee (ROC).

The U.S. ended with a cumulative score of 170.562, while the athletes from Russia finished with 171.629. While those numbers do not factor into the finals scores, it sent a message to the previously dominant American team.

“I truly do feel like I have the weight of the world on my shoulders at times,” Biles posted on Instagram after the qualifying event. “I know I brush it off and make it seem like pressure doesn’t affect me but damn sometimes it’s hard hahaha! The olympics is no joke!”

The U.S. has medaled in every women’s gymnastics team event at the Olympics since 1992. That included three golds, two silvers and two bronzes.

In the team event, three athletes from a four-person team compete on each apparatus. For the women, this includes balance beam, uneven bars, vault and floor.

The U.S. men’s gymnastics team came in fifth at their final Monday.

Both individual American men and women will have more opportunities for medals as the all-around and apparatus finals take place later in the Games. While Biles had qualified for those individual events, it remains to be determined if she will be able to compete.

For more Olympics coverage, see: https://abcnews.go.com/Sports/Olympics

Copyright © 2021, ABC Audio. All rights reserved.

Naomi Osaka knocked out of Tokyo Olympics in surprise loss

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(TOKYO) — Naomi Osaka, ranked second and competing in her home country, will leave the Tokyo Olympics without a medal.

Osaka, 23, lost to Marketa Vondrousova of the Czech Republic 6-1, 6-4 in the third round of the Olympic tennis tournament on Tuesday.

“I’m disappointed in every loss, but I feel like this one sucks more than the others,” Osaka said after the match, according to ESPN.

Osaka was born in Japan but raised in the United States. She lit the Olympic cauldron during the opening ceremony last week in Tokyo, a moment that she described as “undoubtedly the greatest athletic achievement and honor I will ever have in my life.”

The Tokyo Olympics marked Osaka’s first tournament back after taking a mental health break from professional tennis this summer.

Osaka withdrew from the French Open in June after being penalized for not doing post-match press conferences, which she said at the beginning of the tournament she would not do to preserve her mental health.

The tennis superstar also decided not to compete in Wimbledon. Her agent said at the time that Osaka would be “ready for the Olympics and is excited to play in front of her home fans.”

Osaka acknowledged the huge expectations she faced as she competed in her first Olympics.

“I definitely feel like there was a lot of pressure for this,” Osaka said after her loss. “I think it’s maybe because I haven’t played in the Olympics before and for the first year [it] was a bit much.”

“I’ve taken long breaks before and I’ve managed to do well,” added Osaka, who, according to ESPN, met with a small group of reporters after her loss. “I’m not saying that I did bad right now, but I do know that my expectations were a lot higher.”

“I feel like my attitude wasn’t that great because I don’t really know how to cope with that pressure, so that’s the best that I could have done in this situation,” she said.

ABC and ESPN are both owned by parent company, The Walt Disney Co.

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Naomi Osaka knocked out of Tokyo Olympics in surprise loss

Clive Brunskill/Getty Images

(TOKYO) — Naomi Osaka, ranked second and competing in her home country, will leave the Tokyo Olympics without a medal.

Osaka, 23, lost to Marketa Vondrousova of the Czech Republic 6-1, 6-4 in the third round of the Olympic tennis tournament on Tuesday.

“I’m disappointed in every loss, but I feel like this one sucks more than the others,” Osaka said after the match, according to ESPN.

Osaka was born in Japan but raised in the United States. She lit the Olympic cauldron during the opening ceremony last week in Tokyo, a moment that she described as “undoubtedly the greatest athletic achievement and honor I will ever have in my life.”

The Tokyo Olympics marked Osaka’s first tournament back after taking a mental health break from professional tennis this summer.

Osaka withdrew from the French Open in June after being penalized for not doing post-match press conferences, which she said at the beginning of the tournament she would not do to preserve her mental health.

The tennis superstar also decided not to compete in Wimbledon. Her agent said at the time that Osaka would be “ready for the Olympics and is excited to play in front of her home fans.”

Osaka acknowledged the huge expectations she faced as she competed in her first Olympics.

“I definitely feel like there was a lot of pressure for this,” Osaka said after her loss. “I think it’s maybe because I haven’t played in the Olympics before and for the first year [it] was a bit much.”

“I’ve taken long breaks before and I’ve managed to do well,” added Osaka, who, according to ESPN, met with a small group of reporters after her loss. “I’m not saying that I did bad right now, but I do know that my expectations were a lot higher.”

“I feel like my attitude wasn’t that great because I don’t really know how to cope with that pressure, so that’s the best that I could have done in this situation,” she said.

ABC and ESPN are both owned by parent company, The Walt Disney Co.

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Mask mandates return at local level as some officials defy state rules

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(NEW YORK) — As the delta variant drives a surge in COVID-19 cases across the U.S., some local health departments are taking the lead to reimpose indoor mask mandates for all residents — despite CDC guidance that most fully vaccinated Americans can go maskless.

The move from local municipalities in several states, including Massachusetts and Nevada, follows the announcement earlier this month by Los Angeles County — the most populous county in the nation — that it would reinstate mandatory indoor masks after seeing an uptick in coronavirus cases and hospitalizations.

The CDC said in May that fully vaccinated Americans could go without masks — but that was before the delta variant dramatically changed the landscape of the pandemic.

Vaccines are still working, experts say. But the highly transmissible delta variant means that cases are once again surging — especially among the one-half of all Americans who are not yet fully vaccinated. Over the past few weeks, coronavirus cases and hospitalizations among unvaccinated people in nearly every state have been on the rise, just as some states were in the process of declaring an end of their state of emergency from the pandemic.

ABC News identified at least a dozen states that have seen a reversal of their mask guidance at the local level — from cities, counties and school districts — in the past couple weeks. Some of these efforts have received solid support from state government, while some others are being challenged by state officials.

In some states, local governments have imposed new mask mandates, while in other states, local officials have instead announced new recommendations or reiterated existing recommendations.

In California, while the new mask mandate has only been issued in Los Angeles County, at least 10 additional counties across the state are now strongly recommending indoor mask-wearing for all residents — including those who are fully vaccinated. In Massachusetts, several counties and municipalities have brought back mask mandates.

In the cities of Las Vegas and New Orleans, health officials have moved to implement masks for county employees regardless of their vaccination status. Savannah became the first major city in Georgia to reinstate an indoor masks policy for all residents in response to a spike in coronavirus cases in the surrounding counties.

“It’s clear to us we’re on a very dangerous trend,” Savannah Mayor Van Johnson said on Monday. “And in order to try to slow this trend down, the mask mandate was the least invasive and destructive way to do it.

In some states, efforts to bring back mask requirements have faced immediate pushback.

In Missouri, as the case rate has increased and the vaccination rate remains low, St. Louis city and county officials announced last week that they will require masks to be worn in indoor public places and on public transportation — but state Attorney General Eric Schmitt said that he will be filing a lawsuit to stop the city and the county from bringing back such a mandate.

In Florida, where hospitalizations in some areas are increasing at the fastest rate since the start of the pandemic, Palm Beach officials this week went against Gov. Ron DeSantis’ statewide ban on mask mandates by imposing an indoor mask mandate for residents regardless of vaccination status.

And Miami Dade and Orange counties, while stopping short of imposing a mandate, have brought back recommendations to wear masks in crowded areas, prompting DeSantis to warn Orange County that it “cannot impose civil or criminal penalties on citizens who choose not to wear masks.”

Similar laws restricting local governments from imposing mask orders have been passed in Iowa, Montana, Arizona, and Arkansas, while governors in Texas, Tennessee and South Carolina have signed executive orders prohibiting local governments from imposing mask mandates.

In Montana, Missoula County’s health officer has blamed the state ban for the county’s inability to bring back a mask mandate despite a rise in cases.

And in Texas, many lawmakers and health officials are urging Gov. Greg Abbott to reverse his school ban and allow mask mandates in schools to be reinstated.

“We now know that even vaccinated people can catch and spread coronavirus,” 31 Texas lawmakers wrote in a letter to Abbott on Friday. “Under these circumstances, we must continue to fight against this virus with all the tools at our disposal.”

Some local school districts in Atlanta, Ohio, Michigan and Illinois have announced various mask mandates for school students and staff members, regardless of vaccine status, for the fall semester.

Officials in other states including Pennsylvania, Kansas and New York are focusing on increasing the number of vaccinations instead of reconsidering their mask guidance.

On Monday, New York City Mayor Bill de Blasio announced that the entire city workforce will be mandated to either get vaccinated or get tested once per week in response to rising coronavirus cases in the state.

As officials move to restore mask recommendations on the local level, Dr. Anthony Fauci, chief medical adviser to President Biden, told CNN on Sunday that revising national mask guidance for vaccinated individuals is “under active consideration.”

“The CDC agrees with that ability and discretion to say, you know, you’re in a situation where we’re having a lot of dynamics of infection,” Fauci said of the local mask mandates. “Even if you are vaccinated, you should wear a mask. That’s a local decision that’s not incompatible with the CDC’s overall recommendations that give a lot of discretion to the locals.”

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Woman shares warning on TikTok after having 7-pound cyst removed

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(NEW YORK) — Kayley Reese first noticed what seemed like a growing bump in her stomach over a year ago.

“The reason I really noticed it was because I own a clothing store and am in all the photos and it got to a point where I could see it in every single photo,” Reese, of Richmond, Virginia, told Good Morning America. “It looked like I was pregnant.”

Reese, 23, said she did not notice any other physical symptoms, so she did not do anything about it.

“On social media I would see some things like it’s your uterus protruding or everyone has it, it’s a protective layer,” she said. “So I kind of made it normal in my head.”

It was not until June when Reese flew home to Orlando, Florida, that she began to feel symptoms and sought treatment.

“I was nauseous and dizzy and my appetite wasn’t normal and I had shortness of breath, painful urination, all that,” said Reese. “My mom asked to feel the spot that I was complaining about and said, ‘That is not normal.'”

Reese went to a local emergency department, where she underwent testing that found a large cyst near her left ovary.

“The [doctors] weren’t sure how long it had been there but they said the symptoms I was having were from that,” she said. “At 23, I had no idea this could ever happen to me.”

Reese underwent a two-hour surgery to remove the cyst, which she said was eight inches in length, seven pounds in weight and was filled with two liters of fluid.

The cyst was diagnosed as a paratubal, or paraovarian cyst, a type of cyst that forms near an ovary or fallopian tube but does not adhere to an internal organ, like an ovary.

“It was the best possible case scenario because they were able to save both my ovaries,” she said. “When I went into surgery they said they were likely going to have to take out an ovary and my fallopian tube.”

While she was recovering, Reese said she saw a video on TikTok that prompted her to share her own story publicly.

“I saw someone else’s TikTok about having something similar and all the comments on her video were like, ‘That’s normal. Everyone has it,'” said Reese. “I thought this was exactly why I didn’t think much of my own [stomach bump].”

Reese posted a now-viral video sharing her own story, explaining, “I feel like if I had seen my own TikTok, I would have gone to the doctor a lot earlier.”

She said she was overwhelmed by the response, both from women thanking her for the information and women who also had paratubal cysts.

“When it started to get picked up I was very nervous because I’m like I’m not a doctor, but I saw that it brought awareness to a lot of women,” said Reese. “I got messages from women who had the same situation and they said was the first time they heard anyone even talk about it, so it was super emotional.”

The type of paratubal cyst Reese had differs from the more well-known ovarian cyst because a paratubal cyst does not attach to the ovary or fallopian tube.

While most paratubal cysts do not cause symptoms, some develop and become extremely large before causing symptoms including abdominal pain, frequent urination and feelings of fullness in the abdomen.

Problematic cysts can be removed through surgery.

Women with frequent or painful cysts, including paratubal cysts or ovarian cysts, may be advised by their doctor to take over-the-counter pain medication or hormonal birth control, according to the U.S. Office on Women’s Health.

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Over 50 major health care organizations call for mandating vaccines in their own industry

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(NEW YORK) — The American Medical Association and the American Nurses Association have joined up with over 50 other health care organizations to call for mandatory vaccinations in their industry, citing rising COVID cases and their trust in the vaccine.

“Due to the recent COVID-19 surge and the availability of safe and effective vaccines, our health care organizations and societies advocate that all health care and long-term care employers require their workers to receive the COVID-19 vaccine,” the organizations wrote in a joint statement on Monday morning.

Between them, these health care organizations represent millions of physicians, nurses and other health care workers across the country, including pediatricians, oncologists and pharmacists.

And they don’t think the health care industry should be the only one to require vaccines. They also called on other industries to follow suit.

“As the health care community leads the way in requiring vaccines for our employees, we hope all other employers across the country will follow our lead and implement effective policies to encourage vaccination,” the joint statement said. “The health and safety of U.S. workers, families, communities, and the nation depends on it.”

According to the Centers for Medicare and Medicaid, just 58% of nursing home staff are vaccinated. According to one estimate in late May, 1 in 4 health care workers were unvaccinated in the U.S. In some places, like Florida, the rates were as low as 40%.

Nationwide, the U.S. is struggling to increase its vaccination rates past 50% of the total population, including children, and missed President Joe Biden’s goal to get 70% of adults vaccinated with one shot by July Fourth. As of Monday, about three weeks later, still just 69% of adults had met that goal, while 60% of adults were fully vaccinated, according to Centers for Disease Control and Prevention data.

The influential statement has the potential to move the needle on an issue that, so far, has held up in court and proven to be effective at increasing vaccinations, at least in the health care field. Over the winter, Houston Methodist became the first hospital to require vaccines for its staff, and many hospital systems around the country have followed suit. In Houston, the hospital was sued, but won a lawsuit over the requirement and saw the vast majority of its 26,000-person staff get vaccinated, while around 150 quit or were fired for not adhering to the policy.

That decision spurred a recent statement from another massive health care organization, the American Hospital Association, to call for mandatory vaccinations in hospitals and paved the way for even more to get on board as they did on Monday.

“I think it’s incredible to see these organizations come together and make the bold statement to mandate vaccinations, which we know are safe and effective,” said Dr. Jay Bhatt, the former chief medical officer for the AHA and an ABC News contributor.

“We know, as Americans, it’s hard for folks to agree on a lot of things. So if we’re seeing big organizations agree on vaccinations, we should be paying attention to it,” Bhatt said.

In defending their reasons, the groups that came out in support of vaccine mandates on Monday said it was necessary for caregivers to protect patients who might be immunocompromised or not yet eligible for a vaccine, and for their own health.

The organizations emphasized their confidence in the vaccines, which are safe and effective, and hinted at the fact that the vaccines would be fully approved by the FDA soon, which will also bring more employer mandates. Currently, the vaccine is authorized under an Emergency Use Authorization, which is a temporary approval.

“As we move towards full FDA approval of the currently available vaccines, all health care workers should get vaccinated for their own health, and to protect their colleagues, families, residents of long-term care facilities and patients. This is especially necessary to protect those who are vulnerable, including unvaccinated children and the immunocompromised,” the joint statement said. “Indeed, this is why many health care and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.”

Also on Monday, the Department of Veteran Affairs announced that it would mandate the vaccine for its doctors and nurses. The decision came after four unvaccinated employees of the department died in recent weeks. The mandate will go into place in two months.

Department of Veterans Affairs Secretary Dennis McDonough said the mandate is “the best way to keep veterans safe, especially as the Delta variant spreads across the country.”

While there is a risk of pushback that could lead to people leaving their jobs, particularly in parts of the country where there is more refusal to get the vaccine, the rising levels of the delta variant, which currently makes up 83% of all cases in the U.S., could also hit hospital workforces hard, particularly for doctors and nurses on the frontlines of the pandemic.

“Either way, there’s a risk of them not being in the workforce. And I would say the cost of getting COVID is great enough that it warrants vaccination,” said Bhatt.

But for those who can’t be vaccinated because of medical reasons, which the groups estimated to be “a small minority of all workers,” they should be evaluated individually.

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Eight dead in Utah, including four children, after sandstorm causes series of car crashes

Utah Highway Patrol

(MILLARD COUNTY, Utah) — Eight people are dead in Utah, including four children under the age of 15, after a sandstorm caused a series of car crashes Sunday, according to the Utah Highway Patrol.

The crash happened around 4:30 p.m. local time on Interstate 15 in Millard County and involved 22 vehicles. There are still three others in critical condition following the pileup, authorities said Monday.

Utah Highway Patrol released the names of the victims Monday afternoon, including five victims that are from one family. The victims of Sunday’s accident are Kortni Sawyer, 30; Riggins Sawyer, 6; Franki Sawyer, 2; Race Sawyer, 37; Ryder Sawyer, 12; Richard Lorenzon, 51; Maricela Lorenzon, 47 and Cameron Valentine, 15.

“We’re stunned and saddened by the horrific accidents in Millard County,” Utah Gov. Spencer Cox tweeted. “We fervently pray for the loved ones of those who perished and for those fighting for their lives.”

Officials said winds caused a sand or dust storm and severely impaired visibility on the roadway, which led to the crash.

“It’s very tragic, it’s very hard to see the loss of life, and the families and the people affected,” Utah Highway Patrol Sgt. Cameron Roden told ABC News Salt Lake City affiliate KTVX.

Authorities said a couple of minor crashes forced a semi-truck to rear-end a pickup truck. The “most significant crashes happened behind the semi with two vehicles becoming wedged underneath the back of the trailer. They appear to have been hit from behind by another pickup,” according to UHP.

“Heartbroken over the tragic deaths and injuries following a 22-vehicle pileup near Fillmore on Sunday, Utah Sen. Mitt Romney tweeted Monday night. “Ann and I are praying for the victims and their loved ones as we grieve this terrible loss.”

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Trump’s endorsement looms over Texas special runoff election

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(WASHINGTON) — Nearly three months after the crowded race in Texas’ 6th Congressional District advanced into a runoff between two Republicans — Susan Wright and state Rep. Jake Ellzey — the major theme of the contest remains the same: will former President Donald Trump’s influence translate into victory on the campaign trail?

In April, Trump endorsed Susan Wright — the widow of the late Congressman Ron Wright who died in February after suffering from COVID-19 and complications from cancer — before the special election even took place. In the leadup to Tuesday’s contest, Trump publicly reiterated his support for Wright in a statement, saying she “supports America First policies” which earned her his “Complete and Total Endorsement.”

The former president also recorded a robo-call that was circulated online that touted Wright as “a great Republican (and) a great woman” who would carry on her husband’s politically conservative legacy in Congress. Although Wright’s inheritance of her late husband’s congressional track record is not an unusual phenomenon in the history of campaign politics, the widow-turned-congressional-hopeful is not yet guaranteed to win outright given Ellzey’s fundraising prowess.

Despite not having Trump’s endorsement, Ellzey has been able to raise more than double that of Wright. As of July 7, the state congressman raised more than $1.2 million compared to Wright’s $454,000, which could have helped him streamline his campaign’s voter mobilization efforts ahead of Tuesday’s contest.

Going into the matchup, Ellzey also has the backing of several high-profile Texas Republicans — including former Gov. Rick Perry, who also served as energy secretary in the Trump administration, and Rep. Dan Crenshaw who represents the district bordering Houston. The pair defended Ellzey on the campaign trail after he faced weeks of attacks from the conservative, anti-tax group, the Club for Growth, through mailers and advertisements.

“Nothing irritates me more than the junk that I have seen in the mailboxes talking about him. If you want to win an election that bad, I don’t want you to be my congressman,” Perry said at a campaign rally for Ellzey in mid-July.

Following that rally, Club for Growth President David McIntosh issued a statement in which he praised Wright as a “principled conservative” while calling Ellzey a “serial opportunist with a record of missing votes and supporting higher taxes.”

But the political back-and-forth could take a backseat to voter engagement given that special elections historically draw far fewer voters to the polls than midterm or general election cycles.

“Susan Wright is still probably the favorite based on the early judgments people made and the Trump endorsement in particular, but I think what makes it unpredictable is that Ellzey is probably a better campaigner than Susan Wright is, and in a very low turnout race — which this is expected to be — it’s very hard to tell (who will win),” said Cal Jillson, a political science professor at Southern Methodist University who specializes in Texas politics.

Jillson predicts it will be unlikely that Independent and Democratic voters turn out in large enough numbers on what is expected to be a scorching hot day to cast their ballots in opposition to the Trump-backed candidate. Still, the uncertainty of how many voters plan to participate in an off-cycle runoff election looms over the contest.

“You don’t know how many people are going to turn out. You don’t know who they’re going to be, (or) where they’re going to be — the northern part of the district leans toward Wright, the southern part of the district leans toward Ellzey,” he said in an interview with ABC News Monday.

Regardless of who comes out on top, the outcome of Tuesday’s election signals an inherent victory for congressional Republicans and will further narrow Democrats’ majority in the House. The lack of an opposing party member in the running allows Republicans to focus their spending in more competitive contests in the future.

“I look forward to welcoming a new Republican colleague to Congress,” National Republican Congressional Committee Chair Tom Emmer said in May following Wright and Ellzey’s runoff advancements.

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FDA says its ‘working as quickly as possible’ to review for full approval of vaccines

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(WASHINGTON) — As pressure grows for the Food and Drug Administration to give full approval for the vaccine, a move that could drive up vaccinations by allowing vaccine mandates in places such as the military and schools, the agency told ABC News on Monday that reviewing the vaccines is among its “highest priorities.”

“The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval,” FDA spokesperson Alison Hunt said in a statement.

But critics maintain that full approval of the Pfizer and Moderna vaccines, beyond the temporary approval that they currently have, needs to happen quicker. The argument is that the vaccine has proven to be safe and effective, and full FDA approval could increase Americans’ confidence in the vaccines at a time when the country is teetering dangerously at just 50% full vaccination while up against the fast-spreading delta variant.

“I think a lot of us are baffled why the FDA is taking so long,” Dr. Ashish Jha, dean of the Brown University School of Public Health, said on ABC’s Good Morning America on Monday.

The FDA will surely approve of the vaccines, Jha said, but needed to “move a bit faster now.”

So what do we know about the timeline?

Full approval of a vaccine under priority review, as both Pfizer and Moderna are, usually takes six months. The FDA has said it intends to complete it much quicker than that, and Dr. Anthony Fauci, chief medical adviser to the White House, recently said he expected full approval for Pfizer in a month or so, by August, and Moderna to follow thereafter.

Pfizer submitted for full approval on May 7, almost three months ago, and Moderna on June 1, almost two months ago. So, the decision should not be too far off.

And what does FDA say about the criticism that it’s moving too slowly?

Asked by ABC News on Monday if the review is moving slower than anticipated, the FDA stood by the process.

FDA spokesperson Alison Hunt said that reviewing the vaccines is “among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date.” The goal date is January 2022, though that’s a regulatory deadline and not when it’s expected.

“The FDA recognizes that vaccines are key to ending the COVID-19 pandemic and is working as quickly as possible to review applications for full approval,” Hunt said.

The FDA also emphasized that the current authorization — an Emergency Use Authorization — was conducted thoroughly, signaling that it stands on solid ground and should be fully approved.

“Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” Hunt said.

Some have also argued that the FDA has to take its time so that any vaccine mandates that follow the full approval go as smoothly as possible. Any cracks in the approval process or accusations of rushing, could lead to even more pushback. That’s already played out over the last few months, as hesitant Americans have refused to take the vaccine because they fear it was given emergency authorization too hastily.

That was White House press secretary Jen Psaki’s defense on Monday.

“The FDA is the gold standard in our view, and they move at the speed of science,” Psaki said to ABC News Chief White House Correspondent Cecilia Vega, who asked why the FDA hadn’t yet given full approval of the vaccines.

“It wouldn’t be responsible to expedite that process at a faster speed than the science and data allows.”

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