ABC - Health News

Bill Oxford/iStockBy MORGAN WINSOR, ABC News

(LONDON) -- U.K.-based pharmaceutical giant AstraZeneca and England's University of Oxford announced Monday that late-stage trials show their COVID-19 vaccine was up to 90% effective in preventing the disease.

The results are based on interim analysis of phase 3 trials in the United Kingdom and Brazil, which looked at two different dosing regimens. One regimen showed vaccine efficacy of 90% when the drug, called AZD1222, was given as a half dose, followed by a full dose at least one month apart. A second regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens showed an average efficacy of 70%, according to press releases from AstraZeneca and Oxford.

There were a total of 131 COVID-19 cases in the analysis, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine candidate, according to the press releases.

"These findings show that we have an effective vaccine that will save many lives," Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford vaccine trial, said in a statement Monday. "Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply."

AstraZeneca, which has promised not to profit from the vaccine "for the duration of the pandemic," said it will now immediately prepare to submit the data to regulators around the world -- including in the United Kingdom, Europe and Brazil -- that have framework in place for conditional or early approval. The company will also seek an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income nations.

Meanwhile, Oxford said it is submitting the full analysis of the interim results for independent scientific peer review and publication.

"Today marks an important milestone in our fight against the pandemic," AstraZeneca CEO Pascal Soriot said in a statement Monday. "This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency."

Clinical trials of AZD1222 are also being conducted in the United States, Japan, Russia, South Africa, Kenya and Latin America, with planned studies in other European and Asian countries. In total, AstraZeneca said it expects to enroll up to 60,000 participants globally.

The company said it is "making rapid progress in manufacturing" and expects to produce up to 3 billion doses of AZD1222 in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing health care settings.

"The vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval," Soriot said.

The U.K. government has already placed orders for 100 million doses of the AstraZeneca/Oxford vaccine candidate, along with 40 million doses of another developed by Pfizer and BioNTech, which has shown in a phase 3 trial to have 95% efficacy with no serious safety concerns to date.

Pfizer and BioNTech announced Friday that they had submitted a request to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.

Copyright © 2020, ABC Audio. All rights reserved.


Boyloso/iStockBy KATIE KINDELAN, ABC News

(NEW YORK) -- As the number of COVID-19 cases continue to spike across the country and hospitals become full, nurses and doctors are taking to social media to beg the public to take COVID-19 seriously and follow safety guidelines.

"We are physically, socially and mentally exhausted," Dr. Kate Grossman, a pulmonary and critical care physician in Columbia, Missouri, wrote in a message shared on Twitter.

"I have seen so many emergent intubations. I've seen people more sick than I've ever seen in my life," Lacie Gooch, an intensive care unit nurse at Nebraska Medicine in Omaha, said in a video that Nebraska Medicine shared on Twitter this week.

"I have seen so many emergent intubations. I've seen people more sick than I've ever seen in my life." COVID ICU nurse Lacie Gooch hopes you will listen. @UNMC_ID @unmc @Prof_Lowe @DanielWJohnson9 @KellyCawcuttMD @JamesLawler11

— Nebraska Medicine (@NebraskaMed) November 17, 2020

Gooch, 25, is a cardiovascular ICU nurse who has been working shifts in her hospital's COVID-19 ICU since April.

She described a sense of frustration and exasperation at the disconnect between what she and her colleagues are doing to save lives inside the hospital, and what some people are doing to flaunt safety guidelines outside the hospital.

"We're tired. We're understaffed. We're taking care of very, very sick patients and our patient load just keeps going up. We're exhausted and frustrated that people aren't listening to us," said Gooch, who said she has patients who don't believe in COVID-19 even as they are hospitalized for it. "It kind of blows my mind and it's frustrating."

Gooch recalled driving to the hospital one night for an overnight shift and passing a car festival that was packed with people, most not wearing masks.

"I was just shocked and it was infuriating," she said. "It just kind of feels like a slap in the face to all the hard work that we're doing."

Nine months into the coronavirus pandemic, the United States remains the worst-affected nation, with about 12 million diagnosed cases of COVID-19 and over 250,000 deaths.

The U.S. Centers for Disease Control and Prevention have recommended mask wearing, hand-washing and social distancing to prevent the spread of COVID-19, but not all state and local governments, nor private businesses, follow those guidelines.

Grossman, a mom of two who works with COVID-19 patients in the ICU, described the situation she sees by simply saying, "People don't get it."

"Nurses and nurse practitioners and [physician assistants] and doctors and respiratory therapists who are in the hospital, we see it," she said. "And it is so disheartening and demoralizing to leave work and just not see it, to see people gathering and talking about their Thanksgiving plans and travel plans, to see people waiting in a line outside a bar to get in when you're driving home after a horrible day. It's so upsetting."

Grossman shared her experience as a health care worker on the front lines in response to a question from her childhood best friend, actress and author June Diane Raphael, about how she was doing. Raphael then shared Grossman's text, with her permission, on Twitter, where it has more than 60,000 retweets.

This is the text I just received after asking my best friend ( pulmonary and critical care doctor) how she was doing. #WearAMask #SocialDistance

— June Diane Raphael (@MsJuneDiane) November 15, 2020

"I asked her how she was doing and the text that I got back just gutted me," said Raphael. "I could hear in her voice over text message that my friend is really going through it and really being traumatized by this health care situation that we've never been in before."

"When [Grossman] put her feelings out there, I really wanted to share it," she explained. "It really is up to all of us, with our platforms or even our own family members, to spread the word about how we can keep each other safe and healthy."

Grossman said she wants people to know that health care workers are doing all they can to help patients, but they need support from the entire community. She pointed out that health care workers like herself are also moms and dads whose kids are home doing remote learning and daughters and sons who miss visiting their parents and siblings.

Many of them will also be working over the holidays and will not travel to visit family and friends, following CDC guidance for all Americans to not travel for Thanksgiving this year.

"I leave work and I go home and I have a ninth grader at home who would love to be back in person starting high school and I have a 3-year-old to get to bed and I have a partner who is somehow keeping our house going while she works full-time and has a demanding job," said Grossman. "That's everyone in health care right now."

Grossman said she too has had experiences with patients where their first realization of how serious COVID-19 can be is when they're being taken to the ICU, or when she has to phone patients' families and its their first realization too.

That experience drove Ashley Bartholomew, an ICU nurse in El Paso, Texas, to take to Twitter to share her conversation with a patient who questioned whether those in the hospital were really dying of COVID-19.

"I'm brutally honest. I tell him in 10 years of being a nurse I've done more CPR and seen more people die in the last 2 weeks than I have in my entire career combined," she wrote on Twitter.

I’m an RN in El Paso and was recently transferred from the OR to COVID ICU.

I resigned from my job last week and I’ve been asked several times, “What was the breaking point?” I don’t know a specific one, but I’ll share this: a thread 🧵1/

— Ashley Bartholomew, BSN, RN (@TheBlondeRN) November 16, 2020

Bartholomew, a mom of three kids ages 7 and under, said she had to resign from her nursing job because of family logistics, but she stayed on an extra three weeks in the role this month to help with the rising COVID-19 patient load in the ICU.

While describing being a COVID-19 nurse as a "physically draining and mentally and emotionally draining" job, she also expressed feelings of defeat and frustration over people not taking the virus seriously.

"We're called heroes in the springtime and then by fall people are questioning what we're trying to say," said Bartholomew, referring to the beginning of the pandemic when people would stand outside and clap and cheer for health care workers. "It makes me feel defeated and it makes me feel scared."

Bartholomew said she worries that if people don't believe medical professionals about COVID-19 now, they may also not believe the science when a vaccine becomes available.

"That's our one glimmer of hope for the future," she said of a potential vaccine. "Trust the professionals that you've trusted for decades in your most vulnerable moments."

Copyright © 2020, ABC Audio. All rights reserved.


Liliboas/iStockBy KATIE KINDELAN, ABC News

(NEW YORK) -- In any year, Thanksgiving can be both the best of times and the worst of times for families, but 2020 is bringing with it some even bigger potential landmines for conflict.

First, the holiday is taking place just weeks after a divisive election, the results of which some people are still protesting.

This Thanksgiving is also taking place amid the coronavirus pandemic, which has left families stressed emotionally, financially and physically.

With the Centers for Disease Control and Prevention now advising Americans not to travel for Thanksgiving, the holiday is also creating new conflict between family members with different ideas about how to celebrate safely.

"There’s the old saying, you only hurt the ones you love," Sherrill W. Hayes, Ph.D., professor of conflict management at Kennesaw State University in Georgia, said. "Because we say this stuff to one another, and we’ve got the long history of knowing that even after we’ve fought for a while we’re going to make up and everything is going to be okay, we feel we can have these debates."

The pandemic also means many families will be communicating on Thanksgiving this year via technology rather than in-person, another potential stressor.

"The truth is conflict happens every year for families, and that can make holidays so stress-inducing because people know that potential is there," said Kory Floyd, Ph.D., an author and professor of interpersonal communication at the University of Arizona. "Add to that the stresses of the pandemic and the stresses of the national election, and it can be very tough."

Here are five tips from mental health and communications experts to help keep the peace in the family:

1. Make a decision and move on

Once you make the decision about what's best for your family for celebrating the holidays safely, communicate it clearly and move on, advises Nicole Beurkens, Ph.D., a holistic child psychologist and the founder and director of Horizons Developmental Resource Center in Caledonia, Michigan.

"Once you’ve communicated that, 'yes we’re coming,' or 'no, we’re not,' or 'this is how we feel about it,' it’s important to not continue to feel obligated to engage in discussions or arguments about it," she said. "Ultimately each of us as individuals and as a family unit needs to decide what is best for us and then just calmly and respectfully communicate that and try to let go of how other people are going to feel around that."

Beurkens recommends communicating your decision by framing it around doing what's best for yourself and your family versus what is right or wrong to do.

"If there’s people in the family who do want to get together for the regular gathering, they can do that and it’s not our role to be argumentative or judgmental about that," she said. "Everybody needs to decide what’s best for them and stick with that and say, ‘I’m doing what’s right for me and whatever other people do is totally fine.’"

2. Use 'I' statements when the conversation gets heated

Whether you are talking politics or the pandemic, the experts say to frame the conversation around what you believe, instead of what your friend or family member should think.

"How we phrase things and how we present things is really half the battle," said Deborah Duley, the owner of Empowered Connections, LLC, a women-focused counseling center in Maryland. "Sometimes it’s not what you say but how you say it."

Using "I" statements, like "I believe," or "I hear what you're saying, but this is how I think," keeps your feelings to you and invites more of a conversation than a heated debate, according to Duley.

"When you say something to somebody, like, 'You should be feeling this,' or 'You should be feeling that,' they’re automatically not hearing what you’re saying anymore and going right to the defensive," she said. "Make it around what you think and what you believe using 'I' statements because people don’t automatically take offense to it."

3. Decide to be the one to defuse arguments

Experts say to take these words of former first lady Michelle Obama to heart at the Thanksgiving table -- "When they go low, we go high."

Specifically, Floyd says to have a conversation with yourself ahead of time to make sure you are the one going high when the conversation goes low.

"When a conversation starts to get heated, what keeps it from devolving is that someone in the conversation has the resolve not to let that happen," he said. "All it takes is one person to derail that sort of downward spiral that can happen in conflict."

"Resolve before going to the event or taking part in the conversation, that if things start to get heated, I’m going to be the bigger person. I’m going to be the one who makes the decision not to let the conversation devolve into a heated fight," added Floyd. "I’m going to be the one to say, ‘I understand your point of view,’ or, ‘Tell me more about it. I want to understand where you’re coming from,’ instead of the one who says, ‘You’re wrong.’"

4. De-escalate with humor and deep breaths

Duley, who described her political beliefs as being very different from her family's, said she has learned to take a few seconds before replying to something hurtful or inflammatory said by a family member.

"It's just a deep breath or just reminding myself that I don’t need to go there if I don’t want to," she said.

Floyd said simply cracking a joke can ease the tension of a stressful conversation.

"Whenever my wife and I feel like we’re going down the road of conflict, we derail it with humor," he said. "One of us will crack a joke, like, why are we even fighting about this? It reminds us that it’s not important enough to drive a wedge into our relationship."

"Humor has enormous stress relieving and tension relieving properties," Floyd added.

5. Set ground rules ahead of time

Before you even sit down at the dinner table or log onto a family Zoom call, experts say you should already have set ground rules with your family.

The ground rules can focus on everything from what topics will and will not be discussed to how potentially tough conversations will be handled, according to Hayes.

"What are the things we can talk about, and if we want to talk about important things, what are the ground rules for those conversations," he said. "One ground rule could be, we’re not going to make personal attacks."

Especially when it comes to families, people also need to set ground rules about fully hearing people out, Hayes noted.

"My ground rule number one is always, are you listening or are you waiting to talk," he said. "In families, we know the other people sitting around the table, whether it’s a virtual table or a real table, we think we know them so well, we’re not listening, but just hearing what we think they’re going to say."

Hayes says to listen to people by asking why they think that way, and then look for what your views and life experiences have in common.

"It’s way easier to focus on differences and chaos and disorder, but focusing on those commonalities makes a huge difference in breaking things down," he said.

Copyright © 2020, ABC Audio. All rights reserved.



(NEW YORK) -- The co-creator of the ALS Ice Bucket Challenge died Sunday following his long battle with the neurodegenerative disease.

Pat Quinn's family posted on social media that the 37-year-old from Yonkers, New York, passed away in the morning. Quinn and Pete Frates launched the viral video campaign where people around the world poured ice-cold water over themselves and then nominated others to do the same to raise awareness and fund research into ALS.

"He was a blessing to us all in so many ways," the family wrote on his social media page.

ALS, also called Lou Gehrig's Disease after the Yankees legend who lost his life to it in 1941, is a neurological disease that mainly affects nerve cells responsible for controlling voluntary movements, such as walking, chewing and talking, according to the National Institutes of Health. There is no known cure, and scientists have worked for decades to determine a cause.

Quinn was diagnosed with ALS in 2013, a month after his 30th birthday, according to the ALS Association. He and Frates were friends and started two online groups, Quinn for the Win and Team Frate Train, to raise awareness and funds for the fight against ALS.

Their online presence and connections led to the co-creation of the Ice Bucket Challenge in 2014. Quinn and Frates saw fellow New York ALS patient Anthony Senerchia perform the challenge on his social media page and amplified the campaign, the ALS Association said.

Quinn and Frates recorded their own Ice Bucket videos and reached out to athletes, including Matt Ryan of the Atlanta Falcons, to participate and raise awareness and donations.

During the summer of 2014, the Ice Bucket Challenge included several big-name supporters and donors including Lady Gaga, Oprah Winfrey and Meghan Markle. Quinn told ABC's Nightline in an interview last year that he was surprised by how fast the campaign grew around the world.

"I am a huge basketball fan, so when people like Michael Jordan and Lebron James got involved, I lost it," he told Nightline.

The campaign raised $220 million for ALS research and sparked a wave of studies and development into finding new treatments.

"Pat fought ALS with positivity and bravery and inspired all around him. Those of us who knew him are devastated but grateful for all he did to advance the fight against ALS," the ALS Association said in a statement.

Frates died last year, and Senerchia died in 2017.

Quinn continued to conduct the challenge in the subsequent years, and he spoke around the country about the need for more awareness about the disease.

"The Ice Bucket Challenge connected with a sweet left hook to the jaw of ALS and shook the disease up, but by no means is this fight over. We need to knock this disease out," he said at an event in Boston last year to mark the campaign's fifth anniversary.

Copyright © 2020, ABC Audio. All rights reserved.



(NEW YORK) -- Goshen Health Hospital in Indiana has had to issue a public call for help from people with medical experience. In a Facebook post, the CEO wrote, “We invite you to consider if you are someone who could make a difference.”

The Mayo Clinic in Minnesota is bringing back retirees, redeploying employees from other parts of the country, and reassigning researchers to patient care after 905 employees contracted COVID-19 in the last two weeks.

And in North Dakota, the governor announced last week that to avoid a shortage of staff the state would implement “crisis” guidelines that allow nurses who test positive for COVID-19 to continue to work, as reported by the Grand Forks Herald.

Hospitals across the country are facing an influx of COVID-19 patients, the most Americans hospitalized for the disease at any other point in the pandemic. And after struggling with shortages of personal protective equipment, intensive care unit beds, ventilators and other equipment, hospitals are now facing a shortage of a harder to replace resource - health care workers.

“While hospitals can add beds, it is much harder to bring in additional health care workers, many of whom are justifiably experiencing a significant emotional and physical toll due to the impact of the pandemic,” Nancy Foster, vice president of quality and patient safety policy for the American Hospital Association said in a statement.

Eighteen percent of hospitals in the country said they had a critical shortage of medical staff on Nov. 18, according to data from the Department of Health and Human Services first obtained by The Atlantic. And 22% say they expect to experience a critical staffing shortage in the next week.

In some states the statistics are even worse. In five states, more than a third of hospitals report critical staffing shortages.

In North Dakota, more than half of the state’s 47 hospitals faced a staffing shortage last week. And in the U.S. Virgin Islands, one of the islands’ two hospitals was overwhelmed, with the second expected to face a staffing shortage within the next week.

Six states, Arkansas, Kansas, Missouri, New Mexico, Oklahoma, and Wisconsin, report that more than 30% of hospitals had a critical shortage of staff last week and several other states are just below 30%.

In North Dakota and the U.S. Virgin Islands, at least half of hospitals don’t have enough staff, and the second hospital in the Virgin Islands is expected to become overwhelmed in the next week.

Alex Garza, chief community health officer of SSM Health told ABC News Live the hospital’s staff is two weeks away from being overwhelmed by the increasing number of COVID-19 cases in the St. Louis area.

“Our health care heroes have fought valiantly day after day but we have no reserves, we have no backup that we can suddenly muster to come in and save the day,” Alex Garza, chief community health officer of SSM Health said in a briefing last week.

Nurses at St. Mary’s Medical Center in Bucks County, Pennsylvania, made the difficult decision to strike last week. Jim Gentile, a registered nurse at St. Mary’s, said they were being put in a dangerous situation because so many nurses have left that hospital for higher-paying jobs, leaving them without enough staff to deal with the surge.

“In two weeks we've doubled the number of COVID patients in our hospital and we thought we have to sound the alarm now because there are not enough nurses to take care of the patients,” he told ABC’s Brad Mielke on “Start Here.”

“That's called dangerous. It's extremely dangerous. When a patient comes to a hospital, they deserve a registered nurse to take care of them. If you have six to one ratio and they're all COVID patients and one starts to go bad, you spend the next two hours with that one patient. Those other five patients are totally ignored behind glass, behind isolation room. We can't even see them. It's dangerous.”

Vice President Mike Pence told governors Monday the federal government was “ready to roll our sleeves up and meet those capacity needs” on staffing shortages.

The North Dakota Department of Health announced that 60 Air Force medical personnel were being dispatched to the state. And White House Spokesman Michael Bars said more than 2,100 federal medical personnel are on the ground around the country.

“Currently, several thousand public health and medical personnel have been surged across all 50 states, territories, and tribal nations to support frontline responders and our hospital systems, as well as over 21,000 additional federal personnel deployed throughout the U.S. to support the whole-of-government coronavirus response,” he said in a statement.

Federal agencies have sent medical staff to more than 10 states in response to requests for help over the last two weeks, the Federal Emergency Management Administration said in a statement Friday.

Some nurses from New York City are also traveling to parts of the country where the virus is more severe to repay the favor from hospitals that send hundreds of nurses to help when New York was the epicenter of cases in the U.S. in April.

Intermountain Healthcare in Utah announced that 31 nurses from New York City were helping in intensive care, emergency, and surgical units around the state. The system is also hiring more than 200 traveling nurses, officials said in a press conference Friday.

But nurses across the country say more staff isn’t the only thing they need. They say everyone in communities around the country need to wear masks and follow guidelines like social distancing and avoiding indoor gatherings to slow the rapid spread of infections.

CDC studies have shown that parts of the country that require people to wear masks see less of the virus circulating in the community. In Kansas, COVID-19 cases decreased 6% in counties that kept a mask mandate over the summer. But in counties without a mandate COVID-19 cases increased 100%.

The CDC says wearing a face mask provides protection from exposure to the particles that carry the virus for both the person wearing it and anyone they come in contact with.

Public health experts say if 95% of Americans wore a face mask consistently it would make it much more difficult for the virus to spread, possibly preventing as many as 130,000 deaths.

“Everyone’s saying ‘it’s the year of the nurse,’ you know, health care heroes, and the thing is we can all be heroes just by doing one little thing and that’s wearing a mask and keeping our six feet,” Sarah Grabauskas, an ICU nurse in Idaho told ABC News.

Copyright © 2020, ABC Audio. All rights reserved.


FILE photo - Tempura/iStockBy EMILY SHAPIRO, ABC News

(AURORA, Ill.) -- A nurse's words on the immense personal toll of treating COVID-19 patients has gone viral, including grabbing the attention of her local mayor.

At this week's city council committee meeting in Aurora, Illinois, Mayor Richard Irvin read the powerful message posted to Facebook Saturday by intensive care unit nurse Carol Williams.

"Look in her eyes, look at her face. The pain, the frustration," Irvin said at the meeting. "I want to read her words to you, to everybody listening, so I
Williams posted this selfie after spending five hours working to save a COVID-19 patient.

"In this moment, I felt defeated because I already knew what the outcome would be even though it hadn’t happened yet," Williams wrote.

"The inability to save a patient despite doing everything you can is mentally exhausting. Now imagine doing that on repeat for eight months and counting," she said. "Imagine watching a patient suffocating through a door while scrambling to get your PPE on because they inadvertently removed the mask they desperately need to breathe but you still need to protect yourself first."

"Imagine being the nurse and doctor telling a patient we need to put them on the ventilator because we have exhausted all other measures," Williams wrote. "Imagine being the nurse or doctor holding that same patient’s hand and stroking their head weeks later while their ventilator is removed because they haven’t improved and their family then says goodbyes and I love yous over FaceTime while they take their last breath."

Williams then urged readers to put themselves in the COVID-19 patient's shoes.

"The breathlessness, pain, fear, loneliness, isolation, anxiety, hopelessness and sadness. The need to use all your energy just to breathe," she said. "The true realization you may not get better and facing your own mortality."

Williams pleaded, "Stop kidding yourself that this isn’t going to affect you or someone you love or know, it will. Stop thinking that only unhealthy people with preexisting medical conditions or elderly people are the ones dying, they aren’t the only ones."

"Please do not discount all the lives lost or affected by this pandemic any longer," Williams concluded, asking for Americans to work together and come together as a country.

Mayor Irvin said at the meeting, "Remember her words. Remember the anguish on her face."

Many council members appeared overcome with emotion after hearing Williams' words, with one member saying, "So moved."

Aurora, Illinois, has over 10,000 COVID-19 cases and at least 155 deaths. The U.S. now has over 11.7 million cases and at least 252,654 deaths.

Copyright © 2020, ABC Audio. All rights reserved.


Amanda Edwards/Getty Images(NEW YORK) -- Alex Trebek died earlier this month after his long battle with stage 4 pancreatic cancer, but not before delivering a heartfelt message to Jeopardy! viewers.

At the beginning of Thursday's episode of the game show, which was pre-taped, Trebek shared a message in honor of World Pancreatic Cancer Day -- dedicated to raising awareness and funds to battle the disease.

During the short intro, the popular TV personality urged anyone who has experienced symptoms of the disease to seek out medical attention and get tested.

"I want you to be safe. This is a terrible disease," he said.

Jeopardy! social media accounts also shared a PSA to raise awareness to the disease.

Trebek, best-known for hosting Jeopardy! for over 30 years, died at the age of 80 after being diagnosed in March 2019. Despite his diagnosis, he continued working up until about 10 days before he passed.

The episodes he recorded will run through Christmas Day.

Copyright © 2020, ABC Audio. All rights reserved.


Bill Oxford/iStockBy MORGAN WINSOR, ABC News

(NEW YORK) -- Pfizer and partner BioNTech announced they will submit a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.

The submission, which is based on a vaccine efficacy rate of 95% demonstrated in the Phase 3 clinical study with no serious safety concerns to date, will potentially enable the use of the drug in high-risk populations in the United States by the middle to end of December, according to a joint press release.

"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Dr. Albert Bourla, chairman and CEO of Pfizer, said in a statement Friday. "Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential."

The companies have already initiated rolling submissions with several drug regulatory agencies around the world, including in Australia, Canada, Europe, Japan and the United Kingdom, and plan to submit applications to others in the coming days. The companies said they will be ready to distribute the vaccine within hours after authorization.

Based on current projects, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021, according to the press release.

"Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible," Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement Friday. "We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process."

The FDA requires at least two months of safety data among at least half of the trial volunteers before it will consider granting a limited emergency authorization.

Pfizer, a New York City-based pharmaceutical company, and BioNTech, a German biotechnology firm, announced earlier this week that their COVID-19 vaccine candidate, called BNT162b2, is more than 95% effective in the final analysis of their massive Phase 3 trial and has reached a key safety milestone that will allow them to apply for the FDA authorization "within days."

Among the 170 volunteers to develop COVID-19 in the clinical trial, 162 had been given placebo shots while only eight volunteers to become infected were administered the real vaccine. Pfizer and BioNTech didn't record any serious safety concerns in the clinical trial. Like most vaccines, BNT162b2 -- which is administered in two doses over the course of three weeks -- caused mild side effects. The most common "grade 3" adverse effects were fatigue, which happened in about 3.7% of volunteers, and headache, in 2%, according to a joint press release issued Wednesday.

Just last week, Pfizer and BioNTech announced that BNT162b2 was more than 90% effective according to a preliminary analysis based on the first 94 patients to develop symptomatic COVID-19 in a trial of more than 43,000 volunteers.

The updated efficacy data follows news from competitor Moderna, which announced Monday that its vaccine candidate was 94.5% effective in its own preliminary analysis.

Once the FDA receives the application for emergency use authorization, it will review the data and convene a panel of outside experts to offer an opinion about whether the vaccine should be approved. Then, the agency will make its final decision.

If the FDA gives the Pfizer/BioNTech vaccine the green light, the companies will likely make history as the first with an FDA-authorized COVID-19 vaccine. The limited authorization would come as the United States reports record-high numbers of COVID-19 cases, deaths and hospitalizations.

Copyright © 2020, ABC Audio. All rights reserved.


University of Pittsburgh School of MedicineBy MARIYA MOSELEY, ABC News

(NEW YORK) -- A group of medical students are hoping to spark change by tackling deeply-rooted racial disparities in the health industry during the COVID-19 pandemic.

Incoming first-year medical students at the University of Pittsburgh School of Medicine have teamed up to put their spin on the Hippocratic oath.

With their new oath, they hope to destroy biases, combat disinformation and address systemic racism.

"As the entering class of 2020, we start our medical journey amidst the COVID-19 pandemic and a national civil rights movement reinvigorated by the killings of Breonna Taylor, George Floyd and Ahmaud Arbery," the oath reads.

It goes on to address other concerns of the American health care system in serving vulnerable communities, including people of color, who have been disproportionately impacted by the coronavirus pandemic.

Sean Sweat, a 26-year-old student from Hopkins, South Carolina, who is set to become the first doctor in her family, was among the students involved in presenting the material to the Class of 2024.

"In what's already a very exciting journey ... being able to play a role in writing our class oath just made the experience all the more special," Sweat told ABC News' Good Morning America.

The 12-person oath-writing committee recited the new pledge in addition to the traditional version during their orientation at the start of the fall semester.

The oath, which is the first of its kind in the school's 134-year history, came about by committee members working alongside advisors and student affairs leaders. In addition to dedicating dozens of hours to the project, the committee also presented information to the entire class of about 150 students where they each had an opportunity to offer feedback.

The move comes as medical schools across the country still fall behind in diversity as Black, Hispanic and American Indian students remain underrepresented in medical schools, despite increasing initiatives, according to a study published last year that was conducted by researchers from the Perelman School of Medicine at the University of Pennsylvania.

"It really addresses what's going on right now ... and the racial injustices that have been brought to the forefront. Overall, our oath really addresses what it means to be a physician and how it is so much more complicated," Sweat said.

Since the oath was created by the group this fall, it has gained nationwide attention, including recognition from the American Medical Association. It has also sparked a new tradition as all future incoming students of the University of Pittsburgh School of Medicine will be invited to put their own spin on the oath during orientation week each year.

Nia Buckner, of Charlotte, North Carolina, a first-generation medical student, said she is proud she got to contribute to such an impactful project.

She said that she, along with her colleagues, have personal copies of the oath that they carry to serve as a daily reminder of their purpose as they embark on their medical journey.

"It's something that we hold near and dear to our hearts as med students," Buckner told GMA.

The 23-year-old believes that although her class isn't the first to create their own promises -- as schools have been permitted to do so now for 20 years, according to the Association of American Medical Colleges -- she believes their oath is special due to its relevance.

"Not only does it embody what we believe ... but you can visualize the time that we are stepping into medicine and I think that was one of the things that had our personalized oath stand out," Buckner said.

Copyright © 2020, ABC Audio. All rights reserved.


LeoPatrizi/iStockBy ERIN SCHUMAKER, ABC News

(DENVER) -- Colorado's contact tracing capacity is tapped out, according to local health departments.

"Right now, we have about 1,400 cases or contacts of cases waiting to be reached out to," Christine Billings, the emergency preparedness and response coordinator for Jefferson County Public Health, told ABC Denver affiliate KMGH-TV.

Earlier in the pandemic, tracers were able to reach out to people who were potentially exposed to COVID-19 within 24 hours. The backlog means tracers are only able to connect with 1 out of every 4 case contacts who have been exposed to the virus.

"We can't make a dent," Billings said.

While previously tracers reached 10 to 20 people for every positive case, now they reach two.

On Nov. 5, several local health departments in Colorado, including Jefferson County's, sent a letter to the state outlining their concern.

"Cases are increasing at an alarming rate," they wrote. "Contact tracing and investigation capacity is tapped."

As of Nov. 19, new cases, testing positivity rate, hospitalizations and deaths all were rising in Colorado, according to an ABC News analysis of data from The COVID Tracking Project. So far, 176,694 people have been infected with COVID-19 in Colorado and 2,324 have died of the virus, according to the state health department.

Copyright © 2020, ABC Audio. All rights reserved.


Daisy-Daisy/iStockBy ANTHONY RIVAS and BRAD MIELKE, ABC News

(SACRAMENTO, Calif.) -- Eight months since the coronavirus caused widespread lockdowns across the country, a dietitian at a nursing home in Sacramento, California, said its residents have been suffering from isolation, and it has led to a slate of emotional and behavioral problems.

“The older population already runs the risk of being very lonely in our society, whether they live in a facility such as ours or they live at home. So that was something we saw right away among the dementia patients — the ones who really require a lot of routine and normalcy,” Katy Tenner told ABC News’ daily podcast, “Start Here.” “There was nothing normal or routine about suddenly having their loved ones not being able to come visit.”

Nursing homes were among the hardest-hit facilities early on in the pandemic. By the end of October, there had been at least 82,000 COVID-19 deaths in nursing homes and long-term care facilities throughout the 41 states where data was available, according to ABC News’ analysis of state-released figures.

Along the way, improvements in COVID-19 treatments and protocols throughout these facilities led to a reduction in the percentage of cases and deaths when compared to the overall counts. But Tenner said that without the ability to see their families and friends, there’s been an “uptick” in depression and, specific to her profession, a lack of appetite among residents. She also says there’s a lot of fear.

“A lot of our residents are stuck in their rooms watching TV, and what are they watching? They’re watching the news,” she said. “So a lot of the information they’re getting is dependent upon which news outlet they’re watching — either this is fake, this doesn’t exist or this is really super scary and everybody’s going to die,” Tenner said.

The nursing home in which Tenner works has been caring for some patients for upward of 10 years, she said. Many of the patients would have daily visitors, providing social and emotional support to complement physical care from the staff. Since the pandemic began, Tenner said whether the staff members are “qualified or not,” they’re now the ones who have to step into “this social services” role.

“We are now some of the only people that our residents see on a daily basis — the only familiar faces,” she said.

At the same time, these restrictions have been keeping everyone within the facility safe. Eight out of 10 deaths related to COVID-19 have been in those ages 65 and older, according to the Centers for Disease Control and Prevention.

Tenner said that while her facility has seen several isolated cases of the virus, it’s been “one of the few” that haven’t seen a full-blown outbreak. She said it’s far more dangerous to the residents than the flu.

“Every year ... there might be one or two deaths out of a population of about 160 patients. That’s normal,” Tenner said. “When this comes in, it can decimate a population of older people. ... It’s not like the flu. It’s not one of those, ‘Oh, they’re kind of fine,’ and then two days later, Susie Smith is in the [intensive care unit] on a ventilator. I’ve never seen that from the flu in any of our patients ever.”

“It definitely seems that once it’s in a facility, it spreads like wildfire,” she added.

Tenner said she and her colleagues are also concerned they’ll accidentally bring the virus into the facility. None of them want to be “patient zero,” she said.

“Knowing what we know, you know what this can do if it gets into a nursing home,” Tenner said. “We care about our residents even in a normal year. We’ve grown to love them, and none of us want to be that person.”

This report was featured in the Thursday, Nov. 19, 2020, episode of “Start Here,” ABC News’ daily news podcast.

Copyright © 2020, ABC Audio. All rights reserved.


CasPhotography/iStockBy ERIN SCHUMAKER and MARK NICHOLS, ABC News

(NEW YORK) -- A South Dakota doctor is moonlighting as a newspaper columnist, urging readers to protect themselves against the virus that killed both his parents.

The sheriff in a Kansas town is fighting for his life in a Denver hospital he was sent to for critical care.

In Georgia, a minister who now leads up to three COVID-19 funerals a day dreads his phone's ringer, announcing more death.

On Thursday, the United States crossed a tragic threshold, marking at least 250,537 American lives lost to COVID-19 since the pandemic's start, according to Johns Hopkins University. After nine months of numbers, it's hard to conceptualize the immense tragedy behind that figure. But we should try.

A quarter million dead.

In different terms, as Dr. Jorge Caballero, a clinical instructor at Stanford Medicine, explained, our current outbreak trajectory is expected to bring the American death toll to 300,000 in less than a month.

"That's as if you took the entire population of St. Louis, Missouri and wiped it off the map," Caballero said.

As the virus has ripped across the country, from densely populated cities on the coasts to the Sun Belt and back up to the heartland, the face of the pandemic has shifted.

Today, rural America is caught squarely in the virus' crosshairs and the impact of the virus is much more widespread than it was in the spring.

As a proportion of the population, rural counties were always experiencing a disproportionately high death toll. A cluster of deaths at a nursing home in a small town has a different effect, statistically and personally, then it does in a large city. But what's changed since the early pandemic is the number of counties that have lost residents to the virus.

To better understand who is dying from COVID-19 in America and where they live, ABC News analyzed U.S. counties with the highest COVID-19 death rates per capita -- a metric used by researchers at Johns Hopkins University of Medicine and the Centers for Disease Control and Prevention (CDC) to measure COVID-19 data. Within four weeks of the first reported death on Feb. 29 in Washington State, 2.3% of the United States's 3,142 counties were averaging at least one COVID-19 death each week. By the week ending Nov. 13, 26.6% of U.S. counties saw at least one weekly death from the virus.

As the pandemic has evolved and spread, those counties are increasingly rural, ABC News found, with the poorest counties that have the fewest health resources bearing the brunt of the burden.

"Rural is older, sicker and poorer," Alan Morgan, CEO of the National Rural Health Association, explained. "There's a higher percentage of people with multiple chronic issues and comorbidities," he said.

"If you throw in that they have the fewest options available for seeking care, it's the worst possible public health setup you could imagine."

The face of COVID-19 death in America is changing

As the first eight months of the U.S. outbreak unfolded, striking disparities emerged.

In addition to having higher rates of infections, counties with majority non-white populations experienced COVID-19 death rates at least three times higher than the death rates in counties in which less than 10% of the population was non-white.

Then in recent months came an explosion of cases in the upper Midwest and Plains states, where most of the population is mostly white, causing deaths to increase at a higher rate in white counties and the disparity between non-white and white death rates to narrow.

While it's tempting to view the narrowing gap between Black and white deaths as a sign that COVID-19 racial disparities are improving, that's likely a false narrative, according to Theresa Chapple-McGruder, a Washington D.C.-area epidemiologist.

Coronavirus outbreak sparks global health emergency

"We’re seeing more of a regional shift than a racial shift," Chapple-McGruder said.

Black and Hispanic people in the U.S. are still disproportionately dying of COVID-19. Black people in the United States were 2.1 times more likely to die from COVID-19 than white people were, according to a CDC report published in August. Hispanic people were 1.1 times more likely to die from the virus.

Where people live in the U.S. is highly segregated by race and deaths are currently spiking in areas with very low rates of Black and Hispanic residents, Chapple-McGruder noted.

The COVID-19 death rate was highest in the Northeast counties over the past nine months, but in mid-summer, the death rate in Southern counties rose by double digits. In the past four weeks, the biggest regional jump in deaths was in Midwestern counties.

"Even in places where we’re not seeing the insane peaks that we’re seeing in the middle of the country, Black and Hispanic people are still overrepresented in the number of cases," Chapple-McGruder said. "Where Black and Hispanic people live, they are going to carry the highest burden."

Terrell County, Georgia, for instance, has four funeral homes, no hospital and one of the worst COVID death rates in the nation. In a place with just 9,000 residents, most of whom are Black and poor, 33 people have died of the coronavirus. Terrell County’s COVID-19 death rate of 383 per 100,000 residents is four times higher than Georgia’s overall rate of 80 per 100,000.

Rev. William Weston Sr. has buried many of them.

If you thumb through obituaries in Dawson, Terrell's biggest town, you'd be hard-pressed to find a funeral that doesn't mention Weston officiating. Throughout the pandemic, he led back-to-back funerals, on several Saturdays two or more. Before a graveside service where he was to eulogize a married couple from his congregation, his phone rang in his pocket.

"For a good couple of months or so, every time I got a call, someone had passed," Weston said. This time the virus struck close to home. The voice on the other end of the line told Weston that his first cousin had died of COVID-19.

When Weston celebrates 17 years as the senior pastor of Sardis Baptist Church next month, it will be the first time his cousin won't be seated in the pew to join in.

"This town was shattered," Weston said of the unrelenting deaths.

Old, sicker, poorer

Early on, as thousands of people in New York City perished from COVID-19, many Americans viewed the virus as a big-city problem.

But as summer transitioned into fall and outbreaks developed in more rural Midwestern states, the narrative shifted. Since mid-July, monthly jumps in death rates in 1,888 rural counties -- those with a majority of population living outside an incorporated city or town -- have outpaced the increases in their urban counterparts, where most of the residents live in an incorporated area.

Geography, it seems, is no match for COVID-19. "Very few places in the country are actual bubbles," Caballero said.

Now that the virus has been unleashed in rural America, it's clear just how vulnerable the nation's older, sicker and poorer rural communities are. Problems with the rural health care system have long been documented, as have myriad health issues that Americans in these areas face.

According to an ABC News' analysis, counties in which 10% of residents lacked health insurance reported COVID-19 death rates more than 10 percentage points higher than better-insured areas. "Medically underserved" counties, a designation the Health Resources and Services Administration uses for areas with insufficient primary care providers, high infant mortality, concentrated elderly population, or high poverty, had an overall death rate of 77 per 100,000 residents -- 1.5 times higher than in all other U.S. counties.

Independent of health care, poverty is its own risk factor for a high COVID-19 death rate. In counties where the median household income was below $35,000, the death rate was 1.6 times higher than in counties where household income was higher than $75,000. In the very poorest counties, where a quarter of residents are below the poverty time, the death rate was 2.5 times higher than in richer areas.

ABC News owned stations reported from hardest-hit counties across the country. Of those counties, Gove, Kansas, stands at the top of the list.

Nineteen people in the 2,600-person county have died of COVID-19 since early October, many of them residents in the local nursing home.

In a small town, even one death has a ripple effect.

"Everybody knows somebody who has died,” said Dr. Doug Gruenbacher, a physician in the county.

The virus has also strained the hospital system, Gruenbacher explained. Rural hospitals rely on transferring out critical patients to better-equipped hospitals and right now, no one has space for his patients, Gruenbacher said. Instead, there’s a waiting list and patients are transferred days later than they otherwise would have been.

"That puts an undue amount of stress on our hospital and our physicians,” he added. "It’s just unnerving to be taking care of a patient and you’re not able to do in the best manner possible for them.”

Among the patients transferred out of state for higher level care was Gove County Sheriff Allan Weber, who struggled with COVID-19 complications for more than a month.

"He’s got tremendous risk factors and it's pretty worrisome,” Gruenbacher said.

For rural doctors, no safety net

It was a "burst of bad events," as Dr. Tom Dean put it.

Dean is one of just three doctors in Jerauld County, South Dakota, where COVID-19 invaded the local nursing home, killing both of Dean's parents.

The county's 13 deaths, largely due to the nursing home outbreak, rocked the 2,000-person community and propelled the death rate to the second-worst in the nation.

"It’s different than anything I’ve encountered over 40 years of practice," Dean said of the virus. "It's invisible, it's silent and sneaks around. It flares up when you don't expect it," he said. "Because of that, people tend to think that it flared up and went away and we’re done with it."

The town is small enough that Dean has also taken on the role of clarifying public health advice for his neighbors in a weekly newspaper column he's been writing for the local newspaper.

"We are in the middle of an outbreak, even when we think we are not," he wrote in The True Dakotan in September.

Accurate public health messaging is just one of several battles rural doctors like Dean are fighting right now.

Hundreds of rural communities that used to have a hospital lost them in recent years. Ninety-five rural hospitals closed between January 2010 and January 2019, according to the Department of Health and Human Services' Federal Office of Rural Health Policy. Of those facilities, 32 were critical access hospitals, meaning they offered 24-hour emergency care services 7 days a week.

The 1,821 rural community hospitals that were still standing this year standing aren't well-equipped to handle critically ill COVID-19 patients and traditionally rely on transferring patients who need ICU care to partner hospitals.

"Rural hospitals are designed for primary care and general surgery," Morgan said. "They were never designed for a global pandemic response." Already the National Rural Health Association's member hospitals are seeing transfer delays in South Dakota and Kansas, he added.

Making matters worse, local health departments were outright gutted over the past decade.

The last tool in the toolbox, fundamental public health interventions like masks and social distancing, haven't been embraced in many rural areas.

"What we didn't know back in April was the extent to which these rural communities would not employ public health measures such as mask wearing and social distancing," Morgan said. "Everything that could go wrong is going wrong in these small towns."

Part of that is political. South Dakota is one of the states where the governor declined to issue a statewide mask mandate for residents even as COVID-19 cases, hospitalizations and deaths in the state exploded.

The other piece of the puzzle may be ineffective messaging. Rural counties may not have a designated public health department at all, meaning residents may not have easy access to whatever state or regional resources may be available and often travel long distances for health care and testing.

"They're hearing messages from places they've probably had very little interaction with," Chapple-McGruder said. "When the pandemic was hitting New York and New Jersey really badly, the majority of the country went into a lockdown," she added. "Our national messaging was all the same. That might not have been appropriate for areas with zero cases."

Disillusionment could partially explain why Dean said he has struggled to get his community to take COVID-19 seriously.

"People in more rural areas experienced the pandemic from a policy perspective, but not a health perspective," Chapple-McGruder said. "There was time to build up mistrust in those areas and make it seem as if the pandemic was not real."

Even as loved ones die of coronavirus, that mistrust lives on. Public health messaging just isn't resonating in many rural counties, Morgan said. "It's an incredibly difficult time to be a public health official in rural America."

It's a phenomenon Gruenbacher recognizes. "All of us physicians love our small town. People will bend over backward for you to help you, but those same people are the last ones you can tell to put a mask on,” he added. “They are pretty strong-willed. They don’t want to be told what to do.”

Mistrust and politicization of the pandemic are making life tough for doctors like Dean, who described the political conflict over masks as "terribly unfortunate."

"In too many situations, whether or not you wear a mask has in taken on some kind of political message and that’s totally wrong," he said.

"He’s just beyond frustrated," Morgan said of the doctor and his newspaper column. "He’s a small-town doctor who is trying the best he can to keep this community alive and they are fighting him on it."

Copyright © 2020, ABC Audio. All rights reserved.


Meyer & Meyer/iStockBy ZOE MAGEE, ABC News

(LONDON) -- Oxford University Thursday morning announced more promising news in the development of its COVID-19 vaccine. The results from Phase 2 of its AZD122 vaccine trial, published in the Lancet on Thursday, show that the vaccine is as effective for the older demographic as it is for the younger.

According to the Lancet report, “the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups.” This news was welcomed by the team at Oxford University as a significant next step in its path to producing a viable vaccine against COVID-19, and is particularly important as the elderly demographic is among the most vulnerable to the novel coronavirus.

Researchers are still awaiting data from the much larger Phase 3 trial -- the last step before authorization or approval. But for now, researchers are celebrating this reassuring early data.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” explains the co-author of the study, Dr. Maheshi Ramasamy from the University of Oxford. “The populations at greatest risk of serious COVID-19 disease include people with existing health conditions and older adults.” Adding that, “We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

There were 560 participants in the trial, 400 of whom were in the over 56 years old category and the vaccine was shown to work just as effectively for them as it did for the younger participants. The study also showed that adverse reactions to the vaccine were mild and the most common side effects were injection-site pain and tenderness, fatigue, headache, feverishness and muscle pain.

The Oxford University vaccine, which is being produced in conjunction with the pharmaceutical company Astra Zeneca, was an original front runner in the race for a vaccine but it has since been outflanked by both Moderna and Pfizer/BioNTech which both announced their Phase 3 trial results in the last couple of weeks.

Those two vaccines use a similar technology known as mRNA. These vaccines' genetic codes introduce an instruction manual comprised of genetic material called RNA or DNA. This instruction manual tells your cells to start churning out a protein normally found on the outside of the virus. When your body senses that viral protein, it activates an immune response.

These mRNA vaccines can be manufactured quickly but could face more distribution challenges and be slower to distribute than the Oxford vaccine. The Pfizer/BioNTech vaccine needs to be stored and transported at extremely low temperatures -- around -94 degrees Fahrenheit -- which means distribution to some parts of the world could be problematic. Similarly, the Moderna vaccine must be kept frozen -- but only at -4 degrees Fahrenheit -- but could be easier to ship as it can be kept for up to 30 days in a normal refrigerator.

The Oxford University vaccine, if proved successful, is expected to be much easier to transport as it only requires standard refrigeration. It follows a different type of science and is known as a viral vector vaccine. This mean it uses a different virus as a "vector," or delivery mechanism, to introduce a bit of coronavirus’ genetic material for coronavirus antigens into the cells, prompting an immune response, which your immune system then learns to identify and overcome.

Having published its Phase 2 results on Thursday, Oxford is a step behind its rivals and many are wondering why Oxford’s results are slower in coming, especially as virus levels are high in the areas it is being tested including in the U.K., South Africa and Brazil.

Oxford’s much anticipated Phase 3 results are expected within weeks and should conclusively show whether this vaccine is effective and safe across the board.

The scientists involved in the research conceded Thursday that there were some limitations in the Phase 2 part of Oxford’s trials. They began during a national lockdown in the U.K. so it wasn’t possible to recruit volunteers from the most vulnerable groups.

“The study includes only healthy participants and not those with co-morbidities or who are frail,” the Lancet reports.

The study’s participants in the oldest age group had an average age of 73 to 74 and few had underlying health conditions, so the older age bracket was excluded as were those living in residential care homes. Nor was there a wide range of backgrounds in the trial participants and “almost all participants of all ages were white and non-smokers.”

The next phase of the trials will therefore focus on these groups.

“Larger studies are now underway to evaluate immunogenicity, safety and efficacy in older adults with a wider range of comorbidities,” the Lancet report notes.

Professor Sarah Gilbert, a co-author of the report and professor of vaccinology at Oxford University, pointed to these limitations: “The WHO has outlined a number of critical factors for COVID-19 vaccines, including that they must be targeted at the most at-risk groups including older adults. They must also be safe, effective in preventing disease and/or transmission, and provide at least six months of protection for people frequently exposed to the virus – such as healthcare workers.”

She notes that while Thursday’s results are a definite step in the right direction, further evidence is needed before any concrete judgement can be made on their vaccine candidate.

“Our new study answers some of these questions about protecting older adults, but questions remain about effectiveness and length of protection, and we need to confirm our results in older adults with underlying conditions to ensure that our vaccine protects those most at risk of severe COVID-19 disease,” she said.

Although there is still more work to be done, the research team was encouraged by Thursday’s results.

“Immune responses from vaccines are often lessened in older adults because the immune system gradually deteriorates with age, which also leaves older adults more susceptible to infections,” noted Professor Andrew Pollard, University of Oxford, who was the study’s lead author. These Phase 2 results show that this was not the case for the Oxford vaccine.

In a statement given to ABC News, Astra Zeneca also stressed the importance of these findings.

“It is essential that a COVID-19 vaccine can be effective across a broad age range particularly in older individuals where they are disproportionately at risk of COVID-19 disease. The Phase 2 interim data for AZD122 suggests that individuals have lower reactogenicity whilst still maintaining a robust immune response,” said Mene Pangalos, executive vice president of BioPharmaceuticals Research and Development.

Copyright © 2020, ABC Audio. All rights reserved.


simon2579/iStockBy SONY SALZMAN, ABC News

(NEW YORK) -- Pfizer and Moderna are likely to be the first companies to see their respective vaccines authorized in the United States, possibly before the end of this year.

Though their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different. Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market.

Yet when the COVID-19 pandemic began, both companies bet big on a brand-new vaccine technology called mRNA. Moderna had been working on the technology for years, while Pfizer partnered with a smaller German biotechnology company BioNTech for its mRNA research.

If authorized, these would be the first mRNA vaccines, which use pieces of genetic material to coax the body into developing defenses against future infection.

After rapidly testing their vaccines in early-stage studies, Pfizer and Moderna launched their massive Phase 3 trials, which is the last step before authorization, on July 27. And the companies have been neck in neck since then, with Moderna ultimately emerging with key data milestones about a week behind Pfizer because of subtle differences in its trial design and vaccine dosing.

Pfizer declined an initial research investment from the U.S. government’s Operation Warp Speed, a multibillion-dollar program to accelerate the development and distribution of COVID-19 vaccines. But Moderna has been partnered with the government from the start, enjoying a longstanding research collaboration with the National Institutes of Health, accepting $955 million in funding from the Biomedical Advanced Research and Development Authority (BARDA).

Both companies have accepted Operation Warp Speed funding in exchange for a promise that the first 100 million doses of their respective vaccines will be delivered to the U.S. government.

And when it comes to their vaccines, both Pfizer and Moderna’s are quite similar.

“They’re using something called an mRNA technology, which is relatively new in vaccine development,” said Azra Behlim, senior director of pharmacy sourcing and program services at Vizient.

Compared to some other vaccine technologies, mRNA is a more delicate product, Behlim told ABC News, meaning it needs to be kept frozen for long term storage.

Moderna’s vaccine can be kept in normal freezer temperatures, like the freezer you have at home. Pfizer’s vaccine, meanwhile, must be kept in a specialized ultra-cold freezer at -94 degrees Fahrenheit.

Once thawed, the Moderna vaccine can be kept in a normal refrigerator for a month, while Pfizer’s can only be kept in a typical fridge for five days.

“Some of those cold chain storage issues that the Pfizer vaccine brought up … could be alleviated with [Moderna's] vaccine,” said Dr. Colleen Kelley, associate professor of medicine at Emory University School of Medicine and principal investigator for the Moderna study at the Ponce de Leon Center.

“This is good news for places that may not have access to that ultra-cold storage,” said Kelley.

That could include more rural parts of America.

Operation Warp Speed Vaccine Development Lead Dr. Matt Hepburn said, "the fridge-for-a-month distribution point we made really enables for a much more distributed model to get the vaccine out there, potentially for example in very rural areas."

But with limited supplies of each vaccine available at first, enough to vaccinate only 20 million Americans by the end of the year, experts agree the U.S. needs multiple vaccines to fight the pandemic. That includes not only Pfizer and Moderna's vaccine but also even more that are further behind in development.

Two other companies that received funding for clinical research from Operation Warp Speed -- AstraZeneca and Johnson & Johnson -- had brief setbacks when their late-stage trials were paused over safety concerns. But those trials are now back up and running and may have data available in the coming weeks and months.

“We will not see the other side of this pandemic without an effective vaccine, and multiple effective vaccines,” Kelley said.

Copyright © 2020, ABC Audio. All rights reserved.


Wolterk/iStockBy MEREDITH DELISO, ABC News

(NEW YORK) -- Over 900 Mayo Clinic staff in the Midwest have contracted COVID-19 in the past two weeks, officials said, as the region experiences a surge in cases.

The medical center is "very worried" about the health of its staff and having enough people to care for patients as health care professionals themselves become infected with the virus or have to quarantine due to exposure, Dr. Amy Williams, executive dean of the Mayo Clinic Practice, said during a press call Tuesday.

In the last 14 days, 905 Mayo Clinic employees in the Midwest, including in Minnesota and Wisconsin, have been diagnosed with COVID-19, officials said. That number represents more than 30% of the total number of staff cases during the pandemic.

Most of the exposure -- about 93% -- happened in the community, not at work, Williams said.

"It shows how widely spread this is in our communities, and how easy it is to get COVID-19 in the communities here in the Midwest," Williams said.

Across the Midwest, about 1,500 Mayo Clinic employees have work restrictions due to COVID-19 exposure, diagnosis or having to care for family members who are sick, officials said. About 1,000 of those are at the Mayo Clinic's campus in Rochester, Minnesota.

To help with staffing shortages in the Midwest, the Mayo Clinic is recruiting health care workers back from recent retirement, bringing in staff from other sites (primarily Arizona), temporarily moving research nurses into patient care roles and reducing elective care to redeploy staff to COVID-19 patients, officials said.

Minnesota recorded a record number of hospitalizations on Wednesday, with 1,706, according to the COVID Tracking Project. The areas of the state bordering Wisconsin are also reporting over 85% usage of critical care beds at hospitals, according to an internal Health and Human Services memo obtained by ABC News Wednesday night.

Hospitalizations are only expected to increase in the coming weeks. In preparation, the Mayo Clinic Hospital's Saint Marys Campus in Rochester is increasing the number of medical beds to care for patients with and without COVID-19, Williams said.

"We need to be very vigilant and not assume that things are going to settle down," she said.

Amid rising cases and hospitalizations in the state, Gov. Tim Walz on Wednesday announced new coronavirus restrictions.

Starting at 11:59 p.m. Friday and lasting for the next four weeks, all restaurants will be closed to in-person dining. Gyms and indoor entertainment venues will also be closed.

In-person social gatherings outside of the household are prohibited, as are weddings and private parties.

"We are at a breaking point," Walz said in a statement. "As hospitals near the crisis of turning away new patients, continuing as things are is simply not sustainable."

Copyright © 2020, ABC Audio. All rights reserved.


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