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These immunocompromised college students felt isolated when the fall semester began. So they did something about it

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By Saba Hamedy, CNN
Updated 7:27 AM ET, Tue September 15, 2020

(CNN) — At first, Cameron Lynch thought she would need prepared questions for the group to discuss in their first Zoom call.

On the list of proposed topics: “Have you had a hard time with friends in the pandemic?”, “Are you planning to go back to school in the fall?” and “How have you been coping on a day-to-day basis?”
But Lynch quickly realized that the group of immunocompromised college students didn’t need questions to guide them. They just wanted to talk about their shared feeling of isolation during the pandemic.
They bonded over the fact that people assume that all teens are healthy. They questioned whether their schools were taking the right measures to help those who are more at-risk. They vented about their friends not understanding their inability to leave the house without fear of contracting Covid.
    It’s a virtual support group for immunocompromised students — but its members don’t call it that. They prefer the name “Chronic and Iconic.”
    It all started with a social media post. Lynch, who has Type 1 diabetes, celiac disease and a form of muscular dystrophy, opened up in a heartfelt letter to her friends and followers.
    “While I have been preparing my body to fight the virus by running so my lung capacity can be better, eating healthy so that my body has enough nutrients to fight, and attempting to manage my disease (which is difficult with teenage hormones), it seems that everyone else has stopped caring,” Lynch, 19, wrote in the letter, which she shared with CNN. “My reality is different. My reality is isolating.”
    Her reality means she can’t hang out with other college students who she said she sees on her social media feed “flood to the beaches to drink their White Claws.” Instead, it means she sits alone in her bed “afraid that no one cares.”
    Much to Lynch’s surprise, the post resonated beyond her own social network. What started in July as a five-person Zoom hangout has turned into a 50-plus person group — with students from across the US — who have an ongoing GroupMe text messaging chain and frequent video calls.
    As US colleges and universities return — either in-person, online only or both in what’s called the “hybrid model” — immunocompromised students are struggling to figure out how to navigate school during a pandemic. If their classes aren’t offered online, some are forced to rearrange their schedules or risk falling behind. If they don’t feel safe going to campus, some have to take a leave of absence. And throughout it all, some say the feeling of isolation has become overwhelming.
    “I think one thing that the media and schools don’t seem to understand is how these policies are impacting the mental health of their students,” Lynch told CNN.
    “By saying that in-person learning is essential, that’s basically saying the community can function without us, and is better off when we’re not there.”

    Covid puts life on hold for high-risk students

    In her letter, Lynch emphasized that her new normal means limiting time outside, even though she’s sick of watching shows on Netflix. Unlike her peers, who can cautiously partake in activities, she feels she has to keep her life on hold until Covid is no longer a threat.
    People with underlying medical conditions are more likely to become seriously ill if they get Covid-19. Some of them are young and most of them may not look sick at all. Millions of them are living with a compromised immune system.
    “People with weakened immune systems are at higher risk of getting severely sick from SARS-CoV-2, the virus that causes COVID-19,” the US Centers for Disease Control and Prevention (CDC) writes on its website. “They may also remain infectious for a longer period of time than others with COVID-19.”
    Aside from worrying about getting infected, many of these immunocompromised students said they feel anxious about people — specifically their peers — disobeying health and safety guidelines.
    To date, there are more than 40,000 cases of Covid-19 among students, faculty and staff at colleges and universities nationwide. The number represents cases that CNN has reported so far — and is likely higher due to a lag from schools that update their data every few days.
    With social life trickling back to life on campuses, coronavirus outbreaks have hit places where students congregate, like fraternities and sororities, where some have continued to gather despite remote learning. While most students will likely recover, health experts have expressed concern that young people would spread the virus to the more vulnerable in their communities.
    “With the pandemic, we don’t have same sense of immortality as other people,” Lynch said. “This is very real for us. If we get a cold, we’re in hospital for four days. We have to take it more seriously. If there aren’t systems in place we have to make them.”

    They found comfort in a virtual community

    Samantha Price, who has Type 1 diabetes, was among the first to respond to Lynch’s letter.
    Price and Lynch met doing community theater in Richmond, Virginia, when they were 10 and nine years old, respectively. They bonded after realizing they both have diabetes. Over the years, they lost touch. But Price saw Lynch’s post and reached out.
    Together, the two created the support group, which now includes people with a range of disabilities.
    “We always say, ‘Can you explain what that is please?’ when people say what their disability is,” Lynch said. “We learn what everyone’s going through, and how we can better support each other.”
    Price, a junior at the University of Mary Washington in Fredericksburg, Virginia, said it’s been comforting to connect with people who understand how she’s been feeling.
    “We’re not normally surrounded by people who can relate to us,” Price told CNN.
    “It (the group) helps us have our feelings validated. If I’m super depressed or down in the dumps one day because my friends are going out and posting about it … complaining isn’t going to do anything,” the 20-year-old said.
    “But if I’m able to go to this group and say, ‘this happened’ 15 people like it or respond and say, ‘I totally understand, that happened to me.'”
    Kaitlin Ahern, a 20-year-old student at Lafayette College, saw Lynch’s social media post circulating online and reached out, eventually joining the group.
    “At this time it’s very easy to feel ostracized and alone,” said Ahern, who said she is immunocompromised because of a medication she takes. “Because everyone’s kind of paying attention to older people because they are immunocompromised, and younger people kind of expect all young people to be able to reckless and go out and party and everything.”
    Ahern’s college is mostly remote for the semester, but she lives near other schools and sees students everywhere.
    “I can’t see my friends because they are all partying, they aren’t willing to give up partying just to wear a mask and social distance (and) see me,” she said. “There’s very little contact outside of my family. It’s very lonely not interacting with anyone.”
    The virtual group has been “amazing,” especially as she struggled to connect to her existing social circle during the pandemic, she said.
    It’s not surprising that the pandemic has affected the mental health of many nationwide, including young people. The National Center for Health Statistics and the US Census Bureau estimate that more than a third of Americans have experienced symptoms of depression and anxiety since spring.
    A recent CDC survey found that almost 41% of respondents are struggling with mental health issues stemming from the pandemic — both related to the pandemic itself and the measures used to contain it, including physical distancing and stay-at-home orders.
    “A lot of students in the group text us, like ‘Today was a terrible day, I’m so frustrated,'” Lynch said. “We’re kind of like a help line in a sense. We’re all at home so people respond very quickly.”
    Now, the group has gone beyond just sharing their problems.
    “People will talk about their highlight of the week, what quarantine crafts they’ve started,” Price said. “Some people will tell us about their personal lives. We’ve actually gotten to know these people really well.”

    Students ask peers to ‘stay safely away’

    Aleah Colón-Alfonso, who has small fiber neuropathy, Lyme disease and accompanying secondary illnesses, said she felt the need to do something after noticing the lack of social distancing and facial coverings in Sarasota, Florida.
    Though the junior at the New College of Florida isn’t part of the virtual support group, she has found a different way to help people who are in similar situations.
    In July, she officially launched a business called Stay Safely Away, which sells wearable merchandise that lets people display their immunocompromised status to urge others around them to “stay safely away.”
    “Communicating behind masks and from a distance is difficult, so my idea and all my products attempt to serve as an unspoken and polite assertion,” she told CNN.
    The company now sells more than 150 products, including beach towels, face masks, backpacks, school supplies, swimwear and stickers. All merchandise includes some sort of catchy yet informative message, like: “I’m not rude, I’m just immunocompromised” and “science is real.”
    “‘I’m not rude, I’m just immunocompromised’ was a direct quote of what I wanted to say to every person I socially distanced myself from,” she said. “The phrase is essentially a shortened version of ‘I really don’t want to be rude — but I also really don’t want to end up on a ventilator!'”

    Big plans beyond fall

    In recent interviews with CNN, three developmental psychologists said they believe the majority of students are taking the pandemic seriously and acting accordingly.
    Viral videos of maskless parties and packed bars account for hundreds out of the nearly 20 million college students in the US, they said.
    But for at-risk students, the fear is still there — and some must decide whether they feel safe enough to return to campus.
    “The first feeling I had about universities and schools reopening was fear,” Colón-Alfonso said. “Fear of lives lost, fear of the academic and social impact, and fear of how to accurately make decisions in a time where everything seems uncertain and ever changing. I also felt a distinct trepidation towards institutions who need student tuition if they want to remain afloat.”
    Colón-Alfonso said her school has been very “accommodating,” and she feels safe returning to in-person learning. However, she added, “I know that my experience is an exception to the rule. Seeing parties on the news, receiving texts from family and friends in college with stories of the danger they see every day is unsettling.”
    Many at-risk students remain wary of the risks. Lynch, who is in the UK with her family, and Price, who is in Virginia with her parents, said they have barely left their homes.
    But the time in quarantine has also given them a renewed sense of purpose — and the two said they have big plans. Eventually, Lynch said, she and Price want to create a national organization for disabled students, with branches at universities and colleges.
    “There’s college diabetes network which we’re both apart of,” Lynch said, “but this would be for more disabilities — physical, learning and invisible disabilities.”
    The two also hope to create a conference when it’s safe to meet in person.
    “My goal is getting people to even acknowledge that there are young disabled people,” Lynch said. “It’s really important.”
      For now, though, they continue to focus on building their community virtually — and staying healthy while studying remotely.
      “We have an understanding that things suck right now,” Price said. “But (staying home) is what we have to do. It’s going to be better for us in long run.”

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      Unpopular teens could be at higher risk of heart conditions later in life, study suggests

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      By Katie Hunt, CNN
      Updated 6:30 PM ET, Tue September 15, 2020

      (CNN) — Many of us hope to escape who we were in high school — particularly if you were last in line to be picked in gym class — but a growing body of research suggests that how popular you are in adolescence has a link with psychological and physical health decades later.

      Thirteen-year-olds who weren’t very popular with their peers growing up, a new study released Tuesday has found, seem to have a heightened risk of developing circulatory system disease in later life. This includes higher risk for conditions such as narrowed and hardened arteries and abnormal heartbeat that affect the normal functioning of the heart and blood vessels.
      “Although not many realize it, peer status is one of the strongest predictors of later psychological and health outcomes, even decades later, said Mitch Prinstein, the John Van Seters distinguished professor of psychology and neuroscience at the University of North Carolina.
      “Several early studies revealed that our likeability among peers in grade school predicts life outcomes more strongly than does IQ, parental income, school grades, and pre-existing physical illness,” Prinstein, who wasn’t involved with the research, said.
        Prinstein, and the authors of the study, said that it’s important to note that peer status is a specific form of popularity — likeability rather than being the cool kid.
        “Many would perhaps think of high-status kids as those who were highly visible and influential — hanging out in the smoking area during breaks and partying during the weekends. That is another type of popularity, which is sometimes referred to as perceived popularity,” said Ylva Almquist, an associate professor and senior lecturer at the department of public health sciences at Stockholm University and an author of the study, which published in the journal BMJ Open.
        “Peer status is rather an indicator of likability, and the degree to which a child is accepted and respected by their peers.”
        Chronic health problems are usually explained by genetic factors or actions like smoking, drinking or an unhealthy diet, but research has suggested that high-quality relationships are a key indicator of mortality.

        Observational study

        In this study from Sweden, the researchers used data from the Stockholm Birth Cohort Multigenerational Study, which includes everyone born in 1953 and residing in Stockholm, the Swedish capital, in 1963.
        The health of 5,410 men and 5,990 women was tracked into their 60s. At age 13, they had been asked who among their classmates they preferred to work with. They used the results to determine “peer group status,” which they divided into four categories: zero nominations, which they termed “marginalized”; one (“low status”); two or three (“medium status”); and four or more (“high status”).
        Thirty-three percent of the boys enjoyed high peer group status at the age of 13, slightly more than girls (28.5%), the researchers found. Some 16% of the girls were classed as “marginalized,” compared to 12% of boys.
        Circulatory disease was more common among the men than it was among the women, but the children classed as “marginalized” at age 13 had a 33% to 34% higher risk of circulatory disease in adulthood in both sexes, the study found.
        In their analysis, the researchers said they accounted for factors such as number and position of siblings, parental education and mental health, socioeconomic conditions, and school factors, such as intellect, academic performance and any criminal behavior.
        But as an observational study, it can only show a link, and Almquist said there could be many explanations for the association.
        “A common dilemma in this kind of research is that we have the information we need to establish associations between conditions in childhood and health outcomes in adulthood, but we know quite little about whatever is happening in between,” Almquist said.

        Potential for chronic inflammation due to stress

        Katherine Ehrlich, an assistant professor of psychology at the University of Georgia, who wasn’t involved in the research, said one explanation could be chronic inflammation linked to stressful experiences of relationships, both in adolescence and in adulthood.
        “It is plausible that stressful social experiences (like being socially isolated) could lead to persistent unresolved inflammation, and if these levels are sustained over time, that could increase one’s risk for plaques in the arteries, heart attacks, and other cardiovascular problems,” said Ehrlich, who wasn’t involved in the research.
        “It seems likely that health behaviors also play a role in the progression from low peer status to circulatory diseases decades later. Individuals who are socially isolated may be more likely to have unhealthy diets, engage in excessive drinking, and lead sedentary lifestyles, all of which could also increase one’s risk for cardiovascular problems.”
        There is also an evolutionary logic, according to Prinstein, who is also the author of “Popularity: Finding Happiness and Success in a World That Cares Too Much About the Wrong Kinds of Relationships.”
        “Our species is uniquely and remarkably attuned to our social position because many years ago we relied on each other for safety,” he said.
        “Research now reveals that social rejection activates the same regions of the brain that are known to respond to physical pain, and also expresses dormant DNA to prepare our bodies for imminent injury. Unfortunately, this response is no longer necessary, so the expression of these genes leaves us more vulnerable to viral infections and more likely to suffer from inflammation-related illnesses,” Prinstein said.
        He added that it was also possible that those higher in peer status are more likely to be afforded opportunities for learning and access to more resources — including ones that could promote their health.
        “We spend so much time, energy, and funding attending to factors we think can improve children’s chances at a happy and successful life, but we have neglected the one factor that is perhaps most important of all: our children’s ability to get along well with others and be perceived as likeable,” he said.
        For parents worried about their kids’ social life, Almquist stressed that problematic experiences with peers do not automatically lead to health problems and having caring and supportive parents was a “protective factor.”
          Ehrlich agreed that strong ties between parents and teens could act as a buffer against problematic peer relationships. “It is understandable to see these findings and worry about the long-term consequences for teens who might be more socially isolated.
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          “Additionally, many adolescents struggle at one point or another with their peer relationships — finding it difficult to fit in or ‘find their people,'” she said. “The advice I would give to families is: keep trying. Join new clubs, try to meet people online, put yourself out there — you never know who could turn out to be a lifelong friend.”

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          Health

          Crowded parties and coronavirus concerns keep high schoolers from returning to the classroom

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          By Madeline Holcombe and Ray Sanchez , CNN
          Updated 7:08 PM ET, Tue September 15, 2020

          (CNN) — The deadly coronavirus may have circulated in the United States as early as December, about a month earlier than believed by the US Centers for Disease Control and Prevention, according to researchers with UCLA.

          Their study, published last Thursday in the Journal of Medical Internet Research, found a statistically significant increase in clinic and hospital visits by patients who reported respiratory illnesses as early as the week of December 22.
          The first known case of Covid-19 in the US was thought to be a patient in Washington who had visited Wuhan, China, according to the CDC. The case was reported in January.
          Dr. Joann Elmore and colleagues looked through nearly 10 million medical records from the UCLA Health system, including three hospitals and 180 clinics.
            Elmore said she started the search after receiving a number of emails from anxious patients in March through her clinic’s patient portal at UCLA. Patients kept asking if the cough they had in January could have been Covid-19.
            “With the outpatients, I found a 50% increase in the percentage of patients coming in complaining of a cough. It came out to over 1,000 extra patients above the average of what we would typically see,” Elmore told CNN.
            The number of patient visits to the ER for respiratory complaints, as well as the number of people hospitalized with acute respiratory failure between December 2019 and February 2020, were all up, compared to records from the past five years. The uptick in cases started in the final week of December.
            “Some of these cases could have been due to the flu, some could be for other reasons, but to see these kinds of higher numbers even in the outpatient setting is notable,” Elmore said.
            Elmore hopes the research shows that real-time data collected on diseases like this could potentially help public health experts identify and track emerging outbreaks much earlier and potentially slow or stop the spread of disease.
            Dr. Claudia Hoyen, an infectious disease specialist at University Hospitals Cleveland Medical Center who did not work on the study, said she believes it’s possible Covid-19 may have been in the US much sooner than first realized.
            But Kristian Andersen, a professor of immunology and microbiology at Scripps Research, disagreed.
            “We know from the SARS-CoV-2 genetic data that the pandemic started in late November / early December in China so there’s absolutely no way the virus could have been spreading widely in December 2019. From the same genetic data we know that widespread transmission didn’t start in the United States until (around) February 2020,” Andersen said in an email.
            “The paper is picking up spurious signals and the hospitalizations are more likely from flu or other respiratory diseases,” Andersen wrote.

            Parties and virus concerns keep high schoolers from returning to class

            Overcrowded parties have forced several high schools to go back to online learning in hopes of staving off Covid-19 outbreaks.
            Two of those schools are in Massachusetts, which is reporting fewer cases than last week, and New York, which has maintained an infection rate less than 1% for 38 days. Although the states’ numbers are promising, experts have warned that people attending large gatherings are a serious threat to managing the spread of the virus that has infected more than 6.5 million and killed 195,275 people in the US.
            Student parties have already sent colleges and universities scrambling to manage outbreaks, and now high school administrators are working to avoid the same.
            A crowded student party “that involved alcohol and complete lack of safety precautions” pushed Lincoln-Sudbury High School outside of Boston to go back to remote learning the first two weeks of school, a letter from the superintendent said. And Pelham High School in Westchester, New York, has extended online learning after two nights in a row of students partying in the woods, the school district announced.
            But students’ social lives are not the only cause for concern. The president of the United Federation of Teachers said Monday that New York City is “not making the grade” when it comes to enacting the safety measures needed to reopen schools for in-person learning.
            Michael Mulgrew cited insufficient staffing and a two to three day delay in testing results as major roadblocks.
            “If you asked me if we are ready to open today, I would say we are not,” he said.
            In New York City Public Schools, at least 422,190 students have requested the entirely remote learning option for the fall, according to data provided by the city’s Department of Education — a little over 40% of the more than 1 million students enrolled in the nation’s largest public school system.
            Roughly 58% of students plan to return to school buildings as part of a hybrid learning model beginning next week, according to the department.
            Parents in the New York City public school system could opt out of the in-person hybrid plan since it was first announced. In August, Mayor Bill de Blasio said 74% of families had said they were planning to participate in in person learning at the time.
            The city’s daily Covid-19 indicators are all under desired thresholds, de Blasio said Tuesday.

            Schools plan ahead for safe reopenings

            As several schools make last minute changes to their plans in response to parties, others are implementing systems ahead of time to respond to changes in the virus.
            Kentucky officials outlined a color-coded system Monday to help individual districts determine every week if they should continue with in-person learning based on coronavirus levels in their area.
            “If you’re in the red, it means there’s widespread community spread of COVID-19, and if you’re in the red it’s not responsible — it is not responsible — to be doing every day in-person learning,” Gov. Andy Beshear said.
            And though students in the Los Angeles Unified School District are still learning remotely, a “report card” will show the number of cases in each school as part of the district’s testing and tracing endeavor, Superintendent Austin Beutner said.
            To address childcare concerns, about 3,000 children of essential workers will be able to return to school in groups of six after being tested for the virus, Beutner said.

            States cracking down on large gatherings

            Some states are doing their part to curb the spread and limit the number of fall and winter infections by cracking down on large gatherings.
            Officials from New York City parks and New York University are patrolling Washington Square Park and encouraging personal protective equipment use after two back to back weekends of parties with NYU students.
            After the first weekend gathering, Gov. Andrew Cuomo criticized the city’s police and the university officials for not taking firmer action to stop the parties.
            NYU has instructed all residents and employees the Rubin Hall dormitory to quarantine until at least Tuesday night after the diagnosis of six positive cases out of roughly 400 students living in the building, the university announced in its latest campus update.
            “Out of an abundance of caution, we are also retesting all residents of Rubin Hall (and employees, too), and instructed them on Saturday to begin quarantining until at least Tuesday night,” the university said.
            NYU has reported a total of 65 cases since August 1, according to the school’s coronavirus dashboard — an overall positivity rate of .19%. The school has reported 48 cases in the most recent 14-day period, a positivity rate of .31%.
            The University of Missouri in Columbia has expelled two students and suspended three others for violating the school’s Covid-19 rules, including “requirements that COVID positive individuals isolate and comply with social distancing requirements,” the university said Tuesday.
            “These students willfully put others at risk, and that is never acceptable,” Chancellor and UM System President Mun Choi said in a statement, without elaborating on their alleged actions.
            “We will not let the actions of a few take away the opportunity for in-person learning that more than 8,000 faculty and staff have worked so hard to accomplish for the more than 30,000 MU students.”
            MU has referred roughly 470 students to the Office of Student Conduct for possible Covid-19 safety violations since August 16, and 11 student organizations are currently under investigation.
            MU has 332 active cases among students, according to the university dashboard — down from 700 active cases earlier this month. The school has reported more than 1,300 cases since August 19.
            On Monday, the University of Arizona — in accordance with the local county health department — strongly urged students to shelter in place until September 30, following an increase in positive Covid-19 cases.
            Exceptions include obtaining food, attending work, seeking medical treatment and going outside where social distancing is possible.
            The school limited in-person instruction to “essential courses” only until September 27.
            The University of Arizona reported 261 positive Covid-19 tests on Monday, according to the school’s coronavirus dashboard, and has seen roughly 1,400 cases since July 31.

            Pennsylvania appealing court ruling on large gatherings

            In the face of possible fall and winter resurgence, Pennsylvania Gov. Tom Wolf’s office is appealing a federal court ruling that keeps the state from banning certain types of large gatherings.
            The state has instituted measures against indoor gatherings of more than 25 people and outdoor events with more than 250 people to stop the spread of coronavirus.
            The action is used by many governors across the US, said Wolf’s press secretary Lyndsay Kensinger, and continues to “save lives in the absence of federal action.”
            Connecticut has also had ordinances in place to prohibit large gatherings and require face masks in the time of coronavirus, but now law enforcement will have the authority to impose fines to enforce them, Gov. Ned Lamont announced Monday.
            People not wearing masks can be fined $100. Organizers of large gatherings can be fined $500, with those attending fined $250, Lamont said.
            Despite the importance of masks to halting the spread, White House Coronavirus Task Force member Dr. Anthony Fauci said a national mask mandate “probably would not work.”
            Speaking at a news conference with Vermont Gov. Phil Scott on Tuesday, Fauci said, “There is such a degree of variability of accepting mandates throughout the country.”
            Fauci said issues arise when a majority of the population in an area do not agree with the mandate — and that begs the question: How do you enforce the mandate?
            Anything that puts an “authoritative statement to the citizenry often is met with a considerable amount of pushback,” he said.
            Dr. Mike Ryan, executive director of the World Health Organization’s health emergencies program, said in Geneva that countries approaching winter will have to choose between having bars and nightclubs open or schools in session.
              “We have to sustain pressure on this virus, we have to reduce transmission at community level in order to lower the risk to those older and vulnerable people and to maintain an environment in which our children can continue to attend school,” Ryan said at a briefing.
              “So, what is more important? Are children back at school? Are the nightclubs and the bars open?” he said. “I think these are decisions that we have to make in coming into the winter months.”

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              NIH ‘very concerned’ about serious side effect in AstraZeneca coronavirus vaccine trial

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              By Arthur Allen and Liz Szabo, Kaiser Health News
              Updated 8:44 AM ET, Tue September 15, 2020

              (Kaiser Health News) — The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.

              “The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
              A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.
              AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.
                AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”
                Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.
                “So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”
                The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.
                Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.
                Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.
                If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.
                A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.
                Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.
                The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.
                More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.
                In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.
                Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.
                “It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”
                Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.
                FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.
                It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.
                Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.
                “There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.
                AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.
                But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.
                “While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”
                The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.
                “There are also potential consequences if you stop a study,” Goodman said.
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                If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.
                “This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”
                  Schaffner said researchers need to remember that vaccine research is unpredictable.
                  “The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.'”

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                  Trump knew testing Covid-19 vaccines would take months, Woodward book shows

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                  By Jamie Gangel, Elizabeth Stuart and Maggie Fox, CNN
                  Updated 3:35 PM ET, Wed September 16, 2020

                  (CNN) — President Donald Trump knew back in the spring that it would probably take a year to develop a coronavirus vaccine, according to interviews with journalist Bob Woodward.

                  Trump also suggests that’s why he initially pushed so hard for the use of the malaria drug hydroxychloroquine, because the malaria drug had already been tested and approved for other uses.
                  “Well, we’re doing great on vaccines,” Woodward quotes Trump as saying in his latest book, “Rage.”
                  “The problem with a vaccine is a vaccine will take 13 to 14 months once you have it. Because you have to test a vaccine. As opposed to the hydroxy, you have to test it. Because the hydroxy’s been there for 25 years.”
                    Hydroxychloroquine was indeed an approved drug, but it had never been tested in people with coronavirus. The Food and Drug Administration gave hydroxychloroquine emergency use approval but later rescinded it after several studies showed the drug did not help patients were coronavirus and might be harmful.
                    Trump heavily promoted hydroxychloroquine for months but after the FDA rescinded the EUA, began talking about development of a vaccine. He has repeatedly said he believes a vaccine could be approved before the Nov. 3 election.
                    His interviews with Woodward — also recorded on audiotapes — show he was briefed on the timetable for a coronavirus vaccine. The US government had been working with vaccine makers, including Moderna Inc, and Johnson & Johnson, to develop a coronavirus vaccine. The new vaccines are made using pieces of genetic material and researchers started testing the first vaccines in human clinical trials in March.
                    “We probably already have the vaccine,” Trump said on April 13, according to the book. “You know the biggest problem though? You have to test it, so you have to make sure it kills the virus, but you’ve got to make sure it doesn’t kill the person. Can you imagine? You vaccinate a hundred million people and you find out it’s poison, right?”
                    Administration officials have told CNN that in meetings focused on vaccine development throughout the spring and summer, Trump consistently pressed officials to speed up the timeline for developing a vaccine, and the President appeared intent on being able to deliver at least the solid promise of an effective vaccine by the time he faces reelection.
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                    Those efforts have scaled up as Election Day nears, and Trump has repeatedly complained that some officials at federal health agencies are actively working to stymie his reelection chances by slow-walking announcements.
                      “It will be delivered before the end of the year, in my opinion, before the end of the year, but it really might even be delivered before the end of October,” Trump said about a vaccine at a rally this month. “How do you like that? Wouldn’t that be nice? And you know why? Not because of the election. It’d be nice because we want to save people.”
                      Trump’s press secretary, Kayleigh McEnany, has denied there’s pressure on the FDA “to do anything.”

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                      ICUs are nearing capacity in this French city. And it’s only September

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                      By Melissa Bell and Pierre Bairin, CNN
                      Updated 11:48 AM ET, Thu September 17, 2020

                      Bordeaux, France (CNN) — Dealing with the first wave was like a sprint, the second will be more like a marathon.

                      That’s how Dr. Olivier Joannes-Boyau, head of the intensive care unit at University Hospital in the southwestern city of Bordeaux, describes the resurgence of Covid-19 in France. After young French people took advantage of the lifting of lockdown and summer months to socialize freely, Covid-19 hospitalizations have risen in large cities like Paris, Bordeaux and Marseille on the Mediterranean coast. French hospitals are now preparing for the long slog.
                      The last time University Hospital dealt with a rise in Covid-19 cases, it put aside all other emergency procedures to deal the crisis. This time, it is trying to keep the rest of its services going too. Just like the wider country, it is adapting to a virus that looks like it is here to stay.
                      Hospital staff are more experienced than they were when the coronavirus first swept through France, and Bordeaux University Hospital is now armed with steroids to reduce Covid-19 symptoms and improved ventilators, both of which can reduce intubation rates.
                        But juggling the swelling number of Covid-19 patients alongside those with other conditions will be difficult, says Dr. Catherine Fleureau, the hospital’s director. “It’s also going to be harder than last time, because this wave, I think, will grow progressively and then last over time.”
                        Earlier this year, the first coronavirus wave spiked fast, but was cut short by a strict nationwide lockdown. In total more than 31,000 people died from the disease in France, out of over 433,000 cases, according to Johns Hopkins University.
                        Now, the number of new cases is rising fast. A record was set over the weekend with more than 10,000 new cases in a single day. The number of clusters has been rising steadily and, most worryingly, nationwide, the number of people in intensive care has risen 25% in the past week. That number is still 10 times lower than they it was in the spring but it is a worrying trend; like in the spring it will be about how fast the numbers move upwards.
                        The French government is determined to avoid a second general lockdown that could cripple its economy, so is tasking local authorities with responsibility for reducing the virus’s spread.
                        In response, Bordeaux and Marseille have tightened their Covid-19 regulations, extending the places where masks must be worn, limiting the size of public gatherings and hardening enforcement. More checks are to be carried out to ensure that Covid-19 regulations are being respected.
                        In Bordeaux, the plan announced by regional officials includes a ban on gatherings of more than 10 people in public parks, along the river banks and on beaches. In cafes and restaurants clients will no longer be able to eat and drink while standing up.
                        In both cities regional officials lowered the number of people allowed to gather for large events to 1,000 from 5,000 previously, resulting in the cancellation of sporting fixtures.
                        And just since the start of the school year, 81 schools and 2,100 classes have had to close due to Covid cases. Minister for Education Jean-Michel Blanquer also said Wednesday 1,200 new infections among students had been recorded, compared to last week.
                        The success of these measures will dictate the number of patients that ultimately reach doctors like Dr. Joannes-Boyau. “The major problem will be to keep the wave, really low,” he says. “Because if this wave grows a lot, we will face a large number of patients with Covid-19 that will come and we will not able to treat them.”
                        It’s too early to judge whether local restrictions can keep the coming wave manageable, but his intensive care unit is already nearing capacity, with 33 of the 35 available ICU beds occupied on Wednesday.
                          As Joannes-Boyau says, it takes about three weeks for any change in the state of a population’s health to be measurable. Now the city is braced to see if it has the endurance to last the marathon.
                          An earlier version of this story incorrectly understated the number of ICU beds that were occupied in Bordeaux on Wednesday. It was 33.

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