White House aims to give 70% of American adults at least one Covid-19 vaccine dose by July 4

To reach that goal, Biden’s team said he will expand walk-up vaccinations at pharmacies and vaccination sites, open additional mobile vaccination units, and accelerate a public-relations campaign aimed at boosting vaccine confidence.

The announcement comes as the pace of the U.S. vaccination effort has nosedived. As of mid-April, the country was administering just under 3.4 million vaccine doses each day. As of Tuesday, the rate had dropped to just under 2.3 million.

Still, the country is currently on track to reach President Biden’s latest goal. Over 56% of adults 18 and over have already received at least one dose of a Covid-19 vaccine, according to federal data. That number represents roughly 145 million people; to reach the 70% threshold, about 36 million additional adults would need to receive a first dose in the next two months.

The White House, additionally, set a goal of giving a full vaccine regimen — either two doses each of the Pfizer-BioNTech or Moderna vaccines, or one dose of Johnson & Johnson’s — to 160 million Americans.

That benchmark, too, appears within reach. Currently, 105 million Americans have received a full course of vaccine doses, in addition to the 40 million who’ve only received one dose. During a press briefing, a senior Biden aide said the administration estimated that reaching each goal would require administering about another 100 million doses to adults in the next two months, roughly three-quarters of the current pace.

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Story credit: STAT

By Lev Facher  

Energy Unleashed by Volcanic Eruptions Deep in Our Oceans Could Power All of the United States

Eruptions from deep-sea volcanoes were long-thought to be relatively uninteresting compared with those on land. While terrestrial volcanoes often produce spectacular eruptions, dispersing volcanic ash into the environment, it was thought that deep marine eruptions only produced slow moving lava flows.

But data gathered by remotely operated vehicles deep in the North East Pacific and analyzed by scientists at the University of Leeds, has revealed a link between the way ash is dispersed during submarine eruptions and the creation of large and powerful columns of heated water rising from the ocean floor, known as megaplumes.

These megaplumes contain hot chemical-rich water and act in the same way as the atmospheric plumes seen from land-based volcanoes, spreading first upwards and then outwards, carrying volcanic ash with them. The size of megaplumes is immense, with the volumes of water equivalent to forty million Olympic-sized swimming pools. They have been detected above various submarine volcanoes but their origin has remained unknown. The results of this new research show that they form rapidly during the eruption of lava.

The research was carried out by Sam Pegler, from the School of Mathematics and David Ferguson, from the School of Earth and Environment and is being published today (April 21, 2021) in the journal Nature Communications.

Together they developed a mathematical model which shows how ash from these submarine eruptions spreads several kilometers from the volcano. They used the ash pattern deposited by a historic submarine eruption to reconstruct its dynamics. This showed that the rate of energy released and required to carry ash to the observed distances is extremely high — equivalent to the power used by the whole of the USA.

David Ferguson said: “The majority of Earth’s volcanic activity occurs underwater, mostly at depths of several kilometers in the deep ocean but, in contrast to terrestrial volcanoes, even detecting that an eruption has occurred on the seafloor is extremely challenging. Consequently, there remains much for scientists to learn about submarine volcanism and its effects on the marine environment.”

The research shows that submarine eruptions cause megaplumes to form but the release of energy is so rapid that it cannot be supplied from the erupted molten lava alone. Instead, the research concludes that submarine volcanic eruptions lead to the rapid emptying of reservoirs of hot fluids within the earth’s crust. As the magma forces its way upwards towards the seafloor, it drives this hot fluid with it.

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Story credit: University of Leeds

The Clock is Ticking: as TB claims some 1.4 million lives in 2019

More than a century has passed since the March 24, 1882, announcement by Robert Koch that Mycobacterium tuberculosis (Mtb) bacteria cause tuberculosis (TB), but the disease still ranks as one of the world’s great killers, claiming some 1.4 million lives in 2019 alone.

The National Institute of Allergy and Infectious Diseases (NIAID) of the United states on Wednesday joined the World Health Organization and others in acknowledging the need for continued, concerted efforts to combat TB, even as the world stand in the shadow of the COVID-19 pandemic, which threatens to slow or reverse progress in global TB control.

“The 2021 World TB Day theme, The Clock is Ticking, reminds us that time is of the essence. We cannot delay the research needed to identify, develop, test, and deliver new or improved TB diagnostics, treatments, and vaccines. On this World TB Day, NIAID stands with the global health community in a renewed commitment to ending this disease”.

TB-causing bacteria spread through the air and the disease usually affects the lungs, although other organs and parts of the body can be involved. Most people infected with the disease can co-exist with the bacterium for months, years or a lifetime without ever developing symptoms (termed latent TB infection.)

By some estimates, up to a quarter of the world’s population has latent Mtb infection. People with latent TB infection cannot transmit the bacteria to others. However, they have a 5-to-10% lifetime risk of developing active TB. Symptoms of active pulmonary TB disease include cough, fever, and weight loss. Malnourished individuals, smokers, people receiving immunosuppressive therapies, and those with compromised immune systems, including those with untreated HIV infections, are at increased risk of developing active TB.

In collaboration with the Bill and Melinda Gates Foundation, NIAID is funding studies to analyze clinical samples collected in trials of BCG and M72/AS01 E vaccines. These studies aim to define the immunological basis of the observed protection from TB disease. Defining how and which immune responses correlate with high degrees of disease protection allows investigators to design new and improved TB vaccines.

To further advance the development of potential TB vaccines, NIAID established three Immune Mechanisms of Protection Against Mycobacterium tuberculosis (IMPAc-TB) Centers in 2019. Multi-disciplinary research teams in the Centers are elucidating the immune responses involved in preventing initial TB infection, establishing latent TB infection, or transitioning from latent infection to active TB disease. Findings are informing development of novel TB vaccine candidates.

NIAID says the clock is indeed ticking, and on World TB Day 2021, NIAID takes time to reflect on the dedication of scientists, clinicians, trial volunteers, and others who work tirelessly to make TB a disease of the past.

“We stand with global health partners in firm resolve to apply cutting-edge research, investment, and collaboration to make that day come soon.”

Clinical trials of monoclonal antibodies to prevent COVID-19 now enrolling

Two Phase 3, randomized, placebo-controlled, double-blind clinical trials testing whether experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronavirus are now enrolling healthy adults at clinical trial sites in the United States.

Image of an antibody binding to the surface of a virus, blocking entry into a human cell.Lisa Donohue, CoVPN

Many of the trial sites and study investigators are part of the COVID-19 Prevention Network(link is external) (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. SARS-CoV-2 is the virus that causes coronavirus disease 2019 (COVID-19). The trials are enrolling adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection.

“The COVID-19 Prevention Network is designed to conduct large-scale trials rapidly and efficiently,” said NIAID Director Anthony S. Fauci, M.D. “This network will allow us to test the safety and efficacy of monoclonal antibodies and other preventive measures to help identify how best to reduce the level of SARS-CoV-2 infection and ultimately end the COVID-19 pandemic.”   

Monoclonal antibodies(link is external) are laboratory-made versions of proteins naturally produced by the immune system in response to invading viruses or other pathogens. Neutralizing antibodies, whether natural or monoclonal, can bind directly to portions of viruses that they use to attach to and enter cells, preventing them from initiating the infection cycle. Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the COVID-19 pandemic response until vaccines become available.

One trial is being conducted jointly by NIAID and trial sponsor Regeneron Pharmaceuticals of Tarrytown, New York. It will evaluate Regeneron’s investigational double mAb combination, REGN-COV-2, which is designed to bind to two points on the SARS-CoV-2 spike protein and prevent it from entering healthy cells. The trial will enroll approximately 2,000 asymptomatic adults who are household contacts of persons with SARS-CoV-2 infection. Participants must have been in close contact (typically due to residing at the same address) with the infected person in a 96-hour window preceding administration of either REGN-CoV-2 or placebo. In addition to assessing safety, the trial will seek to define whether REGN-COV-2 can prevent infection or disease symptoms in those already infected. The efficacy assessment will be a one-month period following administration of REGN-COV-2 or placebo. All trial participants will be followed for safety for seven months after efficacy assessment period ends.

NIH leadership details unprecedented initiative to ramp up testing technologies for COVID-19

RADx efforts seek to create capacity for 6 million daily tests by the end of 2020, address underserved populations.

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In a paper in the New England Journal of Medicine(link is external), scientific leaders from the National Institutes of Health set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease.

Colorized scanning electron micrograph of an apoptotic cell (green) heavily infected with SARS-CoV-2 virus particles (orange), isolated from a patient sample. Image at the NIAID Integrated Research Facility (IRF) in Fort Detrick, MarylandNIAID

The authors describe the current testing landscape and explain the urgent need for nationwide deployment of low-complexity, point-of-care molecular diagnostics with rapid results.

To fill this urgent need, the Rapid Acceleration of Diagnostics (RADx) program was established in just five days following the announcement of $1.5 billion in federal stimulus funding in April 2020. RADx covers the entire life cycle of the target testing technologies, is tightly focused on timelines and outcomes, receives applications from small and large companies and is expressly focused on health disparities. While based at NIH, RADx is closely coordinating with the Office of the Assistant Secretary for Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense.

Current testing methods to diagnose COVID-19 detect either viral RNA or viral antigens. These tests are highly sensitive and specific when conducted in centralized laboratories with standardized protocols, but require a large amount of lab space, complex equipment, regulatory approvals for the laboratory operations and skilled technicians. Results may take hours to days, and samples often need transport to a central laboratory, furthering delays. During that time someone who is unknowingly carrying the virus may go on to infect others, instead of being quickly isolated.  These issues highlight the need for reliable, rapid, point-of-care testing diagnostics.

RADx includes four major components to enable approximately 6 million daily tests in the United States by December 2020, many times the current daily testing rate. In the near term, RADx confronts the pandemic by expanding testing capacity by fall 2020 as the nation faces the beginning of seasonal flu.  In the slightly longer-term RADx aims to produce additional innovative diagnostic technologies and strategies for making testing available to diverse, vulnerable and underserved populations.

• RADx Tech aims to identify, accelerate development, scale up and deploy innovative point-of-care technologies throughout the fall of 2020. The program uses an “innovation funnel” design where applications quickly move through multiple stages of review with increasing scrutiny. This has been compared to a “shark tank” model.  About 15-20% of RADx Tech applications will qualify for additional consideration and review. Of those applications, less than one-third will move to rigorous Phase 1 testing and validation through NIH’s Point-of-care Technology Research Network (POCTRN). If a project is judged successful at that point, rapid scale up and clinical testing gets underway, with substantial financial assistance provided. As of July 13, over 600 applications had been submitted, with 27 projects advancing to Phase 1 and one project advancing to Phase 2.
• RADx Advanced Technology Platforms (RADx-ATP), will support the scale-up of more advanced technologies that can achieve immediate, substantial increases in capacity. The program uses a rapid-response application process for companies with existing point-of-care technologies authorized by the U.S. Food and Drug Administration for detecting SARS-CoV-2 that can scale production to between 20,000 and 100,000 tests per day by the fall. Additionally, RADx-ATP will seek to expand “mega-labs” across the country that can increase testing capacity to 100,000 to 250,000 tests per day.
• RADx Radical (RADx-rad) will focus on truly non-traditional approaches for testing that have a slightly longer horizon. This program will evaluate a wide range of technologies, such as home-based testing and repurposing of existing technologies for detecting SARS-CoV-2. Moreover, RADx-rad will support projects that use of biological or physiological biomarkers to detect an infection or predict the severity of disease, including the likelihood of developing multisystem inflammatory syndrome in children (MIS-C), or using chemosensory changes as an early indicator of viral positivity. Other examples include the use of biosensors to detect the presence of the virus in the breath, or the analysis of wastewater to conduct community-based surveillance.
• RADx Underserved Populations (RADx-UP) will establish community-engaged implementation projects to improve access to testing in underserved and vulnerable populations. Racial and ethnic minorities bear a higher burden of disease and mortality from COVID-19. Blacks, Latinos and American Indians/Alaska Natives are hospitalized and die at disproportionately higher rates compared to other groups. The goal of RADx-UP is to understand factors that have led to the disproportionate burden of the pandemic on underserved populations, and to support optimal access and uptake of SARS-CoV-2 testing. The program aims to examine infection patterns and efforts to increase access to and effectiveness of testing methods by building an infrastructure that can be leveraged for the ongoing COVID-19 public health efforts.

Outdoor light linked with teens’ sleep and mental health

Large-scale study of U.S. teens shows associations between outdoor, artificial light at night and health outcomes.

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Research shows that adolescents who live in areas that have high levels of artificial light at night tend to get less sleep and are more likely to have a mood disorder relative to teens who live in areas with low levels of night-time light. The research was funded by the National Institute of Mental Health (NIMH), part of the National Institutes of Health, and is published in JAMA Psychiatry.

“These findings illustrate the importance of joint consideration of both broader environmental-level and individual-level exposures in mental health and sleep research,” says study author Diana Paksarian, Ph.D., a postdoctoral research fellow at NIMH.

Daily rhythms, including the circadian rhythms that drive our sleep-wake cycles, are thought to be important factors that contribute to physical and mental health. The presence of artificial light at night can disrupt these rhythms, altering the light-dark cycle that influences hormonal, cellular, and other biological processes. Researchers have investigated associations among indoor artificial light, daily rhythms, and mental health, but the impact of outdoor artificial light has received relatively little attention, especially in teens.

In this study, Paksarian, Kathleen Merikangas, Ph.D., senior investigator and chief of the Genetic Epidemiology Research Branch at NIMH, and coauthors examined data from a nationally representative sample of adolescents in the United States, which was collected from 2001 to 2004 as part of the National Comorbidity Survey Adolescent Supplement (NCS-A). The dataset included information about individual-level and neighborhood-level characteristics, mental health outcomes, and sleep patterns for a total of 10,123 teens, ages 13 to 18 years old.

As part of in-person interviews for the NCS-A, the adolescents completed a validated assessment to determine whether they met the diagnostic criteria for various mental disorders. The teens also answered questions about their sleep habits, reporting what time they usually went to bed and how many hours of sleep they usually got on weeknights and on weekends.

To gauge the teens’ exposure to outdoor artificial light at night, the researchers used satellite imagery data to calculate the average artificial light levels for each census block group in the U.S. As expected, levels of artificial light at night varied according to certain neighborhood-level factors, such as urbanicity, socioeconomic levels, and population density.

Importantly, teens who lived in areas with high levels of artificial light at night tended to report later weeknight bedtimes and shorter weeknight sleep duration. This association held even after the researchers accounted for various individual-level factors (such as age, sex, race/ethnicity, number of siblings, parental education) and neighborhood-level factors (such as county-level urbanicity and population density). The analyses showed that, on average, teens in areas with the highest levels of outdoor light went to bed about 29 minutes later and got 11 fewer minutes of sleep than did teens in areas with the lowest levels.

The data showed that greater levels of artificial light at night were also associated with increased likelihood of having a mood disorder or anxiety disorder. Specifically, teens who lived in areas with higher levels of artificial light at night were more likely to meet the diagnostic criteria for bipolar disorder or specific phobia.

According to Paksarian and coauthors, this association is noteworthy because disruptions to sleep and circadian rhythms is a well-documented feature of certain mental disorders, including bipolar disorder. The study findings point to disrupted sleep as a possible link between artificial nighttime light exposure and mental health outcomes, a link that should be tested in future prospective research.

The study findings also highlight social disparities in exposure to artificial light, indicating that teens who belong to racial/ethnic minority groups, who come from immigrant families, or who come from families with lower income are more likely to live in areas with high levels of outdoor light at night. To the extent that exposure to artificial light disrupts daily rhythms such as sleep patterns, it could serve as an added stressor for teens who are already at increased risk for health problems due to social disadvantage.

Future experimental studies that examine the effects of different properties of artificial light – such as brightness and spectral composition – could help researchers determine whether lighting-focused interventions are likely to benefit adolescent sleep and mental health.

“Although environmental light exposure is only one factor in a more complex network of influences on sleep and behavior, it is likely to be an important target for prevention and interventions in adolescent health,” says Merikangas. 

NIH begins study to quantify undetected cases of coronavirus infection

A new study has begun recruiting at the National Institutes of Health in Bethesda, Maryland, to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have antibodies to the virus.

Colorized scanning electron micrograph of an apoptotic cell (blue) infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. NIAID

The presence of antibodies in the blood indicates a prior infection. In this “serosurvey,” researchers will collect and analyze blood samples from as many as 10,000 volunteers to provide critical data for epidemiological models. The results will help illuminate the extent to which the novel coronavirus has spread undetected in the United States and provide insights into which communities and populations are most affected.

The study will be conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), with additional support from the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI), all parts of NIH.

“This study will give us a clearer picture of the true magnitude of the COVID-19 pandemic in the United States by telling us how many people in different communities have been infected without knowing it, because they had a very mild, undocumented illness or did not access testing while they were sick,” said Anthony S. Fauci, M.D., NIAID director. “These crucial data will help us measure the impact of our public health efforts now and guide our COVID-19 response moving forward.”

Investigators will test participants’ blood samples for the presence of SARS-CoV-2 antibodies , proteins the immune system produces to fight a specific infectious agent. A positive test result indicates previous infection. To date, reporting of U.S. cases of COVID-19 has mostly relied on molecular tests that determine the presence of the virus in a person’s airways using a noninvasive cotton swab. While these cotton swab-based tests rapidly and effectively identify active infection, they do not determine whether a person was previously infected with SARS-CoV-2 and recovered.

“An antibody test is looking back into the immune system’s history with a rearview mirror,” said Matthew J. Memoli, M.D., M.S., principal investigator of the study and director of NIAID’s Laboratory of Infectious Diseases Clinical Studies Unit. “By analyzing an individual’s blood, we can determine if that person has encountered SARS-CoV-2 previously.”

Investigators will analyze blood samples for two types of antibodies, anti-SARS-CoV-2 S protein IgG and IgM, using an ELISA (enzyme-linked immunosorbent assay) developed by researchers at NIAID and NIBIB. In blood samples found to contain antibodies against SARS-CoV-2, researchers may perform additional tests to evaluate the volunteers’ immune responses to the virus. These data may provide insight as to why these cases were less severe than those that lead to hospitalization.

Healthy volunteers over the age of 18 from anywhere in the United States can participate and will be asked to consent to enrollment over the telephone. Individuals with a confirmed history of COVID-19 or current symptoms consistent with COVID-19 are not eligible to participate.

After enrollment, study participants will attend a virtual clinic visit, complete a health assessment questionnaire and provide basic demographic information—including race, ethnicity, sex, age and occupation—before submitting samples in one of two ways. Participants working at the NIH Bethesda campus will have blood drawn at the NIH Clinical Center. Other volunteers will participate in at-home blood sampling. Neoteryx, a medical device firm based in Torrance, California, will supply at-home blood collection kits. Researchers will ship each study participant a Mitra^®Home Blood Collection Kit and provide detailed instructions on collecting a microsample of blood and mailing it back for future analysis in the laboratory.

“Researchers have considerable experience using these at-home blood collection kits to track the spread of other infectious diseases like influenza, and this method is safe, effective and easy-to-use,” said Kaitlyn Sadtler, Ph.D., study lead for laboratory testing and chief of NIBIB’s Section for Immunoengineering. “With a small finger-pick, volunteers can help scientists fight COVID-19 from their homes.”