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Coordination of COVID-19 Vaccine Clinical Trials Produces a ‘Treasure Trove’ of Data and a Model for the Future

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Harmonized approach and vast database of trial participants could bolster future research well beyond SARS-CoV-2

Newswise — SEATTLE – The federally funded COVID-19 Prevention Network (CoVPN), headquartered at Fred Hutchinson Cancer Center in Seattle, was instrumental in the rapid development of safe, effective and lifesaving COVID-19 vaccines during earlier phases of the pandemic.

Its vital work to expedite Phase 3 COVID-19 vaccine clinical trials also resulted in a highly collaborative and harmonized approach that can serve as a national and even international model for major research initiatives while also guiding responses to future public health emergencies.

That’s the overarching theme from a new study published Monday, Jan. 23, in JAMA Network Open.

“Our success, which depended entirely on the investments into HIV vaccine research, can be replicated for other important research initiatives and highlights the importance of investments that boost pandemic preparedness for years to come,” explained James G. Kublin, MD, MPH, executive director of CoVPN and senior and corresponding author of the study.

Additionally, he and his colleagues, including  Alfredo Mena Lora, MD, assistant professor of medicine at the University of Illinois at Chicago, and co-first author Jessica Long, PhD, MPH, a postdoctoral fellow at the University of Washington Department of Medicine in Seattle, noted that the COVID-19 clinical trials produced a vast database of critical information that could help researchers answer pressing questions about this novel virus moving forward. 

“The harmonization of data across trials is a new strategy that will set the standard for collaboration in future clinical trials,” said Mena Lora. 

The authors detail how CoVPN was able to help secure authorized vaccines in less than a year by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health as part of Operation Warp Speed. Its mission was, and continues to be, to support the rapid development of vaccines for the U.S. and global populations by coordinating and implementing Phase 3 trials for COVID-19 vaccine candidates.

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CoVPN officials were able to leverage existing resources, including clinical and laboratory infrastructure, community partnerships and research expertise, to get clinical sites to quickly pivot to conduct the vaccine trials as soon as investigational products were ready for Phase 3 testing.

“The CoVPN approach drew on years of experience and infrastructure from partnering networks and institutions, which not only allowed for rapid rollout of the trials, but also contributed to broader representation of trial participants,” said Long.

Overall, CoVPN deployed five Phase 3 clinical trials involving more than 136,000 participants to test the safety and effectiveness of COVID-19 vaccines. While doing so, it implemented several innovative procedures that were essential to its ultimate success. These included:

  • Harmonized study designs that were similar in relative size, number of endpoints and time to analysis.
  • A model that accelerated vaccine development by allowing phases to occur in parallel rather than sequentially. For example, vaccine manufacturing and scale-up were greenlighted while the trials were ongoing in anticipation of meeting efficacy targets.
  • Establishment of a single Data Safety Monitoring Board for review and oversight of all vaccine studies.
  • Targeted outreach and enrollment efforts supported by an online screening registry to ensure broad and diverse representation among study participants. Extensive engagement was conducted with communities and community leaders to build and enhance trust in the science to help enroll more Black, Indigenous and people of color (BIPOC) volunteers who are historically underrepresented in clinical trials.
  • A cross-platform approach that led to harmonization of data collection across trials and the ability to analyze data from all studies.

“This unique, cross-platform concept allowed for sharing of data from all of the studies and helped bridge gaps in understanding so we could better answer key research questions and guide policy decisions,” explained Kublin, who’s also a principal staff scientist at Fred Hutch. 

Larry Corey, MD, an internationally renowned expert in vaccine development, and principal co-investigator of CoVPN, believes the success of COVID-19 clinical trials should be thought of as an important model for developing vaccines for significant infectious diseases globally.

“Harmonizing study design, enrollment, clinical endpoints and methods for follow-up could very well become best practices that shape the future landscape of major research initiatives and pandemic responses,” he said. 

Kublin and colleagues regard the vast database from more than 130,000 trial participants, including over 2,500 with documented COVID-19 cases, as a “treasure trove” of data that could help unlock mysteries about the virus. For example, they noted that the pooled data from five trials can help address specific questions such as:

  • How effective are vaccines for at-risk groups?
  • Can vaccines have an impact on long COVID?
  • Are safety, immunogenicity and vaccine efficacy different in special populations, such as people living with HIV?
  • What impact do chronic health conditions have on vaccine efficacy or protection duration?
  • What are the impacts of variants on both the population at large and within special communities?

Additional CoVPN publications planned for the months ahead will address many of these topics. Researchers who have ideas for further investigation and want to collaborate with CoVPN can find more information here.

Source: Covid-19 Prevention Network (CoVPN)

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Biden helped bring science out of the lab and into the community − emphasizing research focused on solutions

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Biden began his presidency in the throes of the COVID-19 pandemic. Evan Vucci/AP Photo

Arthur Daemmrich, Arizona State University

President Joe Biden was inaugurated in January 2021 amid a devastating pandemic, with over 24 million COVID-19 cases and more than 400,000 deaths in the U.S. recorded at that point.

Operation Warp Speed, initiated by the Trump administration in May 2020, meant an effective vaccine was becoming available. Biden quickly announced a plan to immunize 100 million Americans over the next three months. By the end of April 2021, 145 million Americans – nearly half the population – had received one vaccine dose, and 103 million were considered fully vaccinated. Science and technology policymakers celebrated this coordination across science, industry and government to address a real-world crisis as a 21st-century Manhattan Project.

From my perspective as a scholar of science and technology policy, Biden’s legacy includes structural, institutional and practical changes to how science is conducted. Building on approaches developed over the course of many years, the administration elevated the status of science in the government and fostered community participation in research.

Raising science’s profile in government

The U.S. has no single ministry of science and technology. Instead, agencies and offices across the executive branch carry out scientific research at several national labs and fund research by other institutions. By elevating the White House Office of Science and Technology Policy to a Cabinet-level organization for the first time in its history, Biden gave the agency greater influence in federal decision-making and coordination.

Formally established in 1976, the agency provides the president and senior staff with scientific and technical advice, bringing science to bear on executive policies. Biden’s inclusion of the agency’s director in his Cabinet was a strong signal about the elevated role science and technology would play in the administration’s solutions to major societal challenges.

Under Biden, the Office of Science and Technology Policy established guidelines that agencies across the government would follow as they implemented major legislation. This included developing technologies that remove carbon dioxide from the atmosphere to address climate change, rebuilding America’s chip industry, and managing the rollout of AI technologies.

Close-up of gloved hand holding square semiconductor chip
The CHIPS and Science Act of 2022 boosted research and manufacture of semiconductor chips in the U.S. Narumon Bowonkitwanchai/Moment via Getty Images

Instead of treating the ethical and societal dimensions of scientific and technological change as separate from research and development, the agency advocated for a more integrated approach. This was reflected in the appointment of social scientist Alondra Nelson as the agency’s first deputy director for science and society, and science policy expert Kei Koizumi as principal deputy director for policy. Ethical and societal considerations were added as evaluation criteria for grants. And initiatives such as the AI bill of rights and frameworks for research integrity and open science further encouraged all federal agencies to consider the social effects of their research.

The Office of Science and Technology Policy also introduced new ways for agencies to consult with communities, including Native Nations, rural Americans and people of color, in order to avoid known biases in science and technology research. For example, the agency issued government-wide guidance to recognize and include Indigenous knowledge in federal programs. Agencies such as the Department of Energy have incorporated public perspectives while rolling out atmospheric carbon dioxide removal technologies and building new hydrogen hubs.

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Use-inspired research

A long-standing criticism of U.S. science funding is that it often fails to answer questions of societal importance. Members of Congress and policy analysts have argued that funded projects instead overly emphasize basic research in areas that advance the careers of researchers.

In response, the Biden administration established the technology, innovation and partnerships directorate at the National Science Foundation in March 2022.

The directorate uses social science approaches to help focus scientific research and technology on their potential uses and effects on society. For example, engineers developing future energy technologies could start by consulting with the community about local needs and opportunities, rather than pitching their preferred solution after years of laboratory work. Genetic researchers could share both knowledge and financial benefits with the communities that provided the researchers with data.

Fundamentally, “use-inspired” research aims to reconnect scientists and engineers with the people and communities their work ultimately affects, going beyond publication in a journal accessible only to academics.

The technology, innovation and partnerships directorate established initiatives to support regional projects and multidisciplinary partnerships bringing together researchers, entrepreneurs and community organizations. These programs, such as the regional innovation engines and convergence accelerator, seek to balance the traditional process of grant proposals written and evaluated by academics with broader societal demand for affordable health and environmental solutions. This work is particularly key to parts of the country that have not yet seen visible gains from decades of federally sponsored research, such as regions encompassing western North Carolina, northern South Carolina, eastern Tennessee and southwest Virginia.

Community-based scientific research

The Biden administration also worked to involve communities in science not just as research consultants but also as active participants.

Scientific research and technology-based innovation are often considered the exclusive domain of experts from elite universities or national labs. Yet, many communities are eager to conduct research, and they have insights to contribute. There is a decades-long history of citizen science initiatives, such as birdwatchers contributing data to national environmental surveys and community groups collecting industrial emissions data that officials can use to make regulations more cost effective.

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Going further, the Biden administration carried out experiments to create research projects in a way that involved community members, local colleges and federal agencies as more equal partners.

Hand-drawn signs displayed on a fence against a green field, with messages about climate change around a sign that reads 'It's our future'
Collaboration between the community, academia, industry and government can lead to more effective solutions. Deb Cohn-Orbach/UCG/Universal Images Group via Getty Images

For example, the Justice40 initiative asked people from across the country, including rural and small-town Americans, to identify local environmental justice issues and potential solutions.

The National Institutes of Health’s ComPASS program funded community organizations to test and scale successful health interventions, such as identifying pregnant women with complex medical needs and connecting them to specialized care.

And the National Science Foundation’s Civic Innovation Challenge required academic researchers to work with local organizations to address local concerns, improving the community’s technical skills and knowledge.

Frontiers of science and technology policy

Researchers often cite the 1945 report Science: The Endless Frontier, written by former Office of Scientific Research and Development head Vannevar Bush, to describe the core rationales for using American taxpayer money to fund basic science. Under this model, funding science would lead to three key outcomes: a secure national defense, improved health, and economic prosperity. The report, however, says little about how to go from basic science to desired societal outcomes. It also makes no mention of scientists sharing responsibility for the direction and impact of their work.

The 80th anniversary of Bush’s report in 2025 offers an opportunity to move science out into society. At present, major government initiatives are following a technology push model that focuses efforts on only one or a few products and involves little consideration of consumer and market demand. Research has repeatedly demonstrated that consumer or societal pull, which attracts development of products that enhance quality of life, is key to successful uptake of new technologies and their longevity.

Future administrations can further advance science and address major societal challenges by considering how ready society is to take up new technologies and increasing collaboration between government and civil society.

Arthur Daemmrich, Professor of Practice in the School for the Future of Innovation in Society, Arizona State University

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This article is republished from The Conversation under a Creative Commons license. Read the original article.

The science section of our news blog STM Daily News provides readers with captivating and up-to-date information on the latest scientific discoveries, breakthroughs, and innovations across various fields. We offer engaging and accessible content, ensuring that readers with different levels of scientific knowledge can stay informed. Whether it’s exploring advancements in medicine, astronomy, technology, or environmental sciences, our science section strives to shed light on the intriguing world of scientific exploration and its profound impact on our daily lives. From thought-provoking articles to informative interviews with experts in the field, STM Daily News Science offers a harmonious blend of factual reporting, analysis, and exploration, making it a go-to source for science enthusiasts and curious minds alike. https://stmdailynews.com/category/science/


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Know These 4 Core Factors to Avoid a Heart Health Syndrome

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(Family Features) In the U.S., 1 in 3 adults is at risk for a newly recognized syndrome that comes from a combination of heart disease, kidney disease, type 2 diabetes and excess body weight. This cluster of conditions, called cardiovascular-kidney-metabolic (CKM) syndrome, is an example of how problems in one part of your body can affect other parts.

To avoid CKM syndrome, health experts suggest paying close attention to four of the American Heart Association’s Life’s Essential 8 – blood pressure, lipids, body weight and blood sugar level – which are core health factors that impact your metabolic health.

Good metabolic health means your body uses energy well and keeps these factors in a normal range. However, when numbers are off in one area, it can affect others, raising your risk for heart disease, stroke, kidney disease and diabetes.

Consider these tips from the American Heart Association to help keep your core health factors under control.

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Blood Pressure
High blood pressure, also known as hypertension, happens when the force of your blood pushing against the walls of your blood vessels is too high. High blood pressure is a leading cause of heart disease, stroke and kidney disease.

Because high blood pressure doesn’t have symptoms, the only way to know you have it is to get your blood pressure checked. Healthy blood pressure is below 120/80. If your blood pressure is 130/80 or higher, talk to your doctor about checking your other core health factors.

Lifestyle changes can help reduce high blood pressure. One example is a Dietary Approaches to Stop Hypertension (DASH) eating pattern that’s low in fat and rich in fruits, vegetables, whole grains and low-fat dairy products. Losing 10 pounds and reducing alcohol consumption can also reduce blood pressure.

Cholesterol
Cholesterol is a waxy substance your liver makes then circulates in the blood where your body uses it to build cells and make vitamins and hormones. You may also get cholesterol from eating animal products. If there’s too much cholesterol circulating, your risk of type 2 diabetes, heart disease and stroke may increase.

For optimal CKM health, your LDL cholesterol should be below 100 and triglycerides below 150. Triglycerides are the most common type of fat in the body. If your triglyceride level is 135 or higher, talk to your doctor about decreasing your risk.

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Losing body weight and increasing physical activity decrease triglyceride levels. In addition, DASH and Mediterranean (plant-based, high-fiber, low-fat) eating patterns support healthy LDL and triglyceride levels.

Body Weight
Healthy weight may be determined by body mass index (BMI), a number that represents your weight in relation to your height. Extra body fat can mean a higher risk for many health problems, including heart disease, stroke, high blood pressure, high cholesterol and diabetes.

CKM syndrome starts when BMI is 25 or higher and waist circumference is 88 centimeters or higher for women and 102 centimeters or higher for men. Aim for a BMI between 18.5-25.

To lose weight and keep it off, start by setting realistic goals. Understand how much and why you eat, manage portion sizes, make smart snack substitutions and be physically active.

Blood Sugar
High blood sugar can slowly damage the kidneys. In fact, diabetes is the leading cause of kidney disease, and it increases the risk of heart attack and stroke.

Blood sugar is measured in two ways: a fasting blood glucose test (short term blood sugar) and an A1C test (long term blood sugar control). A normal fasting blood glucose level is 70-99 and a normal A1C level is below 5.7%. Fasting blood glucose above 125 and A1C of 6.5% or higher means you have diabetes.

Habits that help you avoid high blood pressure, weight gain and high cholesterol also keep your blood sugar in check. These are especially important if you have a family history of diabetes.

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Learn more about CKM syndrome and how to manage your risk at heart.org/CKMhealth.

Photos courtesy of Shutterstock

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SOURCE:
American Heart Association


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Expert Pregnancy Tips for Staying Healthy This Winter

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(Family Features) Staying up to date on recommended vaccines is important during pregnancy. This is especially true during the winter months when more people tend to get sick from flu, COVID-19 and RSV. These viruses can be especially dangerous for pregnant people and babies.

Vaccines are an important part of routine pregnancy care, both for you and your baby. Getting vaccinated against flu and COVID-19 can cut your risk of hospitalization by about half.

Now is the time to get vaccinated if you haven’t already. Flu vaccines help protect you from getting the flu and getting seriously ill, so it’s a good idea to schedule an appointment now. The latest COVID-19 vaccines are important too because they lower your risk of serious illness. An RSV vaccine may also be recommended for when you are 32-36 weeks pregnant. Be sure to talk to your doctor.

“Right now, we are seeing a concerning increase in cases of respiratory diseases, such as the flu, COVID-19 and RSV,” said Adm. Rachel Levin, MD, assistant secretary for health at the U.S. Department of Health and Human Services. “I encourage all pregnant people to take preventive action to protect their health and the health of their baby. The best and safest way to do this is to get vaccinated. Getting vaccinated is easy and is usually covered by insurance.”

Help Protect Your Baby 
When you get flu, COVID-19 and RSV vaccines, you’re helping protect your baby by passing your immunity on to them. Getting vaccinated against flu, COVID-19 and RSV during pregnancy can protect your baby during the first 6 months of life. These viruses can be very harmful to newborns. In fact, RSV is the leading cause of hospitalization in infants

Talk to Your Doctor About Timing
Millions of people in the U.S. have already gotten vaccinated against flu, COVID-19 and RSV this season. If you haven’t gotten your vaccines yet, be sure to talk with your doctor. They can help you choose the right vaccines and determine the best timing to help protect you and your baby.

Get the Facts
Getting vaccinated can give you peace of mind, ensuring you have done everything you can to protect yourself and your baby from serious respiratory illness. Information can give you power and comfort, especially when you’re pregnant.

Go to cdc.gov/RiskLessDoMore to learn more about flu, COVID-19 and RSV vaccines, or go to vaccines.gov to get started today.

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Photo courtesy of Shutterstock

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SOURCE:
U.S. Department of Health and Human Services


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