Pursuing Data-Driven Responses to Public Health Threats

In my 11th grade civics class, I learned about how a bill becomes a law, and I‘ll bet some of you can even remember the steps. Today, I want to introduce you to another way that the federal government takes actions – executive orders. As head of the executive branch, the president can issue an executive order to manage operations of the federal government.

In light of the COVID-19 pandemic, President Biden has issued executive orders to accelerate the country’s ability to respond to public health threats.

This is where I come in. As Director of the National Library of Medicine (NLM) and a member of the leadership team of the National Institutes of Health, I’m part of a group developing the implementation plan for the Executive Order entitled Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats.

This order directs the heads of all executive departments and agencies to work on COVID-19 and pandemic-related data issues. This includes making data that is relevant to high-consequence public health threats accessible to everyone, reviewing existing public health data systems to issue recommendations for addressing areas for improvement, and reviewing the workforce capacity for advanced information technology and data management. And, like all good government work, a report summarizing findings and providing recommendations will be issued.

Since March 2021, I have been meeting 2 to 3 times a month with public health and health data experts across the U.S. Department of Health & Human Services (HHS). Our committee includes staff from the Office of the National Coordinator for Health Information Technology, Food and Drug Administration, Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, and Office of the Assistant Secretary for Planning and Evaluation.

After creating a work plan, our group arranged briefings with many other groups, including public health officials from states and territories, representatives from major health care systems, and the public, among others. We reviewed many initiatives to promote open data, data sharing, and data protection across the government sphere. We learned about the challenges of developing and adopting data standards, and the ability of different groups to come together to make data more useful in preparing the country to anticipate and respond to high-consequence public health threats. We discussed future strategies for data management and data protection, new analytical models, and workforce development initiatives. Our working group provided a report to the Office of Science and Technology Policy (OSTP), handing it off to the next team who will take the work process and keep moving it toward completion. In coordination with the National Science and Technology Council, OSTP will develop a plan for advancing innovation in public health data and analytics.

This was a beneficial experience for me, and I certainly learned a great deal. Implementing a public health response system requires engagement with many HHS divisions, each of which brings a unique perspective and experience. I also developed new relationships based on trust and collaboration with these colleagues. At NLM, we have experts in data standards and data collection, and we oversee vast data repositories, so we have substantial domain-specific knowledge to contribute. I drew frequently on the knowledge and expertise of NLM staff to inform the process through analyses of information and the preparation of reports. I am grateful for all who helped and supported me.

I believe our country is prepared to have the data necessary to prevent, detect, and respond to future high-consequence public health threats. This is yet another way that NLM is helping shape data-powered health for the future. What else can we do for you?

Thanks, Dr. Fauci!

Perhaps the most famous NIH staffer right now is Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID), and one of the leading voices throughout the COVID-19 pandemic. Prepared by more than 50 years of government service and research on infectious diseases, Dr. Fauci is a public servant who brings reason, expertise, and a keen sense of how to mobilize the public health sector to act against this unprecedented threat to public health.

Like many others around the country and the world, my family and I think of Dr. Fauci as “our doctor.” He speaks to us, giving a personal response to ensure the public’s health. He understands the challenges of having family at a distance during times when travel and family gatherings are discouraged to reduce the spread of infection. He shares the joys of those reunions—full of hugs from family and friends—so long missed. It’s amazing to me that Dr. Fauci has been able to convey such warmth and concern to the world and be the deliverer of trusted knowledge in such a personal manner. More than once, conversation at a family dinner or on a family phone call has included the question, “But what does Dr. Fauci think about . . .?” followed by heartfelt wishes of gratitude from my mother and siblings!

I am privileged to be part of the NIH leadership team who meets weekly to advance the mission of the world’s largest research enterprise. While we address wide ranging issues from advancing biomedical science to NIH infrastructure and operations, discussions about NIH’s response to the COVID-19 pandemic still dominate. Like others, I find Tony a wise and experienced colleague, thoughtful in his contributions, and quick to bring a sometimes much-needed touch of humor into complicated conversations. I marvel at his stamina and the breadth of issues that engage his mind.

Tony Fauci has built a superb team of scientists, clinicians, and administrators within NIAID. The dedication and intellectual generosity evident in his contributions to our efforts are evident across NIAID – clearly an inspirational leader motivates and inspires!

So please join me in expressing gratitude to my colleague, Tony Fauci – a national treasure!

Going Back to School Safely

Guest post by Diana W. Bianchi, MD, Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health

Originally released on the Director’s Corner blog.

As schools across the United States begin to resume full-time, in-person education, I am hopeful that this academic year may be a more typical one. The in-person school environment and the wide range of services offered there are critical for the development and well-being of our nation’s young people. Without in-person schooling, many children miss out on school-based meals, speech or occupational therapy, and after-school programs. Loss of such services disproportionately affects minorities, socially and economically disadvantaged children, children with disabilities, and those with medical complexities.

Generating robust scientific data to inform policies to return children to the classroom safely and equitably during the ongoing COVID-19 pandemic is of paramount importance not only for children, but also to allow their parents to return to work. We now have safe and effective vaccines available for adults and children ages 12 years and older, as well as established public health measures to prevent transmission of SARS-CoV-2, the virus that causes COVID-19. Yet the emergence of the more transmissible delta SARS-CoV-2 variant and the rising COVID-19 cases across the country remind us that we must remain vigilant and adaptable to changing circumstances.

NICHD manages the Safe Return to School Diagnostic Testing Initiative, launched earlier this year as part of the NIH Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program. This initiative addresses the needs of children with unequal access to COVID-19 testing and who face barriers to attending school remotely, including those who do not have adequate equipment, internet access, or adult supervision at home.

The RADx-UP Return to School projects combine frequent COVID-19 testing with proven safety measures to reduce the spread of SARS-CoV-2. They also are exploring the influence of vaccination for eligible staff and students, addressing vaccine hesitancy, and seeking information on circulating SARS-CoV-2 variants and breakthrough infections. Funding for the first set of projects was announced in April, and additional projects were funded in July. Currently, 16 projects are ongoing at schools across the country, including public, charter, tribal, early education, and special education schools. Participating schools serve racially and ethnically diverse populations, including African Americans, American Indians/Alaska Natives, Latinos/Latinas, Asian Americans, and Native Hawaiians and other Pacific Islanders. Critically, several projects include children with medical complexities and/or intellectual and developmental disabilities who may not be able to use COVID-19 mitigation measures such as wearing masks or social distancing.

On August 9, NIH hosted a virtual workshop that brought together RADx-UP Return to School investigators and other researchers conducting school-based research on COVID-19 diagnostic testing to present data acquired to date, learn from each other, and support the safe return of children to in-person school.

Among other topics, workshop participants discussed the critical importance of engaging local communities in this research. Communities need access to the most up-to-date scientific evidence to weigh the benefits and challenges of implementing different COVID-19 mitigation strategies. Scientists need community input to understand the attitudes, knowledge, and barriers that may influence individual choices to enroll in COVID-19 testing programs and return to in-person learning. By working together, we can ensure a safe return to school for all.

One Year of Rapid Acceleration of Diagnostics, and Anticipating New Challenges

This piece was authored in collaboration with leadership across NIH and represents a unified effort to meet the testing-related challenges presented by the COVID-19 pandemic with excellence and innovation.

Over the past year, our team of NIH leaders has used this blog to report on an initiative called Rapid Acceleration of Diagnostics – or RADxSM for short. The RADx initiative includes five key components designed to address the coronavirus (COVID-19) pandemic by ensuring that companies make and distribute tests to detect SARS-CoV-2, the virus that causes COVID-19; develop ways to deliver those tests and results directly to people—independent of their age, race, ethnicity, disability, financial status, or where they live; and invest in innovative approaches to detect emerging and spreading infections. NIH has also added a new component to RADx – to find ways to understand and address the concerns of people worried about testing, vaccine safety, and efficacy. The RADx components are described below.

RADx Underserved Populations (RADx-UP) is a significant investment to bring testing to traditionally underserved communities. Last fall, we launched a nationwide program, involving more than 60 research teams and a Coordination and Data Collection Center, to better understand the needs of people in a wide range of communities, and to ensure that underserved communities have adequate access to COVID-19-testing, and return results in ways that are actionable to promote health. We estimate that up to 500,000 people will participate in the study in more than 33 states, the District of Columbia, and Puerto Rico—representing a broad spectrum of communities of color and socially vulnerable populations. RADx-UP is collaborating with the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities to further amplify the NIH’s focus on communities hardest hit. 

Through two programs within the RADx initiative — RADx Tech and RADx ATP (Advanced Technology Platforms)—researchers aim to accelerate evaluation, validation, and scale up of promising COVID-19 testing technologies for laboratory, point-of-care and at-home settings, and provide guidance on when to test. More than 700 applications were submitted to the programs’ unique “innovation funnel” review process over a three-month period. To date, 29 projects have progressed through multiple phases of review to receive contracts for expansion of manufacturing and clinical studies. RADx Tech and RADx-ATP-supported companies have increased COVID-19 testing capacity across the United States by more than 150 million tests and compressed the typical multi-year tech commercialization process into approximately six months.

RADx Radical (RADx-rad) is designed to support innovative research programs focused on developing novel and potentially “radical” ways to detect infectious disease from SARS-CoV-2 or other agents, and evaluate community spread. Unlike the RADx Tech and RADx-ATP programs, which focus on developing technologies that can be delivered in the near term, projects within RADx-rad may require additional time for development. While some of these projects may not be available in the near term to respond to the current COVID-19 pandemic, they could be potentially applicable to deploy quickly for future pandemics. Currently, RADx-rad projects involve a broad array of activities that range from analysis of wastewater for infectious agents, like SARS-CoV-2, all the way to the development of artificial sensory devices to detect volatile organic compounds that uniquely emanate from individuals carrying an infection. Most notably, RADx-rad provides a mechanism for giving radical ideas a chance to demonstrate efficacy and promise.

A central focus of the RADx data management strategy is the safe management of data that is collected, standardized, and harmonized as a result of the implementation of new and novel testing methodologies. The close collaboration with RADx data and coordinating centers to develop and implement common data elements and models is important to the success of this strategy; along with the facilitation of harmonized data sharing on a secure cloud-based data platform. This platform, the RADx data hub, will provide a research data repository of curated and de-identified RADx COVID-19 data—allowing researchers to find, aggregate, and perform data analysis. The data hub will also enable researchers to share results of their analyses (citing relevant data) with collaborators and the external community; and provide a portal where researchers can find additional data and information from other NIH-supported COVID-19 resources.

Although programs such as RADx have helped create COVID-19 tests and make them more available to the public, our work and your work is not done.

Vaccines will go a long way in bringing protections to society and researchers are still learning how well the vaccine prevents people from spreading the virus. Public health measures, such as wearing face masks and frequent testing, continue to be important in efforts to contain this pandemic and address its consequences on society. Testing resources and places to get tested have become more accessible, but still need to be more widely available, affordable, and convenient. Even once people are vaccinated, testing for the presence of the SARS-CoV-2 virus in the nasal passage or in saliva needs to continue. This will help detect and identify new variants, discover asymptomatic infections, and help reduce community spread. As case rates decrease, these strategies will be complemented by the expansion of contact tracing to control the pandemic.

As vaccines help reduce the overall national prevalence of COVID-19, it’s important to pay attention to local trends in the percent of people who test positive and continue to test accordingly. Baseline testing should be adjusted to match regional and community needs and to prevent surges in community transmission. As the prevalence of positive tests decreases in a population, it will become cost-effective to test pooled samples from multiple donors by highly sensitive molecular tests, followed by testing of individual samples from any pools that are positive. Access to inexpensive rapid antigen tests authorized by FDA for self-testing and serial screening will continue to expand. Finally, tests that are designed to detect the presence of specific SARS-CoV-2 variants will become available. Ultimately, we’ll need to have baseline testing platforms and protocols in place to identify future outbreaks, detect other pathogens, and leverage these advances for accessible testing and treatment of other diseases.

The three W’s will remain an important part of society for some time:

  1. Wash your hands often and for at least 20 seconds.
  2. Wear your mask correctly for maximum protection.
  3. Watch your distance and avoid indoor gatherings without masks.

People need to be aware of and encouraged to sign up and use the exposure notification apps created by public health authorities and available on iPhone and Android devices. This secure electronic effort complements contact tracing and appears to be effective at saving lives by alerting people if they have been exposed to COVID-19 and providing guidance for further action.

Our response to COVID-19 is built not only on lessons learned over the past year, but also on the sustained investment in biomedical research of the past decades. We are proud of our agency and researchers for their efforts to mobilize and tackle this destructive pandemic. We are also very grateful to our research participants in communities around the country.

We’re interested in hearing how we could better serve the public.

Top Row (left to right):
Diana W. Bianchi, MD, Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Patricia Flatley Brennan, RN, PhD, Director, National Library of Medicine
Noni Byrnes, PhD, Director, Center for Scientific Review
Gary H. Gibbons, MD, Director, National Heart, Lung, and Blood Institute

Second Row (left to right):
Joshua Gordon, MD, PhD, Director, National Institute of Mental Health
Susan Gregurick, PhD, Associate Director for Data Science and Director, Office of Data Science Strategy
Richard J. Hodes, MD, Director, National Institute on Aging
Helene Langevin, MD, Director, National Center for Complementary and Integrative Health

Third Row (left to right):
Jon R. Lorsch, PhD, Director, National Institute of General Medical Sciences
George A. Mensah, MD, Division Director, National Heart, Lung, and Blood Institute
Eliseo J. Perez-Stable, MD, Director, National Institute on Minority Health and Health Disparities
William Riley, PhD, Director, NIH Office of Behavioral and Social Sciences Research

Bottom Row (left to right):
Tara A. Schwetz, PhD, Associate Deputy Director, National Institutes of Health
Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering
Nora D. Volkow, MD, Director, National Institute on Drug Abuse
Richard (Rick) P. Woychik, PhD, Director, National Institute of Environmental Health Sciences

Vaccines, Vaccinations, and NLM

As I write this message, I am one of the more than 25 million people in the U.S. who have received both doses of the coronavirus vaccine. I received my first dose of the Pfizer vaccine on February 4, and my second dose on February 25. NIH is distributing vaccines to employees based on priority group following general guidance from the CDC, but I became eligible first through my health plan. I’m sharing my story with you today and highlighting how the NLM has and still plays a role in vaccines and vaccinations during this time of the COVID pandemic.

Getting a spot in the COVID vaccine line will become one of the shared stories of this pandemic. As story tellers, we will likely exchange tales of how each of us got that prized place, particularly for those of us who received the vaccine in the first few weeks of distribution.

Here’s my story: As a resident of Washington, DC, and someone who is over 65 years of age, I became eligible pretty early – January 11. At the time, DC released appointment slots through its public web site. What if you don’t have a computer, typing skills, or access to the internet? Can the public library help here? Of course! In addition to providing internet access and coaching support from library staff, some public libraries are becoming sites for the distribution of the COVID vaccine. Each Monday and every other Thursday, as more appointment slots were released, I dutifully logged into the DC vaccination registration website, entering details and hitting refresh. Unfortunately, the available slots ran out quickly with each attempt. It was indeed frustrating. Through my health plan, I was entered into a vaccine registration list. As an NIH employee, I got my name on a list too. I was probably number 15,543 at NIH since I am healthy and able to work remotely, but I became eligible through my health plan in late January and was spared the déjà vu of type, refresh, repeat!

NLM played a big role in helping get this vaccine to me and people around the world.

We played a key role in making sure the genomic basis for vaccines and therapeutics were freely available to the public. In January 2020, NLM released the first fully annotated SARS-CoV-2 gene sequence to the public through our GenBank database, the world’s largest database of publicly available genetic sequences. Because NLM maintains extensive data repositories of nucleic acid sequences – the building blocks of genes – researchers were able to search NLM’s entire Sequence Read Archive (SRA) to better understand and characterize the biological properties of SARS-CoV-2 in record time. 

NLM created a dedicated website, the Severe acute respiratory syndrome coronavirus 2 data hub, for researchers to search, retrieve, and analyze data for more than 150,000 digital genomic sequences of the virus. In addition, we partnered with publishers around the world to make available for computerized data mining the full text of over 100,000 articles related to the coronavirus, helping scientist to identify key biological targets. Our ClinicalTrials.gov repository includes over 400 studies designed to develop, evaluate, and determine the effects of various COVID-19 vaccines.

Screen shot of MedlinePlus COVID-19 webpage

Our MedlinePlus consumer health information site contains specialized information about COVID-19 vaccines, clinical studies, and the vaccine distribution process. MedlinePlus helps people find information (in English and Spanish) about the COVID-19 vaccination program in the United States, and is a resource where people can find reliable, up-to-date information about how to protect themselves and their loved ones against infection while awaiting the vaccine. Linking to health information from the NIH and other federal government agencies such as the FDA and CDC, MedlinePlus provides access to fact sheets, statistics and research, journal articles, and even videos to help people learn more about COVID-19 vaccines.

What makes NLM unique is not just that it contributed to the process that helped make vaccines available, it’s that NLM has been helping scientists, clinicians and the public understand, prevent, manage, and cope with infectious diseases and health problems for nearly 200 years.

To Prevent Influenza!, 1918
National Library of Medicine #101580385

NLM identifies, selects, and archives a remarkable volume of content documenting these pandemics, from the scientific journals to the public health announcements. We were here 100 years ago, preserving information about the 1918 influenza pandemic, and we’re on track to be here in 100 years when future scholars and members of the public want to peruse the records of the COVID-19 pandemic and other health challenges faced by society.

The NLM serves scientists and society by providing trusted health information to understand, prevent and treat illness in support of public health. How can we help you?