As your partner in health and safety, we are continuously monitoring regulatory updates that may affect your operations. See the NIH's latest COVID-19 updates and resources below.
NIH Delivering New COVID-19 Testing Technologies to Meet U.S. Demand
The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus). NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020. With national demand estimated to be millions more tests per day above current levels, these technologies are expected to make a significant contribution to expanding the nation’s testing capacity.
Experimental COVID-19 Vaccine Protects Upper and Lower Airways in Nonhuman Primates
Scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health reported that two doses of an experimental vaccine to prevent coronavirus disease 2019 (COVID-19) induced robust immune responses and rapidly controlled the coronavirus in the upper and lower airways of rhesus macaques exposed to SARS-CoV-2.
Phase 3 Clinical trial of Investigational Vaccine for COVID-19 Begins
NIH reported that a phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. The vaccine, known as mRNA-1273, was co-developed by a Cambridge, Massachusetts-based biotechnology and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial, which will be conducted at US clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.
NIH Leadership Details Unprecedented Initiative to Ramp Up Testing Technologies
In a paper in the New England Journal of Medicine, 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. To fill this urgent need, the Rapid Acceleration of Diagnostics (RADx) program was established. The four major components of the RADx are listed in full detail at the following link:
Experimental COVID-19 Vaccine Safe, Generates Immune Response
An investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), was generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to interim results published online today in The New England Journal of Medicine. The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured by Moderna, mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells. A Phase 2 clinical trial of mRNA-1273, began enrollment in late May. Plans are underway to launch a Phase 3 efficacy trial in July 2020.
Placenta Lacks Major Molecules Used by SARS-CoV-2 Virus to Cause Infection
The placental membranes that contain the fetus and amniotic fluid lack the messenger RNA (mRNA) molecule required to manufacture the ACE2 receptor, the main cell surface receptor used by the SARS-CoV-2 virus to cause infection, according to a study by researchers at the National Institutes of Health. Their findings appear in the journal eLife.
NIH Launches Clinical Trials Network to Test COVID-19 Vaccines
The COVID-19 Prevention Trials Network (COVPN) was established to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19. People also can learn more about the different stages of vaccine research and the new network’s COVID-19 vaccine and monoclonal antibody studies by visiting the COVPN’s website. The first Phase 3 clinical trial that the COVPN is expected to conduct will involve testing the investigational mRNA-1273 vaccine, developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. That study is expected to begin this summer.
Vaccine Working Group Weighs Role of Human Challenge Studies for SARS-CoV-2 Vaccine Development
Experts determine a timeline for developing robust Controlled Human Infection Model (CHIM) that meets the essential criteria for limiting risk for study volunteers could take one to two years. Members of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group assess practical considerations and prerequisites for using controlled human infection models, which can be used for human challenge studies, to support SARS-CoV-2 vaccine development. In a CHIM study, participants are intentionally exposed to an infectious agent to help scientists understand the virus or test interventions to prevent or treat infection. CHIMs use well-characterized microorganisms that either do not cause serious disease, are easily treated, or both. In addition, CHIM studies must take place in laboratories with rigorous isolation to ensure that the infection does not spread into the community.
Steps to Expand and Improve Antibody Tests
More than 300 scientists and clinicians that were NIH workshop attendees reviewed capabilities and limits of SARS-CoV-2 serology testing. Attendees recommended that additional research is needed to determine if and to what extent a positive antibody test means a person may be protected from reinfection with SARS-CoV-2. Attendees emphasized that until such data is available, serology tests should not be used as a stand-alone tool to make decisions about personal safety related to SARS-CoV-2 exposure. Researchers are now pursuing studies in humans and in animal models to better understand SARS-CoV-2 immunity. Attendees noted that such understanding could help identify optimal donors of convalescent plasma that potentially could be used to help treat those with severe COVID-19.
Broad Spectrum Infectious Diseases Immunotherapy Study Shows Promise
National Institutes of Health investigators and colleagues have discovered that when the immune system first responds to infectious agents such as viruses or bacteria, a natural brake on the response prevents overactivation. Their new study in mBio describes this brake and the way pathogens such as SARS-CoV-2, the virus that causes COVID-19, turn it on.
Experts Identify Steps to Expand and Improve Antibody Tests in COVID-19 Response
More than 300 scientists and clinicians from the federal government, industry and academia published a report of their conclusions and recommendations on COVID-19 serology studies online in Immunity. While such tests do not diagnose active infection, they can indicate prior infection with SARS-CoV-2 that may have been missed because a person did not experience significant symptoms or access testing while infected. Attendees recommended that additional research is needed to determine if and to what extent a positive antibody test means a person may be protected from reinfection with SARS-CoV-2. Attendees emphasized that until such data is available, serology tests should not be used as a stand-alone tool to make decisions about personal safety related to SARS-CoV-2 exposure.
NIH Halts Clinical Trial of Hydroxychloroquine
A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with coronavirus disease 2019 (COVID-19) has been stopped by the National Institutes of Health. A data and safety monitoring board (DSMB) met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19.
Leveraging Existing Program for Antibody Testing
The All of Us Research Program, part of the National Institutes of Health, today announced that it is leveraging its significant and diverse participant base to seek new insights into COVID-19—through antibody testing, a survey on the pandemic’s impacts and collection of electronic health record information. All of Us will test blood samples from 10,000 or more participants who joined the program most recently, starting with samples from March 2020 and working backward until positive tests are no longer found. The tests will show the prevalence of novel coronavirus exposure among All of Us participants, and help researchers assess varying rates across regions and communities.
Analytics Platform for Nationwide COVID-19 Patient Data
The NIH has launched National COVID Cohort Collaborative (N3C), centralized, secure enclave to store and study vast amounts of medical record data from people diagnosed with coronavirus disease across the country. It is designed to help scientists analyze these data to understand the disease and develop treatments. Data access will be open to all approved users, regardless of whether they contribute data. The data are being provided to NCATS as a Limited Data Set (LDS) that retains only 2 of 18 HIPAA-defined elements: health care provider zip code and dates of service.
Researchers Identify Key Genomic Features of CoV-2
A team of researchers identified genomic features of SARS-CoV-2, and other high-fatality coronaviruses that distinguish them from other members of the coronavirus family. The difference in features include insertions of specific stretches of amino acids into two virus proteins, the nucleocapsid and the spike. These features are found in all three high-fatality coronaviruses and their closest relatives that infect animals, such as bats, but not in four other human coronaviruses that cause non-fatal disease. Implications include potential targets for diagnostics and therapies.
Study to Evaluate Drugs Prescribed to Children with COVID-19
Researchers funded by the National Institutes of Health have launched an effort to evaluate drugs prescribed to treat COVID-19 in infants, children and adolescents across the country. The study leverages an existing clinical trial that examines drugs that are prescribed off-label to children for a variety of medical conditions. Products will be added or removed from the list as researchers learn more about the treatment needs of patients with COVID-19. The study is not a clinical trial with a control group. Rather, healthcare providers who are already treating patients with drugs on the list may enroll patients whose parents or guardians have given their consent.
Potential Treatment Approach for Severe COVID-19 Cases
Early data from a clinical study suggest that blocking the Bruton tyrosine kinase (BTK) protein provided clinical benefit to a small group of patients with severe COVID-19. Researchers observed that the off-label use of the cancer drug Acalabrutinib, a BTK inhibitor that is approved to treat several blood cancers, was associated with reduced respiratory distress and a reduction in the overactive immune response in most of the treated patients. These findings should not be considered clinical advice but are being shared to assist the public health response to COVID-19.
Remdesivir Improves COVID-19 Time to Recovery
A study published in the New England Journal of Medicine found that patients with moderate to severe COVID-19 that were hospitalized and required oxygen discharged from the hospital on average 4 days earlier than those given placebo (11 days instead of 15 days). Trial results also suggested a survival benefit with a 14-day mortality rate of 7.1% in the group receiving remdesivir versus 11.9% for the placebo group; however, the difference in mortality was not statistically significant for the sample size of 1,063 total patients enrolled.
J Beigel, et al. Remdesivir for the Treatment of COVID-19 – A Preliminary Report. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2007764 (2020).
Pregnancy Study During COVID-19
Researchers will analyze the medical records of up to 21,000 women to evaluate whether changes to healthcare delivery that were implemented as a result of the pandemic have led to higher rates of pregnancy-related complications and cesarean delivery.
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
Released a statement describing the initiative referred to Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). Which is a public-private initiative designed to coordinate at least 18 leading biopharmaceutical companies, multiple US Federal agencies, and the European Medicines Agency to developing an international strategy for an integrated research response to COVID-19. Four working groups have been established:
- Preclinical group to standardized evaluation resources and methods
- Therapeutics Clinical group to prioritize and accelerate clinical evaluation of therapeutic candidates
- Clinical trial capacity to assemble and coordinate existing networks of clinical trials.
- Vaccines group to accelerate and evaluate vaccine candidates
Investigational Vaccine Protects Monkeys Against COVID-19 Pneumonia
University of Oxford researchers developed first vaccine using existing methods but applying SARS-CoV-2 protein. The vaccine was tested with six rhesus monkeys provided adequate immune response to prevent illness when compared to 3 control monkeys that were not given the vaccine.
Coordinated Strategy to Accelerate Multiple COVID-19 Vaccine Candidates is Key, NIH Experts Say
Scientific leaders published in Science a likely path toward vaccine for COVID-19 that includes:
- No single vaccine or vaccine platform is likely to meet the global need
- Researchers need to learn more about how to ensure the vaccine actually protects against COVID-19
- Significant manufacturing capacity will be required to produce the vaccine for worldwide consumption
- Collaboration will be essential
NIH Begins Clinical Trial of Hydroxychloroquine and Azithromycin to Treat COVID-19
Clinical Trial paring the malaria drug hydroxychloroquine and the antibiotic azithromycin to prevent hospitalization and death has begun. A Phase 2b trial will enroll 2000 adults with confirmed SARS-CoV-2 infection and fever, cough and/or shortness of breath. Participants will take either placebo or medication at home and report symptoms/hospitalizations to researches for the next 20 days. FDA cautions that use of hydroxychloroquine has rare risk of life-threatening heart rhythm problems and should only be used for COVID-19 patients in the clinical trial.
NIH Study to Determine Incidence of COVID-19 in Children Begins
Remote surveys of 6,000 children in 2,000 families are designed to increase understanding of full extent of infection in the entire population, and how it manifests in children and spreads to family members.
NIH Released a Strategic Plan to Accelerate Research to Diagnose, Prevent, and Treat COVID-19
The plan has a four-pronged approach:
- Understand the SARS-CoV-2 Virus and resulting COVID-19 illness including transmission surveillance and the role of asymptomatic individuals in viral spread.
- Development of rapid diagnostics to identify new cases, as well as individuals who may have had an infection and recovered. (see “Diagnostics Innovation Initiative” below).
- The testing of treatments for the illness by identifying and evaluating drugs already approved for other conditions.
- Development of safe and effective vaccines to protect individuals from infection and future outbreaks.
NIH Diagnostics Innovation Initiative
The Diagnostics Innovation Initiative is a call to all scientists and inventors with rapid testing technology to compete in the national COVID-19 testing challenge for a share of up to $500M over all phases of development. The goal is to rapidly develop at-home or point-of-care tests.