News Releases
442 Results
January 2021
Media Availability—NIH Officials Highlight COVID-19 Vaccine Facts, Unknowns for Healthcare Providers
January 18, 2021
Healthcare providers must be able to explain the latest data supporting the safety and efficacy of vaccines for coronavirus disease 2019 (COVID-19) so they can strongly encourage vaccination when appropriate while acknowledging that uncertainty and unknowns remain. This message comes from a new commentary co-authored by Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and other leading NIAID scientists in the journal Annals of Internal Medicine.
NIH Scientists Identify Nutrient that Helps Prevent Bacterial Infection
January 15, 2021
Scientists studying the body’s natural defenses against bacterial infection have identified a nutrient—taurine—that helps the gut recall prior infections and kill invading bacteria, such as Klebsiella pneumoniae (Kpn). The finding, published in the journal Cell by scientists from five institutes of the National Institutes of Health, could aid efforts seeking alternatives to antibiotics.
NIH Scientists Study Salmonella Swimming Behavior as Clues to Infection
January 13, 2021
Salmonella enterica serovar Typhimurium bacteria (S. Typhimurium) commonly cause human gastroenteritis, inflammation of the lining of the intestines. The bacteria live inside the gut and can infect the epithelial cells that line its surface. Many studies have shown that Salmonella use a “run-and-tumble” method of short swimming periods (runs) punctuated by tumbles when they randomly change direction, but how they move within the gut is not well understood.
Statement—Large Clinical Trial Will Test Combination Monoclonal Antibody Therapy for Mild/Moderate COVID-19
January 05, 2021
A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
December 2020
Peer-Reviewed Report on Moderna COVID-19 Vaccine Publishes
December 30, 2020
The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease (VAERD).
Phase 3 Trial of Novavax Investigational COVID-19 Vaccine Opens
December 28, 2020
The Phase 3 trial of another investigational coronavirus disease 2019 (COVID-19) vaccine has begun enrolling adult volunteers. The randomized, placebo-controlled trial will enroll approximately 30,000 people at approximately 115 sites in the United States and Mexico. It will evaluate the safety and efficacy of NVX-CoV2373, a vaccine candidate developed by Novavax, Inc., of Gaithersburg, Maryland. Novavax is leading the trial as the regulatory sponsor.
Results of NIH-Sponsored ACTIV-3 Trial Published
December 22, 2020
Preliminary results of a Phase 3, randomized, placebo-controlled clinical trial testing the investigative monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients were published today in the New England Journal of Medicine. The antibody did not provide clinical benefit compared to placebo. The trial, which had been halted to new enrollment in late October following a recommendation by the independent Data and Safety Monitoring Board (DSMB), is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
Reston Ebolavirus Spreads Efficiently in Pigs
December 21, 2020
Reston ebolavirus (RESTV) should be considered a livestock pathogen with potential to affect other mammals, including people, according to National Institutes of Health scientists. The caution comes from a study published in Proceedings of the National Academy of Sciences in which the scientists found that experimental piglets infected with RESTV developed severe respiratory disease and shed the virus from the upper respiratory tract. RESTV can infect humans but is not known to cause disease.
Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine
December 18, 2020
Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID) and Moderna. This innovative and monumental partnership has enabled NIH and Moderna to develop a safe and effective COVID-19 vaccine within the span of a year that will be manufactured and distributed across the U.S.
Investigational COVID-19 Therapeutics to be Evaluated in Large Clinical Trials
December 17, 2020
Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
NIH Observational Study of Coronavirus Infection and Multisystem Inflammatory Syndrome in Children Begins
December 16, 2020
An observational study has launched to evaluate the short- and long-term health outcomes of SARS-CoV-2 infection in children, including multisystem inflammatory syndrome in children (MIS-C), and to characterize the immunologic pathways associated with different disease presentations and outcomes. SARS-CoV-2 is the virus that causes COVID-19. The study, called the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM), will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds at approximately 20 sites nationwide.
Baricitinib Plus Remdesivir Shows Promise for Treating COVID-19
December 11, 2020
The combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, reduced time to recovery for people hospitalized with COVID-19, according to clinical trial results published in the New England Journal of Medicine. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
NIH Statement on World AIDS Day 2020
December 01, 2020
Today on World AIDS Day, we reflect both on the remarkable progress that has been made against HIV as well as the considerable challenges that remain. We now have highly effective HIV treatment and prevention methods, and work is underway to address the remaining challenges in delivering these tools to the people who need them most, as well as to develop new interventions. The National Institutes of Health continues to advance rigorous, innovative research to prevent new HIV transmissions and improve the health of people with HIV worldwide.
November 2020
NIH Announces Restructured HIV Clinical Trials Networks
November 30, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced the clinical investigators and institutions that will lead four NIH HIV clinical trials networks over the next seven years to conduct the innovative, efficient clinical research needed to accelerate progress against the HIV pandemic. NIAID also awarded grants to 35 U.S. and international institutions selected as HIV clinical trials units (CTUs).
Experimental Vaccine for Deadly Tickborne Virus Effective in Cynomolgus Macaques
November 30, 2020
An experimental vaccine developed in Europe to prevent infection by Crimean-Congo hemorrhagic fever virus (CCHFV) has protected cynomolgus macaques in a new collaborative study from National Institutes of Health scientists. The animals received the DNA-based candidate vaccine through intramuscular injection immediately followed by electroporation—a process in development for human vaccines that helps cells absorb DNA. The study, published in Nature Microbiology, comes about three years after the same research group developed the macaque model for CCHFV.
Statement—Fourth Iteration of COVID-19 Treatment Trial Underway
November 25, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, today announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with coronavirus disease 2019 (COVID-19) who require supplemental oxygen. The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries.
Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
November 16, 2020
An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults.
Treatments for People with Early COVID-19 Infection is an Urgent Research Focus
November 11, 2020
COVID-19 treatments for people with early infection are needed urgently, according to a JAMA Viewpoint article by NIAID Director Anthony S. Fauci, M.D., and colleagues. Treating people early in the course of infection with SARS-CoV-2, the virus that causes COVID-19, would speed their recovery, reduce the likelihood that they develop severe outcomes and reduce demand on the healthcare system, they write.
Statement—NIH Study Finds Long-Acting Injectable Drug Prevents HIV Acquisition in Cisgender Women
November 09, 2020
A pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form of the HIV drug cabotegravir injected once every eight weeks was safe and more effective than a daily oral PrEP regimen at preventing HIV acquisition among a group of cisgender women. The women, from southern and east Africa, are enrolled in a clinical trial sponsored by the National Institutes of Health.
October 2020
Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study
October 26, 2020
The ACTIV-3 clinical trial evaluating the investigational monoclonal antibody LY-CoV555 in hospitalized patients with COVID-19 will not enroll more participants into this sub-study following a recommendation from the independent Data and Safety Monitoring Board (DSMB). The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Landmark TB Trial Identifies Shorter-Course Treatment Regimen
October 21, 2020
Results from an international, randomized, controlled clinical trial indicate that a four-month daily treatment regimen containing high-dose, or “optimized,” rifapentine with moxifloxacin is as safe and effective as the existing standard six-month daily regimen at curing drug-susceptible tuberculosis (TB) disease. This regimen is the first successful short-course treatment regimen for drug-susceptible TB disease in almost 40 years.
NIH Study Aims To Identify Promising COVID-19 Treatments for Larger Clinical Trials
October 13, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials.
NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin Plus Remdesivir to Treat COVID-19 Begins
October 08, 2020
A clinical trial to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, has begun. The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents.
September 2020
BULLETIN—NIAID Stops Enrollment of Severely Ill COVID-19 Participants in Clinical Trial of Investigational Treatments
September 29, 2020
The Adaptive COVID-19 Treatment Trial 3 (ACTT-3), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will no longer enroll hospitalized participants with severe COVID-19 requiring high-flow oxygen, and will not begin to enroll patients requiring non-invasive or invasive mechanical ventilation.
Investigational COVID-19 Vaccine Well-Tolerated and Generates Immune Response in Older Adults
September 29, 2020
A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.