February 27, 2021
Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to the Janssen Pharmaceuticals Companies of Johnson & Johnson for its single-shot COVID-19 vaccine, called Ad.26.COV2S or JNJ-78436725. The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19.
February 23, 2021
A randomized, placebo-controlled Phase 1 clinical trial of two monoclonal antibodies (mAbs) directed against the coronavirus that causes Middle East respiratory syndrome (MERS) found that they were well tolerated and generally safe when administered simultaneously to healthy adults. The experimental mAbs, REGN3048 and REGN3051, target the MERS coronavirus (MERS CoV) spike protein used by the virus to attach to and infect target cells. The mAbs were discovered and developed by scientists at the biopharmaceutical company Regeneron, located in Tarrytown, New York.
February 23, 2021
Using viruses instead of antibiotics to tame troublesome drug-resistant bacteria is a promising strategy, known as bacteriophage or “phage therapy.” Scientists at the National Institutes of Health have used two different bacteriophage viruses individually and then together to successfully treat research mice infected with multidrug-resistant Klebsiella pneumoniae sequence type 258 (ST258). The bacterium K.
February 19, 2021
Scientific strides in HIV treatment and prevention have reduced transmissions and HIV-related deaths significantly in the United States in the past two decades. However, despite coordinated national efforts to implement HIV services, the epidemic persists, especially in the South. It also disproportionately impacts marginalized groups, such as Black/African-American and Latinx communities, women, people who use drugs, men who have sex with men, and other sexual and gender minorities.
February 12, 2021
Enrollment has begun to test additional investigational drugs in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of promising COVID-19 treatments and vaccines.
February 12, 2021
The rise of several significant variants of SARS-CoV-2, the virus that causes COVID-19, has attracted the attention of health and science experts worldwide.
February 08, 2021
An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, 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.
February 03, 2021
An experimental single-dose, intranasal influenza vaccine was safe and produced a durable immune response when tested in a Phase 1 study published in the Journal of Clinical Investigation. The investigational vaccine, called Ad4-H5-VTN, is a recombinant, replicating adenovirus vaccine designed to spur antibodies to hemagglutinin, a protein found on the surface of influenza viruses that attaches to human cells.
January 29, 2021
The earliest eye damage from prion disease takes place in the cone photoreceptor cells, specifically in the cilia and the ribbon synapses, according to a new study of prion protein accumulation in the eye by National Institutes of Health scientists. Prion diseases originate when normally harmless prion protein molecules become abnormal and gather in clusters and filaments in the human body and brain.
January 29, 2021
An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.
January 27, 2021
Recently, media reports and pre-print scientific papers on SARS-CoV-2 variants have discussed various genetic mutations in the virus that have occurred. SARS-CoV-2 is the virus that causes COVID-19. Viral variants are not unexpected, as all viruses evolve and mutate over time. Variants are more likely to occur if a virus transmits unabated in a population.
January 26, 2021
An investigational anti-HIV antibody delivered intravenously once every eight weeks safely and effectively prevented acquisition of HIV strains sensitive to that antibody, but did not significantly reduce overall HIV acquisition after 80 weeks among participants in two multinational clinical trials. Known as the Antibody-Mediated Prevention (AMP) Studies, the Phase 2b trials are sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
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.
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.
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 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).
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.
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.
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.
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.
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.
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.
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.