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March 2021

Statement—NIH-Sponsored ACTIV-3 Clinical Trial Closes Enrollment into Two Sub-Studies

March 04, 2021

The ACTIV-3 clinical trial, which is evaluating the safety and efficacy of investigational therapeutics for COVID-19 in hospitalized patients, has closed enrollment in two sub-studies: one examining the investigational monoclonal antibody therapy VIR-7831, and another evaluating the investigational combination monoclonal antibody therapy containing BRII-196 and BRII-198.

February 2021

Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Janssen COVID-19 Vaccine

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.

MERS virus particles on camel epithelial cells

Monoclonal Antibodies Against MERS Coronavirus Show Promise in Phase 1 NIH-Sponsored Trial

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.

Statement—Four Potential COVID-19 Therapeutics Enter Phase 2/3 Testing in NIH ACTIV-2 Trial

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.

NIH Experts Discuss SARS-CoV-2 Viral Variants

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.

A scanning electron micrograph of a cell infected with SARS-CoV-2 virus particles

Clinical Trial in Hospitalized COVID-19 Patients Evaluates Long-Acting Antibody Therapy

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. 

January 2021

Statement—Janssen Investigational COVID-19 Vaccine—Interim Analysis

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.

Bulletin—Update on SARS-CoV-2 Variants

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.

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.

cell (green) heavily infected with SARS-CoV-2 virus particles (purple)

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

Dr. Fauci is sitting while a healthcare worker administers a vaccine in his upper arm.

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.

Cell infected with SARS-CoV-2 virus

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.

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.

A scanning electron micrograph shows an apopototic cell heavily infected with SARS-CoV-2 virus particles

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. 

Cell infected with the SARS-CoV-2 virus

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.

A transmission electron micrograph showing particles of the SARS-CoV-2 virus

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.

November 2020

red circular virus particles with orange surface spikes

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.

Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles (yellow), isolated from a patient sample.

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.

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. 

Scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab.

NIH Study Aims To Identify Promising COVID-19 Treatments for Larger Clinical Trials

October 13, 2020

NIAID launches a new study to identify promising COVID-19 treatments for larger clinical trials.

Transmission electron micrograph of SARS-CoV-2 virus particles

NIH Clinical Trial Testing Hyperimmune Intravenous Immunoglobulin Plus Remdesivir to Treat COVID-19 Begins

October 08, 2020

An NIH clinical trial began to test the hyperimmune intravenous immunoglobin plus remdesivir combination treatment regimen for COVID-19.

September 2020

A transmission electron micrograph showing SARS-CoV-2 virus particles

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.

Scanning electron micrograph of a cell infected with SARS-CoV-2

Scientists Discover Genetic and Immunologic Underpinnings of Some Cases of Severe COVID-19

September 24, 2020

New findings by scientists at the National Institutes of Health and their collaborators help explain why some people with COVID-19 develop severe disease. The findings also may provide the first molecular explanation for why more men than women die from COVID-19.