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June 2021

Biden Administration to Invest $3 Billion from American Rescue Plan as Part of COVID-19 Antiviral Development Strategy

June 17, 2021

Through collaboration within the HHS, including NIH, NIAID, and BARDA, the Antiviral Program for Pandemics will respond to the urgent need for antivirals to treat COVID-19.

close up of vaccine needle in arm

Statement—U.S. Clinical Trial Results Show Novavax Vaccine is Safe and Prevents COVID-19

June 14, 2021

Results from the PREVENT-19 clinical trial show that the investigational NVX-CoV2373 vaccine demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease.

Transmission electron micrograph of a SARS-CoV-2 virus particle (UK B.1.1.7 variant)

Clinical Trial Evaluating Mixed COVID-19 Vaccine Schedules Begins

June 01, 2021

The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.

computer-generated image of nanoparticle influenza vaccine

NIH Launches Clinical Trial of Universal Influenza Vaccine Candidate

June 01, 2021

A first-in-human, Phase 1 trial assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine designed to provide long-lasting protection against multiple flu virus strains has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland. Healthy participants 18 to 50 years old will receive either a licensed seasonal influenza vaccine or the experimental vaccine, FluMos-v1.

May 2021

Scanning electron micrograph of Salmonella Typhimurium invading a human epithelial cell.

NIH Scientists Find that Salmonella Use Intestinal Epithelial Cells to Colonize the Gut

May 26, 2021

The immune system’s attempt to eliminate Salmonella bacteria from the gastrointestinal (GI) tract instead facilitates colonization of the intestinal tract and fecal shedding, according to National Institutes of Health scientists. The study, published in Cell Host & Microbe, was conducted by National Institute of Allergy and Infectious Diseases (NIAID) scientists at Rocky Mountain Laboratories in Hamilton, Montana.

A DNA double helix rests on a print-out illustration of the DNA letters A, T, C and G.

Gene Therapy Restores Immune Function in Children with Rare Immunodeficiency

May 11, 2021

An investigational gene therapy can safely restore the immune systems of infants and children who have a rare, life-threatening inherited immunodeficiency disorder, according to research supported in part by the National Institutes of Health.

NIH Statement on World Asthma Day 2021

May 05, 2021

On World Asthma Day, the National Institutes of Health reaffirms its commitment to research to improve the lives of people with asthma. More than 25 million people in the United States have asthma, including 5.1 million children, according to the Centers for Disease Control and Prevention. This chronic lung disease can reduce quality of life, contributes to considerable emotional and financial stress, and is a major contributing factor to missed time from school and work.

April 2021

Scanning electron micrograph of a human neutrophil ingesting MRSA (yellow).

Trial of Existing Antibiotic for Treating Staphylococcus aureus Bacteremia Begins

April 27, 2021

A clinical trial to test the antibiotic dalbavancin for safety and efficacy in treating complicated Staphylococcus aureus (S. aureus) bacteremia has begun. The trial will enroll 200 adults hospitalized with complicated S. aureus infection at approximately 20 trial sites around the United States. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Zebra-print ribbon, a symbol for awareness of primary immunodeficiencies and other rare diseases.

COVID-19 Vaccine Responses to be Studied in People with Immune Deficits

April 23, 2021

A study assessing how people with immune system deficiencies or dysregulations respond to COVID-19 vaccination has begun enrolling participants at the National Institutes of Health Clinical Center in Bethesda, Maryland. The single-site study is led by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and aims to enroll 500 people, 400 with primary or secondary immune system disorders and 100 without such conditions. 

NIH Establishes New Childhood Asthma Clinical Research Network

April 23, 2021

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded $10 million in first-year funding to establish a clinical research network called Childhood Asthma in Urban Settings (CAUSE). This nationwide network will conduct observational studies and clinical trials to improve understanding of asthma and develop treatment and prevention approaches tailored to children of low-income families living in urban communities. NIAID intends to provide approximately $70 million over seven years to support the CAUSE network.

A transmission electron micrograph of three circular SARS-CoV-2 virus particles, colored green in this image, against a lilac background.

Clinical Trial of Therapeutics for Severely Ill Hospitalized COVID-19 Patients Begins

April 22, 2021

A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure.

A transmission electron micrograph of a circular SARS-CoV-2 virus particle, colored yellow in this image

Statement—Large NIH Clinical Trial Will Test Polyclonal Antibody Therapeutic for COVID-19

April 21, 2021

A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19. The trial, ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The therapeutic was developed by SAB Biotherapeutics, Inc. (Sioux Falls, South Dakota).

scanning electron microscope image shows SARS-CoV-2 (orange), the virus that causes COVID-19

Experimental Antiviral for COVID-19 Effective in Hamster Study

April 16, 2021

The experimental antiviral drug MK-4482 significantly decreased levels of virus and disease damage in the lungs of hamsters treated for SARS-CoV-2 infection, according to a new study from National Institutes of Health scientists. SARS-CoV-2 is the virus that causes COVID-19. MK-4482, delivered orally, is now in human clinical trials. Remdesivir, an antiviral drug already approved by the U.S. Food and Drug Administration for use against COVID-19, must be provided intravenously, making its use primarily limited to clinical settings.

Flu virus particles on a cell

NIAID Funds New Influenza Research Network

April 14, 2021

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a network of research sites to study the natural history, transmission and pathogenesis of influenza and provide an international research infrastructure to address influenza outbreaks.

Statement—NIH Closes Enrollment in Trial Comparing COVID-19 Treatment Regimens

April 14, 2021

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 closed to enrollment because the study met pre-defined futility criteria indicating that neither treatment regimen studied is likely significantly better than the other.

A transmission electron micrograph of circular SARS-CoV-2 virus particles, colored green and blue

NIH Experts Discuss Post-Acute COVID-19

April 13, 2021

Many people who have COVID-19 make a full recovery and return to their baseline state of health; however, some people have symptoms or other sequelae weeks or months after initial SARS-CoV-2 infection. These heterogeneous symptoms were the subject of the virtual “Workshop on Post-acute Sequelae of COVID-19” hosted on Dec. 2 and 4, 2020, by the National Institute of Allergy and Infectious Diseases (NIAID), in collaboration with other institutes and centers of the National Institutes of Health. A paper published recently in Annals of Internal Medicine describes the workshop.

Transmission electron microscope image of SARS-CoV-2, the virus that causes COVID-19, emerging from human cells.

NIH Trial of Anti-CD14 Antibody to Treat COVID-19 Respiratory Disease Begins

April 13, 2021

A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. 

A surgical mask and an HIV/AIDS awareness ribbon.

NIH Experts Call for Accelerated Research to Address Concurrent HIV and COVID-19 Pandemics

April 08, 2021

The COVID-19 pandemic is affecting people with or at risk for HIV both indirectly, by interfering with HIV treatment and prevention services, and directly, by threatening individual health. An effective response to these dual pandemics requires unprecedented collaboration to accelerate basic and clinical research, as well as implementation science to expeditiously introduce evidence-based strategies into real-world settings. This message comes from a review article co-authored by Anthony S.

Transmission electron micrograph of SARS-CoV-2 virus particles

NIH Begins Study of Allergic Reactions to Moderna, Pfizer-BioNTech COVID-19 Vaccines

April 07, 2021

A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. A systemic allergic reaction to a vaccine occurs in one or more parts of the body beyond the injection site. If such an allergic reaction occurs in study participants, investigators will assess whether the reactions are more frequent in participants who are highly allergic or have a mast cell disorder than in participants with no allergic history.

March 2021

NIH Clinical Trial Evaluating Moderna COVID-19 Variant Vaccine Begins

March 31, 2021

An investigational vaccine designed to protect against the B.1.351 SARS-CoV-2 variant has been administered as part of a new Phase 1 clinical trial evaluating the vaccine candidate’s safety and immunogenicity in adult volunteers. The vaccine, known as mRNA-1273.351, was developed by the biotechnology company ModernaTX, Inc., based in Cambridge, Massachusetts. The trial is led and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Human T cell

T Cells Recognize Recent SARS-CoV-2 Variants

March 30, 2021

When variants of SARS-CoV-2 (the virus that causes COVID-19) emerged in late 2020, concern arose that they might elude protective immune responses generated by prior infection or vaccination, potentially making re-infection more likely or vaccination less effective. To investigate this possibility, researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues analyzed blood cell samples from 30 people who had contracted and recovered from COVID-19 prior to the emergence of virus variants.

NIAID Statement on AstraZeneca Vaccine

March 23, 2021

NIAID urges AstraZeneca to work with the Data and Safety Monitoring Board (DSMB) to review the efficacy data from its COVID-19 vaccine clinical trial and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible. 

Statement—Investigational AstraZeneca Vaccine Prevents COVID-19

March 22, 2021

Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization.

A baby's foot and leg

NIH Study of Early Predictors, Mechanisms of Food Allergy and Eczema has Begun

March 19, 2021

A study to identify prenatal and early childhood markers of high risk for food allergy and atopic dermatitis, or eczema, as well as biological pathways that lead to these conditions, has begun. The observational study of children from birth to age 3 years will examine the origins of allergic disease by integrating interdisciplinary analyses of data from more than 260 biological and environmental samples and survey responses from each of 2,500 families.

A computer-generated image of a bacteriophage, featuring a bulbous “head” on top of a long stalk with spindly “legs”

NIH Awards Grants to Support Bacteriophage Therapy Research

March 11, 2021

NIAID has awarded $2.5 million in grants to 12 institutes around the world to support research on bacteriophage therapy.