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NIH-Sponsored Trial of Nasal COVID-19 Vaccine Opens
July 1, 2024
A Phase 1 trial testing the safety of an experimental nasal vaccine that may provide enhanced breadth of protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19, is now enrolling healthy adults at three sites in the United States. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.
COVID-19 Vaccination and Boosting During Pregnancy Protects Infants for Six Months
February 14, 2024
Women who receive an mRNA-based COVID-19 vaccination or booster during pregnancy can provide their infants with strong protection against symptomatic COVID-19 infection for at least six months after birth. These findings reinforce the importance of receiving both a COVID-19 vaccine and booster during pregnancy to ensure that infants are born with robust protection that lasts until they are old enough to be vaccinated.
Study Reveals How Young Children’s Immune Systems Tame SARS-CoV-2
October 13, 2023
A study of infants and young children found those who acquired SARS-CoV-2 had a strong, sustained antibody response to the virus and high levels of inflammatory proteins in the nose but not in the blood. This immune response contrasts with that typically seen in adults with SARS-CoV-2 infection.
Clinical Trial to Test Immune Modulation Strategy for Hospitalized COVID-19 Patients Begins
September 22, 2023
A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study will enroll approximately 1,500 people at research sites around the world.
Severe COVID-19 May Lead to Long-Term Innate Immune System Changes
August 18, 2023
Severe COVID-19 may cause long-lasting alterations to the innate immune system, the first line of defense against pathogens, according to a small study funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. These changes may help explain why the disease can damage so many different organs and why some people with long COVID have high levels of inflammation throughout the body. The findings were published online today in the journal Cell.
COVID-19 Vaccination and Boosting During Pregnancy Benefits Pregnant People and Newborns
August 11, 2023
Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings recently published in Vaccine. The paper describes results from the Multisite Observational Maternal and Infant Study for COVID-19 (MOMI-VAX), which was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The Potential and Challenges of Mucosal COVID-19 Vaccines
April 13, 2023
In November 2022, the National Institute of Allergy and Infectious Diseases (NIAID) co-hosted a virtual workshop on the importance and challenges of developing mucosal vaccines for SARS-COV-2. The highlights of this workshop have now been published as a report in npj Vaccines.
SARS-CoV-2 Infection Weakens Immune-Cell Response to Vaccination
March 20, 2023
The magnitude and quality of a key immune cell’s response to vaccination with two doses of the Pfizer-BioNTech COVID-19 vaccine were considerably lower in people with prior SARS-CoV-2 infection compared to people without prior infection, a study has found. In addition, the level of this key immune cell that targets the SARS-CoV-2 spike protein was substantially lower in unvaccinated people with COVID-19 than in vaccinated people who had never been infected. Importantly, people who recover from SARS-CoV-2 infection and then get vaccinated are more protected than people who are unvaccinated.
NIH Trial to Evaluate Shionogi Antiviral in Adults Hospitalized with COVID-19
February 15, 2023
The National Institutes of Health has initiated a multi-site clinical trial evaluating an investigational antiviral for the treatment of COVID-19. The therapeutic, known as S-217622 or ensitrelvir fumaric acid, was discovered by Hokkaido University, Sapporo, Japan; and Shionogi & Co., Ltd., Osaka, Japan. The trial is assessing whether S-217622 can improve clinical outcomes for patients who are hospitalized for management of COVID-19 as compared to a placebo and will enroll approximately 1,500 people at sites worldwide.
Developing Mucosal Vaccines for Respiratory Viruses
January 11, 2023
Vaccines that provide long-lasting protection against influenza, coronaviruses and respiratory syncytial virus (RSV) have proved exceptionally difficult to develop. In a new review article in Cell Host & Microbe, researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, explore the challenges and outline approaches to improved vaccines. Anthony S. Fauci, M.D., former NIAID director, is an author along with Jeffery K. Taubenberger, M.D., Ph.D., and David M. Morens, M.D.
Findings Suggest COVID-19 Rebound Not Caused by Impaired Immune Response
October 6, 2022
Findings from a small study of eight patients published in Clinical Infectious Diseases suggest that COVID-19 rebound is likely not caused by impaired immune responses. The study, led by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, aimed to define the clinical course and the immunologic and virologic characteristics of COVID-19 rebound in patients who have taken nirmatrelvir/ritonavir (Paxlovid), an antiviral therapeutic developed by Pfizer, Inc.
SARS-CoV-2 Antigen Levels Linked to Patient Outcomes
August 29, 2022
The amount of SARS-CoV-2 antigen measured in the blood of patients hospitalized with COVID-19 is associated with illness severity and other clinical outcomes, according to a new study published in the Annals of Internal Medicine.
Statement from NIH and BARDA on the Novavax COVID-19 Vaccine
July 20, 2022
The Centers for Disease Control and Prevention (CDC) has recommended that Novavax’s COVID-19 vaccine be used as another primary series option for adults in the United States ages 18 years and older. The Food and Drug Administration (FDA) previously authorized for emergency use the protein-based vaccine, known as NVX-CoV2373.
Vaccine-Induced Immune Response to Omicron Wanes Substantially Over Time
July 19, 2022
Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substantially within 3 months, according to new clinical trial data. The findings, published today in Cell Reports Medicine, are from a study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was led by NIAID’s Infectious Diseases Clinical Research Consortium.
Food Allergy Is Associated with Lower Risk of SARS-CoV-2 Infection
June 1, 2022
A National Institutes of Health-funded study has found that people with food allergies are less likely to become infected with SARS-CoV-2, the virus that causes COVID-19, than people without them. In addition, while previous research identified obesity as a risk factor for severe COVID-19, the new study has identified obesity and high body mass index (BMI) as associated with increased risk for SARS-CoV-2 infection. In contrast, the study determined that asthma does not increase risk for SARS-CoV-2 infection.
NIAID Announces Antiviral Drug Development Awards
May 18, 2022
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
NIH Experts Discuss Controlling COVID-19 in Commentary on Herd Immunity
March 31, 2022
Achieving classical herd immunity against SARS-CoV-2, the virus that causes COVID-19, may not be attainable, according to a new perspective published in The Journal of Infectious Diseases. However, widespread use of currently available public health interventions to prevent and control COVID-19 will enable resumption of most activities of daily life with minimal disruption, the authors note. Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, David M.
NIH Begins Clinical Trial Evaluating Second COVID-19 Booster Shots in Adults
March 31, 2022
A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The trial aims to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
NIH Launches Trial to Study Allergic Reactions to COVID-19 mRNA Vaccine
March 9, 2022
Researchers from the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial designed to help understand rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines. The single-site trial will enroll up to 100 people aged 16 to 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. Study participants will receive a second dose of vaccine as inpatients under carefully controlled conditions at the NIH Clinical Center in Bethesda, Maryland.
Leadership Transition at the NIAID Vaccine Research Center
February 16, 2022
I extend my heartfelt gratitude and deepest respect to John R. Mascola, M.D., as he announces his retirement as Director of the Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. Dr. Mascola will leave NIAID at the end of March.
NIAID Pandemic Preparedness Plan Targets ‘Prototype’ and Priority Pathogens
February 2, 2022
As the global COVID-19 pandemic continues into its third year, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is focusing on preparing for a range of other viral threats that could cause a public health emergency. For decades, NIAID has launched major research responses and developed medical countermeasures to combat multiple emerging infectious diseases, including HIV/AIDS, SARS-CoV-1, Middle East respiratory syndrome coronavirus (MERS-CoV), Ebola virus, Zika virus, and SARS-CoV-2.
Trial Tests Strategy to Augment Response to COVID-19 Vaccines in Transplant Recipients
January 31, 2022
A study has begun to assess the antibody response to an additional dose of a COVID-19 mRNA vaccine in kidney and liver transplant recipients, either alone or with a concurrent reduction in immunosuppressive medication. The clinical trial will enroll people for whom two to four doses of a COVID-19 mRNA vaccine did not elicit a detectable antibody response.
Hyperimmune Intravenous Immunoglobulin Does Not Improve Outcomes for Adults Hospitalized with COVID-19
January 27, 2022
A clinical trial has found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, is not more effective than remdesivir alone for treating adults hospitalized with the disease. The trial also found that the safety of this experimental treatment may vary depending on whether a person naturally generates SARS-CoV-2-neutralizing antibodies before receiving it. The results of the multinational Phase 3 trial were published today in the journal The Lancet.
Mix-and-Match Trial Finds Additional Dose of COVID-19 Vaccine Safe, Immunogenic
January 26, 2022
In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine. The findings served as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late fall 2021 to permit mix-and-match COVID-19 booster vaccinations in the United States.
NIH Scientists Urge Pursuit of Universal Coronavirus Vaccine
December 16, 2021
A growing body of scientific evidence, considered together with ecological reality, strongly suggests that novel coronaviruses will continue to infect bats and other animal reservoirs and potentially emerge to pose a pandemic threat to humans. To counter future coronavirus outbreaks the global research community should focus on characterizing the range of coronavirus genetic diversity in multiple animal species; better understanding coronavirus disease pathogenesis in laboratory animal models and people; and applying this knowledge to the development of long-lasting, broadly protective coronavirus vaccines.
