42 Results
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.
Experimental mRNA HIV Vaccine Safe, Shows Promise in Animals
December 9, 2021
An experimental HIV vaccine based on mRNA—the same platform technology used in two highly effective COVID-19 vaccines—shows promise in mice and non-human primates, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Their results, published in Nature Medicine, show that the novel vaccine was safe and prompted desired antibody and cellular immune responses against an HIV-like virus.
NIAID Issues New Awards to Fund “Pan-Coronavirus” Vaccines
September 28, 2021
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $36.3 million to three academic institutions to conduct research to develop vaccines to protect against multiple types of coronaviruses and viral variants. The awards are intended to fuel vaccine research for a diverse family of coronaviruses, with a primary focus on potential pandemic-causing coronaviruses, such as SARS-CoV-2.
NIH Launches Study of Extra COVID-19 Vaccine Dose in People with Autoimmune Disease
August 27, 2021
The National Institutes of Health has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population.
NIH Launches Study of Third COVID-19 Vaccine Dose in Kidney Transplant Recipients
August 10, 2021
A pilot study has begun to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Investigational Malaria Vaccine Gives Strong, Lasting Protection
June 30, 2021
Two U.S. Phase 1 clinical trials of a novel candidate malaria vaccine have found that the regimen conferred unprecedentedly high levels of durable protection when volunteers were later exposed to disease-causing malaria parasites. The vaccine combines live parasites with either of two widely used antimalarial drugs—an approach termed chemoprophylaxis vaccination. A Phase 2 clinical trial of the vaccine is now underway in Mali, a malaria-endemic country.
Adjuvant Developed with NIH Funding Enhances Efficacy of India’s COVID-19 Vaccine
June 29, 2021
An adjuvant developed with funding from the National Institutes of Health has contributed to the success of the highly efficacious COVAXIN COVID-19 vaccine, which roughly 25 million people have received to date in India and elsewhere. Adjuvants are substances formulated as part of a vaccine to boost immune responses and enhance a vaccine’s effectiveness. COVAXIN was developed and is manufactured in India, which is currently suffering a devastating health crisis due to COVID-19.
NIH Begins Study of COVID-19 Vaccination During Pregnancy and Postpartum
June 23, 2021
A new observational study has begun to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
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.
NIH Launches Clinical Trial of Universal Influenza Vaccine Candidate
June 1, 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.
Clinical Trial Evaluating Mixed COVID-19 Vaccine Schedules Begins
June 1, 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. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs).
NIH Begins Study of Allergic Reactions to Moderna, Pfizer-BioNTech COVID-19 Vaccines
April 7, 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.
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.
Clinical Trial in Hospitalized COVID-19 Patients Evaluates Long-Acting Antibody Therapy
February 8, 2021
A NIAID clinical trial began evaluating the safety of an investigational long-acting antibody combination for people hospitalized with COVID-19.
Statement—Janssen Investigational COVID-19 Vaccine—Interim Analysis
January 29, 2021
NIH reports that an investigational COVID-19 vaccine by Janssen Pharmaceuticals appears to be safe and effective at preventing COVID-19 in adults.
Media Availability—NIH Officials Highlight COVID-19 Vaccine Facts, Unknowns for Healthcare Providers
January 18, 2021
NIAID Director urges healthcare providers to be able to explain the latest data supporting the safety and efficacy of vaccines for COVID-19.