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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.

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.