10 Results
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.

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.

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.

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 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 NIAID. The trial will enroll approximately 210 healthy adult volunteers at four clinical research sites in the United States that are part of the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC).
NIH-Sponsored Trial of Enterovirus D68 Therapeutic Begins
June 27, 2024
The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM) – similar to polio. Scientists are striving to better understand AFM, which has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade. The U.S. Centers for Disease Control and Prevention (CDC) identified increases in AFM cases in 2014, 2016, and 2018. EV-D68 is a virus of growing public health concern due to its association with the intermittent AFM outbreaks.

Lower Dose of Mpox Vaccine Is Safe and Generates Six-Week Antibody Response Equivalent to Standard Regimen
April 27, 2024
A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six weeks (two weeks after the second dose), according to findings presented today at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Barcelona. The results suggest that antibody responses contributed to the effectiveness of dose-sparing mpox vaccine regimens used during the 2022 U.S. outbreak.

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.

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.

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).
