BARDA and Moderna TX expand COVID-19 vaccine clinical trials with pediatric population


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BARDA has expanded collaboration with Moderna on the development of the SARS-CoV-2 mRNA-1273 vaccine to include clinical trials with the pediatric population. BARDA is providing program management support and up to $144 million in funding from the Coronavirus Response and Relief Supplemental Appropriations Act for the Phase 2/3 clinical trial (KidCOVE, NCT04796896) to include approximately 7,000 children ages six months to less than 12 years old.

The study, which is currently underway, represents the next step in protecting people of all ages from COVID-19 and help reduce the spread of the virus within the U.S. Results from a BARDA-supported Phase 2/3 clinical trial of this vaccine for adolescents, ages 12-17 years old, were announced in May. Based on the results, the company applied for emergency use authorization from the U.S. Food and Drug Administration to expand use of the vaccine to prevent COVID-19 in adolescents.

Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), collaborated to develop mRNA-1273 and to conduct the clinical trials with adults and younger children (KIDCOVE). BARDA's support of Moderna's COVID-19 vaccine candidate started in April 2020. This vaccine’s platform is the same one BARDA support to develop Moderna's Zika vaccine candidate starting in 2016.

BARDA also has supported ongoing Phase 2 adult dose confirmation study and adding a crossover arm to the adult Phase 3 efficacy study (COVE) to provide the vaccine to people who received a placebo in the adult clinical trials.

Moderna was the second company to be granted emergency use authorization by the U.S. FDA for a coronavirus vaccine that uses messenger RNA (mRNA). Messenger RNA vaccines take advantage of the process that cells use to make proteins to trigger an immune response and build immunity to a virus.

About Moderna:

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

Moderna Inc. is a leader in the discovery and development of messenger RNA (mRNA) vaccines and therapeutics. With a breakthrough platform technology, Moderna is creating mRNA medicines for a wide range of diseases and conditions. These innovative mRNA medicines are being developed for infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases, through its own programs and collaborations with strategic partners. Founded in 2011 and headquartered in Cambridge, Massachusetts, Moderna is a publicly traded company and employs over 800 people to develop the mRNA platform technology.

Last Updated: June 16, 2021

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