Moderna Says Dosing Started in Pediatric Study of Covid Shot
(Bloomberg) -- Moderna Inc. said the first children have been dosed in a clinical trial of its Covid-19 vaccine in kids from six months to less than 12 years old.
The phase 2-phase 3 trial is being conducted in conjunction with the National Institute of Allergy and Infectious Diseases, the company said in a statement on Tuesday. The study is expected to enroll approximately 6,750 participants in the U.S. and Canada.
The Cambridge, Massachusetts-based company’s shares rose 5.2% to $151.14 at 10:12 a.m. in New York trading.
The two-part study will look at three dose levels in the youngest children and two dose levels in older kids in its first phase. An interim analysis will be conducted to determine what dose will be used in the second part of the study. Kids who receive the vaccine will be followed for 12 months.
“This pediatric study will help us assess the potential safety and immunogenicity of our Covid-19 vaccine candidate in this important younger age population,” Moderna Chief Executive Officer Stephane Bancel said.
The new trial in young children complements a big trial testing Moderna’s vaccine in adolescents that began in December. The adolescent trial aims to generate data that could allow the shot to be used in adolescents before they go back to school in the fall, Moderna has said.
Moderna’s statement did not provide details of when initial results from the trial in younger children might be available.
For adults, Moderna’s vaccine was found to be safe and 94.1% effective at preventing Covid-19, and it appears to work well across demographic groups and in people with underlying medical conditions. It is given in a two-dose regimen.
Moderna got emergency authorization for use of the shot in people age 18 and older from the U.S. Food and Drug Administration in December. It has since become a key component of the immunization campaign in the U.S., with more than 52 million Moderna doses administered as of Monday, according to the Centers for Disease Control and Prevention.
©2021 Bloomberg L.P.