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On Dec. 10, 2020, American biotechnology company Moderna, Inc., which is pioneering the development of experimental messenger RNA (mRNA) therapeutics and vaccines, gave a 12-year old a dose of the company’s mRNA-1273 vaccine in a Phase 2/3 study of the new vaccine. Moderna CEO Stephane Bancel said, “Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year”.1
Moderna was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) on Dec. 18, 2020 for administration of the experimental COVID-19 biologic to adults 18 years or older. The estimated study completion date is June 30, 2022.2
Moderna Admits Struggling to Find Tweens and Teens Willing to Sign Up
Moderna needs to enroll at least 3,000 adolescent participants to provide valid safety and efficacy data, and to get authorization from the FDA for the COVID-19 biologic to be administered to children as young as age 12.3 However, by mid-January, the company acknowledged it was struggling to find enough adolescent volunteers,4 which will potentially delay FDA authorization for the mRNA coronavirus vaccine to be given to this age group.5
Moncef Slaoui, PhD, the scientific head of the previous administration’s Operation Warp Speed COVID-19 vaccination program expressed concern about having trouble getting adolescent volunteers to enroll in clinical trials. On Jan. 12, 2020 he said that, while a vaccine trial in adults is accruing 800 volunteers per day, the teen trial is getting only about 800 per month.6
The Moderna teen trial, called TeenCove, expects to enroll adolescents at up to 15 sites nationwide.7 Katherine Luzuriaga, MD, principal investigator at the University of Massachusetts Medical Center, one of the 15 clinical trial sites, said study participants will receive either the experimental biologic or a saline placebo in a 2:1 ratio.
Those receiving the experimental biologic will receive two doses of 100 micrograms each, given 28 days apart, as is authorized for adults. Participants will be followed for one year after receipt of the second dose.8 They’re hoping to enroll children from diverse communities,