Initial analysis of the Phase II/III TeenCOVE study of Moderna’s mRNA vaccine, in which UMass Medical School is participating, showed vaccine efficacy against COVID-19 of 96 percent and the vaccine was generally well tolerated with no serious safety concerns identified to date, the company reported in a business update May 6.
The study, which has completed enrollment, included adolescents ages 12 to 17 in the United States. Participants were randomized with twice as many receiving the vaccine as the number who received placebo. Initial analyses were reported for 3,235 participants who received at least one injection. Moderna is continuing to collect data in TeenCOVE and is in discussions with regulators about a potential amendment to its regulatory filings, according to its news release. The company is also currently conducting a Phase II COVID-19 vaccine study with children ages 6 months to 11 years, called KidCOVE.
UMass Medical School investigators, led by Katherine Luzuriaga, MD, the UMass Memorial Health Chair in Biomedical Research; professor of molecular medicine, pediatrics and medicine; director of the CCTS; and vice provost for clinical and translational research, have conducted the TeenCOVE trial and plan to start enrolling participants in KidCOVE later this month.
Currently, the U.S. Food and Drug Administration has only authorized Moderna’s vaccine for ages 18 and older. Pfizer-BioNTech received emergency use authorization for ages 16 and older in December, 2020. Data reported by Pfizer in March showed its vaccine demonstrated “100 percent efficacy and robust antibody responses” in young teens and was “well tolerated.” This week, emergency use authorization was extended to teens between 12 and 15 years of age, and a CDC panel will meet shortly to make recommendations. Pfizer-BioNTech is also studying its vaccine for use in children as young as 6 months.
“Results from both the Pfizer and Moderna trials indicate that these vaccines are both safe and effective for adolescents,” said Robert Finberg, MD, distinguished professor of medicine and a member of Gov. Baker’s COVID-19 Advisory Group. “It is important that we vaccinate this group of people so we can end the pandemic for all.”
UMass Medical School pediatricians have reported that adolescents typically don’t get severe cases of COVID-19, but they may be more likely to transmit the disease to older, more frail family members at home. There has also been a large increase in the number of teens struggling with mental health concerns during the pandemic.
“We are absolutely grateful to teens and their families for their participation in the trials,” said Dr. Luzuriaga. “I am also grateful to my study co-investigators and our UMCCTS Clinical Research Center and Biorepository lab staff for their excellent work on the Moderna TeenCOVE trial. “Together, they have contributed to a robust data set that will inform the use of the vaccine in teens. These vaccines will be an important tool for keeping teens healthy and active in their communities, while reducing the spread of SARS-CoV-2.”
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