Moderna has completed enrollment for a Phase 2/3 study of its COVID-19 vaccine in adolescents ages 12 to 17. In an update posted Thursday, the company said it had completed enrollment “of 3,000 participants.”
The company has previously predicted that it will have results ahead of the upcoming school year.
The two-dose jab received emergency use authorization in December for individuals ages 18 and older. The Pfizer-BioNTech vaccine, also a two-dose jab, was approved weeks earlier for use in individuals 16 and older. Johnson & Johnson submitted an EUA request for use of its one-shot vaccine in individuals 18 years and older, with the decision pending.
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Since the initial approvals, both Moderna and Pfizer have announced plans to study the vaccine in pediatric patients. Pfizer has since completed enrollment for its trial involving children ages 12 to 15 years old.
Moderna’s CEO Stephane Bancel has said that he believes data on children younger than 11 will not be available until 2022. The company must first see the data from the trials involving 12 to 17 year olds before it can adjust for the younger populations.
Combatting vaccine hesitancy among adults in the U.S. has been a pivotal point of the nation’s rollout, with many questioning the timeline of development versus the typical years-long process. Top officials, like Dr. Anthony Fauci, the nation’s leading infectious disease expert, has repeatedly said that technological advancements and federal funding made it possible.
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“Vaccines are key, safe mechanisms that protect individuals and populations against infectious diseases,” the American Academy of Pediatrics said, in it’s interim guidance for COVID-19 vaccination in children and adolescents. “Building on existing science, numerous vaccines directed against SARS-CoV-2, the virus that casues COVID-19, have proceeded through development and are now in clinical trials.”
The group lauded the FDA and Centers for Disease Control and Prevention (CDC) process for approval and vaccination recommendations before stating:
“The AAP recommends that anyone 16 years of age and older who meets criteria in phased implementation groups, as recommended by the ACIP, receive the COVID-19 vaccine.”
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It later added that it is “critical that pediatric patients of all ages be included in trials as quickly as possible.”