The first participants, aged six months to 11 years, received Pfizer’s COVID-19 vaccine as part of a global trial that evaluated safety and tolerability in younger age groups, the company announced on Thursday. Positive results from a final-stage study in a 12 to 15-year-old group encouraged testing in even younger children, Pfizer said.
“We are proud to start this much-needed study for children and families who are eagerly awaiting a possible vaccine option,” according to the company’s statement shared with Fox News.
MODERN BEGINS TESTING THE COVID-19 VACCINE ON CHILDREN UNDER 12
The initial phase of the trial will determine the correct dose levels of 10, 20 to 30 micrograms, in three age groups; 5 to 11 years, 2 to 5 years and six months to 2 years among 144 children in total. The vaccine is currently authorized for use in people aged 16 and over, administered in doses of two to 30 micrograms with an interval of 21 days.
The company will first test the lowest dose (10 µg) in the older group (5-11 years) and then proceed to higher doses, while starting to give injections to the younger age groups with the lowest doses. The later phases of the study will examine factors such as safety and tolerability of the dose chosen for each group against a placebo arm.
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A follow-up visit six months later will reveal which participants were vaccinated and which were not, at which point those in the placebo group can choose to receive the vaccines.
“As part of our fundamental Phase 3 study, Pfizer and BioNTech enrolled 2,259 children aged 12 to 15,” the statement continues. “We were encouraged by the blind tolerability data from this cohort, which supported the rationale for our study in younger children. We hope to share the data from the 12-15 year old cohort soon.”