The first participants aged six months to 11 years have been administered Pfizer’s COVID-19 vaccine as part of a global trial assessing safety and tolerability in younger age groups, the company announced Thursday. Positive findings from a late-stage study in a 12 to 15 age group encouraged the trials in even younger kids, Pfizer said.
“We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option,” according to company statement shared with Fox News.
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The initial phase of the trial will determine the right dose levels from 10, 20 to 30 micrograms, across three age groups; 5 to 11 years, 2 to 5 years and six months to 2 years among 144 kids total. The vaccine is currently authorized for use in people aged 16 and older, administered in two-30 microgram doses spaced 21 days apart.
The company will first test the lowest dose (10 µg) in the oldest group (5-11 years), and then proceed to higher doses, while starting to administer shots in the younger age groups with the lowest doses. Later phases in the trial will examine factors like safety and tolerability of the chosen dose 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 time those in the placebo group can opt to receive vaccinations.
“As part of our pivotal Phase 3 study, Pfizer and BioNTech enrolled 2,259 children between the ages of 12 and 15,” the statement continues. “We were encouraged by the blinded tolerability data from this cohort which supported the rationale for our study in younger children. We hope to share data from the 12-15-year-old cohort soon.”