The first participants ages six months to 11 years were given Pfizer’s COVID-19 vaccine as part of a global trial evaluating safety and tolerability in younger age groups, the company announced Thursday. Positive results from a late-stage study in a 12-15-year-old age group encouraged trials in even younger children, Pfizer said.
“We are proud to begin this much-needed study for children and families anxiously awaiting a possible vaccine option,” according to a company statement shared with Fox News.
MODERN BEGINS TO TEST THE COVID-19 VACCINE IN CHILDREN UNDER 12 YEARS OLD
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 licensed for use in persons 16 years of age and older, administered in doses of two to 30 micrograms 21 days apart.
The company will first test the lowest dose (10 µg) in the oldest age group (5-11 years), and then proceed to higher doses, while starting injections in the younger age groups with the lowest doses. . Later phases of the trial will examine factors such as the safety and tolerability of the chosen dose for each group versus a placebo arm.
CLICK HERE TO GET FULL CORONAVIRUS COVERAGE
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 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 cohort soon.”