“We are actively discussing a proposal with the FDA. The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events,” Moderna spokesperson Ray Jordan said in a statement to CNN.
The original size of the trial was 6,750 children ages 6 months to 12 years. Moderna did not say how many additional children the trial will now include.
Jordan said Moderna would likely seek authorization for the vaccine in “winter 2021/early 2022.” Moderna’s vaccine is currently authorized for people ages 18 and older, and it is seeking authorization for people ages 12 to 17.
The FDA did not immediately return CNN’s request for comment.
A Pfizer representative told CNN on Monday it has no updates to it previous timelines or details about its pediatric trial. Pfizer noted it began testing its Covid-19 vaccine in people ages 5 to 11 in on June 8 and in those younger than 5 starting on June 21, and said its trial would include up to 4,500 participants in the United States, Finland, Poland and Spain.
Pfizer has said it expects initial results of the Phase 2/3 trials in September for children 5 to 11, and results for younger children shortly after.
Many parents are eager to vaccinate younger children as schools prepare to open for in-person learning in the fall. Pfizer vaccine is currently authorized for people as young as 12, but there’s no vaccine available for younger children.