FDA presses leading vaccine makers to expand vaccine studies of
The Times reported the FDA asked both Moderna and Pfizer to include 3,000 children in that age group.
Story at a glance
Federal authorities have reportedly asked COVID-19 manufacturers Pfizer and Moderna to expand vaccine studies in children ages 5 to 11 to better understand rare side effects, including heart inflammation issues that have occurred in some young people.
The New York Times reports the two vaccine makers are moving to expand their ongoing clinical trials at the request of the Food and Drug Administration (FDA).
The agency reportedly indicated to the companies that the initial size and scope of their pediatric studies were not sufficient to detect the rare side effects of myocarditis, heart muscle inflammation, and pericarditis, inflammation of the membrane surrounding the heart.
The Times reported the FDA asked both Moderna and Pfizer to include 3,000 children 5-to-11-year-old studies.
The issues have been reported in a small number of COVID-19 vaccine recipients under the age of 30. The Centers for Disease Control and Prevention (CDC) said last month there had been more than 1,200 cases of heart inflammation out of the some 300 million mRNA doses given in the U.S.
Moderna says it plans to expand the trial in children ages 5 to 11 and is actively in discussions with the FDA. The company said authorization could come by winter 2021 or early 2022.
“The objective is to enroll a larger safety database which increases the likelihood of detecting rarer events. Timelines are regularly re-evaluated based on agency discussions and requests,” a Moderna spokesperson told Changing America.
Pfizer told Changing America it has not provided any updates to its study or timeline.
The pharmaceutical giant began testing its vaccine in 5-to-11-year-old children on June 8 and those younger than 5 on June 21. The study will include up to 4,500 participants.
The company expects to have initial results for those 5 to 11 by September, with results from children aged 2 to 5 to follow shortly after. Results for children as young as 6 months could come in October or November.
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