At the F.D.A.'s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11
Source: New York Times
At the urging of federal regulators, two coronavirus vaccine makers are expanding the size of their studies in children ages five to 11 — a precautionary measure designed to detect rare side effects including heart inflammation problems that turned up in vaccinated people younger than 30. Appearing at a televised town-hall-style meeting in Ohio last week, President Biden said that emergency clearance for pediatric vaccines would come “soon.” The White House has declined to be more specific on the timeline, and it was unclear whether expanding the studies will have any impact on when vaccines could be authorized for children.
Multiple people familiar with the trials said the Food and Drug Administration has indicated to Pfizer-BioNTech and Moderna that the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect the rare side effects, including myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart. Members of a C.D.C. advisory committee have said that the benefits of shots for people older than 12 greatly outweigh the risks, including of heart problems. The F.D.A. has asked the companies to include 3,000 children in the 5-to-11 year old age group, the group for whom results were expected first, according to people familiar with the situation.
One of the people, granted anonymity to speak freely, described that as double the original number of study participants envisioned. A spokesman for Moderna, Ray Jordan, confirmed that the company intends to expand its trial “to enroll a larger safety database which increases the likelihood of detecting rarer events” and expects to seek emergency authorization in “winter 2021/early 2022.” The Moderna trial began recruiting patients in March with the aim of enrolling 6,795 participants between the ages of six months and less than 12 years. Mr. Jordan said the company is “actively discussing” a proposal with the FDA.
Pfizer is on a faster timetable than Moderna, and may be able to meet the F.D.A.’s expectations on a bigger trial size and still file a request to expand emergency authorization of its vaccine by the end of September. Reviewing all the safety and efficacy data will likely take regulators at least a few weeks. Pfizer has previously said it expects to have results for the 5-to-11-year old group in September, with results for children aged two to five shortly after. Results for the youngest children between the ages of six months and two years old are expected in October or November. A spokeswoman said Monday that the company had no updates on its timetable.
Read more: https://www.nytimes.com/2021/07/26/us/politics/fda-covid-vaccine-trials-children.html
Those are who amount to tens of millions of the "unvaccinated" (where the 0 - 11 age would be about 50 million infants and children). That range being targeted is generally "school age".
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