Read: We are turning COVID-19 into a young person’s diseaseĪs we get closer to that amorphous deadline, you can keep an eye out for signs of progress. When I asked the agency for its best estimate of when it might issue an emergency-use authorization for either the Pfizer or Moderna shots in young kids, a spokesperson referred me to comments that the director of the agency’s Center for Biologics Evaluation and Research made in early July indicating that he expected results from the clinical trials “later this year.” The FDA has been saying since May that it expects vaccines to be available for kids under 12 on a “fall or winter timeline.” But it hasn’t offered much in the way of updates.
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After this article was published, a Moderna spokesperson told me that the company’s full data set will likely be ready “later this year or towards the very beginning of 2022,” and that information on different age subgroups might be available at different (as yet unspecified) times.
A Pfizer spokesperson told me that the company plans to submit an EUA application for the 5-to-11-year-old group “by the end of September,” and for the six-month-to-5-year-old group “shortly thereafter.” Then the FDA will take the reins. Read: Why kids might be key to reaching herd immunityĮveryone involved has some control-but not full control-over how long it’s all going to take. (The latter step took only one day after the FDA authorized each of the Pfizer, Moderna, and Johnson & Johnson vaccines for adults.)
Once the FDA grants an emergency-use authorization, the CDC has to weigh in, offering recommendations to the nation’s doctors and public-health bodies about when and how the shots should be used. The companies have to recruit participants, perform clinical trials, collect data, and submit that information to the government, and the FDA has to tell the companies what sorts of data it’s looking for, how much, and over what timeline. The process is a bit of a push-and-pull between vaccine makers and the government. Vaccines for young kids are most likely to be authorized via the same emergency-use mechanism that allowed adults to get their shots starting last December. Even though the timeline is still uncertain, the government and vaccine makers have offered hints to help us understand how the process might unfold. To that end, as we hurtle toward the fall, parents, teachers, and pediatricians are eager to know when, exactly, the youngest Americans will have a shot at getting a shot.
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But it will help curb the spread of the virus for everyone, and give many families a better sense of how to plan for the future. Vaccine availability will not bring this pediatric outbreak to a halt. Millions have already started the school year, the rest will do so in the coming weeks, and COVID-19 vaccines aren’t yet available for the 50 million Americans who haven’t reached their 12th birthday. The timing of the latest COVID-19 surge isn’t great for children.
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