Question: When can we expect vaccines for young children (e.g. those <5 years old)?

Answer: It looks like Pfizer could submit to the FDA data on safety/efficacy of its vaccine for 2-4 year olds as early as the end of this month and data for younger children (ages 6 months to <2 years) could be submitted in early 2022 (think: Jan/Feb/Mar).  After the data are submitted, the FDA will need time to review, meet, and make a determination, after which point, CDC’S ACIP will also need to convene to make a recommendation.  If the process follows a similar timeline as the process for 5-11 year olds, Pfizer could submit data to the FDA one week after initial results are announced.  It would take another ~4 weeks for FDA to review and meet and another ~1 week for CDC’s ACIP to meet and make its recommendation.  So– if initial results are announced on December 27th (and they are as positive as we hope and expect them to be), we could expect vaccines for children ages 2-4 to be available on/about February 7th.     

Pfizer is the furthest along in its vaccine trials for children, with two studies ongoing– one focused on vaccine safety and efficacy for children ages 6 months to <2 years and the other for children ages 2-4.  Just this Friday (12/3), the company’s CEO stated that Pfizer expects to have data from these clinical trials “by the end of the year, beginning of next year…”.  This is in keeping with earlier statements made by Pfizer’s CEO in the company’s November 2nd Third Quarter Earnings Call, “Looking ahead, we expect initial pivotal data from the studies in 2 to less than 5-year olds this quarter [ends December 2021], and in 6 month to less than two year olds next quarter, with full data readouts to follow.”  It’s also in keeping with Dr. Fauci’s recent statements.  As The Hill recently reported, “Hopefully within a reasonably short period of time, likely the beginning of next year in 2022, in the first quarter of 2022, it will be available to them,” Fauci told Insider in an interview, though he cautioned that he was speculating, adding, “you’ve got to do the clinical trial.” In October 2021, the USG purchased an additional 50 million pediatric doses of Pfizer to ensure availability of doses for children, including children <5, pending regulatory approval.  Note: Moderna is also conducting clinical trials for children, though it is not quite as far along in its timeline as Pfizer.