COVID-19 Vaccines for Preschoolers
Where’s the evidence?
On 2021–12–17, Pfizer announced that initial results from its clinical study evaluating two doses of its COVID-19 vaccine for children under five showed that high efficacy was demonstrated only in the six to 24 month population, but not among those two to five years of age.
As a result, the company expanded its clinical study to include a third dose given at least two months after the second dose. Based on the efficacy of this three-dose regime, Pfizer said that it expected to ask for Emergency Use Authorization (EUA)of its pediatric vaccine in the first half of 2022.
However, despite the ineffectiveness of two doses of the pediatric vaccine and the company’s desire to take more time to research a third dose, the FDA asked Pfizer to apply for the EUA now. On 2022–02–01, FDA Director, Dr. Janet Woodcock, tweeted that the agency asked Pfizer to submit data because of the Omicron surge. She announced a 2022–02–15 virtual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee to review the data for the EUA request. Comments can be made here.
Unexpectedly, on 2022–02–11, the FDA reversed its request, cancelled the 2022–02–15 virtual meeting of its advisory committee, and announced it would wait for data from Pfizer on the effectiveness of three doses…
